Trial Outcomes & Findings for A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00556712)

NCT ID: NCT00556712

Last Updated: 2015-02-11

Results Overview

Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 889 participants
• Primary outcome timeframe: Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
• Results posted on: 2015-02-11

Participant Flow

Participant milestones

Measure	Placebo Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were randomized to receive a placebo, orally (PO) as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 Milligrams Per Day (mg/Day) Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Study STARTED	451	438
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	451	438

Reasons for withdrawal

Measure	Placebo Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were randomized to receive a placebo, orally (PO) as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 Milligrams Per Day (mg/Day) Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Study Adverse Event	7	19
Overall Study Death	5	10
Overall Study Progressive Disease	383	320
Overall Study Protocol Violation	3	2
Overall Study Refused Treatment	17	16
Overall Study Failure to Return	2	3
Overall Study Other	2	2
Overall Study Ongoing at Data Cutoff	32	66

Baseline Characteristics

A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Measure	Placebo n=451 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=438 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Total n=889 Participants Total of all reporting groups
Age, Continuous	59.7 years STANDARD_DEVIATION 9.39 • n=5 Participants	59.8 years STANDARD_DEVIATION 9.52 • n=7 Participants	59.8 years STANDARD_DEVIATION 9.44 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	117 Participants n=7 Participants	230 Participants n=5 Participants
Sex: Female, Male Male	338 Participants n=5 Participants	321 Participants n=7 Participants	659 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; participants with PD prior to randomization were excluded from analysis.

Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.

Outcome measures

Measure	Placebo n=447 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=437 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)	89.5 percentage of participants	79.9 percentage of participants

PRIMARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; participants with PD prior to randomization were excluded from analysis.

The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=447 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=437 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
PFS in All Participants (Data Cutoff 17 May 2008)	11.1 weeks Interval 8.1 to 11.7	12.3 weeks Interval 12.0 to 13.3

PRIMARY outcome

Timeframe: 6 months

Population: FAS; participants with PD prior to randomization were excluded from analysis.

PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=447 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=437 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)	15.0 percentage of participants Interval 12.0 to 19.0	25.0 percentage of participants Interval 21.0 to 29.0

PRIMARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; only participants with EGFR IHC positive tumors were included in the analysis.

PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.

Outcome measures

Measure	Placebo n=311 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=307 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)	89.4 percentage of participants	79.5 percentage of participants

PRIMARY outcome

Timeframe: Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS;only participants with EGFR IHC positive tumors were included in the analysis.

The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=311 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=307 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)	11.1 weeks Interval 7.1 to 11.7	12.3 weeks Interval 12.0 to 17.7

PRIMARY outcome

Timeframe: 6 months

Population: FAS; only participants with EGFR IHC positive tumors were included in the analysis.

PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=311 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=307 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)	16.0 percentage of participants Interval 12.0 to 21.0	27.0 percentage of participants Interval 22.0 to 32.0

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months).

Population: FAS

Outcome measures

Measure	Placebo n=451 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=438 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of All Participants Who Died (Data Cutoff 12 January 2012)	87.1 percentage of participants	82.0 percentage of participants

SECONDARY outcome

Timeframe: Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)

Population: FAS

OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=451 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=438 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)	11.0 months Interval 9.9 to 12.0	12.4 months Interval 10.6 to 13.9

SECONDARY outcome

Timeframe: 1 year

Population: FAS

OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=451 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=438 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)	45.0 percentage of participants Interval 41.0 to 50.0	50.0 percentage of participants Interval 45.0 to 55.0

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)

Population: FAS; only participants with EGFR IHC positive tumors were included in the analysis.

Outcome measures

Measure	Placebo n=313 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=308 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)	87.5 percentage of participants	80.5 percentage of participants

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)

Population: FAS; only participants with EGFR IHC positive tumors were included in the analysis.

OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=313 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=308 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)	11.0 months Interval 9.7 to 12.8	12.8 months Interval 11.1 to 14.7

SECONDARY outcome

Timeframe: 1 year

Population: FAS

OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=313 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=308 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)	47.0 percentage of participants Interval 41.0 to 52.0	52.0 percentage of participants Interval 47.0 to 58.0

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months)

Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.

PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.

Outcome measures

Measure	Placebo n=59 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=62 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)	89.8 percentage of participants	77.4 percentage of participants

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.

The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=59 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=62 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)	9.0 weeks Interval 6.4 to 12.0	11.0 weeks Interval 6.6 to 13.1

SECONDARY outcome

Timeframe: 6 months

Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.

PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=59 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=62 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)	11.0 percentage of participants Interval 2.0 to 20.0	22.0 percentage of participants Interval 11.0 to 34.0

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.

Outcome measures

Measure	Placebo n=59 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=62 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)	50.8 percentage of participants	41.9 percentage of participants

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.

OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=59 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=62 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)	10.2 months Interval 7.4 to 11.2	8.6 months Interval 7.4 to The upper limit of the 95% CI could not be calculated due to the large number of censored events.

SECONDARY outcome

Timeframe: 1 year

Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.

OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=59 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=62 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)	20.0 percentage of participants Interval 3.0 to 37.0	42.0 percentage of participants Interval 25.0 to 59.0

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; participants with PD prior to randomization were excluded from analysis.

The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy.

Outcome measures

Measure	Placebo n=447 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=437 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Time to Progression (Data Cutoff 17 May 2008)	11.3 weeks Interval 8.1 to 11.9	12.3 weeks Interval 12.0 to 14.1

SECONDARY outcome

Timeframe: 6 months

Population: FAS; participants with PD prior to randomization were excluded from analysis.

TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=447 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=437 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)	15.0 percentage of participants Interval 11.0 to 19.0	26.0 percentage of participants Interval 21.0 to 30.0

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.

BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.

Outcome measures

Measure	Placebo n=445 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=436 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)	5.4 percentage of participants Interval 3.5 to 7.9	11.9 percentage of participants Interval 9.0 to 15.3

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis; and 7 and 17 participants were not assessed from the Placebo and Erlotinib, 150 mg/day groups, respectively.

For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.

Outcome measures

Measure	Placebo n=445 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=436 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) CR	0.7 percentage of participants Interval 0.1 to 2.0	0.9 percentage of participants Interval 0.3 to 2.3
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) PR	4.7 percentage of participants Interval 2.9 to 7.1	11.0 percentage of participants Interval 8.2 to 14.3
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) SD	45.4 percentage of participants Interval 40.7 to 50.1	48.6 percentage of participants Interval 43.8 to 53.4
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) PD	47.6 percentage of participants Interval 42.9 to 52.4	35.6 percentage of participants Interval 31.1 to 40.2

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.

Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.

Outcome measures

Measure	Placebo n=445 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=436 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)	1.3 percentage of participants Interval 0.5 to 2.9	5.5 percentage of participants Interval 3.6 to 8.1

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.

For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.

Outcome measures

Measure	Placebo n=445 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=436 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) PR to CR	0.4 percentage of participants Interval 0.1 to 1.6	0.5 percentage of participants Interval 0.1 to 1.6
Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) SD to PR	0.9 percentage of participants Interval 0.2 to 2.3	4.8 percentage of participants Interval 3.0 to 7.3
Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) SD to CR	0.0 percentage of participants Interval 0.0 to 0.8	0.2 percentage of participants Interval 0.0 to 1.3

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.

Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.

Outcome measures

Measure	Placebo n=445 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=436 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) CR Plus (+) PR + SD	50.8 percentage of participants Interval 46.0 to 55.5	60.6 percentage of participants Interval 55.8 to 65.2
Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) CR + PR + SD >12 Weeks	27.4 percentage of participants Interval 23.3 to 31.8	40.8 percentage of participants Interval 36.2 to 45.6

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; 56 and 48 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.

LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline.

Outcome measures

Measure	Placebo n=395 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=390 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)	44.1 percentage of participants	47.7 percentage of participants

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS

The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=395 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=390 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Time to Symptom Progression (Data Cutoff 17 May 2008)	17.6 weeks Interval 12.4 to 19.1	18.3 weeks Interval 13.1 to 24.1

SECONDARY outcome

Timeframe: 6 months

Population: FAS

LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = "not at all" and 4 = "very much." The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=395 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=390 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)	35.0 percentage of participants Interval 27.0 to 42.0	41.0 percentage of participants Interval 34.0 to 47.0

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; 59 and 49 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.

The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment.

Outcome measures

Measure	Placebo n=392 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=389 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)	43.1 percentage of participants	50.9 percentage of participants

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS

The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=392 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=389 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Time to Deterioration in TOI (Data Cutoff 17 May 2008)	18.9 weeks Interval 13.6 to 24.1	18.1 weeks Interval 12.3 to 19.0

SECONDARY outcome

Timeframe: 6 months

Population: FAS

TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=392 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=389 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)	41.0 percentage of participants Interval 34.0 to 48.0	39.0 percentage of participants Interval 33.0 to 45.0

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; 62 and 51 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively,

Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L.

Outcome measures

Measure	Placebo n=389 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=387 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)	51.7 percentage of participants	55.3 percentage of participants

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS

The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=389 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=387 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Time to Deterioration in QoL (Data Cutoff 17 May 2008)	12.3 weeks Interval 11.9 to 17.9	12.6 weeks Interval 12.1 to 18.1

SECONDARY outcome

Timeframe: 6 months

Population: FAS

Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = "not at all" and 4 = "very much." Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Placebo n=389 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=387 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)	34.0 percentage of participants Interval 27.0 to 40.0	32.0 percentage of participants Interval 26.0 to 38.0

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; n=number of participants assessed for the given parameter at the specified timepoint.

Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0="not at all" and 4="very much"). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0="Not at all" to 4="Very much"; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL.

Outcome measures

Measure	Placebo n=397 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=392 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) BL: Physical Well-Being (n=397,392)	20.85 score on a scale Standard Deviation 4.817	20.96 score on a scale Standard Deviation 4.781
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) BL: Social Well-Being (n=397,392)	20.84 score on a scale Standard Deviation 5.496	20.98 score on a scale Standard Deviation 5.285
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) BL: Emotional Well-Being (n=397,393)	16.92 score on a scale Standard Deviation 4.534	16.77 score on a scale Standard Deviation 4.862
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) BL: Functional Well-Being (n=397,393)	16.15 score on a scale Standard Deviation 5.488	16.84 score on a scale Standard Deviation 5.514
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) BL: FACT-L Subscale Score (n=397,391)	24.17 score on a scale Standard Deviation 4.892	24.46 score on a scale Standard Deviation 4.697
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) BL: Lung Cancer Subscale Score (n=397,391)	19.82 score on a scale Standard Deviation 4.188	20.07 score on a scale Standard Deviation 4.240
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) BL: Total FACT-General (FACT-G) Score (n=396,391)	74.68 score on a scale Standard Deviation 14.787	75.52 score on a scale Standard Deviation 14.612
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) BL: Trial Outcome Index (n=396,390)	56.83 score on a scale Standard Deviation 11.830	57.90 score on a scale Standard Deviation 11.682
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) BL: Total FACT-L Score (n=395,389)	98.85 score on a scale Standard Deviation 18.007	100.02 score on a scale Standard Deviation 17.751
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 6: Physical Well-Being (n=274,304)	21.44 score on a scale Standard Deviation 5.117	20.69 score on a scale Standard Deviation 5.180
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 6: Social Well-Being (n=274,303	20.62 score on a scale Standard Deviation 5.437	21.43 score on a scale Standard Deviation 5.178
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 6: Emotional Well-Being (n=275,302)	16.53 score on a scale Standard Deviation 4.587	17.17 score on a scale Standard Deviation 4.748
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 6: Functional Well-Being (n=275,302)	16.41 score on a scale Standard Deviation 5.234	16.87 score on a scale Standard Deviation 5.614
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 6: FACT-L Subscale Score (n=275,300)	24.45 score on a scale Standard Deviation 5.231	24.80 score on a scale Standard Deviation 5.000
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 6: Lung Cancer Subscale Score (n=275,300)	19.78 score on a scale Standard Deviation 4.463	20.13 score on a scale Standard Deviation 4.336
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 6: Total FACT-G Score (n=274,300)	74.82 score on a scale Standard Deviation 14.380	76.14 score on a scale Standard Deviation 15.132
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 6: Trial Outcome Index (n=274,299)	57.59 score on a scale Standard Deviation 12.292	57.64 score on a scale Standard Deviation 12.482
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 6: Total FACT-L Score (n=274,297)	99.27 score on a scale Standard Deviation 17.857	100.95 score on a scale Standard Deviation 18.360
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 12: Physical Well-Being (n=144,194)	21.93 score on a scale Standard Deviation 4.734	20.78 score on a scale Standard Deviation 5.368
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 12: Social Well-Being (n=143,194)	20.38 score on a scale Standard Deviation 5.637	20.04 score on a scale Standard Deviation 5.691
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 12: Emotional Well-Being (n=144,194)	17.21 score on a scale Standard Deviation 4.376	16.85 score on a scale Standard Deviation 4.521
