## Protocol Section
### Identification Module
**NCT ID:** NCT01250379

**Brief Title:** A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)

**Official Title:** A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment

#### Organization Study ID Info
**ID:** MO22998
#### Organization
**Class:** INDUSTRY
**Full Name:** Hoffmann-La Roche
#### Secondary ID Infos
**ID:** 2010-020998-16
### Status Module
#### Completion Date
**Date:** 2015-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-02-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-01-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-06-30

**Type:** ESTIMATED

**Results First Submit Date:** 2015-06-05

**Results First Submit QC Date:** 2015-06-05

#### Start Date
**Date:** 2011-02

**Status Verified Date:** 2016-01

#### Study First Post Date
**Date:** 2010-11-30
**Type:** ESTIMATED
**Study First Submit Date:** 2010-11-25
**Study First Submit QC Date:** 2010-11-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hoffmann-La Roche

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.

### Conditions Module

**Conditions:**

- Breast Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 494

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Chemotherapy

**Label:** 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: bevacizumab [Avastin]

- Drug: Chemotherapy

**Label:** 2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 2

**Description:** 10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks

**Name:** bevacizumab [Avastin]

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 1

- 2

**Description:** Standard chemotherapy (doublets not allowed)

**Name:** Chemotherapy

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)

**Time Frame:** Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years

**Description:** The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Second-Line PFS

**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years

**Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6

**Time Frame:** Month 6

**Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12

**Time Frame:** Month 12

**Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18

**Time Frame:** Month 18

**Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24

**Time Frame:** Month 24

#### Secondary Outcomes

**Description:** The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (\<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (\>) 1.5 ULN, \< 65 years of age, ≥ 65 years of age, \< 70 years of age, ≥ 70 years of age, \< 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free \> 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free \> 24 months, D-free ≤ 12 months, and D-free \> 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology.

**Measure:** Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)

**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years

**Description:** BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method.

**Measure:** Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)

**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years

**Description:** For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method.

**Measure:** Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)

**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years

**Description:** The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.

**Measure:** Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)

**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years

**Description:** Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.

**Measure:** Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)

**Time Frame:** Months 3, 6, and 9

**Description:** Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Percentage of Participants With Third-Line PFS According to RECIST v1.1

**Time Frame:** First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months)

**Description:** The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Third-Line PFS

**Time Frame:** First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months)

**Description:** Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1

**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years

**Description:** The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Second- and Third-Line PFS

**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years

**Description:** Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Percentage of Participants With Second- and Third-Line Tumor Progression

**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years

**Description:** The median time, in months, from randomization to second- and third-line tumor progression. Second- and third-line tumor progression was defined as third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.

**Measure:** Time to Second- and Third-Line Tumor Progression

**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years

**Description:** Percentage of participants who died due to any reason were reported.

**Measure:** Percentage of Participants Who Died

**Time Frame:** Baseline until death (up to approximately 4 years)

**Description:** OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive.

**Measure:** Overall Survival (OS)

**Time Frame:** Baseline until death (up to approximately 4 years)

**Description:** OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.

**Measure:** Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24

**Time Frame:** Months 6, 12, 18, and 24

**Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility (M) ("no problems"="I have no problems in walking about" to "extreme problems"="I am confined to bed"), self-care (SC) ("no problems"="I have no problems with self-care" to "extreme problems"="I am unable to wash or dress myself"), usual activities (UA) ("no problems"="I have no problems performing my usual activities" to "extreme problems"="I am unable to perform my usual activities"), pain/discomfort (P/D) ("no problems"="I have no pain or discomfort" to "extreme problems"="I have extreme pain or discomfort"), and anxiety/depression (A/D) ("no problems"="I am not anxious or depressed" to "extreme problems"='I am extremely anxious or depressed").

**Measure:** Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)

**Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)

**Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems).

**Measure:** Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)

**Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)

**Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.

**Measure:** Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)

**Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)

**Description:** The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state.

**Measure:** Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)

**Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)

**Description:** The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.

**Measure:** Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)

**Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)

**Description:** The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.

**Measure:** Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)

**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)

**Description:** The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.

**Measure:** Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)

**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Female patients, \>/= 18 years of age
* Histologically confirmed HER2-negative breast cancer
* Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer
* Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy
* ECOG performance status 0-2
* At least 28 days since prior radiation therapy or surgery and recovery from treatment

Exclusion Criteria:

* Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment
* Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years
* Inadequate renal function
* Clinically relevant cardio-vascular disease
* Known CNS disease except for treated brain metastases
* Chronic daily treatment with high-dose aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day)
* Pregnant or lactating women

