Trial Outcomes & Findings for An Expanded Access Program of Tarceva (Erlotinib) in Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00949910)

NCT ID: NCT00949910

Last Updated: 2016-10-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 6586 participants
• Primary outcome timeframe: 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
• Results posted on: 2016-10-05

Participant Flow

Participant milestones

Measure	Erlotinib 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.
Overall Study STARTED	6586
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	6576

Reasons for withdrawal

Measure	Erlotinib 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.
Overall Study Progressive Disease	3750
Overall Study Symptomatic Deterioration	1088
Overall Study Lost to Follow-up	100
Overall Study Study Drug-Related Adverse Event	315
Overall Study Participant Refusal	390
Overall Study Death Due to Malignant Disease	456
Overall Study Death Due to Progression/Deterioration	4
Overall Study Death Due to Adverse Event	115
Overall Study Death Due to Toxicity	3
Overall Study Death from Unknown Cause	5
Overall Study Unspecified Progression/Deterioration	13
Overall Study Switched to Compassionate/Other Use	174
Overall Study Switched to Commercial Treatment	4
Overall Study Violation of Eligibility	23
Overall Study Logistical Reasons	13
Overall Study Non-Compliance	10
Overall Study Prolonged Dosing Interruption	4
Overall Study Adverse Event	83
Overall Study Serious Adverse Event	6
Overall Study Physician/Participant Decision	7
Overall Study Other	4
Overall Study No Data	9

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Erlotinib n=6586 Participants 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.
Age, Continuous	62.4 years STANDARD_DEVIATION 11.24 • n=5 Participants
Sex: Female, Male Female	2608 Participants n=5 Participants
Sex: Female, Male Male	3978 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: ITT/Safety Population.

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.

Outcome measures

Measure

Erlotinib n=6586 Participants 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.

Percentage of Participants With Objective Response According to Response Evaluation Criteria in Solid Tumors (RECIST)

11 percentage of participants

SECONDARY outcome

Timeframe: 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

Population: ITT/Safety Population.

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.

Outcome measures

Measure

Erlotinib n=6586 Participants 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.

Percentage of Participants With Disease Control According to RECIST

56 percentage of participants

SECONDARY outcome

Timeframe: 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

Population: ITT/Safety Population.

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.

Outcome measures

Measure	Erlotinib n=6586 Participants 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.
Percentage of Participants by Best Overall Response According to RECIST Complete Response (CR)	0.7 percentage of participants
Percentage of Participants by Best Overall Response According to RECIST Partial Response (PR)	10 percentage of participants
Percentage of Participants by Best Overall Response According to RECIST Stable Disease (SD)	45 percentage of participants
Percentage of Participants by Best Overall Response According to RECIST Progressive Disease (PD)	23 percentage of participants
Percentage of Participants by Best Overall Response According to RECIST Not Evaluable	3 percentage of participants
Percentage of Participants by Best Overall Response According to RECIST Not Done	18 percentage of participants
Percentage of Participants by Best Overall Response According to RECIST Not Known	0.0 percentage of participants
Percentage of Participants by Best Overall Response According to RECIST No Data	0.3 percentage of participants

SECONDARY outcome

Timeframe: 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

Population: ITT/Safety Population; only participants with available data were included.

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.

Outcome measures

Measure

Erlotinib n=6580 Participants 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.

Percentage of Participants With Death or Disease Progression According to RECIST

93 percentage of participants

SECONDARY outcome

Timeframe: 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

Population: ITT/Safety Population; only participants with available data were included.

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.

Outcome measures

Measure

Erlotinib n=6580 Participants 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.

Progression-Free Survival (PFS) According to RECIST

3.3 months Interval 3.1 to 3.4

SECONDARY outcome

Timeframe: Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter

Population: ITT/Safety Population.

The percentage of participants (in nearest integer) who died from any cause was reported.

Outcome measures

Measure

Erlotinib n=6586 Participants 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.

Percentage of Participants Who Died

81 percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter

Population: ITT/Safety Population.

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.

