## Protocol Section
### Identification Module
**NCT ID:** NCT02751879

**Brief Title:** Real World Data on Gi(l)Otrif® Dose Adjustment

**Official Title:** Real-world Data on Gi(l)Otrif® Dose Adjustment in First-line Treatment, TKI-naïve, Advanced Non-small Cell Lung Cancer Patients With EGFR Activating Mutations

#### Organization Study ID Info
**ID:** 1200.270
#### Organization
**Class:** INDUSTRY
**Full Name:** Boehringer Ingelheim
### Status Module
#### Completion Date
**Date:** 2017-09-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-08-08

**Type:** ACTUAL

**Last Update Submit Date:** 2019-06-24

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-09-30

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-08-08

**Type:** ACTUAL

**Results First Submit Date:** 2018-09-12

**Results First Submit QC Date:** 2019-06-24

#### Start Date
**Date:** 2016-11-24

**Type:** ACTUAL

**Status Verified Date:** 2019-06

#### Study First Post Date
**Date:** 2016-04-26
**Type:** ESTIMATED
**Study First Submit Date:** 2016-04-22
**Study First Submit QC Date:** 2016-04-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Boehringer Ingelheim

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.

### Conditions Module

**Conditions:**

- Carcinoma, Non-Small-Cell Lung

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 228

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), TKI-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label

**Label:** Non small cell lung cancer (NSCLC)

### Outcomes Module

#### Primary Outcomes

**Description:** An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. Grade 1, Grade 2, Grade 3 and Grade 4 ADR severity classes were considered for assessment of this outcome.

**Measure:** Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.

**Time Frame:** From signing the informed consent onwards until the end of the study, up to 104 weeks.

**Description:** Time on treatment with Gi(l)otrif® in real-world setting has been calculated in this assessment. Time on treatment refers to time to treatment failure with Gi(l)otrif®

**Measure:** Time on Treatment With Gi(l)Otrif®

**Time Frame:** From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.

**Description:** Time to progression was calculated from the date of first dose of Gi(l)otrif® treatment to the earliest date of documented progression (clinical, radiographic or both clinical/radiographic progression) or tumour-related death, whatever occurred first.

**Measure:** Time to Progression With Gi(l)Otrif®

**Time Frame:** From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.

#### Secondary Outcomes

**Description:** Percentage of patients with a modified starting dose that is dose other than the recommended 40 mg daily of Gi(l)otrif® has been calculated to assess this outcome measure.

**Measure:** Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif®

**Time Frame:** From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.

**Description:** Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily.

**Measure:** Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif®

**Time Frame:** From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria:

1. Age = 18 years
2. Patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), tyrosine kinase inhibitors (TKI)-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label
3. Signed and dated written informed consent per regulations. (Exemption of a written informed consent for retrospective observational studies in some countries per local regulations and legal requirements.)

Exclusion criteria:

1. Any contraindication to Gi(l)otrif® as specified in label.
2. Patients with uncommon mutations are excluded as uncommon mutations are not within label in all participating countries (e.g. USA).
3. Patients still on treatment with Gi(l)otrif® will be excluded unless treatment period is \> or = 6 months.
4. Patients treated with Gi(l)otrif® within an interventional trial.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** NSCLC patients