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Buenos Aires

**Country:** Argentina

**Zip:** C1199ACI

**Location 2:**

**City:** Buenos Aires

**Country:** Argentina

**Zip:** C1280AEB

**Location 3:**

**City:** Buenos Aires

**Country:** Argentina

**Zip:** C1426ANZ

**Location 4:**

**City:** San Miguel de Tucuman

**Country:** Argentina

**Zip:** T4000IAK

**Location 5:**

**City:** Feldkirch

**Country:** Austria

**Zip:** 6807

**Location 6:**

**City:** Graz

**Country:** Austria

**Zip:** 8036

**Location 7:**

**City:** Innsbruck

**Country:** Austria

**Zip:** 6020

**Location 8:**

**City:** Krems

**Country:** Austria

**Zip:** 3500

**Location 9:**

**City:** Salzburg

**Country:** Austria

**Zip:** 5020

**Location 10:**

**City:** Steyr

**Country:** Austria

**Zip:** 4400

**Location 11:**

**City:** Villach

**Country:** Austria

**Zip:** 9500

**Location 12:**

**City:** Wien

**Country:** Austria

**Zip:** 1090

**Location 13:**

**City:** Goiania

**Country:** Brazil

**State:** GO

**Zip:** 74140-050

**Location 14:**

**City:** Porto Alegre

**Country:** Brazil

**State:** RS

**Zip:** 90430-090

**Location 15:**

**City:** Itajai

**Country:** Brazil

**State:** SC

**Zip:** 88301-220

**Location 16:**

**City:** Split

**Country:** Croatia

**Zip:** 21000

**Location 17:**

**City:** Amiens

**Country:** France

**Zip:** 80090

**Location 18:**

**City:** Angers

**Country:** France

**Zip:** 49933

**Location 19:**

**City:** Besancon

**Country:** France

**Zip:** 25030

**Location 20:**

**City:** Bordeaux

**Country:** France

**Zip:** 33000

**Location 21:**

**City:** Boulogne Sur Mer

**Country:** France

**Zip:** 62222

**Location 22:**

**City:** Brest

**Country:** France

**Zip:** 29609

**Location 23:**

**City:** Caen

**Country:** France

**Zip:** 14076

**Location 24:**

**City:** Clermont Ferrand

**Country:** France

**Zip:** 63011

**Location 25:**

**City:** Dijon

**Country:** France

**Zip:** 21079

**Location 26:**

**City:** Grenoble

**Country:** France

**Zip:** 38028

**Location 27:**

**City:** Limoges

**Country:** France

**Zip:** 87039

**Location 28:**

**City:** Marseille

**Country:** France

**Zip:** 13285

**Location 29:**

**City:** Montpellier

**Country:** France

**Zip:** 34298

**Location 30:**

**City:** Nancy

**Country:** France

**Zip:** 54100

**Location 31:**

**City:** Nantes

**Country:** France

**Zip:** 44202

**Location 32:**

**City:** Paris

**Country:** France

**Zip:** 75970

**Location 33:**

**City:** Pierre Benite

**Country:** France

**Zip:** 69495

**Location 34:**

**City:** Reims CEDEX

**Country:** France

**Zip:** 51056

**Location 35:**

**City:** Rouen

**Country:** France

**Zip:** 76038

**Location 36:**

**City:** Saint Gregoire

**Country:** France

**Zip:** 35768

**Location 37:**

**City:** Saint Jean

**Country:** France

**Zip:** 31240

**Location 38:**

**City:** St Cloud

**Country:** France

**Zip:** 92210

**Location 39:**

**City:** St Priest En Jarez

**Country:** France

**Zip:** 42271

**Location 40:**

**City:** St Quentin

**Country:** France

**Zip:** 02321

**Location 41:**

**City:** Strasbourg

**Country:** France

**Zip:** 67010

**Location 42:**

**City:** Toulouse

**Country:** France

**Zip:** 31076

**Location 43:**

**City:** Amberg

**Country:** Germany

**Zip:** 92224

**Location 44:**

**City:** Aschaffenburg

**Country:** Germany

**Zip:** 63739

**Location 45:**

**City:** Berlin

**Country:** Germany

**Zip:** 10367

**Location 46:**

**City:** Berlin

**Country:** Germany

**Zip:** 10719

**Location 47:**

**City:** Bielefeld

**Country:** Germany

**Zip:** 33604

**Location 48:**

**City:** Chemnitz

**Country:** Germany

**Zip:** 09116

**Location 49:**

**City:** Dresden

**Country:** Germany

**Zip:** 01307

**Location 50:**

**City:** Düsseldorf

**Country:** Germany

**Zip:** 40235

**Location 51:**

**City:** Essen

**Country:** Germany

**Zip:** 45122

**Location 52:**

**City:** Essen

**Country:** Germany

**Zip:** 45136

**Location 53:**

**City:** Freiburg

**Country:** Germany

**Zip:** 79110

**Location 54:**

**City:** Göttingen

**Country:** Germany

**Zip:** 37073

**Location 55:**

**City:** Hamburg

**Country:** Germany

**Zip:** 20249

**Location 56:**

**City:** Hannover

**Country:** Germany

**Zip:** 30177

**Location 57:**

**City:** Heidelberg

**Country:** Germany

**Zip:** 69115

**Location 58:**

**City:** Heidelberg

**Country:** Germany

**Zip:** 69120

**Location 59:**

**City:** Karlsruhe

**Country:** Germany

**Zip:** 76135

**Location 60:**

**City:** Koeln

**Country:** Germany

**Zip:** 50935

**Location 61:**

**City:** Mannheim

**Country:** Germany

**Zip:** 68161

**Location 62:**

**City:** Muenster

**Country:** Germany

**Zip:** 48149

**Location 63:**

**City:** München

**Country:** Germany

**Zip:** 80639

**Location 64:**

**City:** Naunhof

**Country:** Germany

**Zip:** 04683

**Location 65:**

**City:** Neuss

**Country:** Germany

**Zip:** 41462

**Location 66:**

**City:** Nordhausen

**Country:** Germany

**Zip:** 99734

**Location 67:**

**City:** Osnabrueck

**Country:** Germany

**Zip:** 49076

**Location 68:**

**City:** Ravensburg

**Country:** Germany

**Zip:** 88212

**Location 69:**

**City:** Stade

**Country:** Germany

**Zip:** 21680

**Location 70:**

**City:** Stralsund

**Country:** Germany

**Zip:** 18435

**Location 71:**

**City:** Wiesbaden

**Country:** Germany

**Zip:** 65199

**Location 72:**

**City:** Athens

**Country:** Greece

**Zip:** 11528

**Location 73:**

**City:** Ioannina

**Country:** Greece

**Zip:** 455 00

**Location 74:**

**City:** Patras

**Country:** Greece

**Zip:** 265 00

**Location 75:**

**City:** Thessaloniki

**Country:** Greece

**Zip:** 546 45

**Location 76:**

**City:** Budapest

**Country:** Hungary

**Zip:** 1122

**Location 77:**

**City:** Budapest

**Country:** Hungary

**Zip:** 1145

**Location 78:**

**City:** Szeged

**Country:** Hungary

**Zip:** 6720

**Location 79:**

**City:** Beer Sheva

**Country:** Israel

**Zip:** 8410101

**Location 80:**

**City:** Jerusalem

**Country:** Israel

**Zip:** 91120

**Location 81:**

**City:** Kfar-Saba

**Country:** Israel

**Zip:** 4428164

**Location 82:**

**City:** Petach Tikva

**Country:** Israel

**Zip:** 4941492

**Location 83:**

**City:** Ramat Gan

**Country:** Israel

**Zip:** 52620-00

**Location 84:**

**City:** Rehovot

**Country:** Israel

**Zip:** 7610001

**Location 85:**

**City:** Tel Aviv

**Country:** Israel

**Zip:** 6423906

**Location 86:**

**City:** Tel Aviv

**Country:** Israel

**Location 87:**

**City:** Cosenza

**Country:** Italy

**State:** Calabria

**Zip:** 87100

**Location 88:**

**City:** Benevento

**Country:** Italy

**State:** Campania

**Zip:** 82100

**Location 89:**

**City:** Napoli

**Country:** Italy

**State:** Campania

**Zip:** 80131

**Location 90:**

**City:** Reggio Emilia

**Country:** Italy

**State:** Emilia-Romagna

**Zip:** 42100

**Location 91:**

**City:** Udine

**Country:** Italy

**State:** Friuli-Venezia Giulia

**Zip:** 33100

**Location 92:**

**City:** Roma

**Country:** Italy

**State:** Lazio

**Zip:** 00168

**Location 93:**

**City:** Monza

**Country:** Italy

**State:** Lombardia

**Zip:** 20052

**Location 94:**

**City:** Macerata

**Country:** Italy

**State:** Marche

**Zip:** 62100

**Location 95:**

**City:** Cagliari

**Country:** Italy

**State:** Sardegna

**Zip:** 09121

**Location 96:**

**City:** Sassari

**Country:** Italy

**State:** Sardegna

**Zip:** 07100

**Location 97:**

**City:** Catania

**Country:** Italy

**State:** Sicilia

**Zip:** 95100

**Location 98:**

**City:** Firenze

**Country:** Italy

**State:** Toscana

**Zip:** 50134

**Location 99:**

**City:** Pisa

**Country:** Italy

**State:** Toscana

**Zip:** 56100

**Location 100:**

**City:** Pontedera

**Country:** Italy

**State:** Toscana

**Zip:** 56025

**Location 101:**

**City:** Verona

**Country:** Italy

**State:** Veneto

**Zip:** 37126

**Location 102:**

**City:** Bardejov

**Country:** Slovakia

**Zip:** 085 01

**Location 103:**

**City:** Bratislava

**Country:** Slovakia

**Zip:** 812 50

**Location 104:**

**City:** Kosice

**Country:** Slovakia

**Zip:** 04001

**Location 105:**

**City:** Nove Zamky

**Country:** Slovakia

**Zip:** 940 34

**Location 106:**

**City:** Presov

**Country:** Slovakia

**Zip:** 080 01

**Location 107:**

**City:** Santander

**Country:** Spain

**State:** Cantabria

**Zip:** 39008

**Location 108:**

**City:** San Sebastian

**Country:** Spain

**State:** Guipuzcoa

**Zip:** 20080

**Location 109:**

**City:** Palma De Mallorca

**Country:** Spain

**State:** Islas Baleares

**Zip:** 07014

**Location 110:**

**City:** La Laguna

**Country:** Spain

**State:** Tenerife

**Zip:** 38320

**Location 111:**

**City:** Barcelona

**Country:** Spain

**Zip:** 08035

**Location 112:**

**City:** Barcelona

**Country:** Spain

**Zip:** 08036

**Location 113:**

**City:** Barcelona

**Country:** Spain

**Zip:** 08041

**Location 114:**

**City:** Castellon

**Country:** Spain

**Zip:** 12002

**Location 115:**

**City:** Cordoba

**Country:** Spain

**Zip:** 14004

**Location 116:**

**City:** Leon

**Country:** Spain

**Zip:** 24071

**Location 117:**

**City:** Lerida

**Country:** Spain

**Zip:** 25198

**Location 118:**

**City:** Madrid

**Country:** Spain

**Zip:** 28007

**Location 119:**

**City:** Madrid

**Country:** Spain

**Zip:** 28033

**Location 120:**

**City:** Madrid

**Country:** Spain

**Zip:** 28034

**Location 121:**

**City:** Madrid

**Country:** Spain

**Zip:** 28040

**Location 122:**

**City:** Madrid

**Country:** Spain

**Zip:** 28041

**Location 123:**

**City:** Madrid

**Country:** Spain

**Zip:** 28046

**Location 124:**

**City:** Madrid

**Country:** Spain

**Zip:** 28223

**Location 125:**

**City:** Malaga

**Country:** Spain

**Zip:** 29010

**Location 126:**

**City:** Murcia

**Country:** Spain

**Zip:** 30008

**Location 127:**

**City:** Sevilla

**Country:** Spain

**Zip:** 41014

**Location 128:**

**City:** Valencia

**Country:** Spain

**Zip:** 46009

**Location 129:**

**City:** Zaragoza

**Country:** Spain

**Zip:** 50009

**Location 130:**

**City:** Aarau

**Country:** Switzerland

**Zip:** 5000

**Location 131:**

**City:** Chur

**Country:** Switzerland

**Zip:** 7000

**Location 132:**

**City:** Zürich

**Country:** Switzerland

**Zip:** 8038

#### Overall Officials

**Official 1:**

**Affiliation:** Hoffmann-La Roche

**Name:** Clinical Trials

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Vrdoljak E, Marschner N, Zielinski C, Gligorov J, Cortes J, Puglisi F, Aapro M, Fallowfield L, Fontana A, Inbar M, Kahan Z, Welt A, Levy C, Brain E, Pivot X, Putzu C, Gonzalez Martin A, de Ducla S, Easton V, von Minckwitz G. Final results of the TANIA randomised phase III trial of bevacizumab after progression on first-line bevacizumab therapy for HER2-negative locally recurrent/metastatic breast cancer. Ann Oncol. 2016 Nov;27(11):2046-2052. doi: 10.1093/annonc/mdw316. Epub 2016 Aug 8.

**PMID:** 27502725

**Citation:** von Minckwitz G, Puglisi F, Cortes J, Vrdoljak E, Marschner N, Zielinski C, Villanueva C, Romieu G, Lang I, Ciruelos E, De Laurentiis M, Veyret C, de Ducla S, Freudensprung U, Srock S, Gligorov J. Bevacizumab plus chemotherapy versus chemotherapy alone as second-line treatment for patients with HER2-negative locally recurrent or metastatic breast cancer after first-line treatment with bevacizumab plus chemotherapy (TANIA): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1269-78. doi: 10.1016/S1470-2045(14)70439-5. Epub 2014 Sep 28.

**PMID:** 25273342

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000020533

- Term: Angiogenesis Inhibitors

- ID: D000043924

- Term: Angiogenesis Modulating Agents

- ID: D000006133

- Term: Growth Substances

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000006131

- Term: Growth Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M246

- Name: Bevacizumab

- Relevance: HIGH

- As Found: Non-

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

- ID: M22318

- Name: Angiogenesis Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9231

- Name: Growth Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068258

- Term: Bevacizumab

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** All randomized participants who received at least 1 dose of bevacizumab and/or chemotherapy were included in the analysis.

#### Event Groups

**Group ID:** EG000

**Title:** CT Arm

**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.

**ID:** EG000

**Other Num Affected:** 181

**Other Num at Risk:** 238

**Serious Number Affected:** 55

**Serious Number At Risk:** 238

**Title:** CT Arm

**Group ID:** EG001

**Title:** CT+BV Arm

**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.

**ID:** EG001

**Other Num Affected:** 218

**Other Num at Risk:** 245

**Serious Number Affected:** 89

**Serious Number At Risk:** 245

**Title:** CT+BV Arm

**Frequency Threshold:** 5

#### Other Events

**Term:** Proteinuria

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Hypertension

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Palmar-plantar erythrodysaesthesia syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Leukopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Mucosal inflammation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Abdominal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Urinary tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

**Term:** Decreased appetite

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Peripheral sensory neuropathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

**Term:** Epistaxis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (17.1)

#### Serious Events

**Term:** Febrile neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 5

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 12

**Num At Risk:** 245

**Term:** Neutropenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 10

**Num At Risk:** 245

**Term:** Leukopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Thrombocytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 245

**Term:** Anaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Pancytopenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 245

**Term:** Bronchitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 245

**Term:** Pneumonia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Device related infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Device related sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Ear infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Enterocolitis infectious

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Erysipelas

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Herpes zoster

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Injection site infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Osteomyelitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Sepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Tooth infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Urinary tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Wound infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Pyrexia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 245

**Term:** Fatigue

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** General physical health deterioration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Chest discomfort

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Chest pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Device failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Mucosal inflammation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 245

**Term:** Pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Sudden death

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Diarrhoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 245

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Abdominal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Anal fissure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Diverticular perforation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Faecaloma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Melaena

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Pancreatitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Pulmonary embolism

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 245

**Term:** Pleural effusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Dyspnoea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 245

**Term:** Pneumothorax

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Ischaemic stoke

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Cerebrovascular accident

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Cerebrovascular disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Convulsion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Headache

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Motor dysfunction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Partial seizures

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Polyneuropathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Spinal cord compression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Cardiac failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Acute coronary syndrome

