## Protocol Section
### Identification Module
**NCT ID:** NCT03434379

**Acronym:** IMbrave150

**Brief Title:** A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

**Official Title:** A Phase III, Open-Label, Randomized Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

#### Organization Study ID Info
**ID:** YO40245
#### Organization
**Class:** INDUSTRY
**Full Name:** Hoffmann-La Roche
#### Secondary ID Infos
**ID:** 2017-003691-31
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2022-11-17

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-23

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-05

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-08-31

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2021-11-05

**Type:** ACTUAL

**Results First Submit Date:** 2021-08-16

**Results First Submit QC Date:** 2021-10-07

#### Start Date
**Date:** 2018-03-15

**Type:** ACTUAL

**Status Verified Date:** 2023-09

#### Study First Post Date
**Date:** 2018-02-15
**Type:** ACTUAL
**Study First Submit Date:** 2018-01-31
**Study First Submit QC Date:** 2018-02-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hoffmann-La Roche

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**Brief Summary:** This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.

**Detailed Description:** The participants will be randomized in a 2:1 ratio to one of the two treatment arms: Arm A (experimental arm): Atezolizumab +bevacizumab; Arm B (control arm): Sorafenib

### Conditions Module

**Conditions:**

- Carcinoma, Hepatocellular

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 558

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator

**Intervention Names:**

- Drug: Atezolizumab

- Drug: Bevacizumab

**Label:** Atezolizumab + Bevacizumab

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will receive Sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator

**Intervention Names:**

- Drug: Sorafenib

**Label:** Sorafenib

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Atezolizumab + Bevacizumab

**Description:** Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle

**Name:** Atezolizumab

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Atezolizumab + Bevacizumab

**Description:** Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle

**Name:** Bevacizumab

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Sorafenib

**Description:** Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle

**Name:** Sorafenib

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** OS was defined as the time from randomization to death from any cause.

**Measure:** Overall Survival (OS) in the Global Population

**Time Frame:** From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)

**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** OS was defined as the time from randomization to death from any cause.

**Measure:** Overall Survival (OS) in the China Population

**Time Frame:** From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)

**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** PFS-IRF Per RECIST v1.1 in the China Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

#### Secondary Outcomes

**Description:** ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR

**Measure:** Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR

**Measure:** Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR

**Measure:** ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.

**Measure:** Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.

**Measure:** Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.

**Measure:** Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** PFS-IRF Per HCC mRECIST in the Global Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** TTP-IRF Per HCC mRECIST in the Global Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** OS was defined as the time from randomization to death from any cause. Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.

**Measure:** Overall Survival by Baseline AFP in the Global Population

**Time Frame:** From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.

**Measure:** PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.

**Measure:** PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.

**Measure:** Time to Deterioration (TTD) in the Global Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

**Measure:** Number of Participants With Adverse Events (AEs) in the Global Population

**Time Frame:** Up to end of study (up to approximately 56 months)

**Measure:** Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population

**Time Frame:** Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)

**Measure:** Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population

**Time Frame:** Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)

**Measure:** Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population

**Time Frame:** Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 30 months)

**Description:** ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR

**Measure:** Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR

**Measure:** Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR

**Measure:** ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.

**Measure:** Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.

**Measure:** Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.

**Measure:** Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population

**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** PFS-IRF Per HCC mRECIST in the China Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** TTP-IRF Per HCC mRECIST in the China Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).

**Measure:** TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.

**Measure:** Time to Deterioration (TTD) in the China Population

**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)

**Description:** An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

**Measure:** Number of Participants With Adverse Events (AEs) in the China Population

**Time Frame:** Up to end of study (up to approximately 56 months)

**Measure:** Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population

**Time Frame:** Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)

**Measure:** Trough Serum Concentration (Cmin) of Atezolizumab in the China Population

**Time Frame:** Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)

**Measure:** Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population

**Time Frame:** Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 18 months)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
* No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed, provided that these medications are discontinued prior to randomization.
* At least one measurable untreated lesion
* ECOG Performance Status of 0 or 1
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent
* For men: agreement to remain abstinent
* Child-Pugh class A

Exclusion Criteria:

* History of leptomeningeal disease
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
* Known active tuberculosis
* History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib
* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
* Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding
* A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment.
* Moderate or severe ascites
* History of hepatic encephalopathy
* Co-infection of HBV and HCV
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptomatic hypercalcemia
* Treatment with systemic immunostimulatory agents
* Inadequately controlled arterial hypertension
* Prior history of hypertensive crisis or hypertensive encephalopathy
* Evidence of bleeding diathesis or significant coagulopathy
* History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration
* Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
* Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses
* Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure
* Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Phoenix

