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An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT00949910
Recruitment Status : Completed
First Posted : July 31, 2009
Results First Posted : October 4, 2016
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-Small Cell Lung Cancer
Intervention Drug: Erlotinib
Enrollment 6586
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Erlotinib
Hide Arm/Group Description Erlotinib was given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC). Participants were treated with 150 milligrams (mg) oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
Period Title: Overall Study
Started 6586
Completed 10
Not Completed 6576
Reason Not Completed
Progressive Disease             3750
Symptomatic Deterioration             1088
Lost to Follow-up             100
Study Drug-Related Adverse Event             315
Participant Refusal             390
Death Due to Malignant Disease             456
Death Due to Progression/Deterioration             4
Death Due to Adverse Event             115
Death Due to Toxicity             3
Death from Unknown Cause             5
Unspecified Progression/Deterioration             13
Switched to Compassionate/Other Use             174
Switched to Commercial Treatment             4
Violation of Eligibility             23
Logistical Reasons             13
Non-Compliance             10
Prolonged Dosing Interruption             4
Adverse Event             83
Serious Adverse Event             6
Physician/Participant Decision             7
Other             4
No Data             9
Arm/Group Title Erlotinib
Hide Arm/Group Description Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
Overall Number of Baseline Participants 6586
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT)/Safety Population: All participants who received at least one dose of erlotinib.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6586 participants
62.4  (11.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6586 participants
Female
2608
  39.6%
Male
3978
  60.4%
1.Primary Outcome
Title Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Objective response was defined as a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. The percentage of participants (in nearest integer) with objective response was reported.
Time Frame Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
ITT/Safety Population.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
Overall Number of Participants Analyzed 6586
Measure Type: Number
Unit of Measure: percentage of participants
11
2.Secondary Outcome
Title Percentage of Participants With Disease Control According to RECIST
Hide Description Disease control was defined as a best overall response of either CR, PR, or stable disease (SD) as assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but less than (<) 20% increase in sum LD. The percentage of participants (in nearest integer) with disease control was reported.
Time Frame Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
ITT/Safety Population.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
Overall Number of Participants Analyzed 6586
Measure Type: Number
Unit of Measure: percentage of participants
56
3.Secondary Outcome
Title Percentage of Participants by Best Overall Response According to RECIST
Hide Description Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all clinical and radiographic evidence of target and non-target lesions, normal tumor markers, and absence of tumor-related symptoms. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥28 days after the initial assessment of CR or PR. SD was defined as neither sufficient shrinkage to qualify for PR but <20% increase in sum LD. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer unless the percentage is <1) with each type of best overall response was reported.
Time Frame Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
ITT/Safety Population.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
Overall Number of Participants Analyzed 6586
Measure Type: Number
Unit of Measure: percentage of participants
Complete Response (CR) 0.7
Partial Response (PR) 10
Stable Disease (SD) 45
Progressive Disease (PD) 23
Not Evaluable 3
Not Done 18
Not Known 0.0
No Data 0.3
4.Secondary Outcome
Title Percentage of Participants With Death or Disease Progression According to RECIST
Hide Description Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants (in nearest integer) who died or experienced PD was reported.
Time Frame Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
ITT/Safety Population; only participants with available data were included.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
Overall Number of Participants Analyzed 6580
Measure Type: Number
Unit of Measure: percentage of participants
93
5.Secondary Outcome
Title Progression-Free Survival (PFS) According to RECIST
Hide Description Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. The median duration of PFS and corresponding 95% confidence interval (CI) were estimated by Kaplan-Meier analysis and expressed in months.
Time Frame Up to approximately 4.5 years; assessed at Baseline, according to institutional standards during treatment (up to 3.5 years), and every 6 months thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
ITT/Safety Population; only participants with available data were included.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
Overall Number of Participants Analyzed 6580
Median (95% Confidence Interval)
Unit of Measure: months
3.3
(3.1 to 3.4)
6.Secondary Outcome
Title Percentage of Participants Who Died
Hide Description The percentage of participants (in nearest integer) who died from any cause was reported.
Time Frame Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
ITT/Safety Population.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
Overall Number of Participants Analyzed 6586
Measure Type: Number
Unit of Measure: percentage of participants
81
7.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from start of treatment to date of death for any reason. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
Time Frame Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
Hide Outcome Measure Data
Hide Analysis Population Description
ITT/Safety Population.
Arm/Group Title Erlotinib
Hide Arm/Group Description:
Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
Overall Number of Participants Analyzed 6586
Median (95% Confidence Interval)
Unit of Measure: months
7.9
(7.6 to 8.3)
Time Frame Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter
Adverse Event Reporting Description ITT/Safety Population. As planned only unexpected erlotinib-related adverse events (AEs) and erlotinib-related rash were to be reported, with the exception of serious adverse events (SAEs) and AEs leading to premature withdrawal which were collected regardless of causality.
