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Trial record 1 of 6 for:    LUX-Lung 1 trial
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BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)

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ClinicalTrials.gov Identifier: NCT00656136
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : November 27, 2013
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Carcinoma, Non-Small-Cell Lung
Interventions Drug: placebo
Drug: BIBW 2992
Enrollment 585
Recruitment Details  
Pre-assignment Details Two-arm, randomised (2:1 ratio), double-blind , placebo-controlled, multi-centre trial. 585 patients were randomised. All patients randomized received at least one dose of study medication.
Arm/Group Title Placebo Plus Best Supportive Care (BSC) Afatinib 50 mg/Day Plus Best Supportive Care (BSC)
Hide Arm/Group Description Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm. Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus Best Supportive Care (BSC) or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
Period Title: Overall Study
Started 195 [1] 390 [1]
Completed 0 0
Not Completed 195 390
Reason Not Completed
Progressive disease             177             322
Other Adverse Event             5             51
Protocol Violation             2             3
Patient refused to take study medication             7             10
Unknown and others             4             4
[1]
Randomised patients.
Arm/Group Title Placebo Plus Best Supportive Care (BSC) Afatinib 50 mg/Day Plus Best Supportive Care (BSC) Total
Hide Arm/Group Description Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm. Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0). Total of all reporting groups
Overall Number of Baseline Participants 195 390 585
Hide Baseline Analysis Population Description
Randomized Set (RS) included all patients randomised to receive treatment
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 195 participants 390 participants 585 participants
59  (10.4) 58  (10.8) 58  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 390 participants 585 participants
Female
117
  60.0%
231
  59.2%
348
  59.5%
Male
78
  40.0%
159
  40.8%
237
  40.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Number of participants
Number Analyzed 195 participants 390 participants 585 participants
Caucasian 72 121 193
Eastern Asian 110 227 337
Other Asian 12 38 50
Other 1 4 5
Baseline Eastern Cooperative Oncology Group (ECOG) performance score   [1] 
Measure Type: Number
Unit of measure:  Number of participants
Number Analyzed 195 participants 390 participants 585 participants
ECOG score = 0 53 92 145
ECOG score = 1 127 268 395
ECOG score = 2 15 30 45
[1]
Measure Description: ECOG Performance Score was measured on 6 point scale where 0="Fully active", 1="Restricted in physically strenuous activity" and 2="Ambulatory and capable of all self care but unable to carry out any work activities", 3="Capable of only limited self care, confined to bed or chair 50% or more of waking hours", 4="Bedbound", and 5="Death".
1.Primary Outcome
Title Overall Survival
Hide Description

Overall survival was the duration from the date of randomization to the date of death. Patients who were alive were censored at the last contact date prior to the database lock.

For the primary analysis 11 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Primary analysis data cut-off date was 08 July 2010.

For the final analysis 13 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Final analysis data cut-off date was 04 October 2013.

Time Frame From randomization until death or the last patient out date, an average of 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.
Arm/Group Title Placebo Plus Best Supportive Care (BSC) Afatinib 50 mg/Day Plus Best Supportive Care (BSC)
Hide Arm/Group Description:
Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
Overall Number of Participants Analyzed 195 390
Median (95% Confidence Interval)
Unit of Measure: Months
Primary analysis (358 deaths)
11.96
(10.15 to 14.26)
10.78
(9.95 to 11.99)
Final analysis (526 deaths)
11.73
(10.05 to 14.06)
10.87
(9.95 to 12.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Best Supportive Care (BSC), Afatinib 50 mg/Day Plus Best Supportive Care (BSC)
Comments Primary analysis was performed after 358 deaths were observed among randomized patients. The data cut-off date for the primary analysis was 08 July 2010.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7428
Comments P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)
Method Regression, Cox
Comments Model stratified by gender and baseline ECOG score (0,1 vs 2)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.077
Confidence Interval (2-Sided) 95%
0.862 to 1.346
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Plus Best Supportive Care (BSC), Afatinib 50 mg/Day Plus Best Supportive Care (BSC)
Comments Final analysis was performed after 526 deaths were observed among randomized patients. The data cut-off date for the final analysis was 04 October 2013.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3955
Comments P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)
Method Regression, Cox
Comments Model stratified by gender and baseline ECOG score (0,1 vs 2)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.976
Confidence Interval (2-Sided) 95%
0.814 to 1.170
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0).