**Country:** United States

**Facility:** St. Josephs Hospital and Medical Center

**State:** Arizona

**Zip:** 85260

**Location 2:**

**City:** Duarte

**Country:** United States

**Facility:** City of Hope

**State:** California

**Zip:** 91010

**Location 3:**

**City:** La Jolla

**Country:** United States

**Facility:** Uni of California - San Diego; Cancer Center & Dept of Medicine

**State:** California

**Zip:** 92093

**Location 4:**

**City:** Novato

**Country:** United States

**Facility:** Kaiser Permanente Northern California

**State:** California

**Zip:** 94589

**Location 5:**

**City:** Orange

**Country:** United States

**Facility:** University of California Irvine Medical Center

**State:** California

**Zip:** 92868

**Location 6:**

**City:** Sacramento

**Country:** United States

**Facility:** Kaiser Permanente Sacramento Medical Center

**State:** California

**Zip:** 95825

**Location 7:**

**City:** San Francisco

**Country:** United States

**Facility:** California Pacific Medical Center

**State:** California

**Zip:** 94115

**Location 8:**

**City:** San Francisco

**Country:** United States

**Facility:** Kaiser Permanente - San Francisco Medical Center

**State:** California

**Zip:** 94118

**Location 9:**

**City:** Santa Monica

**Country:** United States

**Facility:** University of California Los Angeles

**State:** California

**Zip:** 90404

**Location 10:**

**City:** Walnut Creek

**Country:** United States

**Facility:** Kaiser Permanente - Walnut Creek

**State:** California

**Zip:** 94596

**Location 11:**

**City:** Greeley

**Country:** United States

**Facility:** Banner MD Anderson Cancer Center

**State:** Colorado

**Zip:** 85234

**Location 12:**

**City:** Washington

**Country:** United States

**Facility:** Georgetown University

**State:** District of Columbia

**Zip:** 20007

**Location 13:**

**City:** Tampa

**Country:** United States

**Facility:** Moffitt Cancer Center

**State:** Florida

**Zip:** 33612

**Location 14:**

**City:** Boston

**Country:** United States

**Facility:** Massachusetts General Hospital

**State:** Massachusetts

**Zip:** 02114

**Location 15:**

**City:** Detroit

**Country:** United States

**Facility:** Henry Ford Health System

**State:** Michigan

**Zip:** 48202

**Location 16:**

**City:** Saint Louis

**Country:** United States

**Facility:** Washington University; Wash Uni. Sch. Of Med

**State:** Missouri

**Zip:** 63110

**Location 17:**

**City:** Albuquerque

**Country:** United States

**Facility:** University of New Mexico Comprehensive Cancer Center

**State:** New Mexico

**Zip:** 87102

**Location 18:**

**City:** New York

**Country:** United States

**Facility:** Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

**State:** New York

**Zip:** 10016

**Location 19:**

**City:** Philadelphia

**Country:** United States

**Facility:** Thomas Jefferson University

**State:** Pennsylvania

**Zip:** 19107

**Location 20:**

**City:** Houston

**Country:** United States

**Facility:** M.D Anderson Cancer Center; Uni of Texas At Houston

**State:** Texas

**Zip:** 77030

**Location 21:**

**City:** Seattle

**Country:** United States

**Facility:** Swedish Cancer Inst.

**State:** Washington

**Zip:** 98104

**Location 22:**

**City:** Bankstown

**Country:** Australia

**Facility:** Bankstown-Lidcombe Hospital

**State:** New South Wales

**Zip:** 2200

**Location 23:**

**City:** Kogarah

**Country:** Australia

**Facility:** St George Hospital

**State:** New South Wales

**Zip:** 2217

**Location 24:**

**City:** Woodville

**Country:** Australia

**Facility:** The Queen Elizabeth Hospital

**State:** South Australia

**Zip:** 5011

**Location 25:**

**City:** St Albans

**Country:** Australia

**Facility:** Sunshine Hospital

**State:** Victoria

**Zip:** 3021

**Location 26:**

**City:** Ottawa

**Country:** Canada

**Facility:** Ottawa Hospital Research Institute

**State:** Ontario

**Zip:** K1Y 4E9

**Location 27:**

**City:** Montreal

**Country:** Canada

**Facility:** Centre hospitalier de l'Universite de Montreal (CHUM)

**State:** Quebec

**Zip:** H2X 0A9

**Location 28:**

**City:** Montreal

**Country:** Canada

**Facility:** Jewish General Hospital

**State:** Quebec

**Zip:** H3T 1E2

**Location 29:**

**City:** Montreal

**Country:** Canada

**Facility:** McGill University Health Centre - Glen Site

**State:** Quebec

**Zip:** H4A 3J1

**Location 30:**

**City:** Beijing City

**Country:** China

**Facility:** Peking Union Medical College Hospital

**Zip:** 100032

**Location 31:**

**City:** Beijing

**Country:** China

**Facility:** Beijing Friendship Hospital

**Zip:** 100050

**Location 32:**

**City:** Beijing

**Country:** China

**Facility:** Beijing Cancer Hospital

**Zip:** 100142

**Location 33:**

**City:** Changchun

**Country:** China

**Facility:** the First Hospital of Jilin University

**Zip:** 130021

**Location 34:**

**City:** Changchun

**Country:** China

**Facility:** Jilin Cancer Hospital

**Zip:** 132013

**Location 35:**

**City:** Changsha CITY

**Country:** China

**Facility:** Hunan Cancer Hospital

**Zip:** 410013

**Location 36:**

**City:** Foshan

**Country:** China

**Facility:** The First People's Hospital of Foshan; Local Ethic Committee

**Zip:** 510000

**Location 37:**

**City:** Fuzhou

**Country:** China

**Facility:** The 900th Hospital of PLA joint service support force

**Zip:** 110016

**Location 38:**

**City:** Guangzhou City

**Country:** China

**Facility:** Sun Yet-sen University Cancer Center

**Zip:** 510663

**Location 39:**

**City:** Guangzhou

**Country:** China

**Facility:** Nanfang Hospital, Southern Medical University

**Zip:** 510515

**Location 40:**

**City:** Hangzhou City

**Country:** China

**Facility:** Sir Run Run Shaw Hospital

**Zip:** 310018

**Location 41:**

**City:** Hangzhou City

**Country:** China

**Facility:** Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

**Zip:** 310022

**Location 42:**

**City:** Hangzhou

**Country:** China

**Facility:** The First Affiliated Hospital of College of Medicine, Zhejiang University

**Zip:** 310003

**Location 43:**

**City:** Harbin

**Country:** China

**Facility:** Harbin Medical University Cancer Hospital

**Zip:** 150081

**Location 44:**

**City:** Hefei City

**Country:** China

**Facility:** Anhui Province Cancer Hospital

**Zip:** 230031

**Location 45:**

**City:** Hefei

**Country:** China

**Facility:** The First Affiliated Hospital of Anhui Medical University

**Zip:** 230022

**Location 46:**

**City:** Jinan

**Country:** China

**Facility:** General Hospital of Jinan Military Command of PLA

**Zip:** 250031

**Location 47:**

**City:** Nanjing City

**Country:** China

**Facility:** The 81st Hospital of P.L.A.

**Zip:** 210002

**Location 48:**

**City:** Shanghai City

**Country:** China

**Facility:** Fudan University Shanghai Cancer Center

**Zip:** 200120

**Location 49:**

**City:** Shanghai

**Country:** China

**Facility:** Zhongshan Hospital Fudan University

**Zip:** 200032

**Location 50:**

**City:** Wuhan

**Country:** China

**Facility:** Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

**Zip:** 430030

**Location 51:**

**City:** Brno

**Country:** Czechia

**Facility:** Masarykuv onkologicky ustav

**Zip:** 656 53

**Location 52:**

**City:** Olomouc

**Country:** Czechia

**Facility:** Fakultni nemocnice Olomouc; Onkologicka klinika

**Zip:** 779 00

**Location 53:**

**City:** Lille

**Country:** France

**Facility:** Hopital Claude Huriez;Gastro Enterologie

**Zip:** 59037

**Location 54:**

**City:** Lyon

**Country:** France

**Facility:** Hopital De La Croix Rousse; Hepatologie Gastro Enterologie

**Zip:** 69317

**Location 55:**

**City:** Marseille

**Country:** France

**Facility:** Hopital Timone Adultes; Gastro Enterologie

**Zip:** 13385

**Location 56:**

**City:** Montpellier

**Country:** France

**Facility:** Hopital Saint-Eloi; Hepatologie-Gastro-Enterologie

**Zip:** 34295

**Location 57:**

**City:** Nantes

**Country:** France

**Facility:** Hopital Hotel Dieu Et Hme; Hepatologie Gastro Enterologie

**Zip:** 44093

**Location 58:**

**City:** Nice Cedex

**Country:** France

**Facility:** CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie

**Zip:** 06202

**Location 59:**

**City:** Rouen

**Country:** France

**Facility:** Hopital Charles Nicolle; Gastroenterologie

**Zip:** 76031

**Location 60:**

**City:** Strasbourg

**Country:** France

**Facility:** Hopital Hautepierre; Gastro Enterologie

**Zip:** 67098

**Location 61:**

**City:** Vandoeuvre-les-nancy

**Country:** France

**Facility:** Hôpital d'Adultes; Service hépato-gastro-entérologie

**Zip:** 54511

**Location 62:**

**City:** Villejuif

**Country:** France

**Facility:** Institut Gustave Roussy; Gastro-Enterologie

**Zip:** 94805

**Location 63:**

**City:** Berlin

**Country:** Germany

**Facility:** Campus Virchow-Klinikum Charité Centrum 13; Medizinische Klinik; Abt.Hepatologie u.Gastroenterologie

**Zip:** 13353

**Location 64:**

**City:** Frankfurt

**Country:** Germany

**Facility:** Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

**Zip:** 60590

**Location 65:**

**City:** Hamburg

**Country:** Germany

**Facility:** Universitaetsklinikum Hamburg-Eppendorf; I. Medizinische Klinik - Gastroenterologie

**Zip:** 20246

**Location 66:**

**City:** Hannover

**Country:** Germany

**Facility:** Med. Hochschule Hannover; Gastroenterologie

**Zip:** 30625

**Location 67:**

**City:** Leipzig

**Country:** Germany

**Facility:** Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.