Outcome measures

Measure

Erlotinib n=6586 Participants 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 Survival (OS)

7.9 months Interval 7.6 to 8.3

Adverse Events

Erlotinib

Serious events: 2983 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Erlotinib n=6586 participants at risk 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.
Vascular disorders Thrombophlebitis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Thrombophlebitis superficial	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Thrombosis	0.11% 7/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Vascular rupture	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Vena cava thrombosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Venous occlusion	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Venous thrombosis limb	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Blood and lymphatic system disorders Anaemia	0.65% 43/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Blood and lymphatic system disorders Anaemia folate deficiency	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Blood and lymphatic system disorders Anaemia of malignant disease	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Blood and lymphatic system disorders Febrile neutropenia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Blood and lymphatic system disorders Leukocytosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Blood and lymphatic system disorders Neutropenia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Blood and lymphatic system disorders Pancytopenia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Blood and lymphatic system disorders Thrombocytopenia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Acute myocardial infarction	0.18% 12/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Angina pectoris	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Arrhythmia	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Atrial fibrillation	0.11% 7/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Atrial flutter	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Atrioventricular block	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Cardiac arrest	0.20% 13/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Cardiac disorder	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Cardiac failure	0.18% 12/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Cardiac failure acute	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Cardiac failure congestive	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Cardiac tamponade	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Cardio-respiratory arrest	0.14% 9/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Cardio-respiratory distress	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Cardiogenic shock	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Cardiopulmonary failure	0.21% 14/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Cor pulmonale	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Coronary artery disease	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Hypertensive heart disease	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Left ventricular failure	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Myocardial infarction	0.27% 18/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Myocardial ischaemia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Pericardial effusion	0.30% 20/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Pericarditis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Sinus bradycardia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Supraventricular tachycardia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Tachyarrhythmia	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Tachycardia	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Ventricular arrhythmia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Cardiac disorders Ventricular fibrillation	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Ear and labyrinth disorders Vertigo	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Eye disorders Conjunctivitis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Eye disorders Diplopia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Eye disorders Iridocele	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Eye disorders Retinal detachment	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Eye disorders Visual disturbance	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Abdominal distension	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Abdominal pain	0.49% 32/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Abdominal pain lower	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Abdominal pain upper	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Acute abdomen	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Appendicitis perforated	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Ascites	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Colitis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Constipation	0.18% 12/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Diarrhoea	1.3% 83/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Diverticular perforation	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Duodenal ulcer	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Dysphagia	0.32% 21/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Enteritis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastric disorder	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastric haemorrhage	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastric perforation	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastric ulcer	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastritis	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastritis erosive	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastrointestinal disorder	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.29% 19/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastrointestinal obstruction	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastrointestinal perforation	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Gastrointestinal ulcer perforation	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Haematemesis	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Haematochezia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Haemorrhoids	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Ileus	0.12% 8/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Inguinal hernia	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Inguinal hernia, obstructive	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Intestinal obstruction	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Intestinal perforation	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Jejunal perforation	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Large intestine perforation	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Mallory-Weiss syndrome	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Mechanical ileus	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Melaena	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Nausea	0.53% 35/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Necrotising oesophagitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Oesophageal haemorrhage	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Oesophageal spasm	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Oesophageal stenosis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Oesophagitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Pancreatitis	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Pancreatitis acute	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Peptic ulcer	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Peritonitis	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Rectal haemorrhage	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Rectal polyp	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Reflux oesophagitis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Small intestinal obstruction	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Stomatitis	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Subileus	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Gastrointestinal disorders Vomiting	0.68% 45/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Asthenia	0.27% 18/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Catheter related complication	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Chest discomfort	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Chest pain	0.77% 51/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Condition aggravated	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Death	0.21% 14/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Disease progression	4.4% 292/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Drug withdrawal syndrome	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Euthanasia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Fatigue	0.24% 16/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Gait disturbance	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders General physical health deterioration	3.0% 195/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Hyperpyrexia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Ill-defined disorder	0.21% 14/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Local swelling	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Malaise	0.11% 7/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Mucosal inflammation	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Multi-organ failure	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Oedema	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Oedema peripheral	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Pain	0.50% 33/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Performance status decreased	0.12% 8/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Pyrexia	0.79% 52/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Sudden cardiac death	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Sudden death	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