Time Frame From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.
Arm/Group Title Placebo Plus Best Supportive Care (BSC) Afatinib 50 mg/Day Plus Best Supportive Care (BSC)
Hide Arm/Group Description:
Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
Overall Number of Participants Analyzed 195 390
Median (95% Confidence Interval)
Unit of Measure: Months
1.08
(0.95 to 1.68)
3.29
(2.79 to 4.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Best Supportive Care (BSC), Afatinib 50 mg/Day Plus Best Supportive Care (BSC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is one-sided (afatinib vs placebo) log rank test stratified by gender and baseline ECOG score (0,1 vs 2)
Method Regression, Cox
Comments Model stratified by gender and baseline ECOG score (0,1 vs 2)
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.381
Confidence Interval (2-Sided) 95%
0.306 to 0.475
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rate (OR)
Hide Description OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.0.
Time Frame From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication.
Arm/Group Title Placebo Plus Best Supportive Care (BSC) Afatinib 50 mg/Day Plus Best Supportive Care (BSC)
Hide Arm/Group Description:
Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm.
Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
Overall Number of Participants Analyzed 195 390
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients with OR
0.5
(0.0 to 2.8)
7.4
(5.0 to 10.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Plus Best Supportive Care (BSC), Afatinib 50 mg/Day Plus Best Supportive Care (BSC)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0071
Comments P-value is derived from logistic regression model adjusted for stratification factors, gender and baseline ECOG score (0, 1 vs 2)
Method Regression, Logistic
Comments Model stratified by gender and baseline ECOG score (0,1 vs 2)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 15.61
Confidence Interval (2-Sided) 95%
2.1 to 115
Estimation Comments [Not Specified]
Time Frame From the date of first drug intake up to 28 days after the last drug intake for on-treatment adverse events or the last patient out date on 4 October 2013.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Afatinib 50 mg/Day
Hide Arm/Group Description Patients received matching placebo for 50 mg, 40 mg or 30 mg afatinib tablets starting with 50 mg/day. Dose reductions were managed in the same way as for the afatinib arm. Patients started with a 50 mg/day dose. Dose reductions were permitted by the protocol to 40 mg/day plus BSC or 30 mg /day plus BSC based upon prespecified Adverse Events and Common Terminology Criteria for Adverse Events (CTCAE) grade (Version 3.0).