**Zip:** 04103

**Location 68:**

**City:** Mainz

**Country:** Germany

**Facility:** Uniklinik Mainz; I. Medizinische Klinik

**Zip:** 55131

**Location 69:**

**City:** Regensburg

**Country:** Germany

**Facility:** Klinikum der Uni Regensburg; Klinik f.Innere Medizin I Abt. Hämatologie und Internistische Onkologie

**Zip:** 93053

**Location 70:**

**City:** Hong Kong

**Country:** Hong Kong

**Facility:** Queen Mary Hospital; Dept. Of Haematology & Oncology

**Location 71:**

**City:** Shatin

**Country:** Hong Kong

**Facility:** Prince of Wales Hosp; Dept. Of Clinical Onc

**Location 72:**

**City:** Benevento

**Country:** Italy

**Facility:** Az. Osp. Rummo; Oncologia Medica

**State:** Campania

**Zip:** 82100

**Location 73:**

**City:** Meldola

**Country:** Italy

**Facility:** IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

**State:** Emilia-Romagna

**Zip:** 47014

**Location 74:**

**City:** Orbassano

**Country:** Italy

**Facility:** Az. Osp. S. Luigi Gonzaga; Divisione Di Oncologia Medica

**State:** Piemonte

**Zip:** 10043

**Location 75:**

**City:** Cagliari

**Country:** Italy

**Facility:** A.O.U. Cagliari-P.O. Monserrato;U.O. Oncologia

**State:** Sardegna

**Zip:** 09100

**Location 76:**

**City:** Pisa

**Country:** Italy

**Facility:** Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria ? Polo Oncologico

**State:** Toscana

**Zip:** 56126

**Location 77:**

**City:** Padova

**Country:** Italy

**Facility:** IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

**State:** Veneto

**Zip:** 35128

**Location 78:**

**City:** Chiba

**Country:** Japan

**Facility:** Chiba University Hospital

**Zip:** 260-8677

**Location 79:**

**City:** Chiba

**Country:** Japan

**Facility:** National Cancer Center Hospital East

**Zip:** 277-8577

**Location 80:**

**City:** Fukuoka

**Country:** Japan

**Facility:** Kurume University Hospital

**Zip:** 830-0011

**Location 81:**

**City:** Hokkaido

**Country:** Japan

**Facility:** Sapporo Kosei Genaral Hospital

**Zip:** 060-0033

**Location 82:**

**City:** Hokkaido

**Country:** Japan

**Facility:** Hokkaido University Hospital

**Zip:** 060-8648

**Location 83:**

**City:** Ishikawa

**Country:** Japan

**Facility:** Kanazawa University Hospital

**Zip:** 920-8641

**Location 84:**

**City:** Kanagawa

**Country:** Japan

**Facility:** Kitasato University Hospital

**Zip:** 252-0375

**Location 85:**

**City:** Kumamoto

**Country:** Japan

**Facility:** Kumamoto University Hospital

**Zip:** 860-8556

**Location 86:**

**City:** Osaka

**Country:** Japan

**Facility:** Osaka Metropolitan University Hospital

**Zip:** 545-8586

**Location 87:**

**City:** Osaka

**Country:** Japan

**Facility:** Kindai University Hospital

**Zip:** 589-8511

**Location 88:**

**City:** Saga

**Country:** Japan

**Facility:** Saga-ken Medical Centre Koseikan

**Zip:** 840-8571

**Location 89:**

**City:** Shizuoka

**Country:** Japan

**Facility:** Shizuoka Cancer Center

**Zip:** 411-8777

**Location 90:**

**City:** Tokyo

**Country:** Japan

**Facility:** Japanese Red Cross Musashino Hospital

**Zip:** 180-8610

**Location 91:**

**City:** Jeollanam-do

**Country:** Korea, Republic of

**Facility:** Chonnam National University Hwasun Hospital

**Zip:** 58128

**Location 92:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

**Zip:** 03080

**Location 93:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Severance Hospital, Yonsei University Health System

**Zip:** 03722

**Location 94:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Asan Medical Center

**Zip:** 05505

**Location 95:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Samsung Medical Center

**Zip:** 06351

**Location 96:**

**City:** Ulsan

**Country:** Korea, Republic of

**Facility:** Ulsan University Hosiptal

**Zip:** 44033

**Location 97:**

**City:** Gdansk

**Country:** Poland

**Facility:** Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

**Zip:** 80-219

**Location 98:**

**City:** Myslowice

**Country:** Poland

**Facility:** ID Clinic

**Zip:** 41-400

**Location 99:**

**City:** Olsztyn

**Country:** Poland

**Facility:** SP ZOZ MSWiA z WARMINSKO-MAZURSKIM CENTRUM ONKOLOGII; CLINICAL ONCOLOGY, CLINICAL IMMUNOLOGY

**Zip:** 10-228

**Location 100:**

**City:** Warszawa

**Country:** Poland

**Facility:** Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

**Zip:** 02-781

**Location 101:**

**City:** Wroc?aw

**Country:** Poland

**Facility:** Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii

**Zip:** 53-413

**Location 102:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** FSBI "National Medical Research Center of Oncology N.N. Blokhin?; Clinical Biotechnologies

**State:** Moskovskaja Oblast

**Zip:** 115478

**Location 103:**

**City:** Saint Petersburg

**Country:** Russian Federation

**Facility:** GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

**State:** Sankt Petersburg

**Zip:** 197758

**Location 104:**

**City:** Singapore

**Country:** Singapore

**Facility:** National Cancer Centre

**Zip:** 169610

**Location 105:**

**City:** Singapore

**Country:** Singapore

**Facility:** Tan Tock Seng Hospital; Oncology

**Zip:** 308433

**Location 106:**

**City:** Barcelona

**Country:** Spain

**Facility:** Hospital Universitari Vall d'Hebron; Oncology

**Zip:** 08035

**Location 107:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Clinico San Carlos; Servicio de Oncologia

**Zip:** 28040

**Location 108:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Universitario La Paz; Servicio de Oncologia

**Zip:** 28046

**Location 109:**

**City:** Madrid

**Country:** Spain

**Facility:** Centro Integral Oncologico Clara Campal; Servicio de Oncología

**Zip:** 28050

**Location 110:**

**City:** Zaragoza

**Country:** Spain

**Facility:** Hospital Universitario Miguel Servet; Servicio de Oncologia Medica

**Zip:** 50009

**Location 111:**

**City:** Tainan

**Country:** Taiwan

**Facility:** National Cheng Kung University Hospital; Oncology

**Zip:** 00704

**Location 112:**

**City:** Tainan

**Country:** Taiwan

**Facility:** Chi-Mei Medical Centre; Hematology & Oncology

**Zip:** 710

**Location 113:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Veterans General Hospital; Cancer Center

**Zip:** 00112

**Location 114:**

**City:** Taipei

**Country:** Taiwan

**Facility:** National Taiwan Uni Hospital; Dept of Oncology

**Zip:** 100

**Location 115:**

**City:** Taoyuan County

**Country:** Taiwan

**Facility:** Chang Gung Memorial Hospital-Linkou; Dept of Oncology

**Zip:** 333

**Location 116:**

**City:** Glasgow

**Country:** United Kingdom

**Facility:** Beatson West of Scotland Cancer Centre

**Zip:** G12 0YN

**Location 117:**

**City:** London

**Country:** United Kingdom

**Facility:** Royal Free Hospital; Dept of Oncology

**Zip:** NW3 2QG

**Location 118:**

**City:** London

**Country:** United Kingdom

**Facility:** King'S College Hospital

**Zip:** SE5 9RS

**Location 119:**

**City:** Manchester

**Country:** United Kingdom

**Facility:** Christie Hospital Nhs Trust; Medical Oncology

**Zip:** M2O 4BX

#### Overall Officials

**Official 1:**

**Affiliation:** Hoffmann-La Roche

**Name:** Clinical Trials

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

**IPD Sharing:** YES

### References Module

#### References

**Citation:** Kaseb AO, Guan Y, Gok Yavuz B, Abbas AR, Lu S, Hasanov E, Toh HC, Verret W, Wang Y. Serum IGF-1 Scores and Clinical Outcomes in the Phase III IMbrave150 Study of Atezolizumab Plus Bevacizumab versus Sorafenib in Patients with Unresectable Hepatocellular Carcinoma. J Hepatocell Carcinoma. 2022 Oct 11;9:1065-1079. doi: 10.2147/JHC.S369951. eCollection 2022.