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bronx

**Country:** United States

**Facility:** Montefiore Medical Center

**State:** New York

**Zip:** 10461

**Location 2:**

**City:** Charlotte

**Country:** United States

**Facility:** Levine Cancer Institute

**State:** North Carolina

**Zip:** 28201

**Location 3:**

**City:** Wien

**Country:** Austria

**Facility:** SMZ Baumgartner Hoehe Otto Wagner Spital

**Zip:** 1140

**Location 4:**

**City:** Vancouver

**Country:** Canada

**Facility:** BC Cancer Agency - Vancouver

**State:** British Columbia

**Zip:** V5Z 4E6

**Location 5:**

**City:** Besancon

**Country:** France

**Facility:** HOP Jean Minjoz

**Zip:** 25030

**Location 6:**

**City:** Dijon Cedex

**Country:** France

**Facility:** HOP Dijon, Cardio-Pneumo, Dijon

**Zip:** 21079

**Location 7:**

**City:** Paris

**Country:** France

**Facility:** HOP Européen G. Pompidou

**Zip:** 75908

**Location 8:**

**City:** Paris

**Country:** France

**Facility:** HOP Tenon

**Zip:** 75970

**Location 9:**

**City:** Essen

**Country:** Germany

**Facility:** Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

**Zip:** 45147

**Location 10:**

**City:** Nürnberg

**Country:** Germany

**Facility:** Klinikum Nürnberg

**Zip:** 90419

**Location 11:**

**City:** Oldenburg

**Country:** Germany

**Facility:** Pius-Hospital, Oldenburg

**Zip:** 26121

**Location 12:**

**City:** Alessandria

**Country:** Italy

**Facility:** Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

**Zip:** 15121

**Location 13:**

**City:** Lecce

**Country:** Italy

**Facility:** Azienda Ospedaliera Vito Fazzi

**Zip:** 73100

**Location 14:**

**City:** Aichi, Nagoya

**Country:** Japan

**Facility:** Aichi Cancer Center Hospital

**Zip:** 464-8681

**Location 15:**

**City:** Okayama, Kurashiki

**Country:** Japan

**Facility:** Kurashiki Central Hospital

**Zip:** 710-8602

**Location 16:**

**City:** Daegu

**Country:** Korea, Republic of

**Facility:** Yeungnam University Medical Center

**Zip:** 705-703

**Location 17:**

**City:** Jeonju

**Country:** Korea, Republic of

**Facility:** Chonbuk National University Hospital

**Zip:** 54907

**Location 18:**

**City:** Pusan

**Country:** Korea, Republic of

**Facility:** Pusan National Univ. Hosp

**Zip:** 49241

**Location 19:**

**City:** Ciudad De México

**Country:** Mexico

**Facility:** Centro Medico ABC

**Zip:** 01120

**Location 20:**

**City:** Monterrey

**Country:** Mexico

**Facility:** Organización para Cuidado Integral en Oncología S.A de C.V

**Zip:** 64060

**Location 21:**

**City:** Zapopan

**Country:** Mexico

**Facility:** Unidad de Cancerologia

**Zip:** 45050

**Location 22:**

**City:** Bydgoszcz

**Country:** Poland

**Facility:** Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz

**Zip:** 85796

**Location 23:**

**City:** Cracow

**Country:** Poland

**Facility:** Grzegorz Czyzewicz Specialised Medical Practice, Cracow

**Zip:** 31331

**Location 24:**

**City:** Poznan

**Country:** Poland

**Facility:** Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland

**Zip:** 60-569

**Location 25:**

**City:** Singapore

**Country:** Singapore

**Facility:** National University Hospital

**Zip:** 119228

**Location 26:**

**City:** Singapore

**Country:** Singapore

**Facility:** National Cancer Centre

**Zip:** 169610

**Location 27:**

**City:** Badalona (Barcelona)

**Country:** Spain

**Facility:** Hospital Germans Trias i Pujol

**Zip:** 08916

**Location 28:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital La Princesa

**Zip:** 28006

**Location 29:**

**City:** Taichung

**Country:** Taiwan

**Facility:** China Medical University Hospital

**Zip:** 40447

#### Overall Officials

**Official 1:**

**Affiliation:** Boehringer Ingelheim

**Name:** Boehringer Ingelheim

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Halmos B, Tan EH, Soo RA, Cadranel J, Lee MK, Foucher P, Hsia TC, Hochmair M, Griesinger F, Hida T, Kim E, Melosky B, Marten A, Carcereny E. Impact of afatinib dose modification on safety and effectiveness in patients with EGFR mutation-positive advanced NSCLC: Results from a global real-world study (RealGiDo). Lung Cancer. 2019 Jan;127:103-111. doi: 10.1016/j.lungcan.2018.10.028. Epub 2018 Nov 2.

**PMID:** 30642537

## Document Section

### Large Document Module

#### Large Docs

- Date: 2016-03-01

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 1535334

- Type Abbrev: Prot

- Upload Date: 2018-09-11T09:50

- Date: 2018-01-17

- Filename: SAP_001.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 118143

- Type Abbrev: SAP

- Upload Date: 2018-09-11T09:50

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Carcinoma, Non-Small-Cell Lung

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11900

- Name: Mitogens

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Full Analysis set (FAS): All registered patients with informed consent (as applicable with local regulations) and at least one administration of Gi(l) otrif® was used for this assessment. This was a single-arm retrospective analysis.