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Atrial fibrillation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Cardiac failure congestive

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Cardiotoxicity

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Left ventricular failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Sinus tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Bone pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Osteonecrosis of jaw

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Musculoskeletal pain

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Pathological fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Gamma-glutamyltransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Alanine aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Aspartate aminotransferase increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Blood bilirubin increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Blood potassium increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Hyponatraemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Hypercalcaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Hypocalcaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Embolism venous

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 245

**Term:** Haemorrhage

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Depression

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Confusional state

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Cholelithiasis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 245

**Term:** Cholecystitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Endometrial adenocarcinoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Metastases to liver

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Obstructive uropathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Postrenal failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Menstrual disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Metrorrhagia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Salpingo-oophorectomy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Tooth extraction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Foot fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Skin ulcer

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Anal abscess

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Peritonitis bacterial

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Pseudomembranous colitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Urosepsis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Femoral neck fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Head injury

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Subdural haematoma

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Biopsy liver

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Hypoglycaemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Facial paresis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Pneumonia aspiration

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Angina pectoris

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Atrial tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Congestive cardiomyopathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Left ventricular dysfunction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Mitral valve incompetence

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Ileus paralytic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Subileus

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Device dislocation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Device occlusion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Impaired healing

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Multi-organ failure

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Cholangitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Hepatitis toxic

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Supraventricular tachycardia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Gastrointestinal disorder

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Patient-device incompatibility

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Osteolysis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Ischaemic cardiomyopathy

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Ruptured cerebral aneurysm

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Large intestine anastomosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 238

**Group ID:** EG001

**Num At Risk:** 245

**Term:** Embolism arterial

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Term:** Infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (17.1)