**PMID:** 36254201

**Citation:** Li Y, Liang X, Li H, Chen X. Atezolizumab plus bevacizumab versus nivolumab as first-line treatment for advanced or unresectable hepatocellular carcinoma: A cost-effectiveness analysis. Cancer. 2022 Nov 15;128(22):3995-4003. doi: 10.1002/cncr.34457. Epub 2022 Sep 16.

**PMID:** 36111952

**Citation:** Cheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Lim HY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Ma N, Nicholas A, Wang Y, Li L, Zhu AX, Finn RS. Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab vs. sorafenib for unresectable hepatocellular carcinoma. J Hepatol. 2022 Apr;76(4):862-873. doi: 10.1016/j.jhep.2021.11.030. Epub 2021 Dec 11.

**PMID:** 34902530

**Citation:** Salem R, Li D, Sommer N, Hernandez S, Verret W, Ding B, Lencioni R. Characterization of response to atezolizumab + bevacizumab versus sorafenib for hepatocellular carcinoma: Results from the IMbrave150 trial. Cancer Med. 2021 Aug;10(16):5437-5447. doi: 10.1002/cam4.4090. Epub 2021 Jun 29.

**PMID:** 34189869

**Citation:** Galle PR, Finn RS, Qin S, Ikeda M, Zhu AX, Kim TY, Kudo M, Breder V, Merle P, Kaseb A, Li D, Mulla S, Verret W, Xu DZ, Hernandez S, Ding B, Liu J, Huang C, Lim HY, Cheng AL, Ducreux M. Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Jul;22(7):991-1001. doi: 10.1016/S1470-2045(21)00151-0. Epub 2021 May 27.

**PMID:** 34051880

**Citation:** Wen F, Zheng H, Zhang P, Liao W, Zhou K, Li Q. Atezolizumab and bevacizumab combination compared with sorafenib as the first-line systemic treatment for patients with unresectable hepatocellular carcinoma: A cost-effectiveness analysis in China and the United states. Liver Int. 2021 May;41(5):1097-1104. doi: 10.1111/liv.14795. Epub 2021 Feb 8.

**PMID:** 33556230

**Citation:** Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.

**PMID:** 32402160

## Document Section

### Large Document Module

#### Large Docs

- Date: 2021-02-01

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1642772

- Type Abbrev: Prot

- Upload Date: 2021-08-16T15:08

- Date: 2019-02-22

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 706880

- Type Abbrev: SAP

- Upload Date: 2021-08-16T15:08

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000008113

- Term: Liver Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008107

- Term: Liver Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M9613

- Name: Carcinoma, Hepatocellular

- Relevance: HIGH

- As Found: Carcinoma, Hepatocellular

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11113

- Name: Liver Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000006528

- Term: Carcinoma, Hepatocellular

### 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

- ID: D000047428

- Term: Protein Kinase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000082082

- Term: Immune Checkpoint 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: M349417

- Name: Atezolizumab

- Relevance: HIGH

- As Found: Measured

- ID: M1680

- Name: Sorafenib

- Relevance: HIGH

- As Found: Setting

- 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

- ID: M25820

- Name: Protein Kinase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068258

- Term: Bevacizumab

- ID: C000594389

- Term: Atezolizumab

- ID: D000077157

- Term: Sorafenib

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2021-09-16

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** All-cause mortality is reported for deaths that occurred during the study based on the ITT population, which included all randomized participants. Serious and other adverse events were reported based on the safety population, which included all randomized participants who received any amount of study drug with participants grouped according to the treatment the participant actually received. Global and China extension periods were analyzed separately.

#### Event Groups

**Group ID:** EG000

**Title:** Sorafenib - Global

**Deaths Num Affected:** 115

**Deaths Num At Risk:** 165

**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

**ID:** EG000

**Other Num Affected:** 147

**Other Num at Risk:** 156

**Serious Number Affected:** 51

**Serious Number At Risk:** 156

**Title:** Sorafenib - Global

**Group ID:** EG001

**Title:** Atezolizumab + Bevacizumab - Global

**Deaths Num Affected:** 228

**Deaths Num At Risk:** 336

**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

**ID:** EG001

**Other Num Affected:** 311

**Other Num at Risk:** 329

**Serious Number Affected:** 171

**Serious Number At Risk:** 329

**Title:** Atezolizumab + Bevacizumab - Global

**Group ID:** EG002

**Title:** Sorafenib - China

**Deaths Num Affected:** 46

**Deaths Num At Risk:** 61

**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

**ID:** EG002

**Other Num Affected:** 55

**Other Num at Risk:** 58

**Serious Number Affected:** 12

**Serious Number At Risk:** 58

**Title:** Sorafenib - China

**Group ID:** EG003

**Title:** Atezolizumab + Bevacizumab - China

**Deaths Num Affected:** 88

**Deaths Num At Risk:** 133

**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

**ID:** EG003

**Other Num Affected:** 129

**Other Num at Risk:** 132

**Serious Number Affected:** 54

**Serious Number At Risk:** 132

**Title:** Atezolizumab + Bevacizumab - China

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Hypothyroidism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Ascites

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

**Term:** Infusion related reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Blood creatinine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Platelet count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** White blood cell count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Hypoalbuminaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Hypophosphataemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Proteinuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Dysphonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Palmar-plantar erythrodysaesthesia syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Hyperthyroidism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Gingival bleeding

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Malaise

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Hepatic function abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Bilirubin conjugated increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Blood bilirubin unconjugated increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Blood lactate dehydrogenase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Blood thyroid stimulating hormone increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Gamma-glutamyltransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Lymphocyte count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Neutrophil count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Protein urine present

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Prothrombin time prolonged

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

**Term:** Hypoproteinaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Cylindruria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Haematuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

**Term:** Haemoptysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

**Term:** Rash maculo-papular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

#### Serious Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 329

**Num Events:** 7

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 3

**Num At Risk:** 132

**Num Events:** 3

**Term:** Immune thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 4

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 58

**Num Events:** 2

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 3

**Term:** Acute coronary syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Cardiac arrest

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Cardiac failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 329

**Num Events:** 4

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 132

**Num Events:** 2

**Term:** Hydrocele

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Congenital, familial and genetic disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hypoacusis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Addison's disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hypophysitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Blindness unilateral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 132

**Num Events:** 2

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Abdominal pain upper

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 132

**Num Events:** 2

**Term:** Anal fissure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Ascites

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 13

**Num At Risk:** 329

**Num Events:** 18

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 6

**Num At Risk:** 132

**Num Events:** 9

**Term:** Colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 329

**Num Events:** 5

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 329

**Num Events:** 5

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Duodenal ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Gastric mucosal lesion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Gastric ulcer haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Gastric ulcer perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Gastric varices haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 329

**Num Events:** 4

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 156

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 11

**Num At Risk:** 329

**Num Events:** 11

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 3

**Num At Risk:** 132

**Num Events:** 3

**Term:** Gastrointestinal necrosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Haematemesis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Haemoperitoneum

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hiatus hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Immune-mediated enterocolitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Incarcerated umbilical hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Large intestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Melaena

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Mesenteric vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Mouth haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Oesophageal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Oesophageal stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Oesophageal varices haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 10

**Num At Risk:** 329

**Num Events:** 12

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 132

**Num Events:** 3

**Term:** Pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Rectal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 5

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Umbilical hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Upper gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 329

**Num Events:** 5

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 5

**Num At Risk:** 132

**Num Events:** 5

**Term:** Varices oesophageal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** General physical health deterioration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Multiple organ dysfunction syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 11

**Num At Risk:** 329

**Num Events:** 15

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 4

**Num At Risk:** 132

**Num Events:** 7

**Term:** Acute hepatic failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Autoimmune hepatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Bile duct stone

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Cholangitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 329

**Num Events:** 6

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Cholecystitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Drug-induced liver injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hepatic cirrhosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hepatic failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 329

**Num Events:** 4

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hepatic function abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 5

**Num At Risk:** 132

**Num Events:** 5

**Term:** Hepatic pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hepatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hepatobiliary disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hepatorenal failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hepatorenal syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hyperbilirubinaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hypertransaminasaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Jaundice

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Liver injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Anaphylactic reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Cytokine release syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Abscess limb

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Biliary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Burkholderia pseudomallei infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Device related infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Empyema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Escherichia sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Gastroenteritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Haemophilus infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hepatitis E

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Herpes simplex encephalitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Lower respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Peritoneal abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Peritonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Peritonsillar abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 329

**Num Events:** 5

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 3

**Num At Risk:** 132

**Num Events:** 3

**Term:** Post procedural infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 329

**Num Events:** 9

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Septic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Skin infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Tooth infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Tuberculosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Urosepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Acetabulum fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Compression fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Fall

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hip fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Humerus fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Infusion related reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 329

**Num Events:** 6

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Pelvic fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Spinal compression fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Amylase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 329

**Num Events:** 4

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 329

**Num Events:** 7

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 132

**Num Events:** 2

**Term:** General physical condition abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Granulocyte count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Lipase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Liver function test increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Platelet count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 132

**Num Events:** 2

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Diabetes mellitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Diabetes mellitus inadequate control

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hyperammonaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hyperglycaemic hyperosmolar nonketotic syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hyperkalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Hypoalbuminaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hypoglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hypoproteinaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Lactic acidosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Metabolic acidosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Type 2 diabetes mellitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Autoimmune arthritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Groin pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Muscular weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Myositis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Pathological fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Tendonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Chronic myeloid leukaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Gastric cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Neoplasm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Oesophageal squamous cell carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Tumour haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Tumour rupture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Altered state of consciousness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Cerebral haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Cerebral infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 132

**Num Events:** 2

**Term:** Cerebrovascular accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 132

**Num Events:** 2

**Term:** Encephalopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Epilepsy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Haemorrhage intracranial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hepatic encephalopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 156

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 329

**Num Events:** 6

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 2

**Term:** Metabolic encephalopathy

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Subarachnoid haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Subdural hygroma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** VIth nerve disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** VIth nerve paralysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Confusional state

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Delirium

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Mental status changes

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Acute kidney injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 4

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 58

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Haematuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Nephritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Renal failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Renal haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Pelvic pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Asthma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Chronic obstructive pulmonary disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Haemoptysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hiccups

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 5

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 2

**Term:** Pneumonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Pneumothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Pulmonary haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Pulmonary hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Respiratory distress

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Drug eruption

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Skin ulcer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Toxic skin eruption

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Bleeding varicose vein

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Deep vein thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 329

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Hypotension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Phlebitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 156

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 329

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Thrombosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Hypersplenism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Bradycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Cardiac failure congestive

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Cataract

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Diaphragmatic hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** COVID-19

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Peritonitis bacterial

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Pneumonia aspiration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Streptococcal bacteraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Subdural haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Toxicity to various agents

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Nephropathy toxic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Proteinuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 329

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Renal impairment

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Scrotal dermatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Acute pulmonary oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num At Risk:** 132

**Term:** Orthopnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Cutaneous vasculitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Term:** Peripheral vascular disorder

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 25.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 156

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 329

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 58

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 132

**Num Events:** 1

**Time Frame:** Up to end of study (up to approximately 56 months)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 183

**Group ID:** BG001

**Value:** 375

**Group ID:** BG002

**Value:** 558

**Units:** Participants

### Group

**ID:** BG000

**Title:** Sorafenib - All

**Description:** All participants either in the Global or China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

### Group

**ID:** BG001

**Title:** Atezolizumab + Bevacizumab - All

**Description:** All participants either in the Global or China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.9

**Value:** 64.4

#### Measurement

**Group ID:** BG001

**Spread:** 11.9

**Value:** 62.9

#### Measurement

**Group ID:** BG002

**Spread:** 11.6

**Value:** 63.4

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 165

**Group ID:** BG001

**Value:** 336

**Group ID:** BG002

**Value:** 501

**Class Title:** Global

#### Measurement

**Group ID:** BG000

**Spread:** 12.7

**Value:** 57.5

#### Measurement

**Group ID:** BG001

**Spread:** 12.0

**Value:** 55.3

#### Measurement

**Group ID:** BG002

**Spread:** 12.3

**Value:** 56.0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 61

**Group ID:** BG001

**Value:** 133

**Group ID:** BG002

**Value:** 194

**Class Title:** China

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 28

#### Measurement

**Group ID:** BG001

**Value:** 59

#### Measurement

**Group ID:** BG002

**Value:** 87

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 137

#### Measurement

**Group ID:** BG001

**Value:** 277

#### Measurement

**Group ID:** BG002

**Value:** 414

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 165

**Group ID:** BG001

**Value:** 336

**Group ID:** BG002

**Value:** 501

**Class Title:** Global

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 29

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 49

#### Measurement

**Group ID:** BG001

**Value:** 116

#### Measurement

**Group ID:** BG002

**Value:** 165

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 61

**Group ID:** BG001

**Value:** 133

**Group ID:** BG002

**Value:** 194

**Class Title:** China

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 13

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 149

#### Measurement

**Group ID:** BG001

**Value:** 306

#### Measurement

**Group ID:** BG002

**Value:** 455

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 21

#### Measurement

**Group ID:** BG002

**Value:** 33

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 165

**Group ID:** BG001

**Value:** 336

**Group ID:** BG002

**Value:** 501

**Class Title:** Global

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 61

#### Measurement

**Group ID:** BG001

**Value:** 133

#### Measurement

**Group ID:** BG002

**Value:** 194

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 61

**Group ID:** BG001

**Value:** 133

**Group ID:** BG002

**Value:** 194

**Class Title:** China

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 96

#### Measurement

**Group ID:** BG001

**Value:** 188

#### Measurement

**Group ID:** BG002

**Value:** 284

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 10

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 52

#### Measurement

**Group ID:** BG001

**Value:** 123

#### Measurement

**Group ID:** BG002

**Value:** 175

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 19

#### Measurement

**Group ID:** BG002

**Value:** 31

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 165

**Group ID:** BG001

**Value:** 336

**Group ID:** BG002

**Value:** 501

**Class Title:** Global

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 61

#### Measurement

**Group ID:** BG001

**Value:** 133

#### Measurement

**Group ID:** BG002

**Value:** 194

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 61

**Group ID:** BG001

**Value:** 133

**Group ID:** BG002

**Value:** 194

**Class Title:** China

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The Global population included 501 participants. The China population included 57 participants enrolled during the China Extension plus 137 Chinese participants from the Global population.
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
**Population Description:** The intent-to-treat (ITT) population included 558 participants (All) with 501 in the Global population. An additional 57 participants enrolled in the China Extension. The China population included 137 Chinese participants from the Global population plus 57 participants from the China Extension. The Global population and China population were analyzed separately.
## 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:** Hoffmann-La Roche
**Phone:** 800 821-8590
**Title:** Medical Communications
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.42
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.79
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** At CCOD 18 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0006
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.58
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.52
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.85
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** At CCOD 30 months; Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline alpha-fetoprotein (AFP: \<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0009
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.66
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.47
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.76
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.59
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 0.25
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.76
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** At CCOD 18 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0026
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.44
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.35
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.80
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** At CCOD 30 months; Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0019
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.53
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 0.40
**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:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0117
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.60
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 1.68
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.01
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 2.90
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 2.02
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.71
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 3.39
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 2.99
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 12.66
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 6.15
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 8
#### Analysis
**CI Lower Limit:** 0.08
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.70
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0051
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.23
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 9
#### Analysis
**CI Lower Limit:** 0.12
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.73
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0048
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.30
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 10
#### Analysis
**CI Lower Limit:** 0.16
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 2.15
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.4187
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.59
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 11
#### Analysis
**CI Lower Limit:** 0.46
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.74
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <.0001
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.59
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 12
#### Analysis
**CI Lower Limit:** 0.36
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.57
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <.0001
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.45
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 13
#### Analysis
**CI Lower Limit:** 0.53
**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:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0105
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.70
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 14
#### Analysis
**CI Lower Limit:** 0.52
**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:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0063
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.69
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 15
#### Analysis
**CI Lower Limit:** 0.35
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.57
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <.0001
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.44
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 16
#### Analysis
**CI Lower Limit:** 0.32
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.78
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0019
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.50
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.42
**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:** AFP \>/= 400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0879
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.67
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 17
#### Analysis
**CI Lower Limit:** 0.37
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.68
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** AFP\<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <.0001
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.50
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.53
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.15
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.2159
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.78
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 18
#### Analysis
**CI Lower Limit:** 0.31
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.57
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** AFP \<400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.42
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.35
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.73
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** AFP \>/=400 ng/mL and stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0002
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.51
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 19
#### Analysis
**CI Lower Limit:** 0.39
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.73
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Physical Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** <.0001
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.53
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.46
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.84
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Role Functioning: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0019
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.62
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.46
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.85
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** GHS/QoL: Stratified by geographic region (Asia \[excluding Japan\] vs. rest of world), macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0028
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.63
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 20
### Outcome Measure 21
### Outcome Measure 22
### Outcome Measure 23
### Outcome Measure 24
#### Analysis
**CI Lower Limit:** 1.53
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 13.86
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0036
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 4.60
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 25
#### Analysis
**CI Lower Limit:** 1.72
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 12.87
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0013
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 4.71
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 26
#### Analysis
**CI Lower Limit:** 1.47
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 17.39
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0052
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 5.05
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** 
### Outcome Measure 27
#### Analysis
**CI Lower Limit:** 0.02
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 5.85
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.4581
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.37
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 28
#### Analysis
**CI Lower Limit:** 0.01
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.91
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** Lower limit: \<0.01
**Group Description:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0100
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.08
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 29
#### Analysis
**CI Lower Limit:** 0.03
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.69
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.3477
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.33
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 30
#### Analysis
**CI Lower Limit:** 0.40
**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:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0103
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.59
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 31
#### Analysis
**CI Lower Limit:** 0.33
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.71
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0002
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.49
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 32
#### Analysis
**CI Lower Limit:** 0.43
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.07
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0927
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.68
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 33
#### Analysis
**CI Lower Limit:** 0.43
**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:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0861
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.67
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 34
#### Analysis
**CI Lower Limit:** 0.33
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.74
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0004
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.49
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 35
#### Analysis
**CI Lower Limit:** 0.26
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.78
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Physical Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0035