#### Event Groups

**Group ID:** EG000

**Title:** Gi(l)Otrif ≥ 40 mg

**Deaths Num Affected:** 8

**Deaths Num At Risk:** 157

**Description:** Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily.

**ID:** EG000

**Other Num Affected:** 147

**Other Num at Risk:** 157

**Serious Number Affected:** 11

**Serious Number At Risk:** 157

**Title:** Gi(l)Otrif ≥ 40 mg

**Group ID:** EG001

**Title:** Gi(l)Otrif ≤ 30 mg

**Deaths Num At Risk:** 71

**Description:** Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily.

**ID:** EG001

**Other Num Affected:** 68

**Other Num at Risk:** 71

**Serious Number Affected:** 7

**Serious Number At Risk:** 71

**Title:** Gi(l)Otrif ≤ 30 mg

**Frequency Threshold:** 5

#### Other Events

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

**Term:** Paronychia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.1

**Term:** Rash pustular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.1

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

**Term:** Dermatitis acneiform

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

**Term:** Dry skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

**Term:** Rash maculo-papular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

**Term:** Dysgeusia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 20.1

**Term:** Nail ridging

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

#### Serious Events

**Term:** Leukocytosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 157

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 71

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Gastrooesophageal reflux disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 157

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 71

**Term:** Pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Sudden death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 157

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 71

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Hypoxia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Pneumonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Term:** Embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 20.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 157

**Group ID:** EG001

**Num At Risk:** 71

**Time Frame:** From signing the informed consent onwards until the end of the study, up to 104 weeks.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 157

**Group ID:** BG001

**Value:** 71

**Group ID:** BG002

**Value:** 228

**Units:** Participants

### Group

**ID:** BG000

**Title:** Gi(l)Otrif ≥ 40 mg

**Description:** Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily.

### Group

**ID:** BG001

**Title:** Gi(l)Otrif ≤ 30 mg

**Description:** Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 12.00

**Value:** 64.50

#### Measurement

**Group ID:** BG001

**Spread:** 10.84

**Value:** 68.10

#### Measurement

**Group ID:** BG002

**Spread:** 11.74

**Value:** 65.62

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 90

#### Measurement

**Group ID:** BG001

**Value:** 48

#### Measurement

**Group ID:** BG002

**Value:** 138

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 67

#### Measurement

**Group ID:** BG001

**Value:** 23

#### Measurement

**Group ID:** BG002

**Value:** 90

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 25

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 120

#### Measurement

**Group ID:** BG001

**Value:** 56

#### Measurement

**Group ID:** BG002

**Value:** 176

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 27

**Category Title:** Unknown or Not Reported

**Class Title:** 

### 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:** 74

#### Measurement

**Group ID:** BG001

**Value:** 26

#### Measurement

**Group ID:** BG002

**Value:** 100

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

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

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 59

#### Measurement

**Group ID:** BG001

**Value:** 37

#### Measurement

**Group ID:** BG002

**Value:** 96

**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:** 22

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 29

**Category Title:** Unknown or Not Reported

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Description:** Age of all patients included in the trial
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** FAS
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Description:** Gender distribution of all patients included in the trial.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** FAS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Description:** Ethnicity of all patients included in the trial.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** FAS
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Description:** Race of all patients included in the trial.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** FAS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
**Population Description:** Full analysis set (FAS): All registered patients with informed consent (as applicable with local regulations) and at least one administration of Gi(l)otrif®.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** Due to non-interventional character there were no predefined examinations, retro- and prospective data could be collected, bias regarding AE documentation, participation of patients on treatment was limited due to one exclusion criterion
### Point of Contact
**Email:** clintriage.rdg@boehringer-ingelheim.com
**Organization:** Boehringer Ingelheim
**Phone:** 1-800-243-0127
**Title:** Boehringer Ingelheim, Call Center
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21.02
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 21.13
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44.59
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 57.75
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 24.84
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16.90
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3.18
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.00
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 14.61
- **Spread:** 
- **Upper Limit:** 21.51
- **Value:** 18.22
- **Comment:** The upper limit of the Confidence Interval has not being reached.
- **Group ID:** OG001
- **Lower Limit:** 12.93
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 19.41
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 18.22
- **Spread:** 
- **Upper Limit:** 23.98
- **Value:** 20.03
- **Comment:** The upper limit of the Confidence Interval has not being reached.
- **Group ID:** OG001
- **Lower Limit:** 17.3
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 25.92
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.74
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94.52
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.74
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 38.03
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5.63
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15.49
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40.85
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. Grade 1, Grade 2, Grade 3 and Grade 4 ADR severity classes were considered for assessment of this outcome.
**Parameter Type:** NUMBER
**Population Description:** Full Analysis set (FAS): All registered patients with informed consent (as applicable with local regulations) and at least one administration of Gi(l)otrif®.
**Reporting Status:** POSTED
**Time Frame:** From signing the informed consent onwards until the end of the study, up to 104 weeks.
**Title:** Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.
**Type:** PRIMARY
**Unit of Measure:** Percentage of patients (%)
##### Group
**Description:** Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily.
**ID:** OG000
**Title:** Gi(l)Otrif ≥ 40 mg
##### Group
**Description:** Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily.
**ID:** OG001
**Title:** Gi(l)Otrif ≤ 30 mg
#### Outcome Measure 2
**Description:** Time on treatment with Gi(l)otrif® in real-world setting has been calculated in this assessment. Time on treatment refers to time to treatment failure with Gi(l)otrif®
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** FAS
**Reporting Status:** POSTED
**Time Frame:** From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
**Title:** Time on Treatment With Gi(l)Otrif®
**Type:** PRIMARY
**Unit of Measure:** Months
##### Group
**Description:** Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily.
**ID:** OG000
**Title:** Gi(l)Otrif ≥ 40 mg
##### Group
**Description:** Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily.
**ID:** OG001
**Title:** Gi(l)Otrif ≤ 30 mg
#### Outcome Measure 3
**Description:** Time to progression was calculated from the date of first dose of Gi(l)otrif® treatment to the earliest date of documented progression (clinical, radiographic or both clinical/radiographic progression) or tumour-related death, whatever occurred first.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** FAS
**Reporting Status:** POSTED
**Time Frame:** From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
**Title:** Time to Progression With Gi(l)Otrif®
**Type:** PRIMARY
**Unit of Measure:** Months
##### Group
**Description:** Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily.
**ID:** OG000
**Title:** Gi(l)Otrif ≥ 40 mg
##### Group
**Description:** Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily.
**ID:** OG001
**Title:** Gi(l)Otrif ≤ 30 mg
#### Outcome Measure 4
**Description:** Percentage of patients with a modified starting dose that is dose other than the recommended 40 mg daily of Gi(l)otrif® has been calculated to assess this outcome measure.
**Parameter Type:** NUMBER
**Population Description:** FAS
**Reporting Status:** POSTED
**Time Frame:** From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
**Title:** Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif®
**Type:** SECONDARY
**Unit of Measure:** Percentage of patients (%)
##### Group
**Description:** All patients who were treated with starting dose other than recommended dose of 40 mg Gi(l)otrif treatment once daily.
**ID:** OG000
**Title:** Modified Starting Dose of Gi(l)Otrif
#### Outcome Measure 5
**Description:** Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily.
**Parameter Type:** NUMBER
**Population Description:** FAS
**Reporting Status:** POSTED
**Time Frame:** From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
**Title:** Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif®
**Type:** SECONDARY
**Unit of Measure:** Percentage of patients (%)
##### Group
**Description:** All patients who were treated with modified dose of 50 mg Gi(l)otrif treatment once daily.
**ID:** OG000
**Title:** Modified Dose of 50 mg Gi(l)Otrif
##### Group
**Description:** All patients who were treated with modified starting dose of less than of equal to 30 mg Gi(l)otrif treatment once daily.
**ID:** OG001
**Title:** Modified Dose of ≤ 30 mg Gi(l)Otrif
### Participant Flow Module
#### Group
**Description:** Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily.
**ID:** FG000
**Title:** Gi(l)Otrif ≥ 40 mg
#### Group
**Description:** Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily.
**ID:** FG001
**Title:** Gi(l)Otrif ≤ 30 mg
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 157
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 71
##### Milestone
**Type:** On Treatment at Study Completion
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 81
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 41
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 157
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 71
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Pre-Assignment Details:** All patients were screened for eligibility to participate in the study. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to study if any of the specific entry criteria were violated.
**Recruitment Details:** This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® tablet once daily as indicated in the approved labels. Between December 2016 and October 2017, 231 patients were screened for study participation and 228 patients were treated.
**Has Results:** True