All-Cause Mortality
Placebo Afatinib 50 mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Afatinib 50 mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   36/195 (18.46%)   136/390 (34.87%) 
Blood and lymphatic system disorders     
Disseminated intravascular coagulation  1  0/195 (0.00%)  1/390 (0.26%) 
Febrile neutropenia  1  0/195 (0.00%)  2/390 (0.51%) 
Lymphadenopathy  1  0/195 (0.00%)  1/390 (0.26%) 
Neutropenia  1  1/195 (0.51%)  0/390 (0.00%) 
Cardiac disorders     
Acute left ventricular failure  1  0/195 (0.00%)  2/390 (0.51%) 
Atrial fibrillation  1  1/195 (0.51%)  1/390 (0.26%) 
Cardiac failure  1  1/195 (0.51%)  2/390 (0.51%) 
Cardiac tamponade  1  0/195 (0.00%)  1/390 (0.26%) 
Cardio-respiratory arrest  1  0/195 (0.00%)  1/390 (0.26%) 
Myocardial infarction  1  0/195 (0.00%)  1/390 (0.26%) 
Pericardial effusion  1  1/195 (0.51%)  2/390 (0.51%) 
Sick sinus syndrome  1  0/195 (0.00%)  1/390 (0.26%) 
Supraventricular tachycardia  1  0/195 (0.00%)  1/390 (0.26%) 
Tachycardia  1  0/195 (0.00%)  1/390 (0.26%) 
Eye disorders     
Blindness  1  0/195 (0.00%)  1/390 (0.26%) 
Diplopia  1  0/195 (0.00%)  1/390 (0.26%) 
Eye movement disorder  1  1/195 (0.51%)  0/390 (0.00%) 
Vision blurred  1  0/195 (0.00%)  1/390 (0.26%) 
Gastrointestinal disorders     
Abdominal discomfort  1  0/195 (0.00%)  1/390 (0.26%) 
Abdominal pain  1  0/195 (0.00%)  2/390 (0.51%) 
Abdominal pain upper  1  0/195 (0.00%)  1/390 (0.26%) 
Ascites  1  0/195 (0.00%)  1/390 (0.26%) 
Diarrhoea  1  0/195 (0.00%)  18/390 (4.62%) 
Dysphagia  1  3/195 (1.54%)  0/390 (0.00%) 
Haematemesis  1  0/195 (0.00%)  1/390 (0.26%) 
Ileus  1  0/195 (0.00%)  1/390 (0.26%) 
Intestinal obstruction  1  0/195 (0.00%)  2/390 (0.51%) 
Nausea  1  0/195 (0.00%)  4/390 (1.03%) 
Pancreatitis  1  0/195 (0.00%)  1/390 (0.26%) 
Pancreatitis acute  1  0/195 (0.00%)  4/390 (1.03%) 
Proctalgia  1  0/195 (0.00%)  1/390 (0.26%) 
Rectal haemorrhage  1  0/195 (0.00%)  2/390 (0.51%) 
Stomatitis  1  0/195 (0.00%)  3/390 (0.77%) 
Vomiting  1  1/195 (0.51%)  5/390 (1.28%) 
General disorders     
Asthenia  1  1/195 (0.51%)  1/390 (0.26%) 
Chest discomfort  1  0/195 (0.00%)  1/390 (0.26%) 
Chest pain  1  2/195 (1.03%)  0/390 (0.00%) 
Condition aggravated  1  0/195 (0.00%)  1/390 (0.26%) 
Death  1  1/195 (0.51%)  3/390 (0.77%) 
Extravasation  1  0/195 (0.00%)  1/390 (0.26%) 
Face oedema  1  0/195 (0.00%)  1/390 (0.26%) 
Fatigue  1  0/195 (0.00%)  3/390 (0.77%) 
General physical health deterioration  1  1/195 (0.51%)  2/390 (0.51%) 
Hernia  1  1/195 (0.51%)  0/390 (0.00%) 
Malaise  1  0/195 (0.00%)  1/390 (0.26%) 
Medical device complication  1  1/195 (0.51%)  0/390 (0.00%) 
Multi-organ failure  1  0/195 (0.00%)  1/390 (0.26%) 
Oedema peripheral  1  0/195 (0.00%)  2/390 (0.51%) 
Pain  1  0/195 (0.00%)  2/390 (0.51%) 
Pyrexia  1  0/195 (0.00%)  7/390 (1.79%) 