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.45
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.42
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.23
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Role Functioning: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.2214
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.71
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.32
**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:** GHS/QoL: Stratified by macrovascular invasion and/or extrahepatic spread (presence vs. absence), and baseline AFP (\<400 vs. \>/= 400 ng/mL).
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0135
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.53
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 36
### Outcome Measure 37
### Outcome Measure 38
### Outcome Measure 39
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 10.41
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 13.24
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 11.37
- **Spread:** 
- **Upper Limit:** 16.85
- **Value:** 13.40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 17.02
- **Spread:** 
- **Upper Limit:** 23.66
- **Value:** 19.22
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.98
- **Spread:** 
- **Upper Limit:** 5.55
- **Value:** 4.27
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.75
- **Spread:** 
- **Upper Limit:** 8.28
- **Value:** 6.83
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 6.74
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 11.37
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 13.50
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 6.74
- **Spread:** 
- **Upper Limit:** 16.07
- **Value:** 11.37
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 17.12
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 24.05
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.56
- **Spread:** 
- **Upper Limit:** 4.76
- **Value:** 3.19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.17
- **Spread:** 
- **Upper Limit:** 8.28
- **Value:** 5.72
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 7.35
- **Spread:** 
- **Upper Limit:** 18.03
- **Value:** 11.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 22.54
- **Spread:** 
- **Upper Limit:** 32.48
- **Value:** 27.3
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 8.42
- **Spread:** 
- **Upper Limit:** 19.60
- **Value:** 13.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 28.13
- **Spread:** 
- **Upper Limit:** 38.64
- **Value:** 33.2
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.54
- **Spread:** 
- **Upper Limit:** 10.16
- **Value:** 5.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 21.01
- **Spread:** 
- **Upper Limit:** 30.61
- **Value:** 25.6
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 4.67
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 6.28
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 4.86
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 6.28
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 5.39
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 13.08
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 13.08
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.98
- **Spread:** 
- **Upper Limit:** 5.45
- **Value:** 4.24
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.72
- **Spread:** 
- **Upper Limit:** 7.69
- **Value:** 6.83
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.76
- **Spread:** 
- **Upper Limit:** 4.17
- **Value:** 2.89
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.68
- **Spread:** 
- **Upper Limit:** 8.44
- **Value:** 7.06
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.21
- **Spread:** 
- **Upper Limit:** 7.72
- **Value:** 5.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.83
- **Spread:** 
- **Upper Limit:** 9.86
- **Value:** 8.57
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.21
- **Spread:** 
- **Upper Limit:** 7.69
- **Value:** 5.55
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.80
- **Spread:** 
- **Upper Limit:** 9.86
- **Value:** 8.28
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.83
- **Spread:** 
- **Upper Limit:** 4.30
- **Value:** 3.98
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.93
- **Spread:** 
- **Upper Limit:** 9.92
- **Value:** 8.54
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 11.73
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 13.93
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 104
- **Group ID:** OG001
- **Value:** 210
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 5.75
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 9.10
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 10.15
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 12.78
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 61
- **Group ID:** OG001
- **Value:** 126
**Units:** Participants
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.01
- **Spread:** 
- **Upper Limit:** 6.21
- **Value:** 4.40
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 6.83
- **Spread:** 
- **Upper Limit:** 11.04
- **Value:** 8.28
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 104
- **Group ID:** OG001
- **Value:** 210
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.76
- **Spread:** 
- **Upper Limit:** 5.26
- **Value:** 4.14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.94
- **Spread:** 
- **Upper Limit:** 6.77
- **Value:** 5.19
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 61
- **Group ID:** OG001
- **Value:** 126
**Units:** Participants
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.79
- **Spread:** 
- **Upper Limit:** 5.62
- **Value:** 3.98
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.06
- **Spread:** 
- **Upper Limit:** 9.66
- **Value:** 8.41
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 104
- **Group ID:** OG001
- **Value:** 210
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.58
- **Spread:** 
- **Upper Limit:** 3.98
- **Value:** 2.79
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.17
- **Spread:** 
- **Upper Limit:** 6.90
- **Value:** 5.42
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 61
- **Group ID:** OG001
- **Value:** 126
**Units:** Participants
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.48
- **Spread:** 
- **Upper Limit:** 6.24
- **Value:** 4.86
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 9.69
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 13.14
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.20
- **Spread:** 
- **Upper Limit:** 5.98
- **Value:** 3.58
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 6.51
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 9.13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.02
- **Spread:** 
- **Upper Limit:** 6.97
- **Value:** 3.58
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 5.98
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 11.24
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 154
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 322
**Title:** 
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 132
- **Upper Limit:** 
- **Value:** 398
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 50.2
- **Upper Limit:** 
- **Value:** 79.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 298
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 55.4
- **Upper Limit:** 
- **Value:** 101
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 41
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 63.7
- **Upper Limit:** 
- **Value:** 131
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 263
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 61.7
- **Upper Limit:** 
- **Value:** 145
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 134
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 82.9
- **Upper Limit:** 
- **Value:** 168
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 153
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 65.0
- **Upper Limit:** 
- **Value:** 167
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 124
**Units:** Participants
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 316
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 318
**Units:** Participants
#### Outcome Measure 24
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.85
- **Spread:** 
- **Upper Limit:** 16.20
- **Value:** 6.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 17.49
- **Spread:** 
- **Upper Limit:** 32.94
- **Value:** 24.6
**Title:** 
#### Outcome Measure 25
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.81
- **Spread:** 
- **Upper Limit:** 18.68
- **Value:** 8.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 21.94
- **Spread:** 
- **Upper Limit:** 38.40
- **Value:** 29.7
**Title:** 
#### Outcome Measure 26
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.03
- **Spread:** 
- **Upper Limit:** 13.71
- **Value:** 4.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 14.47
- **Spread:** 
- **Upper Limit:** 28.97
- **Value:** 21.1
**Title:** 
#### Outcome Measure 27
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 4.86
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 8.15
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 28
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 4.47
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 4.86
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 8.15
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 29
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 4.17
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 5.55
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 30
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.56
- **Spread:** 
- **Upper Limit:** 4.76
- **Value:** 3.19
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.17
- **Spread:** 
- **Upper Limit:** 8.11
- **Value:** 5.72
**Title:** 
#### Outcome Measure 31
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.73
- **Spread:** 
- **Upper Limit:** 3.98
- **Value:** 2.83
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.21
- **Spread:** 
- **Upper Limit:** 8.34
- **Value:** 5.55
**Title:** 
#### Outcome Measure 32
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.76
- **Spread:** 
- **Upper Limit:** 10.15
- **Value:** 4.14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.45
- **Spread:** 
- **Upper Limit:** 9.49
- **Value:** 7.00
**Title:** 
#### Outcome Measure 33
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.76
- **Spread:** 
- **Upper Limit:** 10.15
- **Value:** 4.14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.45
- **Spread:** 
- **Upper Limit:** 9.49
- **Value:** 7.00
**Title:** 
#### Outcome Measure 34
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.79
- **Spread:** 
- **Upper Limit:** 4.17
- **Value:** 2.83
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 5.32
- **Spread:** 
- **Upper Limit:** 9.33
- **Value:** 6.83
**Title:** 
#### Outcome Measure 35
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 2.10
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 5.62
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 9.69
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 13.14
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG000
- **Lower Limit:** 2.14
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 7.20
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.48
- **Spread:** 
- **Upper Limit:** 9.82
- **Value:** 3.58
- **Comment:** NA = not estimable due to the limited number of events observed
- **Group ID:** OG001
- **Lower Limit:** 6.24
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 9.76
**Title:** 
#### Outcome Measure 36
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 131
**Title:** 
#### Outcome Measure 37
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 153
- **Upper Limit:** 
- **Value:** 456
**Title:** 
#### Outcome Measure 38
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 65.7
- **Upper Limit:** 
- **Value:** 92.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 87
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 36.8
- **Upper Limit:** 
- **Value:** 105
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 61.4
- **Upper Limit:** 
- **Value:** 143
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 80
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 61.9
- **Upper Limit:** 
- **Value:** 177
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 97.6
- **Upper Limit:** 
- **Value:** 201
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 20
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 79.4
- **Upper Limit:** 
- **Value:** 208
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 13
**Units:** Participants
#### Outcome Measure 39
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1.1
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 90
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 20.2
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 89
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** OS was defined as the time from randomization to death from any cause.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
**Title:** Overall Survival (OS) in the Global Population
**Type:** PRIMARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 2
**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Progression Free Survival by Independent Review Facility-Assessment (PFS-IRF) Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in the Global Population
**Type:** PRIMARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 3
**Description:** OS was defined as the time from randomization to death from any cause.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** From randomization to death from any cause up to the clinical cut off date (CCOD) of 29Aug2019 (up to approximately 18 months) and 31Aug2020 (up to approximately 30 months)
**Title:** Overall Survival (OS) in the China Population
**Type:** PRIMARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 4
**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause whichever occurs first as determined by an IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** PFS-IRF Per RECIST v1.1 in the China Population
**Type:** PRIMARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 5
**Description:** ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Global ITT population with measurable disease at baseline consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the Global Population
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 6
**Description:** ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Global ITT population with measurable disease at baseline consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the Global Population
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 7
**Description:** ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** Global ITT population with measurable disease at baseline consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the Global Population
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 8