General disorders Ulcer	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Bile duct obstruction	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Bile duct stone	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Cholecystitis	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Gallbladder obstruction	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Hepatic failure	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Hepatic function abnormal	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Hepatic pain	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Hepatitis cholestatic	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Hepatomegaly	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Hyperbilirubinaemia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Jaundice	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Hepatobiliary disorders Liver disorder	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Immune system disorders Anaphylactic reaction	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Immune system disorders Contrast media allergy	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Abscess	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Acute tonsillitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Anal abscess	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Appendicitis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Bacterial sepsis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Biliary sepsis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Bronchitis	0.21% 14/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Bronchitis bacterial	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Bronchopneumonia	0.18% 12/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Bursitis infective	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Catheter related infection	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Catheter sepsis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Catheter site infection	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Cellulitis	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Central line infection	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Cystitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Device related infection	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Diabetic gangrene	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Diarrhoea infectious	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Empyema	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Enterocolitis infectious	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Erysipelas	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Extradural abscess	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Febrile infection	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Folliculitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Gastroenteritis	0.23% 15/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Gastrointestinal infection	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Groin abscess	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Herpangina	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Herpes simplex	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Herpes virus infection	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Herpes zoster	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Infected epidermal cyst	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Infection	0.35% 23/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Lower respiratory tract infection	0.30% 20/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Lung abscess	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Lung infection	0.18% 12/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Lung infection pseudomonal	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Mastitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Mastoiditis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Nasopharyngitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Paronychia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Peritonitis bacterial	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Pneumocystis jiroveci pneumonia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Pneumonia	3.3% 217/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Pneumonia primary atypical	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Post procedural infection	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Pyelonephritis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Respiratory tract infection	0.21% 14/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Sepsis	0.26% 17/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Septic shock	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Sinobronchitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Skin infection	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Tonsillitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Tooth infection	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Tracheobronchitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Upper respiratory tract infection	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Urinary tract infection	0.18% 12/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Urosepsis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Vulval abscess	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Wound infection	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Infections and infestations Wound infection staphylococcal	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Fall	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Femoral neck fracture	0.11% 7/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Femur fracture	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Fracture	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Head injury	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Hip fracture	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Humerus fracture	0.12% 8/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Joint dislocation	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Limb injury	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Multiple fractures	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Overdose	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Pelvic fracture	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Procedural pain	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Radiation pneumonitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Radius fracture	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Rib fracture	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Road traffic accident	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Skin laceration	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Spinal compression fracture	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Spinal fracture	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Tendon rupture	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Thermal burn	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Thrombosis in device	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Transfusion reaction	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Upper limb fracture	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Wound complication	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Wound dehiscence	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Injury, poisoning and procedural complications Wrist fracture	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations Aspiration pleural cavity	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations Blood creatinine increased	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations Bronchoalveolar lavage	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations Drug level increased	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations General physical condition abnormal	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations Haemoglobin decreased	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations Hepatic enzyme increased	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations International normalised ratio abnormal	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations International normalised ratio increased	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations Liver function test abnormal	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations Pulmonary function test decreased	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations Sigmoidoscopy	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Investigations Weight decreased	0.11% 7/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Anorexia	0.18% 12/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Cachexia	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Dehydration	0.44% 29/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Fluid overload	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Hypercalcaemia	0.18% 12/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Hyperglycaemia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Hyperkalaemia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Hypocalcaemia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Hypoglycaemia	0.14% 9/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Hypokalaemia	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Hypomagnesaemia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Hyponatraemia	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Malnutrition	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Oral intake reduced	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Metabolism and nutrition disorders Tetany	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Arthralgia	0.12% 8/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Arthritis	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Back pain	0.55% 36/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Bone pain	0.39% 26/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Bursitis	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Dactylitis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Flank pain	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Joint destruction	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Muscular weakness	0.17% 11/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Neck pain	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Osteolysis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Pain in extremity	0.11% 7/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Pathological fracture	0.11% 7/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial neoplasm	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchioloalveolar carcinoma	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial tumour haemorrhage	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.61% 40/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant ascites	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to abdominal wall	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.17% 11/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.82% 54/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to heart	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to skin	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pain	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.38% 25/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm recurrence	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	12.3% 810/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.14% 9/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer Stage IIIB	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraneoplastic syndrome	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericarditis malignant	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.11% 7/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Altered state of consciousness	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Aphasia	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Ataxia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Brain oedema	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Cerebral haemorrhage	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Cerebral infarction	0.17% 11/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Cerebral ischaemia	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Cerebrovascular accident	0.36% 24/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Coma	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Convulsion	