Sudden cardiac death  1  0/195 (0.00%)  1/390 (0.26%) 
Sudden death  1  0/195 (0.00%)  1/390 (0.26%) 
Hepatobiliary disorders     
Acute hepatic failure  1  0/195 (0.00%)  1/390 (0.26%) 
Hepatitis acute  1  0/195 (0.00%)  1/390 (0.26%) 
Infections and infestations     
Atypical pneumonia  1  0/195 (0.00%)  1/390 (0.26%) 
Bacteraemia  1  0/195 (0.00%)  1/390 (0.26%) 
Candida infection  1  0/195 (0.00%)  1/390 (0.26%) 
Cellulitis  1  0/195 (0.00%)  1/390 (0.26%) 
Device related infection  1  0/195 (0.00%)  1/390 (0.26%) 
Gastroenteritis  1  0/195 (0.00%)  1/390 (0.26%) 
Gastroenteritis viral  1  0/195 (0.00%)  1/390 (0.26%) 
Lower respiratory tract infection fungal  1  0/195 (0.00%)  1/390 (0.26%) 
Lung infection  1  0/195 (0.00%)  4/390 (1.03%) 
Paronychia  1  0/195 (0.00%)  1/390 (0.26%) 
Peritonitis bacterial  1  0/195 (0.00%)  1/390 (0.26%) 
Pneumonia  1  4/195 (2.05%)  10/390 (2.56%) 
Sepsis  1  0/195 (0.00%)  1/390 (0.26%) 
Septic shock  1  0/195 (0.00%)  5/390 (1.28%) 
Soft tissue infection  1  0/195 (0.00%)  1/390 (0.26%) 
Upper respiratory tract infection  1  0/195 (0.00%)  1/390 (0.26%) 
Wound infection  1  0/195 (0.00%)  1/390 (0.26%) 
Injury, poisoning and procedural complications     
Fall  1  0/195 (0.00%)  1/390 (0.26%) 
Head injury  1  1/195 (0.51%)  0/390 (0.00%) 
Humerus fracture  1  0/195 (0.00%)  1/390 (0.26%) 
Multiple fractures  1  0/195 (0.00%)  1/390 (0.26%) 
Thoracic vertebral fracture  1  0/195 (0.00%)  1/390 (0.26%) 
Investigations     
Blood creatinine increased  1  0/195 (0.00%)  4/390 (1.03%) 
Blood culture positive  1  0/195 (0.00%)  1/390 (0.26%) 
Blood potassium increased  1  0/195 (0.00%)  1/390 (0.26%) 
Electrocardiogram T wave inversion  1  0/195 (0.00%)  1/390 (0.26%) 
Oxygen saturation decreased  1  0/195 (0.00%)  1/390 (0.26%) 
Prostatic specific antigen increased  1  0/195 (0.00%)  1/390 (0.26%) 
Metabolism and nutrition disorders     
Decreased appetite  1  0/195 (0.00%)  3/390 (0.77%) 
Dehydration  1  0/195 (0.00%)  8/390 (2.05%) 
Hypocalcaemia  1  0/195 (0.00%)  2/390 (0.51%) 
Hypokalaemia  1  0/195 (0.00%)  5/390 (1.28%) 
Hyponatraemia  1  1/195 (0.51%)  0/390 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/195 (1.03%)  1/390 (0.26%) 
Bone pain  1  1/195 (0.51%)  2/390 (0.51%) 
Flank pain  1  0/195 (0.00%)  1/390 (0.26%) 
Muscular weakness  1  1/195 (0.51%)  3/390 (0.77%) 
Musculoskeletal chest pain  1  0/195 (0.00%)  1/390 (0.26%) 
Pain in extremity  1  1/195 (0.51%)  1/390 (0.26%) 
Pathological fracture  1  0/195 (0.00%)  2/390 (0.51%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  0/195 (0.00%)  1/390 (0.26%) 
Cervix carcinoma  1  0/195 (0.00%)  1/390 (0.26%) 
Colon cancer  1  0/195 (0.00%)  1/390 (0.26%) 
Lung adenocarcinoma metastatic  1  0/195 (0.00%)  1/390 (0.26%) 
Malignant ascites  1  0/195 (0.00%)  1/390 (0.26%) 
Malignant neoplasm progression  1  7/195 (3.59%)  16/390 (4.10%) 
Malignant pleural effusion  1  1/195 (0.51%)  1/390 (0.26%) 
Metastases to central nervous system  1  3/195 (1.54%)  11/390 (2.82%) 
Metastases to liver  1  0/195 (0.00%)  1/390 (0.26%) 
Metastases to meninges  1  0/195 (0.00%)  1/390 (0.26%) 
Metastatic pain  1  0/195 (0.00%)  1/390 (0.26%) 
Non-small cell lung cancer  1  1/195 (0.51%)  0/390 (0.00%) 
Nervous system disorders     
Altered state of consciousness  1  0/195 (0.00%)  1/390 (0.26%) 
Brain mass  1  0/195 (0.00%)  1/390 (0.26%) 
Brain oedema  1  0/195 (0.00%)  2/390 (0.51%) 
Cerebral haemorrhage  1  1/195 (0.51%)  0/390 (0.00%) 
Cerebral infarction  1  1/195 (0.51%)  0/390 (0.00%) 
Cerebrovascular accident  1  0/195 (0.00%)  2/390 (0.51%) 
Convulsion  1  0/195 (0.00%)  1/390 (0.26%) 
Dizziness  1  0/195 (0.00%)  3/390 (0.77%) 
Dysarthria  1  1/195 (0.51%)  0/390 (0.00%) 
Embolic cerebral infarction  1  0/195 (0.00%)  1/390 (0.26%) 
Headache  1  0/195 (0.00%)  1/390 (0.26%) 
Hemiparesis  1  0/195 (0.00%)  1/390 (0.26%) 
Hydrocephalus  1  0/195 (0.00%)  1/390 (0.26%) 
Intracranial pressure increased  1  0/195 (0.00%)  2/390 (0.51%) 
Ischaemic stroke  1  0/195 (0.00%)  1/390 (0.26%) 
Paraesthesia  1  0/195 (0.00%)  1/390 (0.26%) 
Paraplegia  1  0/195 (0.00%)  1/390 (0.26%) 
Partial seizures  1  0/195 (0.00%)  1/390 (0.26%) 
Spinal cord compression  1  0/195 (0.00%)  2/390 (0.51%) 
Tremor  1  1/195 (0.51%)  0/390 (0.00%) 
VIIth nerve paralysis  1  1/195 (0.51%)  1/390 (0.26%) 
Psychiatric disorders     
Delirium  1  0/195 (0.00%)  1/390 (0.26%) 
Renal and urinary disorders     
Acute prerenal failure  1  0/195 (0.00%)  1/390 (0.26%) 
Oliguria  1  0/195 (0.00%)  1/390 (0.26%) 
Renal colic  1  0/195 (0.00%)  1/390 (0.26%) 
Renal failure  1  0/195 (0.00%)  1/390 (0.26%) 
Renal failure acute  1  0/195 (0.00%)  7/390 (1.79%) 
Renal impairment  1  0/195 (0.00%)  1/390 (0.26%) 
Reproductive system and breast disorders     
Pelvic pain  1  1/195 (0.51%)  0/390 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  3/195 (1.54%)  0/390 (0.00%) 
Dyspnoea  1  4/195 (2.05%)  8/390 (2.05%) 
Dyspnoea at rest  1  0/195 (0.00%)  1/390 (0.26%) 
Haemoptysis  1  1/195 (0.51%)  2/390 (0.51%) 
Haemothorax  1  1/195 (0.51%)  0/390 (0.00%) 
Hydropneumothorax  1  0/195 (0.00%)  1/390 (0.26%) 
Pleural effusion  1  7/195 (3.59%)  14/390 (3.59%) 
Pneumonitis  1  0/195 (0.00%)  2/390 (0.51%) 
Pneumothorax  1  0/195 (0.00%)  2/390 (0.51%) 
Pulmonary embolism  1  1/195 (0.51%)  5/390 (1.28%) 
Respiratory failure  1  2/195 (1.03%)  9/390 (2.31%) 
Wheezing  1  0/195 (0.00%)  1/390 (0.26%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  0/195 (0.00%)  1/390 (0.26%) 
Rash  1  0/195 (0.00%)  2/390 (0.51%) 
Stevens-Johnson syndrome  1  0/195 (0.00%)  1/390 (0.26%) 
Vascular disorders     