**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The analysis population included Global participants with a confirmed response (CR or PR).
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 9
**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The analysis population included Global participants with a confirmed response (CR or PR).
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 10
**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The analysis population included Global participants with a confirmed response (CR or PR).
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 11
**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** PFS-IRF Per HCC mRECIST in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 12
**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 13
**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 14
**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** TTP-IRF Per HCC mRECIST in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 15
**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 16
**Description:** OS was defined as the time from randomization to death from any cause. Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Population Description:** Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** From randomization to death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Overall Survival by Baseline AFP in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 17
**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** PFS-IRF Per RECIST v1.1 by Baseline AFP in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 18
**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm). Subpopulations with baseline AFP \<400 ng/mL and AFP\>/= 400 ng/mL were analyzed.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** PFS-INV Per RECIST v1.1 by Baseline AFP in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 19
**Description:** TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** Global ITT population consisted of all randomized participants in the Global population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Time to Deterioration (TTD) in the Global Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 20
**Description:** An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Global safety population included all randomized Global participants who received any amount of study drug with participants grouped according to the treatment the participant actually received.
**Reporting Status:** POSTED
**Time Frame:** Up to end of study (up to approximately 56 months)
**Title:** Number of Participants With Adverse Events (AEs) in the Global Population
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - Global
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 21
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The Global pharmacokinetic (PK)-evaluable population was defined as all participants in the Global population who received any dose of study treatment and who had at least one post-baseline PK sample available.
**Reporting Status:** POSTED
**Time Frame:** Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
**Title:** Maximum Serum Concentration (Cmax) of Atezolizumab at Cycle 1 in the Global Population
**Type:** SECONDARY
**Unit of Measure:** micrograms/milliliter (mcg/mL)
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 22
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The Global pharmacokinetic (PK)-evaluable population was defined as all participants in the Global population who received any dose of study treatment and who had at least one post-baseline PK sample available.
**Reporting Status:** POSTED
**Time Frame:** Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
**Title:** Trough Serum Concentration (Cmin) of Atezolizumab in the Global Population
**Type:** SECONDARY
**Unit of Measure:** mcg/mL
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 23
**Parameter Type:** NUMBER
**Population Description:** The Global ADA-evaluable population was defined as all participants in the Global population who received any dose of atezolizumab and who had at least one post-baseline ADA assessment.
**Reporting Status:** POSTED
**Time Frame:** Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 30 months)
**Title:** Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the Global Population
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 24
**Description:** ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** China ITT population with measurable disease at baseline consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Objective Response Rate by IRF-Assessment (ORR-IRF) Per RECIST v1.1 in the China Population
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 25
**Description:** ORR was defined as the percentage of participants with CR or PR as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver measuring only the residual vital tumor mass in the liver. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** China ITT population with measurable disease at baseline consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Objective Response Rate by IRF-Assessment (ORR-IRF) Per Hepatocellular Carcinoma (HCC) Modified RECIST (mRECIST) in the China Population
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 26
**Description:** ORR was defined as the percentage of participants with CR or PR as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** China ITT population with measurable disease at baseline consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment, and had measurable disease at baseline.
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** ORR by Investigator-Assessment (ORR-INV) Per RECIST v1.1 in the China Population
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 27
**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The analysis population included China participants with a confirmed response (CR or PR).
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Duration of Response by IRF-Assessment (DOR-IRF) Per RECIST v1.1 in the China Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 28
**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The analysis population included China participants with a confirmed response (CR or PR).
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Duration of Response by IRF Assessment (DOR-IRF) Per HCC mRECIST in the China Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 29
**Description:** DOR was defined as the time interval from the date of first occurrence of a documented objective response (CR or PR, whichever status is recorded first) until the first date that disease progression (PD) or death was documented, whichever occurs first as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 mm.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The analysis population included China participants with a confirmed response (CR or PR).
**Reporting Status:** POSTED
**Time Frame:** Randomization up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Duration of Response by Investigator Assessment (DOR-INV) Per RECIST v1.1 in the China Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 30
**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** PFS-IRF Per HCC mRECIST in the China Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 31
**Description:** PFS was defined as the time from randomization to the first occurrence of progressive disease or death from any cause whichever occurs first as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** PFS by Investigator Assessment (PFS-INV) Per RECIST v1.1 in the China Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 32
**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Time to Progression (TTP) by IRF Assessment (TTP-IRF) Per RECIST v1.1 in the China Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 33
**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the IRF according to HCC mRECIST. HCC mRECIST differentiates between vital tumor and necrotic areas in the liver, measuring only the residual vital tumor mass in the liver. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** TTP-IRF Per HCC mRECIST in the China Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 34
**Description:** Time to progression was defined as the time from the date of randomization to the date of the first documented tumor progression as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** TTP by Investigator Assessment (TTP-INV) Per RECIST v1.1 in the China Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 35
**Description:** TTD was defined as the time from randomization to the first deterioration (decrease from baseline of \>/= 10 points) in the patient-reported health-related global health status/quality of life (GHS /HRQoL), physical function or role function scales of the European Organization for Research and Treatment of Cancer quality-of-life questionnaire for cancer (EORTC) QLQ-C30, maintained for two consecutive assessments, or one assessment followed by death from any cause within 3 weeks.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** China ITT population consisted of all randomized participants in the China population, whether or not the participant had received the assigned study treatment.
**Reporting Status:** POSTED
**Time Frame:** Randomization to the first occurrence of disease progression or death from any cause up to CCOD of 29Aug2019 (up to approximately 18 months)
**Title:** Time to Deterioration (TTD) in the China Population
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 36
**Description:** An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** China safety population included all randomized China participants who received any amount of study drug with participants grouped according to the treatment the participant actually received.
**Reporting Status:** POSTED
**Time Frame:** Up to end of study (up to approximately 56 months)
**Title:** Number of Participants With Adverse Events (AEs) in the China Population
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Sorafenib - China
##### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Outcome Measure 37
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The China PK-evaluable population was defined as all participants in the China population who received any dose of study treatment and who had at least one post-baseline PK sample available.
**Reporting Status:** POSTED
**Time Frame:** Post-dose on Day 1 of Cycle 1 (cycle length = 21 days)
**Title:** Maximum Serum Concentration (Cmax) of Atezolizumab in the China Population
**Type:** SECONDARY
**Unit of Measure:** mcg/mL
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 38
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The China PK-evaluable population was defined as all participants in the China population who received any dose of study treatment and who had at least one post-baseline PK sample available.
**Reporting Status:** POSTED
**Time Frame:** Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length = 21 days)
**Title:** Trough Serum Concentration (Cmin) of Atezolizumab in the China Population
**Type:** SECONDARY
**Unit of Measure:** mcg/mL
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Atezolizumab + Bevacizumab - China
#### Outcome Measure 39
**Parameter Type:** NUMBER
**Population Description:** The China ADA-evaluable population was defined as all participants in the China population who received any dose of atezolizumab and who had at least one post-baseline ADA assessment.
**Reporting Status:** POSTED
**Time Frame:** Baseline and post-baseline on Day 1 (pre-dose) of Cycles 2, 3, 4, 8, 12, 16 (cycle length = 21 days) and treatment discontinuation visit (up to approximately 18 months)
**Title:** Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab in the China Population
**Type:** SECONDARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** OG000
**Title:** Atezolizumab + Bevacizumab - China
### Participant Flow Module
#### Group
**Description:** Participants in the Global population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** FG000
**Title:** Sorafenib - Global
#### Group
**Description:** Participants in the Global population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** FG001
**Title:** Atezolizumab + Bevacizumab - Global
#### Group
**Description:** Participants in the China population received sorafenib until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** FG002
**Title:** Sorafenib - China
#### Group
**Description:** Participants in the China population received Atezolizumab + Bevacizumab until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
**ID:** FG003
**Title:** Atezolizumab + Bevacizumab - China
#### Period
**Title:** Global Period
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 6
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 115
###### Reason
**Group ID:** FG001
**Number of Subjects:** 228
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 20
###### Reason
**Group ID:** FG001
**Number of Subjects:** 21
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Reason Unspecified
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Study Ended by Sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 26
###### Reason
**Group ID:** FG001
**Number of Subjects:** 80
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 165
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 336
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 165
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 336
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
#### Period
**Title:** China Extension Period
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
###### Reason
**Group ID:** FG003
**Number of Subjects:** 3
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 46
###### Reason
**Group ID:** FG003
**Number of Subjects:** 88
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 8
###### Reason
**Group ID:** FG003
**Number of Subjects:** 6
##### Withdraw
**Type:** Study Ended by Sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 5
###### Reason
**Group ID:** FG003
**Number of Subjects:** 36
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 61
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 133
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 61
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 133
**Pre-Assignment Details:** The total study population included 558 participants. The Global population included 501 participants. An additional 57 participants enrolled during the China Extension. The total China population included 137 Chinese participants from the Global population plus 57 participants from the China extension. 137 participants were part of the Global as well as China populations. Separate analyses were performed for the Global population and the China population in the study.
**Recruitment Details:** Participants were enrolled at 117 sites in 17 countries: Australia, Canada, China, Czech Republic, Germany, Spain, France, United Kingdom, Hong Kong, Italy, Japan, Republic of Korea, Poland, Russian Federation, Singapore, Taiwan, United States.
**Has Results:** True