 
Arm/Group Title Erlotinib
Hide Arm/Group Description Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
All-Cause Mortality
Erlotinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Erlotinib
Affected / at Risk (%)
Total   2983/6586 (45.29%) 
Blood and lymphatic system disorders   
Anaemia * 1  43/6586 (0.65%) 
Anaemia folate deficiency * 1  1/6586 (0.02%) 
Anaemia of malignant disease * 1  2/6586 (0.03%) 
Disseminated intravascular coagulation * 1  2/6586 (0.03%) 
Febrile neutropenia * 1  2/6586 (0.03%) 
Leukocytosis * 1  1/6586 (0.02%) 
Neutropenia * 1  1/6586 (0.02%) 
Normochromic normocytic anaemia * 1  1/6586 (0.02%) 
Pancytopenia * 1  2/6586 (0.03%) 
Thrombocytopenia * 1  2/6586 (0.03%) 
Cardiac disorders   
Acute myocardial infarction * 1  12/6586 (0.18%) 
Angina pectoris * 1  3/6586 (0.05%) 
Arrhythmia * 1  4/6586 (0.06%) 
Atrial fibrillation * 1  7/6586 (0.11%) 
Atrial flutter * 1  2/6586 (0.03%) 
Atrioventricular block * 1  1/6586 (0.02%) 
Cardiac arrest * 1  13/6586 (0.20%) 
Cardiac disorder * 1  1/6586 (0.02%) 
Cardiac failure * 1  12/6586 (0.18%) 
Cardiac failure acute * 1  2/6586 (0.03%) 
Cardiac failure congestive * 1  3/6586 (0.05%) 
Cardiac tamponade * 1  2/6586 (0.03%) 
Cardio-respiratory arrest * 1  9/6586 (0.14%) 
Cardio-respiratory distress * 1  1/6586 (0.02%) 
Cardiogenic shock * 1  1/6586 (0.02%) 
Cardiopulmonary failure * 1  14/6586 (0.21%) 
Cor pulmonale * 1  1/6586 (0.02%) 
Coronary artery disease * 1  3/6586 (0.05%) 
Hypertensive heart disease * 1  1/6586 (0.02%) 
Left ventricular failure * 1  1/6586 (0.02%) 
Myocardial infarction * 1  18/6586 (0.27%) 
Myocardial ischaemia * 1  2/6586 (0.03%) 
Pericardial effusion * 1  20/6586 (0.30%) 
Pericarditis * 1  2/6586 (0.03%) 
Sinus bradycardia * 1  2/6586 (0.03%) 
Supraventricular tachycardia * 1  2/6586 (0.03%) 
Tachyarrhythmia * 1  5/6586 (0.08%) 
Tachycardia * 1  3/6586 (0.05%) 
Ventricular arrhythmia * 1  1/6586 (0.02%) 
Ventricular fibrillation * 1  1/6586 (0.02%) 
Ear and labyrinth disorders   
Vertigo * 1  5/6586 (0.08%) 
Eye disorders   
Conjunctivitis * 1  2/6586 (0.03%) 
Diplopia * 1  2/6586 (0.03%) 
Iridocele * 1  1/6586 (0.02%) 
Retinal detachment * 1  1/6586 (0.02%) 
Visual disturbance * 1  2/6586 (0.03%) 
Gastrointestinal disorders   
Abdominal distension * 1  4/6586 (0.06%) 
Abdominal pain * 1  32/6586 (0.49%) 
Abdominal pain lower * 1  1/6586 (0.02%) 
Abdominal pain upper * 1  6/6586 (0.09%) 
Acute abdomen * 1  3/6586 (0.05%) 
Appendicitis perforated * 1  1/6586 (0.02%) 
Ascites * 1  6/6586 (0.09%) 
Colitis * 1  2/6586 (0.03%) 
Constipation * 1  12/6586 (0.18%) 
Diarrhoea * 1  83/6586 (1.26%) 
Diverticular perforation * 1  2/6586 (0.03%) 
Duodenal ulcer * 1  1/6586 (0.02%) 
Duodenal ulcer haemorrhage * 1  1/6586 (0.02%) 
Dysphagia * 1  21/6586 (0.32%) 
Enteritis * 1  1/6586 (0.02%) 
Gastric disorder * 1  1/6586 (0.02%) 
Gastric haemorrhage * 1  2/6586 (0.03%) 
Gastric perforation * 1  3/6586 (0.05%) 
Gastric ulcer * 1  3/6586 (0.05%) 
Gastric ulcer haemorrhage * 1  3/6586 (0.05%) 
Gastritis * 1  3/6586 (0.05%) 
Gastritis erosive * 1  2/6586 (0.03%) 
Gastrointestinal disorder * 1  6/6586 (0.09%) 