Deep vein thrombosis  1  1/195 (0.51%)  5/390 (1.28%) 
Hypertensive crisis  1  0/195 (0.00%)  1/390 (0.26%) 
Hypotension  1  0/195 (0.00%)  2/390 (0.51%) 
Thrombosis  1  0/195 (0.00%)  2/390 (0.51%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Afatinib 50 mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   167/195 (85.64%)   383/390 (98.21%) 
Blood and lymphatic system disorders     
Anaemia  1  3/195 (1.54%)  23/390 (5.90%) 
Gastrointestinal disorders     
Abdominal pain upper  1  8/195 (4.10%)  25/390 (6.41%) 
Constipation  1  24/195 (12.31%)  43/390 (11.03%) 
Diarrhoea  1  18/195 (9.23%)  334/390 (85.64%) 
Mouth ulceration  1  0/195 (0.00%)  51/390 (13.08%) 
Nausea  1  39/195 (20.00%)  90/390 (23.08%) 
Stomatitis  1  2/195 (1.03%)  82/390 (21.03%) 
Vomiting  1  25/195 (12.82%)  75/390 (19.23%) 
General disorders     
Asthenia  1  16/195 (8.21%)  36/390 (9.23%) 
Chest pain  1  11/195 (5.64%)  27/390 (6.92%) 
Fatigue  1  23/195 (11.79%)  72/390 (18.46%) 
Mucosal inflammation  1  2/195 (1.03%)  95/390 (24.36%) 
Pyrexia  1  7/195 (3.59%)  36/390 (9.23%) 
Infections and infestations     
Folliculitis  1  0/195 (0.00%)  25/390 (6.41%) 
Paronychia  1  1/195 (0.51%)  131/390 (33.59%) 
Investigations     
Weight decreased  1  2/195 (1.03%)  37/390 (9.49%) 
Metabolism and nutrition disorders     
Decreased appetite  1  22/195 (11.28%)  118/390 (30.26%) 
Hypokalaemia  1  4/195 (2.05%)  29/390 (7.44%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  22/195 (11.28%)  29/390 (7.44%) 
Muscle spasms  1  3/195 (1.54%)  20/390 (5.13%) 
Pain in extremity  1  4/195 (2.05%)  27/390 (6.92%) 
Nervous system disorders     
Dizziness  1  6/195 (3.08%)  20/390 (5.13%) 
Dysgeusia  1  1/195 (0.51%)  22/390 (5.64%) 
Headache  1  9/195 (4.62%)  21/390 (5.38%) 
Psychiatric disorders     
Insomnia  1  10/195 (5.13%)  17/390 (4.36%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  36/195 (18.46%)  54/390 (13.85%) 
Dyspnoea  1  22/195 (11.28%)  54/390 (13.85%) 
Epistaxis  1  1/195 (0.51%)  73/390 (18.72%) 
Productive cough  1  13/195 (6.67%)  9/390 (2.31%) 
Rhinorrhoea  1  2/195 (1.03%)  42/390 (10.77%) 
Skin and subcutaneous tissue disorders     
Acne  1  0/195 (0.00%)  27/390 (6.92%) 
Dermatitis acneiform  1  1/195 (0.51%)  28/390 (7.18%) 
Dry skin  1  14/195 (7.18%)  62/390 (15.90%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/195 (0.00%)  30/390 (7.69%) 
Pruritus  1  11/195 (5.64%)  73/390 (18.72%) 
Rash  1  23/195 (11.79%)  248/390 (63.59%) 
Skin fissures  1  0/195 (0.00%)  32/390 (8.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00656136    
Other Study ID Numbers: 1200.23
2007-005983-28 ( EudraCT Number: EudraCT )
First Submitted: April 4, 2008
First Posted: April 10, 2008
Results First Submitted: August 8, 2013
Results First Posted: November 27, 2013
Last Update Posted: July 26, 2016