0.20% 13/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Depressed level of consciousness	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Diplegia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Dizziness	0.12% 8/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Encephalopathy	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Epilepsy	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Facial paresis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Grand mal convulsion	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Headache	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Hemiparesis	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Hemiplegia	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Hepatic encephalopathy	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Hydrocephalus	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Hypoaesthesia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Hypoglycaemic coma	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Intracranial pressure increased	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Ischaemic stroke	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Lethargy	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Leukoencephalopathy	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Loss of consciousness	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Memory impairment	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Meningeal disorder	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Mental impairment	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Metabolic encephalopathy	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Monoparesis	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Monoplegia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Myelopathy	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Myoclonus	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Nerve root compression	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Nervous system disorder	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Neurological symptom	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Neuropathy peripheral	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Paraesthesia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Paraparesis	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Paraplegia	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Partial seizures	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Peripheral motor neuropathy	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Peripheral paralysis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Polyneuropathy	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Presyncope	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Psychomotor hyperactivity	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Psychomotor skills impaired	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Quadriplegia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Radicular pain	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Sciatica	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Somnolence	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Spinal cord compression	0.18% 12/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Spinal cord disorder	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Subdural hygroma	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Syncope	0.29% 19/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Syncope vasovagal	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Nervous system disorders Transient ischaemic attack	0.11% 7/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Agitation	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Alcohol abuse	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Alcohol withdrawal syndrome	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Anxiety	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Completed suicide	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Confusional state	0.39% 26/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Delirium	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Depression	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Disorientation	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Eating disorder	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Suicide attempt	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Psychiatric disorders Vomiting psychogenic	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Renal and urinary disorders Calculus urinary	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Renal and urinary disorders Dysuria	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Renal and urinary disorders Glomerulosclerosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Renal and urinary disorders Haematuria	0.11% 7/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Renal and urinary disorders Nephrolithiasis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Renal and urinary disorders Renal colic	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Renal and urinary disorders Renal failure	0.09% 6/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Renal and urinary disorders Renal failure acute	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Renal and urinary disorders Renal failure chronic	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Renal and urinary disorders Urinary incontinence	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Renal and urinary disorders Urinary retention	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Reproductive system and breast disorders Cervical polyp	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Reproductive system and breast disorders Pelvic pain	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Reproductive system and breast disorders Uterine haemorrhage	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Acute interstitial pneumonitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.15% 10/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Alveolitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Bronchial haemorrhage	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Bronchostenosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.23% 15/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Cough	0.11% 7/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.2% 340/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.3% 83/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Hydropneumothorax	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pleural disorder	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 107/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pleurocutaneous fistula	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.24% 16/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.26% 17/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Productive cough	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.0% 68/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.14% 9/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pulmonary infarction	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.12% 8/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.7% 115/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Stridor	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Respiratory, thoracic and mediastinal disorders Tracheal disorder	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Acne	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Erythema	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Livedo reticularis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Pemphigoid	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Rash	0.49% 32/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Skin necrosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Skin ulcer	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Urticaria	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Skin and subcutaneous tissue disorders Urticaria chronic	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Surgical and medical procedures Angioplasty	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Surgical and medical procedures Hip arthroplasty	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Surgical and medical procedures Jaw operation	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Surgical and medical procedures Pain management	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Surgical and medical procedures Pleurodesis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Surgical and medical procedures Rehabilitation therapy	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Surgical and medical procedures Renal stone removal	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Surgical and medical procedures Spinal decompression	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Surgical and medical procedures Thoracic cavity drainage	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Aneurysm	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Aortic aneurysm rupture	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Arterial insufficiency	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Arterial occlusive disease	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Arterial thrombosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Arterial thrombosis limb	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Axillary vein thrombosis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Cardiovascular insufficiency	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Circulatory collapse	0.08% 5/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Deep vein thrombosis	0.47% 31/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Embolism	0.06% 4/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Haemorrhage	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Hypertension	0.05% 3/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Hypotension	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Hypovolaemic shock	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Intermittent claudication	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Ischaemia	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Lymphoedema	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Macroangiopathy	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Orthostatic hypotension	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Pelvic venous thrombosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Peripheral arterial occlusive disease	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Peripheral embolism	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Peripheral ischaemia	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Shock	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Shock haemorrhagic	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Subclavian artery stenosis	0.02% 1/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Subclavian vein thrombosis	0.03% 2/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.
Vascular disorders Superior vena caval occlusion	0.17% 11/6586 • Up to approximately 4.5 years; assessed continuously during treatment (up to 3.5 years) and every 6 months thereafter 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.

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER