LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Ver... | NCT01523587

ID	Type	Description	Link
2011-002380-24	EudraCT Number

Label	Type	Description	Intervention Names
Afatinib	Experimental	Patients receive afatinib tablets once daily	Drug: afatinib
Erlotinib	Active Comparator	Patients receive erlotinib tablets once daily	Drug: erlotinib

Name	Type	Description	Arm Group Labels	Other Names
afatinib	Drug	Afatinib taken once daily, continuously until disease progression or unacceptable toxicity.	Afatinib

Measure	Description	Time Frame
Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1	Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).

Measure	Description	Time Frame
Overall Survival	Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint.	From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).
Number of Participants With Objective Response According to RECIST 1.1

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Ironwood Cancer and Research Centers		Chandler	Arizona	85224	United States
University of California

PubMed Identifier	Type	Citation	Retractions
30573970	Derived	Lu S, Li W, Zhou C, Hu CP, Qin S, Cheng G, Feng J, Wang J, Cseh A, Peil B, Gibson N, Ehrnrooth E, Zhang L. Afatinib vs erlotinib for second-line treatment of Chinese patients with advanced squamous cell carcinoma of the lung. Onco Targets Ther. 2018 Nov 30;11:8565-8573. doi: 10.2147/OTT.S161506. eCollection 2018.
29902295	Derived

ID	Title	Description
FG000	Afatinib	Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 24, 2016	Dec 19, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1

Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Randomized Set (RS): All patients who were randomized, regardless of whether they received investigational treatment.

Posted

Median

95% Confidence Interval

Months

First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).

ID	Title	Description
OG000	Afatinib	Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
OG001	Erlotinib	Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

Units	Counts
Participants	OG000398 OG001397

Title

Denominators

Categories

Title	Measurements
	OG0002.63(2.00 to 2.86) OG0011.94(1.87 to 2.10)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	A Cox proportional hazards model without the randomization stratification variable was used for each subgroup category, along with the corresponding log-rank test.	Log Rank		0.0103	P-value from log-rank stratified by Race (two-sided). Hazard ratio (Afatinib vs Erlotinib) from Cox proportional hazards model stratified by Race.	Hazard Ratio (HR)	0.814			2-Sided	95	0.693	0.956					Superiority or Other

Secondary

Overall Survival

Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint.

Posted

Median

95% Confidence Interval

Months

From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

ID	Title	Description
OG000	Afatinib	Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
OG001	Erlotinib	Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

Units	Counts
Participants

Secondary

Number of Participants With Objective Response According to RECIST 1.1

A patient with a best overall response of Complete Responder (CR) or Partial Responder (PR) was considered to show objective response to study medication. For patients with an objective response, time to objective response was defined as the time from randomization to the first objective response; duration of objective response was defined as the time from the first objective response to progression (or death if the patient died before progression). Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Posted

Number

Participants

First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).

ID	Title	Description
OG000	Afatinib	Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
OG001	Erlotinib	Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

Secondary

Number of Participants With Disease Control According to RECIST 1.1

Disease control was assessed based on Independent Radiologic Review (IRR) and investigator assessment. A patient with a best overall response of CR, PR, or Stable Disease (SD) was considered to have disease control. Patients with no baseline target lesions who had no evidence of disease progression in their non-target lesions and had no new lesions were considered to have disease control. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Posted

Number

Participants

First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).

ID	Title	Description
OG000	Afatinib	Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
OG001	Erlotinib	Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

Secondary

Tumour Shrinkage

Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review. The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation.

A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size.

Post-baseline mean is adjusted for baseline sum of diameters and race.

Patients from the randomised set with tumour assessments are considered for the analysis of this endpoint.

Posted

Least Squares Mean

Standard Error

Millimeter (mm)

First treatment administration up until cut off date of 02 March 2015 (up to 1058 days).

ID	Title	Description
OG000	Afatinib	Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
OG001	Erlotinib	Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

Secondary

Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire

Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time.

Posted

Number

Participants

From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

ID	Title	Description
OG000	Afatinib	Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
OG001	Erlotinib

Secondary

Summary of Time to Deterioration in Coughing, Dyspnoea and Pain.

Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration.

Posted

Median

95% Confidence Interval

Months

From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

ID	Title	Description
OG000	Afatinib	Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
OG001	Erlotinib	Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.

Secondary

Change in Score Over Time in Coughing,Dyspnoea and Pain

Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race.

Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant.

The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table). Post-baseline mean is adjusted for baseline and race.

Posted

Least Squares Mean

Standard Error

Units on a scale

From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days).

ID	Title	Description
OG000	Afatinib	Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
OG001

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected392 at risk EG0012 affected395 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0010 affected395 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected392 at risk EG0012 affected395 at risk
Cardiac arrest	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Cardiac failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0013 affected395 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Myocardial infarction	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0014 affected395 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Palpitations	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0010 affected395 at risk
Pericardial effusion	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0012 affected395 at risk
Pericarditis	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected392 at risk EG0010 affected395 at risk
Tachycardia	Cardiac disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected392 at risk EG0015 affected395 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0012 affected395 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Aphagia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG00018 affected392 at risk EG0017 affected395 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0013 affected395 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0012 affected395 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Gastrointestinal telangiectasia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Melaena	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Nausea	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0013 affected395 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Pancreatic duct dilatation	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Vomiting	Gastrointestinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected392 at risk EG0015 affected395 at risk
Asthenia	General disorders	MedDRA 20.1	Systematic Assessment	EG0006 affected392 at risk EG0013 affected395 at risk
Chest discomfort	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0012 affected395 at risk
Chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0016 affected395 at risk
Condition aggravated	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Death	General disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected392 at risk EG0012 affected395 at risk
Device occlusion	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Discomfort	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Fatigue	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0012 affected395 at risk
General physical health deterioration	General disorders	MedDRA 20.1	Systematic Assessment	EG00011 affected392 at risk EG0016 affected395 at risk
Mucosal inflammation	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0011 affected395 at risk
Multi-organ failure	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Necrosis	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Non-cardiac chest pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Oedema peripheral	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0012 affected395 at risk
Pain	General disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0013 affected395 at risk
Performance status decreased	General disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Pyrexia	General disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected392 at risk EG0014 affected395 at risk
Sudden death	General disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Jaundice	Hepatobiliary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Anal abscess	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Bronchitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0016 affected395 at risk
Bronchopneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Endocarditis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Folliculitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Hepatitis C	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Herpes virus infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0013 affected395 at risk
Lung infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0015 affected395 at risk
Oral fungal infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Peritonitis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Pneumonia	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG00026 affected392 at risk EG00116 affected395 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0010 affected395 at risk
Sepsis	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0009 affected392 at risk EG0012 affected395 at risk
Septic shock	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Skin infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0011 affected395 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0011 affected395 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Blood calcium increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Blood creatinine increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0011 affected395 at risk
Blood urea increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
C-reactive protein increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Eastern Cooperative Oncology Group performance status worsened	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
General physical condition abnormal	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Hepatic enzyme increased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Platelet count decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Weight decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
White blood cell count decreased	Investigations	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0010 affected395 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected392 at risk EG0013 affected395 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG00012 affected392 at risk EG0014 affected395 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0016 affected395 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0012 affected395 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0010 affected395 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected392 at risk EG0011 affected395 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0012 affected395 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0010 affected395 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0011 affected395 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG00023 affected392 at risk EG00116 affected395 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0016 affected395 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0010 affected395 at risk
Neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0011 affected395 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0010 affected395 at risk
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Amnesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Aphasia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Brain oedema	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected392 at risk EG0010 affected395 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Convulsion	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected392 at risk EG0011 affected395 at risk
Dizziness	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0014 affected395 at risk
Dysarthria	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Hemiparesis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0012 affected395 at risk
Motor dysfunction	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Myoclonus	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Paraparesis	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Polyneuropathy	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Somnolence	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Spinal cord compression	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0012 affected395 at risk
Syncope	Nervous system disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Confusional state	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0011 affected395 at risk
Delirium	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Disorientation	Psychiatric disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0012 affected395 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Azotaemia	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Bladder mass	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Calculus bladder	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Haematuria	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0012 affected395 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Renal failure	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0012 affected395 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0009 affected392 at risk EG0011 affected395 at risk
Renal impairment	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Urinary bladder polyp	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Urinary retention	Renal and urinary disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected392 at risk EG0011 affected395 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0010 affected395 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0013 affected395 at risk
Bronchial fistula	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected392 at risk EG0014 affected395 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0013 affected395 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG00012 affected392 at risk EG00130 affected395 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0010 affected395 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0005 affected392 at risk EG00110 affected395 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0004 affected392 at risk EG0011 affected395 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0003 affected392 at risk EG0016 affected395 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0013 affected395 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0014 affected395 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG00010 affected392 at risk EG0015 affected395 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0010 affected395 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0012 affected395 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG00112 affected395 at risk
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Dermatomyositis	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Arterial thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0002 affected392 at risk EG0011 affected395 at risk
Haemorrhage	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0012 affected395 at risk
Hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Inferior vena cava syndrome	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Ischaemia	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0010 affected395 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0001 affected392 at risk EG0011 affected395 at risk
Thrombosis	Vascular disorders	MedDRA 20.1	Systematic Assessment	EG0000 affected392 at risk EG0011 affected395 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D000577	Amides
D009930	Organic Chemicals
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Afatinib	Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
BG001	Erlotinib	Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Afatinib	Patients administered 40 milligram (mg) film-coated tablet once daily orally for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.	77	392	174	392	383	392
EG001	Erlotinib	Patients administered 150 mg film-coated tablet once daily orally, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.	71	395	175	395	371	395