Gastrointestinal haemorrhage * 1  19/6586 (0.29%) 
Gastrointestinal obstruction * 1  1/6586 (0.02%) 
Gastrointestinal perforation * 1  1/6586 (0.02%) 
Gastrointestinal ulcer perforation * 1  1/6586 (0.02%) 
Haematemesis * 1  6/6586 (0.09%) 
Haematochezia * 1  1/6586 (0.02%) 
Haemorrhoids * 1  1/6586 (0.02%) 
Ileus * 1  8/6586 (0.12%) 
Inguinal hernia * 1  3/6586 (0.05%) 
Inguinal hernia, obstructive * 1  1/6586 (0.02%) 
Intestinal obstruction * 1  5/6586 (0.08%) 
Intestinal perforation * 1  2/6586 (0.03%) 
Jejunal perforation * 1  1/6586 (0.02%) 
Large intestine perforation * 1  1/6586 (0.02%) 
Mallory-Weiss syndrome * 1  1/6586 (0.02%) 
Mechanical ileus * 1  1/6586 (0.02%) 
Melaena * 1  6/6586 (0.09%) 
Nausea * 1  35/6586 (0.53%) 
Necrotising oesophagitis * 1  1/6586 (0.02%) 
Oesophageal haemorrhage * 1  1/6586 (0.02%) 
Oesophageal spasm * 1  1/6586 (0.02%) 
Oesophageal stenosis * 1  2/6586 (0.03%) 
Oesophageal varices haemorrhage * 1  1/6586 (0.02%) 
Oesophagitis * 1  1/6586 (0.02%) 
Pancreatitis * 1  3/6586 (0.05%) 
Pancreatitis acute * 1  1/6586 (0.02%) 
Peptic ulcer * 1  1/6586 (0.02%) 
Peritonitis * 1  3/6586 (0.05%) 
Rectal haemorrhage * 1  3/6586 (0.05%) 
Rectal polyp * 1  1/6586 (0.02%) 
Reflux oesophagitis * 1  2/6586 (0.03%) 
Small intestinal obstruction * 1  4/6586 (0.06%) 
Stomatitis * 1  5/6586 (0.08%) 
Subileus * 1  3/6586 (0.05%) 
Upper gastrointestinal haemorrhage * 1  4/6586 (0.06%) 
Vomiting * 1  45/6586 (0.68%) 
General disorders   
Asthenia * 1  18/6586 (0.27%) 
Catheter related complication * 1  2/6586 (0.03%) 
Chest discomfort * 1  1/6586 (0.02%) 
Chest pain * 1  51/6586 (0.77%) 
Condition aggravated * 1  2/6586 (0.03%) 
Death * 1  14/6586 (0.21%) 
Disease progression * 1  292/6586 (4.43%) 
Drug withdrawal syndrome * 1  1/6586 (0.02%) 
Euthanasia * 1  2/6586 (0.03%) 
Fatigue * 1  16/6586 (0.24%) 
Gait disturbance * 1  3/6586 (0.05%) 
General physical health deterioration * 1  195/6586 (2.96%) 
Hyperpyrexia * 1  1/6586 (0.02%) 
Ill-defined disorder * 1  14/6586 (0.21%) 
Local swelling * 1  1/6586 (0.02%) 
Malaise * 1  7/6586 (0.11%) 
Mucosal inflammation * 1  3/6586 (0.05%) 
Multi-organ failure * 1  3/6586 (0.05%) 
Oedema * 1  4/6586 (0.06%) 
Oedema peripheral * 1  5/6586 (0.08%) 
Pain * 1  33/6586 (0.50%) 
Performance status decreased * 1  8/6586 (0.12%) 
Pyrexia * 1  52/6586 (0.79%) 
Sudden cardiac death * 1  1/6586 (0.02%) 
Sudden death * 1  2/6586 (0.03%) 
Ulcer * 1  1/6586 (0.02%) 
Hepatobiliary disorders   
Bile duct obstruction * 1  1/6586 (0.02%) 
Bile duct stone * 1  2/6586 (0.03%) 
Cholecystitis * 1  4/6586 (0.06%) 
Gallbladder obstruction * 1  1/6586 (0.02%) 
Hepatic failure * 1  2/6586 (0.03%) 
Hepatic function abnormal * 1  4/6586 (0.06%) 
Hepatic pain * 1  1/6586 (0.02%) 
Hepatitis cholestatic * 1  1/6586 (0.02%) 
Hepatomegaly * 1  1/6586 (0.02%) 
Hyperbilirubinaemia * 1  2/6586 (0.03%) 
Jaundice * 1  5/6586 (0.08%) 
Liver disorder * 1  1/6586 (0.02%) 
Immune system disorders   
Anaphylactic reaction * 1  1/6586 (0.02%) 
Contrast media allergy * 1  1/6586 (0.02%) 
Infections and infestations   
Abscess * 1  1/6586 (0.02%) 
Acute tonsillitis * 1  1/6586 (0.02%) 
Anal abscess * 1  1/6586 (0.02%) 
Appendicitis * 1  2/6586 (0.03%) 
Bacterial sepsis * 1  1/6586 (0.02%) 
Biliary sepsis * 1  1/6586 (0.02%) 
Bronchitis * 1  14/6586 (0.21%) 
Bronchitis bacterial * 1  2/6586 (0.03%) 
Bronchopneumonia * 1  12/6586 (0.18%) 
Bursitis infective * 1  1/6586 (0.02%) 
Catheter related infection * 1  1/6586 (0.02%) 
Catheter sepsis * 1  1/6586 (0.02%) 
Catheter site infection * 1  1/6586 (0.02%) 
Cellulitis * 1  6/6586 (0.09%) 
Central line infection * 1  6/6586 (0.09%) 
Cystitis * 1  1/6586 (0.02%) 
Device related infection * 1  2/6586 (0.03%) 
Diabetic gangrene * 1  1/6586 (0.02%) 
Diarrhoea infectious * 1  1/6586 (0.02%) 
Empyema * 1  4/6586 (0.06%) 
Enterocolitis infectious * 1  2/6586 (0.03%) 
Erysipelas * 1  3/6586 (0.05%) 
Extradural abscess * 1  1/6586 (0.02%) 
Febrile infection * 1  2/6586 (0.03%) 
Folliculitis * 1  1/6586 (0.02%) 
Gastroenteritis * 1  15/6586 (0.23%) 
Gastrointestinal infection * 1  2/6586 (0.03%) 
Groin abscess * 1  1/6586 (0.02%) 
Herpangina * 1  1/6586 (0.02%) 
Herpes simplex * 1  1/6586 (0.02%) 
Herpes virus infection * 1  1/6586 (0.02%) 
Herpes zoster * 1  3/6586 (0.05%) 
Infected epidermal cyst * 1  1/6586 (0.02%) 
Infection * 1  23/6586 (0.35%) 
Infective exacerbation of chronic obstructive airways disease * 1  1/6586 (0.02%) 
Lower respiratory tract infection * 1  20/6586 (0.30%) 
Lung abscess * 1  2/6586 (0.03%) 
Lung infection * 1  12/6586 (0.18%) 
Lung infection pseudomonal * 1  1/6586 (0.02%) 
Mastitis * 1  1/6586 (0.02%) 
Mastoiditis * 1  1/6586 (0.02%) 
Nasopharyngitis * 1  1/6586 (0.02%) 
Paronychia * 1  1/6586 (0.02%) 
Peritonitis bacterial * 1  1/6586 (0.02%) 
Pneumocystis jiroveci pneumonia * 1  1/6586 (0.02%) 
Pneumonia * 1  217/6586 (3.29%) 
Pneumonia primary atypical * 1  2/6586 (0.03%) 
Post procedural infection * 1  1/6586 (0.02%) 
Pyelonephritis * 1  1/6586 (0.02%) 
Respiratory tract infection * 1  14/6586 (0.21%) 
Sepsis * 1  17/6586 (0.26%) 
Septic shock * 1  6/6586 (0.09%) 
Sinobronchitis * 1  1/6586 (0.02%) 
Skin infection * 1  1/6586 (0.02%) 
Tonsillitis * 1  1/6586 (0.02%) 
Tooth infection * 1  1/6586 (0.02%) 
Tracheobronchitis * 1  1/6586 (0.02%) 
Upper respiratory tract infection * 1  4/6586 (0.06%) 
Urinary tract infection * 1  12/6586 (0.18%) 
Urosepsis * 1  2/6586 (0.03%) 
Vulval abscess * 1  1/6586 (0.02%) 
Wound infection * 1  1/6586 (0.02%) 
Wound infection staphylococcal * 1  1/6586 (0.02%) 
Injury, poisoning and procedural complications   
Fall * 1  6/6586 (0.09%) 
Femoral neck fracture * 1  7/6586 (0.11%) 
Femur fracture * 1  6/6586 (0.09%) 
Fracture * 1  1/6586 (0.02%) 
Gastroenteritis radiation * 1  1/6586 (0.02%) 
Head injury * 1  3/6586 (0.05%) 
Hip fracture * 1  2/6586 (0.03%) 
Humerus fracture * 1  8/6586 (0.12%) 
Joint dislocation * 1  1/6586 (0.02%) 
Limb injury * 1  1/6586 (0.02%) 
Multiple fractures * 1  1/6586 (0.02%) 
Overdose * 1  1/6586 (0.02%) 
Pelvic fracture * 1  2/6586 (0.03%) 
Procedural pain * 1  1/6586 (0.02%) 
Radiation pneumonitis * 1  1/6586 (0.02%) 
Radius fracture * 1  1/6586 (0.02%) 
Rib fracture * 1  1/6586 (0.02%) 
Road traffic accident * 1  1/6586 (0.02%) 
Skin laceration * 1  1/6586 (0.02%) 
Spinal compression fracture * 1  2/6586 (0.03%) 
Spinal fracture * 1  1/6586 (0.02%) 
Tendon rupture * 1  1/6586 (0.02%) 
Thermal burn * 1  1/6586 (0.02%) 
Thoracic vertebral fracture * 1  1/6586 (0.02%) 
Thrombosis in device * 1  1/6586 (0.02%) 
Transfusion reaction * 1  1/6586 (0.02%) 
Upper limb fracture * 1  2/6586 (0.03%) 
Wound complication * 1  1/6586 (0.02%) 
Wound dehiscence * 1  1/6586 (0.02%) 
Wrist fracture * 1  1/6586 (0.02%) 
Investigations   
Aspiration pleural cavity * 1  1/6586 (0.02%) 
Blood creatinine increased * 1  1/6586 (0.02%) 
Bronchoalveolar lavage * 1  1/6586 (0.02%) 
Drug level increased * 1  1/6586 (0.02%) 
General physical condition abnormal * 1  1/6586 (0.02%) 
Haemoglobin decreased * 1  2/6586 (0.03%) 
Hepatic enzyme increased * 1  2/6586 (0.03%) 
International normalised ratio abnormal * 1  1/6586 (0.02%) 
International normalised ratio increased * 1  2/6586 (0.03%) 
Liver function test abnormal * 1  1/6586 (0.02%) 
Pulmonary function test decreased * 1  1/6586 (0.02%) 
Sigmoidoscopy * 1  1/6586 (0.02%) 
Weight decreased * 1  7/6586 (0.11%) 
Metabolism and nutrition disorders   
Anorexia * 1  12/6586 (0.18%) 
Cachexia * 1  5/6586 (0.08%) 
Dehydration * 1  29/6586 (0.44%) 
Diabetic ketoacidosis * 1  1/6586 (0.02%) 
Fluid overload * 1  1/6586 (0.02%) 
Hypercalcaemia * 1  12/6586 (0.18%) 
Hyperglycaemia * 1  2/6586 (0.03%) 
Hyperglycaemic hyperosmolar nonketotic syndrome * 1  1/6586 (0.02%) 
Hyperkalaemia * 1  2/6586 (0.03%) 
Hypocalcaemia * 1  1/6586 (0.02%) 
Hypoglycaemia * 1  9/6586 (0.14%) 
Hypokalaemia * 1  5/6586 (0.08%) 
Hypomagnesaemia * 1  1/6586 (0.02%) 
Hyponatraemia * 1  4/6586 (0.06%) 
Malnutrition * 1  1/6586 (0.02%) 
Oral intake reduced * 1  2/6586 (0.03%) 
Tetany * 1  1/6586 (0.02%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  8/6586 (0.12%) 
Arthritis * 1  3/6586 (0.05%) 
Back pain * 1  36/6586 (0.55%) 
Bone pain * 1  26/6586 (0.39%) 
Bursitis * 1  3/6586 (0.05%) 
Dactylitis * 1  2/6586 (0.03%) 
Flank pain * 1  3/6586 (0.05%) 
Joint destruction * 1  1/6586 (0.02%) 
Muscular weakness * 1  11/6586 (0.17%) 
Musculoskeletal chest pain * 1  2/6586 (0.03%) 
Musculoskeletal pain * 1  4/6586 (0.06%) 
Neck pain * 1  4/6586 (0.06%) 
Osteolysis * 1  1/6586 (0.02%) 
Osteonecrosis * 1  2/6586 (0.03%) 
Osteoporotic fracture * 1  1/6586 (0.02%) 
Pain in extremity * 1  7/6586 (0.11%) 
Pathological fracture * 1  7/6586 (0.11%) 
Spondylolisthesis * 1  1/6586 (0.02%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma * 1  1/6586 (0.02%) 
Breast cancer * 1  1/6586 (0.02%) 
Bronchial carcinoma * 1  1/6586 (0.02%) 
Bronchial neoplasm * 1  1/6586 (0.02%) 
Bronchioloalveolar carcinoma * 1  1/6586 (0.02%) 
Cancer pain * 1  1/6586 (0.02%) 
Gastrointestinal neoplasm * 1  1/6586 (0.02%) 
Intracranial tumour haemorrhage * 1  2/6586 (0.03%) 
Lung adenocarcinoma * 1  1/6586 (0.02%) 
Lung cancer metastatic * 1  4/6586 (0.06%) 
Lung neoplasm malignant * 1  40/6586 (0.61%) 
Lymphangiosis carcinomatosa * 1  3/6586 (0.05%) 
Malignant ascites * 1  1/6586 (0.02%) 
Malignant melanoma * 1  1/6586 (0.02%) 
Malignant neoplasm progression * 1  4/6586 (0.06%) 
Malignant pleural effusion * 1  6/6586 (0.09%) 
Metastases to abdominal wall * 1  1/6586 (0.02%) 
Metastases to bone * 1  11/6586 (0.17%) 
Metastases to central nervous system * 1  54/6586 (0.82%) 
Metastases to heart * 1  2/6586 (0.03%) 
Metastases to liver * 1  3/6586 (0.05%) 
Metastases to meninges * 1  3/6586 (0.05%) 
Metastases to peritoneum * 1  1/6586 (0.02%) 
Metastases to skin * 1  2/6586 (0.03%) 
Metastases to spine * 1  6/6586 (0.09%) 
Metastasis * 1  1/6586 (0.02%) 
Metastatic neoplasm * 1  2/6586 (0.03%) 
Metastatic pain * 1  6/6586 (0.09%) 
Neoplasm malignant * 1  1/6586 (0.02%) 
Neoplasm progression * 1  25/6586 (0.38%) 
Neoplasm recurrence * 1  1/6586 (0.02%) 
Non-small cell lung cancer * 1  810/6586 (12.30%) 
Non-small cell lung cancer metastatic * 1  9/6586 (0.14%) 
Non-small cell lung cancer Stage IIIB * 1  1/6586 (0.02%) 
Paraneoplastic syndrome * 1  1/6586 (0.02%) 
Pericardial effusion malignant * 1  1/6586 (0.02%) 
Pericarditis malignant * 1  1/6586 (0.02%) 
Prostate cancer * 1  2/6586 (0.03%) 
Tumour associated fever * 1  3/6586 (0.05%) 
Tumour haemorrhage * 1  1/6586 (0.02%) 
Tumour necrosis * 1  1/6586 (0.02%) 
Tumour pain * 1  7/6586 (0.11%) 
Nervous system disorders   
Altered state of consciousness * 1  3/6586 (0.05%) 
Aphasia * 1  5/6586 (0.08%) 
Ataxia * 1  1/6586 (0.02%) 
Brain oedema * 1  5/6586 (0.08%) 
Cerebral haemorrhage * 1  4/6586 (0.06%) 
Cerebral infarction * 1  11/6586 (0.17%) 
Cerebral ischaemia * 1  4/6586 (0.06%) 
Cerebrovascular accident * 1  24/6586 (0.36%) 
Coma * 1  1/6586 (0.02%) 
Convulsion * 1  13/6586 (0.20%) 
Depressed level of consciousness * 1  2/6586 (0.03%) 
Diplegia * 1  1/6586 (0.02%) 
Dizziness * 1  8/6586 (0.12%) 
Encephalopathy * 1  1/6586 (0.02%) 
Epilepsy * 1  4/6586 (0.06%) 
Facial paresis * 1  1/6586 (0.02%) 
Grand mal convulsion * 1  1/6586 (0.02%) 
Headache * 1  6/6586 (0.09%) 
Hemiparesis * 1  6/6586 (0.09%) 
Hemiplegia * 1  4/6586 (0.06%) 
Hepatic encephalopathy * 1  1/6586 (0.02%) 
Hydrocephalus * 1  1/6586 (0.02%) 
Hypoaesthesia * 1  1/6586 (0.02%) 
Hypoglycaemic coma * 1  1/6586 (0.02%) 
Intracranial pressure increased * 1  2/6586 (0.03%) 
Ischaemic stroke * 1  2/6586 (0.03%) 
Lethargy * 1  1/6586 (0.02%) 
Leukoencephalopathy * 1  1/6586 (0.02%) 
Loss of consciousness * 1  2/6586 (0.03%) 
Memory impairment * 1  1/6586 (0.02%) 
Meningeal disorder * 1  1/6586 (0.02%) 
Mental impairment * 1  1/6586 (0.02%) 
Metabolic encephalopathy * 1  1/6586 (0.02%) 
Monoparesis * 1  3/6586 (0.05%) 
Monoplegia * 1  1/6586 (0.02%) 
Myelopathy * 1  1/6586 (0.02%) 
Myoclonus * 1  1/6586 (0.02%) 
Nerve root compression * 1  1/6586 (0.02%) 
Nervous system disorder * 1  1/6586 (0.02%) 
Neurological symptom * 1  2/6586 (0.03%) 
Neuropathy peripheral * 1  2/6586 (0.03%) 
Paraesthesia * 1  2/6586 (0.03%) 
Paraparesis * 1  4/6586 (0.06%) 
Paraplegia * 1  3/6586 (0.05%) 
Partial seizures * 1  2/6586 (0.03%) 
Peripheral motor neuropathy * 1  2/6586 (0.03%) 
Peripheral paralysis * 1  1/6586 (0.02%) 
Polyneuropathy * 1  1/6586 (0.02%) 
Presyncope * 1  1/6586 (0.02%) 
Psychomotor hyperactivity * 1  1/6586 (0.02%) 
Psychomotor skills impaired * 1  1/6586 (0.02%) 
Quadriplegia * 1  1/6586 (0.02%) 
Radicular pain * 1  1/6586 (0.02%) 
Sciatica * 1  1/6586 (0.02%) 
Somnolence * 1  2/6586 (0.03%) 
Spinal cord compression * 1  12/6586 (0.18%) 
Spinal cord disorder * 1  1/6586 (0.02%) 
Subdural hygroma * 1  1/6586 (0.02%) 
Syncope * 1  19/6586 (0.29%) 
Syncope vasovagal * 1  2/6586 (0.03%) 
Transient ischaemic attack * 1  7/6586 (0.11%) 
Psychiatric disorders   
Agitation * 1  1/6586 (0.02%) 
Alcohol abuse * 1  1/6586 (0.02%) 
Alcohol withdrawal syndrome * 1  1/6586 (0.02%) 
Anxiety * 1  2/6586 (0.03%) 
Completed suicide * 1  1/6586 (0.02%) 
Confusional state * 1  26/6586 (0.39%) 
Delirium * 1  3/6586 (0.05%) 
Depression * 1  6/6586 (0.09%) 
Disorientation * 1  1/6586 (0.02%) 
Eating disorder * 1  1/6586 (0.02%) 
Suicide attempt * 1  1/6586 (0.02%) 
Vomiting psychogenic * 1  1/6586 (0.02%) 
Renal and urinary disorders   
Calculus urinary * 1  1/6586 (0.02%) 
Dysuria * 1  1/6586 (0.02%) 
Glomerulosclerosis * 1  1/6586 (0.02%) 
Haematuria * 1  7/6586 (0.11%) 
Nephrolithiasis * 1  1/6586 (0.02%) 
Renal colic * 1  1/6586 (0.02%) 
Renal failure * 1  6/6586 (0.09%) 
Renal failure acute * 1  2/6586 (0.03%) 
Renal failure chronic * 1  1/6586 (0.02%) 
Urinary incontinence * 1  1/6586 (0.02%) 
Urinary retention * 1  5/6586 (0.08%) 
Reproductive system and breast disorders   
Cervical polyp * 1  1/6586 (0.02%) 
Pelvic pain * 1  1/6586 (0.02%) 
Uterine haemorrhage * 1  1/6586 (0.02%) 
Respiratory, thoracic and mediastinal disorders   
Acute interstitial pneumonitis * 1  1/6586 (0.02%) 
Acute pulmonary oedema * 1  1/6586 (0.02%) 
Acute respiratory distress syndrome * 1  2/6586 (0.03%) 
Acute respiratory failure * 1  10/6586 (0.15%) 
Alveolitis * 1  1/6586 (0.02%) 
Asphyxia * 1  1/6586 (0.02%) 
Atelectasis * 1  3/6586 (0.05%) 
Bronchial haemorrhage * 1  1/6586 (0.02%) 
Bronchial obstruction * 1  2/6586 (0.03%) 
Bronchopleural fistula * 1  1/6586 (0.02%) 
Bronchospasm * 1  1/6586 (0.02%) 
Bronchostenosis * 1  1/6586 (0.02%) 
Chronic obstructive pulmonary disease * 1  15/6586 (0.23%) 
Cough * 1  7/6586 (0.11%) 
Dyspnoea * 1  340/6586 (5.16%) 
Dyspnoea at rest * 1  1/6586 (0.02%) 
Epistaxis * 1  1/6586 (0.02%) 
Haemoptysis * 1  83/6586 (1.26%) 
Haemothorax * 1  3/6586 (0.05%) 
Hydropneumothorax * 1  2/6586 (0.03%) 
Hypoxia * 1  3/6586 (0.05%) 
Interstitial lung disease * 1  5/6586 (0.08%) 
Lung disorder * 1  3/6586 (0.05%) 
Lung infiltration * 1  3/6586 (0.05%) 
Obstructive airways disorder * 1  1/6586 (0.02%) 
Orthopnoea * 1  1/6586 (0.02%) 
Pleural disorder * 1  2/6586 (0.03%) 
Pleural effusion * 1  107/6586 (1.62%) 
Pleurisy * 1  3/6586 (0.05%) 
Pleuritic pain * 1  1/6586 (0.02%) 
Pleurocutaneous fistula * 1  1/6586 (0.02%) 
Pneumonia aspiration * 1  2/6586 (0.03%) 
Pneumonitis * 1  16/6586 (0.24%) 
Pneumothorax * 1  17/6586 (0.26%) 
Productive cough * 1  1/6586 (0.02%) 
Pulmonary artery thrombosis * 1  1/6586 (0.02%) 
Pulmonary embolism * 1  68/6586 (1.03%) 
Pulmonary fibrosis * 1  1/6586 (0.02%) 
Pulmonary haemorrhage * 1  9/6586 (0.14%) 
Pulmonary infarction * 1  1/6586 (0.02%) 
Pulmonary mass * 1  1/6586 (0.02%) 
Pulmonary oedema * 1  8/6586 (0.12%) 
Respiratory arrest * 1  1/6586 (0.02%) 
Respiratory disorder * 1  1/6586 (0.02%) 
Respiratory distress * 1  5/6586 (0.08%) 
Respiratory failure * 1  115/6586 (1.75%) 
Respiratory tract congestion * 1  1/6586 (0.02%) 
Stridor * 1  1/6586 (0.02%) 
Tracheal disorder * 1  1/6586 (0.02%) 
Skin and subcutaneous tissue disorders   
Acne * 1  1/6586 (0.02%) 
Decubitus ulcer * 1  1/6586 (0.02%) 
Erythema * 1  1/6586 (0.02%) 
Livedo reticularis * 1  1/6586 (0.02%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  2/6586 (0.03%) 
Pemphigoid * 1  1/6586 (0.02%) 
Rash * 1  32/6586 (0.49%) 
Skin necrosis * 1  1/6586 (0.02%) 
Skin ulcer * 1  2/6586 (0.03%) 
Stasis dermatitis * 1  1/6586 (0.02%) 
Urticaria * 1  1/6586 (0.02%) 
Urticaria chronic * 1  1/6586 (0.02%) 
Surgical and medical procedures   
Angioplasty * 1  1/6586 (0.02%) 
Hip arthroplasty * 1  1/6586 (0.02%) 
Jaw operation * 1  1/6586 (0.02%) 
Pain management * 1  1/6586 (0.02%) 
Pleurodesis * 1  1/6586 (0.02%) 
Rehabilitation therapy * 1  1/6586 (0.02%) 
Renal stone removal * 1  1/6586 (0.02%) 
Spinal decompression * 1  1/6586 (0.02%) 
Thoracic cavity drainage * 1  1/6586 (0.02%) 
Vascular disorders   
Aneurysm * 1  2/6586 (0.03%) 
Aortic aneurysm rupture * 1  1/6586 (0.02%) 
Arterial insufficiency * 1  1/6586 (0.02%) 
Arterial occlusive disease * 1  1/6586 (0.02%) 
Arterial thrombosis * 1  1/6586 (0.02%) 
Arterial thrombosis limb * 1  4/6586 (0.06%) 
Axillary vein thrombosis * 1  2/6586 (0.03%) 
Cardiovascular insufficiency * 1  3/6586 (0.05%) 
Circulatory collapse * 1  5/6586 (0.08%) 
Deep vein thrombosis * 1  31/6586 (0.47%) 
Embolism * 1  4/6586 (0.06%) 
Haemorrhage * 1  3/6586 (0.05%) 
Hypertension * 1  3/6586 (0.05%) 
Hypotension * 1  1/6586 (0.02%) 
Hypovolaemic shock * 1  1/6586 (0.02%) 
Intermittent claudication * 1  2/6586 (0.03%) 
Ischaemia * 1  1/6586 (0.02%) 
Lymphoedema * 1  1/6586 (0.02%) 
Macroangiopathy * 1  1/6586 (0.02%) 
Orthostatic hypotension * 1  2/6586 (0.03%) 
Pelvic venous thrombosis * 1  1/6586 (0.02%) 
Peripheral arterial occlusive disease * 1  1/6586 (0.02%) 
Peripheral embolism * 1  1/6586 (0.02%) 
Peripheral ischaemia * 1  2/6586 (0.03%) 
Shock * 1  1/6586 (0.02%) 
Shock haemorrhagic * 1  1/6586 (0.02%) 
Subclavian artery stenosis * 1  1/6586 (0.02%) 
Subclavian vein thrombosis * 1  2/6586 (0.03%) 
Superior vena caval occlusion * 1  11/6586 (0.17%) 
Thrombophlebitis * 1  2/6586 (0.03%) 
Thrombophlebitis superficial * 1  1/6586 (0.02%) 
Thrombosis * 1  7/6586 (0.11%) 
Vascular rupture * 1  1/6586 (0.02%) 
Vena cava thrombosis * 1  1/6586 (0.02%) 
Venous occlusion * 1  1/6586 (0.02%) 
Venous thrombosis limb * 1  2/6586 (0.03%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Erlotinib
Affected / at Risk (%)
Total   0/6586 (0.00%) 
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00949910     History of Changes
Other Study ID Numbers: MO18109
2004-000564-28 ( EudraCT Number )
INC-9042 ( Other Identifier: INC Research Netherlands BV )
First Submitted: April 15, 2009
First Posted: July 31, 2009
Results First Submitted: August 9, 2016
Results First Posted: October 4, 2016
Last Update Posted: October 5, 2016