##### Stats

**Group ID:** EG000

**Num At Risk:** 238

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 245

**Time Frame:** Baseline up to approximately 4 years.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 247

**Group ID:** BG001

**Value:** 247

**Group ID:** BG002

**Value:** 494

**Units:** Participants

### Group

**ID:** BG000

**Title:** CT Arm

**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.

### Group

**ID:** BG001

**Title:** CT+BV Arm

**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.83

**Value:** 54.7

#### Measurement

**Group ID:** BG001

**Spread:** 11.17

**Value:** 55.8

#### Measurement

**Group ID:** BG002

**Spread:** 11.01

**Value:** 55.2

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 247

#### Measurement

**Group ID:** BG001

**Value:** 247

#### Measurement

**Group ID:** BG002

**Value:** 494

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
**Population Description:** Intent-to-treat (ITT) population: all randomized participants.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** genentech@druginfo.com
**Organization:** Hoffman-LaRoche
**Phone:** 800-821-8590
**Title:** Medical Communications
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.65
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.97
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The 95% confidence interval (CI) was estimated using Cox proportional hazards methodology. The stratification factors used in the analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and lactate dehydrogenase (LDH) level.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0204
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.79
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.67
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.97
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Unstratified analysis.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0245
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.81
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 0.40
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.88
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: HR-neg
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0088
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.59
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.67
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.05
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: HR-pos/HER-neg
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1196
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.84
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.43
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.90
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: PFS \<6 months
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0110
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.62
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.65
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.03
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: PFS ≥6 months
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0816
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.82
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.31
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.98
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: taxane chemo
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0395
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.55
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.06
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: non-taxane chemo
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1385
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.84
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.22
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.75
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: vinorelbine chemo
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0029
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.41
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.62
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.96
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: LDH ≤ 1.5 ULN
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0171
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.77
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.46
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.16
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: LDH \> 1.5 ULN
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1797
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.73
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.62
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.97
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: \< 65 years of age
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0229
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.77
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.51
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.16
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: ≥ 65 years of age
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2139
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.77
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.59
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.89
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: \< 70 years of age
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0021
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.73
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.64
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.39
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: ≥ 70 years of age
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.5216
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 1.24
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.58
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.94
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: \< 3 metastatic organ sites
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0148
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.74
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.61
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.17
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: ≥ 3 metastatic organ sites
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3102
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.84
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.64
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.04
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: B-free ≤ 6 weeks
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0967
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.82
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.51
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.00
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: B-free \> 6 weeks
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0489
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.72
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.41
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.92
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: D-free ≤ 24 months
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0176
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.62
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.66
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.11
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: D-free \> 24 months
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.2318
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.85
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.26
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.03
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: D-free ≤ 12 months
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0568
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.52
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.66
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.05
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Subgroup analysis: D-free \> 12 months
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1143
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.83
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -4.2
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 12.4
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The 95% CI was estimated using Hauck-Anderson methodology.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3457
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Final Values)
**Parameter Value:** 4.1
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** False
### Outcome Measure 5
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 0.51
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.99
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.9825
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 1.01
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.73
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.34
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Unstratified analysis.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.3601
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 1.31
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** 0.59
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.06
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1080
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.79
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.59
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.02
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Unstratified analysis.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0625
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.78
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
### Outcome Measure 10
### Outcome Measure 11
#### Analysis
**CI Lower Limit:** 0.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.05
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.1349
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.85
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.03
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Unstratified analysis.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0863
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.84
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
### Outcome Measure 12
### Outcome Measure 13
#### Analysis
**CI Lower Limit:** 0.65
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.02
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0744
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.81
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.66
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.00
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Unstratified analysis.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.0503
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.81
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
#### Analysis
**CI Lower Limit:** 0.76
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.21
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** The 95% CI was estimated using Cox proportional hazards methodology. The stratification factors used in stratified analysis were hormone receptor status, first-line PFS, choice of chemotherapy, and LDH level.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.7253
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.96
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** 0.75
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.16
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Unstratified analysis.
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.5332
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.93
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** False
### Outcome Measure 17
### Outcome Measure 18
### Outcome Measure 19
### Outcome Measure 20
### Outcome Measure 21
### Outcome Measure 22
### Outcome Measure 23
### Outcome Measure 24
### Outcome Measure 25
### Outcome Measure 26
### Outcome Measure 27
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 88.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 93.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.9
- **Spread:** 
- **Upper Limit:** 5.3
- **Value:** 4.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.5
- **Spread:** 
- **Upper Limit:** 7.6
- **Value:** 6.3
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.0
- **Spread:** 
- **Upper Limit:** 3.9
- **Value:** 2.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.4
- **Spread:** 
- **Upper Limit:** 6.1
- **Value:** 4.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.2
- **Spread:** 
- **Upper Limit:** 6.2
- **Value:** 4.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 7.8
- **Value:** 6.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.3
- **Spread:** 
- **Upper Limit:** 4.3
- **Value:** 3.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.1
- **Spread:** 
- **Upper Limit:** 6.9
- **Value:** 5.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.9
- **Spread:** 
- **Upper Limit:** 6.1
- **Value:** 4.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.8
- **Spread:** 
- **Upper Limit:** 7.6
- **Value:** 6.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.7
- **Spread:** 
- **Upper Limit:** 5.3
- **Value:** 3.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.9
- **Spread:** 
- **Upper Limit:** 9.8
- **Value:** 6.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.9
- **Spread:** 
- **Upper Limit:** 5.8
- **Value:** 4.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.9
- **Spread:** 
- **Upper Limit:** 6.8
- **Value:** 6.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.8
- **Spread:** 
- **Upper Limit:** 4.3
- **Value:** 2.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.2
- **Spread:** 
- **Upper Limit:** 11.1
- **Value:** 6.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.9
- **Spread:** 
- **Upper Limit:** 6.0
- **Value:** 4.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.5
- **Spread:** 
- **Upper Limit:** 7.6
- **Value:** 6.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.7
- **Spread:** 
- **Upper Limit:** 3.9
- **Value:** 2.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.5
- **Spread:** 
- **Upper Limit:** 7.3
- **Value:** 5.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.9
- **Spread:** 
- **Upper Limit:** 4.7
- **Value:** 4.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.7
- **Spread:** 
- **Upper Limit:** 6.9
- **Value:** 6.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.2
- **Spread:** 
- **Upper Limit:** 7.8
- **Value:** 4.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.5
- **Spread:** 
- **Upper Limit:** 8.0
- **Value:** 6.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.7
- **Spread:** 
- **Upper Limit:** 4.6
- **Value:** 4.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.3
- **Spread:** 
- **Upper Limit:** 7.3
- **Value:** 6.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.2
- **Spread:** 
- **Upper Limit:** 11.9
- **Value:** 7.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.1
- **Spread:** 
- **Upper Limit:** 11.2
- **Value:** 6.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.9
- **Spread:** 
- **Upper Limit:** 6.1
- **Value:** 4.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 8.2
- **Value:** 6.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.1
- **Spread:** 
- **Upper Limit:** 4.9
- **Value:** 4.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.1
- **Spread:** 
- **Upper Limit:** 6.2
- **Value:** 4.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.6
- **Spread:** 
- **Upper Limit:** 4.6
- **Value:** 4.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.4
- **Spread:** 
- **Upper Limit:** 6.6
- **Value:** 5.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.3
- **Spread:** 
- **Upper Limit:** 6.3
- **Value:** 4.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.0
- **Spread:** 
- **Upper Limit:** 9.5
- **Value:** 7.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.0
- **Spread:** 
- **Upper Limit:** 3.9
- **Value:** 2.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.2
- **Spread:** 
- **Upper Limit:** 6.3
- **Value:** 5.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.0
- **Spread:** 
- **Upper Limit:** 6.1
- **Value:** 4.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.5
- **Spread:** 
- **Upper Limit:** 8.1
- **Value:** 6.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.3
- **Spread:** 
- **Upper Limit:** 5.8
- **Value:** 2.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.9
- **Spread:** 
- **Upper Limit:** 9.7
- **Value:** 5.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.9
- **Spread:** 
- **Upper Limit:** 5.7
- **Value:** 4.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.3
- **Spread:** 
- **Upper Limit:** 7.6
- **Value:** 6.3
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 11.7
- **Spread:** 
- **Upper Limit:** 22.9
- **Value:** 16.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15.2
- **Spread:** 
- **Upper Limit:** 27.5
- **Value:** 20.9
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.1
- **Spread:** 
- **Upper Limit:** 3.9
- **Value:** 1.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.0
- **Spread:** 
- **Upper Limit:** 3.0
- **Value:** 0.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 10.8
- **Spread:** 
- **Upper Limit:** 21.7
- **Value:** 15.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.7
- **Spread:** 
- **Upper Limit:** 26.9
- **Value:** 20.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 26.8
- **Spread:** 
- **Upper Limit:** 40.8
- **Value:** 33.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 41.4
- **Spread:** 
- **Upper Limit:** 56.4
- **Value:** 48.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 33.9
- **Spread:** 
- **Upper Limit:** 48.5
- **Value:** 41.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18.1
- **Spread:** 
- **Upper Limit:** 31.1
- **Value:** 24.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 5.0
- **Spread:** 
- **Upper Limit:** 13.7
- **Value:** 8.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.1
- **Spread:** 
- **Upper Limit:** 10.6
- **Value:** 6.0
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.4
- **Spread:** 
- **Upper Limit:** 16.7
- **Value:** 10.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.1
- **Spread:** 
- **Upper Limit:** 10.3
- **Value:** 8.3
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 78.6
- **Spread:** 
- **Upper Limit:** 99.5
- **Value:** 96.7
- **Comment:** 95% CI data was not applicable (NA) because all participants were estimated to be alive and free of disease progression at this time point.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 100.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 48.9
- **Spread:** 
- **Upper Limit:** 82.5
- **Value:** 69.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 55.3
- **Spread:** 
- **Upper Limit:** 84.4
- **Value:** 72.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 40.4
- **Spread:** 
- **Upper Limit:** 76.3
- **Value:** 60.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 24.6
- **Spread:** 
- **Upper Limit:** 56.3
- **Value:** 40.8
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.1
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.2
- **Spread:** 
- **Upper Limit:** 3.9
- **Value:** 2.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.4
- **Spread:** 
- **Upper Limit:** 5.1
- **Value:** 3.8
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 83.4
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.2
- **Spread:** 
- **Upper Limit:** 12.5
- **Value:** 10.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 10.7
- **Spread:** 
- **Upper Limit:** 14.5
- **Value:** 12.8
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75.3
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.4
- **Spread:** 
- **Upper Limit:** 12.7
- **Value:** 11.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12.0
- **Spread:** 
- **Upper Limit:** 15.5
- **Value:** 13.3
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 34.3
- **Spread:** 
- **Upper Limit:** 47.0
- **Value:** 40.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 47.7
- **Spread:** 
- **Upper Limit:** 60.3
- **Value:** 54.2
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66.0
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.4
- **Spread:** 
- **Upper Limit:** 21.2
- **Value:** 18.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 17.6
- **Spread:** 
- **Upper Limit:** 21.0
- **Value:** 19.7
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 79.9
- **Spread:** 
- **Upper Limit:** 89.2
- **Value:** 85.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 85.9
- **Spread:** 
- **Upper Limit:** 93.5
- **Value:** 90.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 62.0
- **Spread:** 
- **Upper Limit:** 74.3
- **Value:** 68.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 66.2
- **Spread:** 
- **Upper Limit:** 77.7
- **Value:** 72.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 46.0
- **Spread:** 
- **Upper Limit:** 59.3
- **Value:** 52.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 48.2
- **Spread:** 
- **Upper Limit:** 61.0
- **Value:** 54.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 31.8
- **Spread:** 
- **Upper Limit:** 44.9
- **Value:** 38.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 31.3
- **Spread:** 
- **Upper Limit:** 43.9
- **Value:** 37.6
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 60.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 64.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 36.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 85.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 46.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 27.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 68.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 33.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 58.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 43.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 23.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 68.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 49.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 46.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 66.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 49.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 81.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 78.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 36.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 42.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 76.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 49.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 43.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 47.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 34.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 48.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.9
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 76.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 39.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 59.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 19.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69.7
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 36.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 26.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 61.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11.8
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.6489
- **Spread:** 
- **Upper Limit:** 0.7122
- **Value:** 0.6806
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.6389
- **Spread:** 
- **Upper Limit:** 0.7061
- **Value:** 0.6725
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.6470
- **Spread:** 
- **Upper Limit:** 0.7437
- **Value:** 0.6953
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.6057
- **Spread:** 
- **Upper Limit:** 0.6973
- **Value:** 0.6515
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.7114
- **Spread:** 
- **Upper Limit:** 0.7879
- **Value:** 0.7496
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.6058
- **Spread:** 
- **Upper Limit:** 0.7010
- **Value:** 0.6534
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.5642
- **Spread:** 
- **Upper Limit:** 0.6938
- **Value:** 0.6290
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.4736
- **Spread:** 
- **Upper Limit:** 0.6370
- **Value:** 0.5553
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.0482
- **Spread:** 
- **Upper Limit:** 0.0276
- **Value:** -0.0103
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.0868
- **Spread:** 
- **Upper Limit:** 0.0127
- **Value:** -0.0370
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.0025
- **Spread:** 
- **Upper Limit:** 0.0800
- **Value:** 0.0387
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.1038
- **Spread:** 
- **Upper Limit:** 0.0021
- **Value:** -0.0508
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.1398
- **Spread:** 
- **Upper Limit:** -0.0371
- **Value:** -0.0884
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.1649
- **Spread:** 
- **Upper Limit:** -0.0107
- **Value:** -0.0878
**Title:** 
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 64.1
- **Spread:** 
- **Upper Limit:** 69.0
- **Value:** 66.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 60.8
- **Spread:** 
- **Upper Limit:** 65.9
- **Value:** 63.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 66.4
- **Spread:** 
- **Upper Limit:** 72.1
- **Value:** 69.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 63.7
- **Spread:** 
- **Upper Limit:** 69.2
- **Value:** 66.5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 63.3
- **Spread:** 
- **Upper Limit:** 71.3
- **Value:** 67.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 63.2
- **Spread:** 
- **Upper Limit:** 69.5
- **Value:** 66.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 59.5
- **Spread:** 
- **Upper Limit:** 68.0
- **Value:** 63.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 57.0
- **Spread:** 
- **Upper Limit:** 66.5
- **Value:** 61.7
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4.8
- **Spread:** 
- **Upper Limit:** 0.9
- **Value:** -2.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.4
- **Spread:** 
- **Upper Limit:** 5.3
- **Value:** 2.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4.7
- **Spread:** 
- **Upper Limit:** 4.3
- **Value:** -0.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.6
- **Spread:** 
- **Upper Limit:** 5.5
- **Value:** 2.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -9.1
- **Spread:** 
- **Upper Limit:** -1.0
- **Value:** -5.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -5.5
- **Spread:** 
- **Upper Limit:** 3.0
- **Value:** -1.3
**Title:** 
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 19.900
- **Spread:** 
- **Upper Limit:** 21.342
- **Value:** 20.621
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 19.500
- **Spread:** 
- **Upper Limit:** 21.006
- **Value:** 20.253
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20.028
- **Spread:** 
- **Upper Limit:** 21.416
- **Value:** 20.722
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 19.923
- **Spread:** 
- **Upper Limit:** 21.425
- **Value:** 20.674
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 14.176
- **Spread:** 
- **Upper Limit:** 15.519
- **Value:** 14.847
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.419
- **Spread:** 
- **Upper Limit:** 15.704
- **Value:** 15.062
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.289
- **Spread:** 
- **Upper Limit:** 16.894
- **Value:** 16.091
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.951
- **Spread:** 
- **Upper Limit:** 16.502
- **Value:** 15.726
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 24.103
- **Spread:** 
- **Upper Limit:** 25.869
- **Value:** 24.986
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 23.578
- **Spread:** 
- **Upper Limit:** 25.198
- **Value:** 24.388
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 59.658
- **Spread:** 
- **Upper Limit:** 63.696
- **Value:** 61.677
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 58.365
- **Spread:** 
- **Upper Limit:** 62.189
- **Value:** 60.277
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 69.919
- **Spread:** 
- **Upper Limit:** 74.419
- **Value:** 72.169
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 69.786
- **Spread:** 
- **Upper Limit:** 73.942
- **Value:** 71.864
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 94.063
- **Spread:** 
- **Upper Limit:** 99.753
- **Value:** 96.908
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 93.485
- **Spread:** 
- **Upper Limit:** 98.746
- **Value:** 96.115
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 19.413
- **Spread:** 
- **Upper Limit:** 21.413
- **Value:** 20.413
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18.158
- **Spread:** 
- **Upper Limit:** 20.153
- **Value:** 19.156
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 19.888
- **Spread:** 
- **Upper Limit:** 21.779
- **Value:** 20.833
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 20.245
- **Spread:** 
- **Upper Limit:** 21.987
- **Value:** 21.116
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.070
- **Spread:** 
- **Upper Limit:** 16.815
- **Value:** 15.943
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15.900
- **Spread:** 
- **Upper Limit:** 17.441
- **Value:** 16.671
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.609
- **Spread:** 
- **Upper Limit:** 17.715
- **Value:** 16.662
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15.180
- **Spread:** 
- **Upper Limit:** 17.158
- **Value:** 16.169
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 25.188
- **Spread:** 
- **Upper Limit:** 27.364
- **Value:** 26.276
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 24.928
- **Spread:** 
- **Upper Limit:** 26.839
- **Value:** 25.884
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 60.975
- **Spread:** 
- **Upper Limit:** 66.118
- **Value:** 63.547
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 58.811
- **Spread:** 
- **Upper Limit:** 63.747
- **Value:** 61.279
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 71.212
- **Spread:** 
- **Upper Limit:** 77.299
- **Value:** 74.255
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 70.603
- **Spread:** 
- **Upper Limit:** 76.184
- **Value:** 73.393
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 96.582
- **Spread:** 
- **Upper Limit:** 104.169
- **Value:** 100.375
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 95.667
- **Spread:** 
- **Upper Limit:** 102.760
- **Value:** 99.213
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20.721
- **Spread:** 
- **Upper Limit:** 22.744
- **Value:** 21.733
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18.571
- **Spread:** 
- **Upper Limit:** 20.688
- **Value:** 19.629
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 19.855
- **Spread:** 
- **Upper Limit:** 22.006
- **Value:** 20.930
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 19.829
- **Spread:** 
- **Upper Limit:** 21.857
- **Value:** 20.843
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.260
- **Spread:** 
- **Upper Limit:** 18.400
- **Value:** 17.330
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15.961
- **Spread:** 
- **Upper Limit:** 17.650
- **Value:** 16.806
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.818
- **Spread:** 
- **Upper Limit:** 18.291
- **Value:** 17.055
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.787
- **Spread:** 
- **Upper Limit:** 17.053
- **Value:** 15.920
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 25.493
- **Spread:** 
- **Upper Limit:** 28.354
- **Value:** 26.923
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 24.630
- **Spread:** 
- **Upper Limit:** 26.880
- **Value:** 25.755
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 62.539
- **Spread:** 
- **Upper Limit:** 68.717
- **Value:** 65.628
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 58.309
- **Spread:** 
- **Upper Limit:** 63.905
- **Value:** 61.107
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 73.269
- **Spread:** 
- **Upper Limit:** 80.318
- **Value:** 76.794
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 70.116
- **Spread:** 
- **Upper Limit:** 76.421
- **Value:** 73.269
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 98.819
- **Spread:** 
- **Upper Limit:** 108.187
- **Value:** 103.503
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 94.865
- **Spread:** 
- **Upper Limit:** 102.948
- **Value:** 98.906
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20.599
- **Spread:** 
- **Upper Limit:** 23.282
- **Value:** 21.940
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 17.515
- **Spread:** 
- **Upper Limit:** 20.416
- **Value:** 18.965
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 19.468
- **Spread:** 
- **Upper Limit:** 22.211
- **Value:** 20.840
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 20.192
- **Spread:** 
- **Upper Limit:** 22.606
- **Value:** 21.399
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.719
- **Spread:** 
- **Upper Limit:** 18.477
- **Value:** 17.098
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15.411
- **Spread:** 
- **Upper Limit:** 17.436
- **Value:** 16.438
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.754
- **Spread:** 
- **Upper Limit:** 19.734
- **Value:** 18.244
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.861
- **Spread:** 
- **Upper Limit:** 17.241
- **Value:** 16.051
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 24.146
- **Spread:** 
- **Upper Limit:** 27.988
- **Value:** 26.067
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 23.231
- **Spread:** 
- **Upper Limit:** 26.033
- **Value:** 24.632
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 61.991
- **Spread:** 
- **Upper Limit:** 69.653
- **Value:** 65.882
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 56.548
- **Spread:** 
- **Upper Limit:** 63.480
- **Value:** 60.014
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 74.166
- **Spread:** 
- **Upper Limit:** 82.443
- **Value:** 78.305
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 69.365
- **Spread:** 
- **Upper Limit:** 76.801
- **Value:** 73.083
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 98.433
- **Spread:** 
- **Upper Limit:** 109.588
- **Value:** 104.011
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 92.995
- **Spread:** 
- **Upper Limit:** 102.595
- **Value:** 97.795
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 21.427
- **Spread:** 
- **Upper Limit:** 24.471
- **Value:** 22.949
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18.121
- **Spread:** 
- **Upper Limit:** 21.250
- **Value:** 19.686
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20.433
- **Spread:** 
- **Upper Limit:** 23.847
- **Value:** 22.140
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 19.645
- **Spread:** 
- **Upper Limit:** 22.798
- **Value:** 21.222
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.690
- **Spread:** 
- **Upper Limit:** 20.079
- **Value:** 18.385
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15.481
- **Spread:** 
- **Upper Limit:** 18.028
- **Value:** 16.755
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 17.875
- **Spread:** 
- **Upper Limit:** 21.356
- **Value:** 19.615
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15.585
- **Spread:** 
- **Upper Limit:** 18.805
- **Value:** 17.195
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 27.722
- **Spread:** 
- **Upper Limit:** 31.415
- **Value:** 29.568
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 24.457
- **Spread:** 
- **Upper Limit:** 27.869
- **Value:** 26.163
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 68.549
- **Spread:** 
- **Upper Limit:** 75.716
- **Value:** 72.132
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 59.199
- **Spread:** 
- **Upper Limit:** 66.836
- **Value:** 63.017
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 78.178
- **Spread:** 
- **Upper Limit:** 87.995
- **Value:** 83.087
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 70.566
- **Spread:** 
- **Upper Limit:** 79.191
- **Value:** 74.879
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 107.315
- **Spread:** 
- **Upper Limit:** 118.494
- **Value:** 112.904
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 95.302
- **Spread:** 
- **Upper Limit:** 106.506
- **Value:** 100.904
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 20.583
- **Spread:** 
- **Upper Limit:** 23.847
- **Value:** 22.215
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18.820
- **Spread:** 
- **Upper Limit:** 22.440
- **Value:** 20.630
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 17.955
- **Spread:** 
- **Upper Limit:** 21.361
- **Value:** 19.658
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 19.146
- **Spread:** 
- **Upper Limit:** 22.685
- **Value:** 20.915
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.708
- **Spread:** 
- **Upper Limit:** 19.412
- **Value:** 17.560
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 13.875
- **Spread:** 
- **Upper Limit:** 18.259
- **Value:** 16.067
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.120
- **Spread:** 
- **Upper Limit:** 20.780
- **Value:** 18.450
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 13.901
- **Spread:** 
- **Upper Limit:** 19.136
- **Value:** 16.519
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 27.156
- **Spread:** 
- **Upper Limit:** 31.616
- **Value:** 29.386
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 21.013
- **Spread:** 
- **Upper Limit:** 26.625
- **Value:** 23.819
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 63.981
- **Spread:** 
- **Upper Limit:** 73.518
- **Value:** 68.750
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 55.065
- **Spread:** 
- **Upper Limit:** 66.870
- **Value:** 60.967
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 71.480
- **Spread:** 
- **Upper Limit:** 82.430
- **Value:** 76.955
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 68.901
- **Spread:** 
- **Upper Limit:** 81.568
- **Value:** 75.235
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 98.512
- **Spread:** 
- **Upper Limit:** 112.568
- **Value:** 105.540
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 90.613
- **Spread:** 
- **Upper Limit:** 107.531
- **Value:** 99.072
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 21.283
- **Spread:** 
- **Upper Limit:** 25.333
- **Value:** 23.308
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18.124
- **Spread:** 
- **Upper Limit:** 21.943
- **Value:** 20.033
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 18.953
- **Spread:** 
- **Upper Limit:** 22.527
- **Value:** 20.740
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 18.310
- **Spread:** 
- **Upper Limit:** 22.590
- **Value:** 20.450
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 17.522
- **Spread:** 
- **Upper Limit:** 21.093
- **Value:** 19.308
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15.494
- **Spread:** 
- **Upper Limit:** 19.045
- **Value:** 17.270
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.586
- **Spread:** 
- **Upper Limit:** 20.491
- **Value:** 18.538
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 13.949
- **Spread:** 
- **Upper Limit:** 18.587
- **Value:** 16.268
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 26.879
- **Spread:** 
- **Upper Limit:** 30.945
- **Value:** 28.912
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 22.842
- **Spread:** 
- **Upper Limit:** 29.632
- **Value:** 26.237
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 66.403
- **Spread:** 
- **Upper Limit:** 75.114
- **Value:** 70.758
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 55.941
- **Spread:** 
- **Upper Limit:** 69.418
- **Value:** 62.679
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 76.424
- **Spread:** 
- **Upper Limit:** 87.363
- **Value:** 81.894
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 67.865
- **Spread:** 
- **Upper Limit:** 80.458
- **Value:** 74.162
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 104.704
- **Spread:** 
- **Upper Limit:** 116.908
- **Value:** 110.806
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 91.294
- **Spread:** 
- **Upper Limit:** 109.503
- **Value:** 100.399
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 18.958
- **Spread:** 
- **Upper Limit:** 24.626
- **Value:** 21.792
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 17.412
- **Spread:** 
- **Upper Limit:** 23.184
- **Value:** 20.298
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.598
- **Spread:** 
- **Upper Limit:** 23.569
- **Value:** 19.583
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 17.629
- **Spread:** 
- **Upper Limit:** 24.004
- **Value:** 20.817
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 13.389
- **Spread:** 
- **Upper Limit:** 20.897
- **Value:** 17.143
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12.606
- **Spread:** 
- **Upper Limit:** 18.823
- **Value:** 15.714
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 13.876
- **Spread:** 
- **Upper Limit:** 20.410
- **Value:** 17.143
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12.633
- **Spread:** 
- **Upper Limit:** 20.319
- **Value:** 16.476
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 23.931
- **Spread:** 
- **Upper Limit:** 32.548
- **Value:** 28.240
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 21.407
- **Spread:** 
- **Upper Limit:** 29.512
- **Value:** 25.459
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 55.888
- **Spread:** 
- **Upper Limit:** 76.469
- **Value:** 66.179
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 53.524
- **Spread:** 
- **Upper Limit:** 70.942
- **Value:** 62.233
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 58.381
- **Spread:** 
- **Upper Limit:** 88.952
- **Value:** 73.667
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 62.863
- **Spread:** 
- **Upper Limit:** 83.746
- **Value:** 73.305
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 81.841
- **Spread:** 
- **Upper Limit:** 120.242
- **Value:** 101.042
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 85.368
- **Spread:** 
- **Upper Limit:** 112.160
- **Value:** 98.764
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 17.376
- **Spread:** 
- **Upper Limit:** 26.338
- **Value:** 21.857
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 19.569
- **Spread:** 
- **Upper Limit:** 24.209
- **Value:** 21.889
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.352
- **Spread:** 
- **Upper Limit:** 21.600
- **Value:** 18.976
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 19.417
- **Spread:** 
- **Upper Limit:** 25.953
- **Value:** 22.685
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 13.758
- **Spread:** 
- **Upper Limit:** 22.527
- **Value:** 18.143
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.274
- **Spread:** 
- **Upper Limit:** 21.503
- **Value:** 17.889
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 14.658
- **Spread:** 
- **Upper Limit:** 22.199
- **Value:** 18.429
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12.890
- **Spread:** 
- **Upper Limit:** 19.184
- **Value:** 16.037
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 22.941
- **Spread:** 
- **Upper Limit:** 31.988
- **Value:** 27.464
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 22.584
- **Spread:** 
- **Upper Limit:** 31.194
- **Value:** 26.889
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 56.306
- **Spread:** 
- **Upper Limit:** 79.194
- **Value:** 67.750
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 56.516
- **Spread:** 
- **Upper Limit:** 73.114
- **Value:** 64.815
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 63.847
- **Spread:** 
- **Upper Limit:** 90.963
- **Value:** 77.405
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 68.852
- **Spread:** 
- **Upper Limit:** 88.148
- **Value:** 78.500
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 87.586
- **Spread:** 
- **Upper Limit:** 122.152
- **Value:** 104.869
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 92.415
- **Spread:** 
- **Upper Limit:** 118.363
- **Value:** 105.389
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 18.906
- **Spread:** 
- **Upper Limit:** 27.260
- **Value:** 23.083
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 16.407
- **Spread:** 
- **Upper Limit:** 25.593
- **Value:** 21.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.238
- **Spread:** 
- **Upper Limit:** 23.095
- **Value:** 19.667
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.019
- **Spread:** 
- **Upper Limit:** 26.067
- **Value:** 20.043
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 13.476
- **Spread:** 
- **Upper Limit:** 21.524
- **Value:** 17.500
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.130
- **Spread:** 
- **Upper Limit:** 22.098
- **Value:** 18.114
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 14.316
- **Spread:** 
- **Upper Limit:** 20.351
- **Value:** 17.333
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 11.339
- **Spread:** 
- **Upper Limit:** 21.518
- **Value:** 16.429
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 24.421
- **Spread:** 
- **Upper Limit:** 32.774
- **Value:** 28.597
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 20.250
- **Spread:** 
- **Upper Limit:** 30.417
- **Value:** 25.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 59.566
- **Spread:** 
- **Upper Limit:** 78.462
- **Value:** 69.014
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 47.031
- **Spread:** 
- **Upper Limit:** 74.635
- **Value:** 60.833
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 62.045
- **Spread:** 
- **Upper Limit:** 90.889
- **Value:** 76.467
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 57.141
- **Spread:** 
- **Upper Limit:** 94.030
- **Value:** 75.586
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 88.146
- **Spread:** 
- **Upper Limit:** 124.087
- **Value:** 106.117
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 73.196
- **Spread:** 
- **Upper Limit:** 121.226
- **Value:** 97.211
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -32.634
- **Spread:** 
- **Upper Limit:** 71.134
- **Value:** 19.250
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.487
- **Spread:** 
- **Upper Limit:** 33.513
- **Value:** 18.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.257
- **Spread:** 
- **Upper Limit:** 29.493
- **Value:** 18.375
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.434
- **Spread:** 
- **Upper Limit:** 36.455
- **Value:** 19.944
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -49.531
- **Spread:** 
- **Upper Limit:** 77.531
- **Value:** 14.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.285
- **Spread:** 
- **Upper Limit:** 34.752
- **Value:** 15.733
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -35.825
- **Spread:** 
- **Upper Limit:** 65.825
- **Value:** 15.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.348
- **Spread:** 
- **Upper Limit:** 26.015
- **Value:** 12.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.490
- **Spread:** 
- **Upper Limit:** 42.844
- **Value:** 21.667
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.172
- **Spread:** 
- **Upper Limit:** 35.828
- **Value:** 25.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -67.969
- **Spread:** 
- **Upper Limit:** 179.802
- **Value:** 55.917
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 20.085
- **Spread:** 
- **Upper Limit:** 90.581
- **Value:** 55.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -110.732
- **Spread:** 
- **Upper Limit:** 243.982
- **Value:** 66.625
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.191
- **Spread:** 
- **Upper Limit:** 129.831
- **Value:** 66.011
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -110.243
- **Spread:** 
- **Upper Limit:** 286.826
- **Value:** 88.292
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 20.313
- **Spread:** 
- **Upper Limit:** 161.709
- **Value:** 91.011
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** Standard deviation (SD) not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 22.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 23.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 20.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 21.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 35.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 78.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 86.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 121.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 26.000
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 22.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.782
- **Spread:** 
- **Upper Limit:** 52.549
- **Value:** 24.383
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 21.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.294
- **Spread:** 
- **Upper Limit:** 34.706
- **Value:** 22.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -7.412
- **Spread:** 
- **Upper Limit:** 43.412
- **Value:** 18.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.318
- **Spread:** 
- **Upper Limit:** 34.848
- **Value:** 21.083
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -46.678
- **Spread:** 
- **Upper Limit:** 67.678
- **Value:** 10.500
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.788
- **Spread:** 
- **Upper Limit:** 63.566
- **Value:** 30.389
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -7.266
- **Spread:** 
- **Upper Limit:** 56.266
- **Value:** 24.500
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 58.060
- **Spread:** 
- **Upper Limit:** 96.884
- **Value:** 77.472
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 59.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 38.830
- **Spread:** 
- **Upper Limit:** 148.103
- **Value:** 93.467
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 74.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 102.396
- **Spread:** 
- **Upper Limit:** 145.315
- **Value:** 123.856
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 96.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 27.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 17.539
- **Spread:** 
- **Upper Limit:** 25.128
- **Value:** 21.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 26.600
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.147
- **Spread:** 
- **Upper Limit:** 26.853
- **Value:** 20.5000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 22.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.616
- **Spread:** 
- **Upper Limit:** 29.384
- **Value:** 18.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 22.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.908
- **Spread:** 
- **Upper Limit:** 23.908
- **Value:** 11.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 27.143
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 19.395
- **Spread:** 
- **Upper Limit:** 36.605
- **Value:** 28.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 76.143
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 45.778
- **Spread:** 
- **Upper Limit:** 74.889
- **Value:** 60.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 97.600
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -50.209
- **Spread:** 
- **Upper Limit:** 191.209
- **Value:** 70.500
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 124.743
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -20.209
- **Spread:** 
- **Upper Limit:** 221.209
- **Value:** 100.500
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 14.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 15.400
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 15.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 11.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 20.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 45.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 55.400
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 75.400
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 17.873
- **Spread:** 
- **Upper Limit:** 20.299
- **Value:** 19.086
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 15.977
- **Spread:** 
- **Upper Limit:** 18.846
- **Value:** 17.412
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 19.456
- **Spread:** 
- **Upper Limit:** 21.790
- **Value:** 20.623
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 20.335
- **Spread:** 
- **Upper Limit:** 22.639
- **Value:** 21.487
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 14.102
- **Spread:** 
- **Upper Limit:** 16.121
- **Value:** 15.111
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 12.872
- **Spread:** 
- **Upper Limit:** 15.478
- **Value:** 14.175
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 14.122
- **Spread:** 
- **Upper Limit:** 16.772
- **Value:** 15.447
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 13.877
- **Spread:** 
- **Upper Limit:** 16.593
- **Value:** 15.235
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 23.602
- **Spread:** 
- **Upper Limit:** 26.354
- **Value:** 24.978
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 22.989
- **Spread:** 
- **Upper Limit:** 25.901
- **Value:** 24.445
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 56.033
- **Spread:** 
- **Upper Limit:** 62.428
- **Value:** 59.230
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 53.234
- **Spread:** 
- **Upper Limit:** 60.770
- **Value:** 57.002
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 66.264
- **Spread:** 
- **Upper Limit:** 73.393
- **Value:** 69.829
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 64.384
- **Spread:** 
- **Upper Limit:** 72.586
- **Value:** 68.485
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 90.240
- **Spread:** 
- **Upper Limit:** 99.619
- **Value:** 94.930
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 87.645
- **Spread:** 
- **Upper Limit:** 98.320
- **Value:** 92.983
**Title:** 
#### Outcome Measure 24
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.219
- **Spread:** 
- **Upper Limit:** -0.344
- **Value:** -1.281
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.239
- **Spread:** 
- **Upper Limit:** -0.338
- **Value:** -1.289
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.283
- **Spread:** 
- **Upper Limit:** 0.994
- **Value:** 0.356
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.226
- **Spread:** 
- **Upper Limit:** 1.640
- **Value:** 0.707
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.274
- **Spread:** 
- **Upper Limit:** 1.089
- **Value:** 0.408
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.314
- **Spread:** 
- **Upper Limit:** 1.734
- **Value:** 1.024
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.043
- **Spread:** 
- **Upper Limit:** 0.591
- **Value:** -0.226
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.027
- **Spread:** 
- **Upper Limit:** 0.548
- **Value:** -0.240
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.659
- **Spread:** 
- **Upper Limit:** 1.116
- **Value:** 0.228
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.121
- **Spread:** 
- **Upper Limit:** 1.780
- **Value:** 0.950
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.295
- **Spread:** 
- **Upper Limit:** 0.573
- **Value:** -1.361
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.407
- **Spread:** 
- **Upper Limit:** 1.693
- **Value:** -0.357
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.920
- **Spread:** 
- **Upper Limit:** 1.399
- **Value:** -0.760
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.945
- **Spread:** 
- **Upper Limit:** 2.684
- **Value:** 0.369
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.332
- **Spread:** 
- **Upper Limit:** 1.876
- **Value:** -0.728
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.544
- **Spread:** 
- **Upper Limit:** 4.229
- **Value:** 1.342
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0,733
- **Spread:** 
- **Upper Limit:** 1.322
- **Value:** 0.294
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.871
- **Spread:** 
- **Upper Limit:** -0.775
- **Value:** -1.823
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.411
- **Spread:** 
- **Upper Limit:** 0.525
- **Value:** -0.443
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.678
- **Spread:** 
- **Upper Limit:** 1.397
- **Value:** 0.359
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.415
- **Spread:** 
- **Upper Limit:** 1.979
- **Value:** 1.197
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.186
- **Spread:** 
- **Upper Limit:** 1.657
- **Value:** 0.921
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.666
- **Spread:** 
- **Upper Limit:** 0.570
- **Value:** -0.548
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.422
- **Spread:** 
- **Upper Limit:** 0.389
- **Value:** -0.517
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.658
- **Spread:** 
- **Upper Limit:** 1.815
- **Value:** 0.578
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.423
- **Spread:** 
- **Upper Limit:** 1.514
- **Value:** 0.546
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.149
- **Spread:** 
- **Upper Limit:** 2.183
- **Value:** -0.483
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -4.049
- **Spread:** 
- **Upper Limit:** 0.586
- **Value:** -1.732
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.970
- **Spread:** 
- **Upper Limit:** 2.931
- **Value:** -0.019
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.494
- **Spread:** 
- **Upper Limit:** 1.821
- **Value:** -0.836
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.744
- **Spread:** 
- **Upper Limit:** 3.730
- **Value:** -0.007
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.421
- **Spread:** 
- **Upper Limit:** 3.167
- **Value:** -0.127
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.236
- **Spread:** 
- **Upper Limit:** 1.598
- **Value:** 0.181
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.306
- **Spread:** 
- **Upper Limit:** -0.685
- **Value:** -1.996
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.490
- **Spread:** 
- **Upper Limit:** 1.104
- **Value:** -0.193
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.001
- **Spread:** 
- **Upper Limit:** 2.750
- **Value:** 1.375
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.101
- **Spread:** 
- **Upper Limit:** 1.834
- **Value:** 0.867
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.366
- **Spread:** 
- **Upper Limit:** 2.067
- **Value:** 1.217
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.405
- **Spread:** 
- **Upper Limit:** 1.643
- **Value:** 0.119
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.053
- **Spread:** 
- **Upper Limit:** 1.166
- **Value:** 0.056
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.723
- **Spread:** 
- **Upper Limit:** 1.647
- **Value:** -0.038
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.106
- **Spread:** 
- **Upper Limit:** 1.262
- **Value:** 0.078
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.411
- **Spread:** 
- **Upper Limit:** 3.853
- **Value:** 0.221
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -4.383
- **Spread:** 
- **Upper Limit:** 1.238
- **Value:** -1.573
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.066
- **Spread:** 
- **Upper Limit:** 4.595
- **Value:** 0.764
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.497
- **Spread:** 
- **Upper Limit:** 4.131
- **Value:** 0.817
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4.106
- **Spread:** 
- **Upper Limit:** 5.693
- **Value:** 0.793
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.828
- **Spread:** 
- **Upper Limit:** 5.142
- **Value:** 1.157
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.913
- **Spread:** 
- **Upper Limit:** 2.673
- **Value:** 0.880
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.799
- **Spread:** 
- **Upper Limit:** 0.329
- **Value:** -1.235
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.754
- **Spread:** 
- **Upper Limit:** 0.979
- **Value:** -0.388
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.209
- **Spread:** 
- **Upper Limit:** 3.281
- **Value:** 1.036
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.298
- **Spread:** 
- **Upper Limit:** 2.426
- **Value:** 1.064
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.204
- **Spread:** 
- **Upper Limit:** 2.906
- **Value:** 1.555
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.103
- **Spread:** 
- **Upper Limit:** 2.863
- **Value:** 1.380
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.201
- **Spread:** 
- **Upper Limit:** 3.471
- **Value:** 1.635
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.916
- **Spread:** 
- **Upper Limit:** 3.771
- **Value:** 0.928
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.435
- **Spread:** 
- **Upper Limit:** 2.990
- **Value:** 1.278
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.390
- **Spread:** 
- **Upper Limit:** 7.637
- **Value:** 3.123
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.522
- **Spread:** 
- **Upper Limit:** 5.464
- **Value:** 1.471
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.313
- **Spread:** 
- **Upper Limit:** 6.547
- **Value:** 2.617
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.346
- **Spread:** 
- **Upper Limit:** 7.740
- **Value:** 3.197
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.074
- **Spread:** 
- **Upper Limit:** 9.132
- **Value:** 3.529
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.579
- **Spread:** 
- **Upper Limit:** 9.370
- **Value:** 3.896
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.051
- **Spread:** 
- **Upper Limit:** 2.325
- **Value:** 0.137
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.930
- **Spread:** 
- **Upper Limit:** 1.570
- **Value:** -0.680
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.436
- **Spread:** 
- **Upper Limit:** 1.259
- **Value:** -0.589
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.590
- **Spread:** 
- **Upper Limit:** 3.492
- **Value:** 0.951
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.598
- **Spread:** 
- **Upper Limit:** 1.998
- **Value:** 0.200
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.658
- **Spread:** 
- **Upper Limit:** 2.754
- **Value:** 1.048
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.562
- **Spread:** 
- **Upper Limit:** 3.395
- **Value:** 1.417
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.893
- **Spread:** 
- **Upper Limit:** 2.608
- **Value:** 0.857
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.268
- **Spread:** 
- **Upper Limit:** 4.058
- **Value:** 1.395
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.358
- **Spread:** 
- **Upper Limit:** 3.247
- **Value:** 0.444
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.496
- **Spread:** 
- **Upper Limit:** 7.360
- **Value:** 2.432
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -4.688
- **Spread:** 
- **Upper Limit:** 5.932
- **Value:** 0.622
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.342
- **Spread:** 
- **Upper Limit:** 6.231
- **Value:** 1.444
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.035
- **Spread:** 
- **Upper Limit:** 7.899
- **Value:** 2.432
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.950
- **Spread:** 
- **Upper Limit:** 7.782
- **Value:** 1.916
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -4.258
- **Spread:** 
- **Upper Limit:** 9.603
- **Value:** 2.673
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.037
- **Spread:** 
- **Upper Limit:** 4.627
- **Value:** 1.295
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.721
- **Spread:** 
- **Upper Limit:** 0.055
- **Value:** -1.833
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.316
- **Spread:** 
- **Upper Limit:** 3.375
- **Value:** 1.529
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.083
- **Spread:** 
- **Upper Limit:** 5.099
- **Value:** 2.008
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.492
- **Spread:** 
- **Upper Limit:** 2.492
- **Value:** 1.492
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.183
- **Spread:** 
- **Upper Limit:** 3.603
- **Value:** 1.710
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.174
- **Spread:** 
- **Upper Limit:** 4.365
- **Value:** 2.269
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.872
- **Spread:** 
- **Upper Limit:** 4.055
- **Value:** 1.592
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.714
- **Spread:** 
- **Upper Limit:** 2.912
- **Value:** 0.599
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.463
- **Spread:** 
- **Upper Limit:** 4.258
- **Value:** 1.897
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.832
- **Spread:** 
- **Upper Limit:** 10.919
- **Value:** 4.044
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.691
- **Spread:** 
- **Upper Limit:** 7.002
- **Value:** 1.656
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.392
- **Spread:** 
- **Upper Limit:** 11.780
- **Value:** 6.586
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.596
- **Spread:** 
- **Upper Limit:** 9.550
- **Value:** 3.477
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.241
- **Spread:** 
- **Upper Limit:** 13.894
- **Value:** 7.067
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.391
- **Spread:** 
- **Upper Limit:** 13.139
- **Value:** 5.374
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -6.094
- **Spread:** 
- **Upper Limit:** 1.969
- **Value:** -2.063
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.996
- **Spread:** 
- **Upper Limit:** 2.944
- **Value:** -0.526
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.699
- **Spread:** 
- **Upper Limit:** 2.699
- **Value:** -1.500
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.729
- **Spread:** 
- **Upper Limit:** 7.796
- **Value:** 3.033
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.781
- **Spread:** 
- **Upper Limit:** 4.495
- **Value:** 0.857
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.190
- **Spread:** 
- **Upper Limit:** 4.097
- **Value:** 0.954
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4.835
- **Spread:** 
- **Upper Limit:** 4.835
- **Value:** 0.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 0.511
- **Spread:** 
- **Upper Limit:** 10.797
- **Value:** 5.654
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -6.133
- **Spread:** 
- **Upper Limit:** 4.474
- **Value:** -0.830
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.291
- **Spread:** 
- **Upper Limit:** 4.641
- **Value:** 1.675
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -17.803
- **Spread:** 
- **Upper Limit:** 10.621
- **Value:** -3.591
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1.093
- **Spread:** 
- **Upper Limit:** 14.699
- **Value:** 6.803
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -22.930
- **Spread:** 
- **Upper Limit:** 14.764
- **Value:** -4.083
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.820
- **Spread:** 
- **Upper Limit:** 22.050
- **Value:** 9.115
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -29.740
- **Spread:** 
- **Upper Limit:** 19.138
- **Value:** -5.301
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.114
- **Spread:** 
- **Upper Limit:** 24.695
- **Value:** 10.791
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -6.733
- **Spread:** 
- **Upper Limit:** 6.733
- **Value:** 0.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.491
- **Spread:** 
- **Upper Limit:** 3.342
- **Value:** 0.926
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.182
- **Spread:** 
- **Upper Limit:** 1.154
- **Value:** -2.014
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.034
- **Spread:** 
- **Upper Limit:** 8.174
- **Value:** 3.570
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -3.537
- **Spread:** 
- **Upper Limit:** 3.423
- **Value:** -0.057
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.630
- **Spread:** 
- **Upper Limit:** 7.964
- **Value:** 3.667
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -4.531
- **Spread:** 
- **Upper Limit:** 4.959
- **Value:** 0.214
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -2.143
- **Spread:** 
- **Upper Limit:** 8.588
- **Value:** 3.222
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -7.507
- **Spread:** 
- **Upper Limit:** 2.912
- **Value:** -2.298
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.361
- **Spread:** 
- **Upper Limit:** 7.534
- **Value:** 3.086
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -17.130
- **Spread:** 
- **Upper Limit:** 12.963
- **Value:** -2.083
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.624
- **Spread:** 
- **Upper Limit:** 18.093
- **Value:** 7.235
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -17.855
- **Spread:** 
- **Upper Limit:** 14.140
- **Value:** -1.857
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.116
- **Spread:** 
- **Upper Limit:** 25.886
- **Value:** 11.385
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -24.302
- **Spread:** 
- **Upper Limit:** 15.993
- **Value:** -4.155
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -4.192
- **Spread:** 
- **Upper Limit:** 33.135
- **Value:** 14.472
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -6.045
- **Spread:** 
- **Upper Limit:** 10.311
- **Value:** 2.133
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.965
- **Spread:** 
- **Upper Limit:** 3.108
- **Value:** -0.429
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.126
- **Spread:** 
- **Upper Limit:** 2.710
- **Value:** -1.208
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.189
- **Spread:** 
- **Upper Limit:** 16.846
- **Value:** 6.829
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.042
- **Spread:** 
- **Upper Limit:** 3.842
- **Value:** -0.600
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.608
- **Spread:** 
- **Upper Limit:** 9.979
- **Value:** 4.686
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.341
- **Spread:** 
- **Upper Limit:** 5.341
- **Value:** 0.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.169
- **Spread:** 
- **Upper Limit:** 15.931
- **Value:** 7.381
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -6.531
- **Spread:** 
- **Upper Limit:** 5.609
- **Value:** -0.461
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.410
- **Spread:** 
- **Upper Limit:** 10.743
- **Value:** 3.667
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -12.563
- **Spread:** 
- **Upper Limit:** 15.907
- **Value:** 1.672
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -7.450
- **Spread:** 
- **Upper Limit:** 24.005
- **Value:** 8.278
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -22.161
- **Spread:** 
- **Upper Limit:** 21.828
- **Value:** -0.167
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.867
- **Spread:** 
- **Upper Limit:** 38.801
- **Value:** 18.467
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -23.085
- **Spread:** 
- **Upper Limit:** 25.432
- **Value:** 1.174
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -9.207
- **Spread:** 
- **Upper Limit:** 43.018
- **Value:** 16.906
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -30.221
- **Spread:** 
- **Upper Limit:** 22.721
- **Value:** -3.750
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -11.605
- **Spread:** 
- **Upper Limit:** 5.605
- **Value:** -3.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -34.229
- **Spread:** 
- **Upper Limit:** 32.479
- **Value:** -0.875
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -9.614
- **Spread:** 
- **Upper Limit:** 24.303
- **Value:** 7.344
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -42.119
- **Spread:** 
- **Upper Limit:** 34.119
- **Value:** -4.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -18.466
- **Spread:** 
- **Upper Limit:** 27.932
- **Value:** 4.733
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -64.531
- **Spread:** 
- **Upper Limit:** 62.531
- **Value:** -1.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -9.165
- **Spread:** 
- **Upper Limit:** 14.276
- **Value:** 2.556
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -29.128
- **Spread:** 
- **Upper Limit:** 17.461
- **Value:** -5.833
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -11.512
- **Spread:** 
- **Upper Limit:** 18.845
- **Value:** 3.667
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -77.291
- **Spread:** 
- **Upper Limit:** 56.124
- **Value:** -10.583
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -30.212
- **Spread:** 
- **Upper Limit:** 36.657
- **Value:** 3.222
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -171.100
- **Spread:** 
- **Upper Limit:** 151.850
- **Value:** -9.625
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -41.554
- **Spread:** 
- **Upper Limit:** 64.821
- **Value:** 11.633
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -153.638
- **Spread:** 
- **Upper Limit:** 122.722
- **Value:** -15.458
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -48.177
- **Spread:** 
- **Upper Limit:** 78.777
- **Value:** 15.300
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -6.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 23.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 0.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 21.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 3.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 18.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 38.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 41.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -51.962
- **Spread:** 
- **Upper Limit:** 66.629
- **Value:** 7.333
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -3.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -23.441
- **Spread:** 
- **Upper Limit:** 27.808
- **Value:** 2.183
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 1.400
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -12.706
- **Spread:** 
- **Upper Limit:** 12.706
- **Value:** 0.000
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 6.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -13.535
- **Spread:** 
- **Upper Limit:** 26.701
- **Value:** 6.583
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -1.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -41.305
- **Spread:** 
- **Upper Limit:** 47.638
- **Value:** 3.167
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -3.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 11.789
- **Spread:** 
- **Upper Limit:** 22.378
- **Value:** 17.083
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -7.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 15.253
- **Spread:** 
- **Upper Limit:** 16.947
- **Value:** 16.100
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 3.067
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -24.358
- **Spread:** 
- **Upper Limit:** 62.891
- **Value:** 19.267
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 0.067
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 3.667
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -40.119
- **Spread:** 
- **Upper Limit:** 36.119
- **Value:** -2.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 4.200
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 8.800
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 0.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -28.119
- **Spread:** 
- **Upper Limit:** 48.119
- **Value:** 10.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 8.000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -56.962
- **Spread:** 
- **Upper Limit:** 61.629
- **Value:** 2.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 6.032
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -59.531
- **Spread:** 
- **Upper Limit:** 67.531
- **Value:** 4.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 17.698
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -156.612
- **Spread:** 
- **Upper Limit:** 165.279
- **Value:** 4.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 15.867
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 29.800
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 21.898
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 38.800
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -11.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -4.200
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 5.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -5.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -5.000
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -21.333
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -15.533
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Zero participants analyzed.
- **Group ID:** OG000
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** SD not calculated as only 1 participant was analyzed.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** -20.533
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.916
- **Spread:** 
- **Upper Limit:** 0.174
- **Value:** -0.871
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -3.783
- **Spread:** 
- **Upper Limit:** -1.231
- **Value:** -2.507
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -0.902
- **Spread:** 
- **Upper Limit:** 0.690
- **Value:** -0.106
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.788
- **Spread:** 
- **Upper Limit:** 0.256
- **Value:** -0.766
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.553
- **Spread:** 
- **Upper Limit:** 0.673
- **Value:** -0.440
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.562
- **Spread:** 
- **Upper Limit:** 0.546
- **Value:** -0.508
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -2.590
- **Spread:** 
- **Upper Limit:** -0.239
- **Value:** -1.415
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -1.809
- **Spread:** 
- **Upper Limit:** 0.263
- **Value:** -0.773
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -1.182
- **Spread:** 
- **Upper Limit:** 1.421
- **Value:** 0.120
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -0.878
- **Spread:** 
- **Upper Limit:** 1.360
- **Value:** 0.241
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.070
- **Spread:** 
- **Upper Limit:** 0.447
- **Value:** -2.311
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -5.734
- **Spread:** 
- **Upper Limit:** -0.273
- **Value:** -3.003
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -5.902
- **Spread:** 
- **Upper Limit:** 0.361
- **Value:** -2.771
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -7.941
- **Spread:** 
- **Upper Limit:** -1.462
- **Value:** -4.702
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** -6.633
- **Spread:** 
- **Upper Limit:** 1.195
- **Value:** -2.719
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** -8.515
- **Spread:** 
- **Upper Limit:** -0.366
- **Value:** -4.440
**Title:** 
#### Outcome Measure 25
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 12.3
- **Spread:** 
- **Upper Limit:** 22.2
- **Value:** 16.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 19.0
- **Spread:** 
- **Upper Limit:** 29.9
- **Value:** 24.2
**Title:** 
#### Outcome Measure 26
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.4
- **Spread:** 
- **Upper Limit:** 14.3
- **Value:** 9.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.4
- **Spread:** 
- **Upper Limit:** 15.5
- **Value:** 11.0
**Title:** 
#### Outcome Measure 27
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.6
- **Spread:** 
- **Upper Limit:** 10.2
- **Value:** 6.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.7
- **Spread:** 
- **Upper Limit:** 10.2
- **Value:** 6.5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
**Parameter Type:** NUMBER
**Population Description:** Intent-to-Treat (ITT) population - all randomized participants.
**Reporting Status:** POSTED
**Time Frame:** Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
**Title:** Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 2
**Description:** The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
**Title:** Second-Line PFS
**Type:** PRIMARY
**Unit of Measure:** months
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 3
**Description:** The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (\<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (\>) 1.5 ULN, \< 65 years of age, ≥ 65 years of age, \< 70 years of age, ≥ 70 years of age, \< 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free \> 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free \> 24 months, D-free ≤ 12 months, and D-free \> 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** ITT population. Here, Number of participants analyzed equals (=) participants evaluable for this outcome measure and number (n) = number of participants included in the analysis for the specified risk factor.
**Reporting Status:** POSTED
**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
**Title:** Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 4
**Description:** BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** ITT population; only randomized participants with measurable disease at baseline were included in the analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
**Title:** Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 5
**Description:** For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** ITT population; only randomized participants with measurable disease at baseline were included in the analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
**Title:** Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 6
**Description:** The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** ITT population; only randomized participants with a CR or PR were included in the analysis.
**Reporting Status:** POSTED
**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
**Title:** Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 7
**Description:** Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** ITT population; only randomized participants with a CR or PR were included in the analysis.
**Reporting Status:** POSTED
**Time Frame:** Months 3, 6, and 9
**Title:** Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 8
**Description:** Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
**Parameter Type:** NUMBER
**Population Description:** Third line ITT population: all randomized participants who received third-line treatment.
**Reporting Status:** POSTED
**Time Frame:** First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months)
**Title:** Percentage of Participants With Third-Line PFS According to RECIST v1.1
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 9
**Description:** The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Third line ITT population
**Reporting Status:** POSTED
**Time Frame:** First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months)
**Title:** Third-Line PFS
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 10
**Description:** Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
**Parameter Type:** NUMBER
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
**Title:** Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 11
**Description:** The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
**Title:** Second- and Third-Line PFS
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 12
**Description:** Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented.
**Parameter Type:** NUMBER
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
**Title:** Percentage of Participants With Second- and Third-Line Tumor Progression
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 13
**Description:** The median time, in months, from randomization to second- and third-line tumor progression. Second- and third-line tumor progression was defined as third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
**Title:** Time to Second- and Third-Line Tumor Progression
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 14
**Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Month 6
**Title:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 15
**Description:** Percentage of participants who died due to any reason were reported.
**Parameter Type:** NUMBER
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Baseline until death (up to approximately 4 years)
**Title:** Percentage of Participants Who Died
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 16
**Description:** OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Baseline until death (up to approximately 4 years)
**Title:** Overall Survival (OS)
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 17
**Description:** OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Months 6, 12, 18, and 24
**Title:** Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 18
**Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility (M) ("no problems"="I have no problems in walking about" to "extreme problems"="I am confined to bed"), self-care (SC) ("no problems"="I have no problems with self-care" to "extreme problems"="I am unable to wash or dress myself"), usual activities (UA) ("no problems"="I have no problems performing my usual activities" to "extreme problems"="I am unable to perform my usual activities"), pain/discomfort (P/D) ("no problems"="I have no pain or discomfort" to "extreme problems"="I have extreme pain or discomfort"), and anxiety/depression (A/D) ("no problems"="I am not anxious or depressed" to "extreme problems"='I am extremely anxious or depressed").
**Parameter Type:** NUMBER
**Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants completing the questionnaires at the corresponding timepoint.
**Reporting Status:** POSTED
**Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
**Title:** Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 19
**Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint
**Reporting Status:** POSTED
**Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
**Title:** Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 20
**Description:** The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either "no problems", "some problems", or "extreme problems" in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.
**Reporting Status:** POSTED
**Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
**Title:** Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 21
**Description:** The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** ITT population; n=number of participants who completed the assessment at the specified timepoint.
**Reporting Status:** POSTED
**Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
**Title:** Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** mm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 22
**Description:** The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.
**Reporting Status:** POSTED
**Time Frame:** Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
**Title:** Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** mm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 23
**Description:** The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the questionnaire at the specified timepoints.
**Reporting Status:** POSTED
**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)
**Title:** Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 24
**Description:** The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.
**Reporting Status:** POSTED
**Time Frame:** Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)
**Title:** Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
**Type:** SECONDARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 25
**Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Month 12
**Title:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 26
**Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Month 18
**Title:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
#### Outcome Measure 27
**Description:** Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** ITT population
**Reporting Status:** POSTED
**Time Frame:** Month 24
**Title:** Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG000
**Title:** CT Arm
##### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** OG001
**Title:** CT+BV Arm
### Participant Flow Module
#### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** FG000
**Title:** Chemotherapy (CT) Arm
#### Group
**Description:** Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 milligrams per kilogram (mg/kg), intravenously (IV), every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
**ID:** FG001
**Title:** Chemotherapy Plus Bevacizumab (CT+BV) Arm
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 141
###### Reason
**Group ID:** FG001
**Number of Subjects:** 148
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 32
###### Reason
**Group ID:** FG001
**Number of Subjects:** 20
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 11
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 8
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 9
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Withdraw
**Type:** Participant noncompliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 247
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 247
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 45
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 54
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 202
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 193
**Recruitment Details:** A total of 556 participants were screened and of these, 494 were randomized.
**Has Results:** True