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 12: Functional Well-Being (n=144,196)	17.04 score on a scale Standard Deviation 5.770	16.35 score on a scale Standard Deviation 5.745
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 12: FACT-L Subscale Score (n=144,196)	25.15 score on a scale Standard Deviation 4.735	24.19 score on a scale Standard Deviation 5.323
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 12: Lung Cancer Subscale Score (n=144,196)	20.22 score on a scale Standard Deviation 4.015	19.50 score on a scale Standard Deviation 4.600
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 12: Total FACT-G Score (n=144,192)	76.42 score on a scale Standard Deviation 14.889	74.06 score on a scale Standard Deviation 15.754
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 12: Trial Outcome Index (n=144,194)	59.19 score on a scale Standard Deviation 12.129	56.57 score on a scale Standard Deviation 13.276
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 12: Total FACT-L Score (n=144,192)	101.56 score on a scale Standard Deviation 17.824	98.30 score on a scale Standard Deviation 19.337
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 18: Physical Well-Being (n=86,143)	21.60 score on a scale Standard Deviation 4.883	21.40 score on a scale Standard Deviation 4.945
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 18: Social Well-Being (n=86,143)	21.08 score on a scale Standard Deviation 5.328	19.94 score on a scale Standard Deviation 6.130
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 18: Emotional Well-Being (n=86,143)	17.33 score on a scale Standard Deviation 4.717	17.14 score on a scale Standard Deviation 4.356
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 18: Functional Well-Being (n=86,143)	16.89 score on a scale Standard Deviation 5.289	16.83 score on a scale Standard Deviation 5.553
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 18: FACT-L Subscale Score (n=86,143)	25.44 score on a scale Standard Deviation 4.645	24.52 score on a scale Standard Deviation 5.344
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 18: Lung Cancer Subscale Score (n=86,143)	20.28 score on a scale Standard Deviation 4.003	19.64 score on a scale Standard Deviation 4.635
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 18: Total FACT-G Score (n=86,143)	76.89 score on a scale Standard Deviation 14.385	75.31 score on a scale Standard Deviation 16.648
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 18: Trial Outcome Index (n=86,143)	58.76 score on a scale Standard Deviation 11.492	57.87 score on a scale Standard Deviation 12.803
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 18: Total FACT-L Score (n=86,143)	102.33 score on a scale Standard Deviation 17.502	99.83 score on a scale Standard Deviation 20.558
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 24: Physical Well-Being (n=59,101)	21.78 score on a scale Standard Deviation 4.665	21.21 score on a scale Standard Deviation 4.898
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 24: Social Well-Being (n=59,101)	20.79 score on a scale Standard Deviation 5.641	20.49 score on a scale Standard Deviation 5.251
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 24: Emotional Well-Being (n=59,100)	16.86 score on a scale Standard Deviation 4.880	16.54 score on a scale Standard Deviation 4.615
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 24: Functional Well-Being (n=59,100)	17.14 score on a scale Standard Deviation 6.062	17.23 score on a scale Standard Deviation 5.300
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 24: FACT-L Subscale Score (n=59,101)	25.18 score on a scale Standard Deviation 5.126	25.13 score on a scale Standard Deviation 5.245
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 24: Lung Cancer Subscale Score (n=59,101)	20.07 score on a scale Standard Deviation 4.246	19.94 score on a scale Standard Deviation 4.487
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 24: Total FACT-G Score (n=59,99)	76.58 score on a scale Standard Deviation 16.091	75.50 score on a scale Standard Deviation 15.754
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 24: Trial Outcome Index (n=59,100)	58.99 score on a scale Standard Deviation 11.837	58.37 score on a scale Standard Deviation 12.686
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 24: Total FACT-L Score (n=59,99)	101.75 score on a scale Standard Deviation 19.347	100.69 score on a scale Standard Deviation 19.831
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 30: Physical Well-Being (n=37,66)	21.74 score on a scale Standard Deviation 4.153	21.77 score on a scale Standard Deviation 4.576
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 30: Social Well-Being (n=37,66)	20.50 score on a scale Standard Deviation 5.180	20.74 score on a scale Standard Deviation 5.491
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 30: Emotional Well-Being (n=37,66)	16.37 score on a scale Standard Deviation 4.164	17.23 score on a scale Standard Deviation 4.675
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 30: Functional Well-Being (n=37,66)	17.92 score on a scale Standard Deviation 5.082	17.93 score on a scale Standard Deviation 5.510
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 30: FACT-L Subscale Score (n=37,66)	25.90 score on a scale Standard Deviation 3.484	25.86 score on a scale Standard Deviation 4.817
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 30: Lung Cancer Subscale Score (n=37,66)	20.66 score on a scale Standard Deviation 3.073	20.61 score on a scale Standard Deviation 4.393
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 30: Total FACT-G Score (n=37,66)	76.54 score on a scale Standard Deviation 11.915	77.66 score on a scale Standard Deviation 15.078
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 30: Trial Outcome Index (n=37,66)	60.32 score on a scale Standard Deviation 9.753	60.30 score on a scale Standard Deviation 11.876
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 30: Total FACT-L Score (n=37,66)	102.44 score on a scale Standard Deviation 14.063	103.52 score on a scale Standard Deviation 18.367
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 36: Physical Well-Being (n=25,47)	21.60 score on a scale Standard Deviation 3.317	22.26 score on a scale Standard Deviation 4.480
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 36: Social Well-Being (n=25,47)	20.02 score on a scale Standard Deviation 5.769	20.15 score on a scale Standard Deviation 4.988
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 36: Emotional Well-Being (n=25,47)	17.31 score on a scale Standard Deviation 3.736	17.54 score on a scale Standard Deviation 4.540
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 36: Fuctional Well-Being (n=25,47)	16.06 score on a scale Standard Deviation 4.287	18.06 score on a scale Standard Deviation 5.720
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 36: FACT-L Subscale Score (n=25,47)	24.48 score on a scale Standard Deviation 4.089	25.83 score on a scale Standard Deviation 5.305
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 36: Lung Cancer Subscale Score (n=25,47)	19.36 score on a scale Standard Deviation 3.893	20.55 score on a scale Standard Deviation 4.463
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 36: Total FACT-G Score (n=25,47)	74.99 score on a scale Standard Deviation 11.066	78.02 score on a scale Standard Deviation 15.688
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 36: Trial Outcome Index (n=25,47)	57.02 score on a scale Standard Deviation 9.426	60.87 score on a scale Standard Deviation 11.963
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 36: Total FACT-L Score (n=25,47)	99.27 score on a scale Standard Deviation 13.672	103.86 score on a scale Standard Deviation 19.244
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 42: Physical Well-Being (n=19,35)	21.76 score on a scale Standard Deviation 3.592	22.19 score on a scale Standard Deviation 5.035
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 42: Social Well-Being (n=19,35)	18.45 score on a scale Standard Deviation 6.262	20.40 score on a scale Standard Deviation 5.234
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 42: Emotional Well-Being (n=19,35)	16.95 score on a scale Standard Deviation 4.089	17.43 score on a scale Standard Deviation 4.984
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 42: Functional Well-Being (n=19,35)	15.32 score on a scale Standard Deviation 3.902	18.57 score on a scale Standard Deviation 5.500
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 42: FACT-L Subscale Score (n=19,35)	24.63 score on a scale Standard Deviation 4.448	26.67 score on a scale Standard Deviation 5.357
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 42: Lung Cancer Subscale Score (n=19,35)	19.50 score on a scale Standard Deviation 4.092	21.21 score on a scale Standard Deviation 4.607
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 42: FACT-G Score (n=19,35)	72.74 score on a scale Standard Deviation 12.406	78.59 score on a scale Standard Deviation 16.316
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 42: Trial Outcome Index (n=19,35)	56.58 score on a scale Standard Deviation 9.562	61.97 score on a scale Standard Deviation 12.622
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 42: FACT-L Score (n=19,35)	97.11 score on a scale Standard Deviation 14.951	105.25 score on a scale Standard Deviation 20.385
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 48: Physical Well-Being (n=13,29)	21.38 score on a scale Standard Deviation 4.154	23.23 score on a scale Standard Deviation 4.016
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 48: Social Well-Being (n=13,29)	17.23 score on a scale Standard Deviation 7.567	20.24 score on a scale Standard Deviation 5.569
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 48: Emotional Well-Being (n=13,29)	18.69 score on a scale Standard Deviation 3.011	17.59 score on a scale Standard Deviation 4.903
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 48: Functional Well-Being (n=13,29)	14.15 score on a scale Standard Deviation 2.672	18.48 score on a scale Standard Deviation 4.501
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 48: FACT-L Subscale Score (n=12,29)	23.35 score on a scale Standard Deviation 3.647	26.80 score on a scale Standard Deviation 5.591
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 48: Lung Cancer Subscale Score (n=12,29)	18.75 score on a scale Standard Deviation 3.646	21.21 score on a scale Standard Deviation 4.967
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 48: FACT-G Score (n=12,29)	71.46 score on a scale Standard Deviation 12.069	79.53 score on a scale Standard Deviation 14.672
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 48: Trial Outcome Index (n=12,29)	54.58 score on a scale Standard Deviation 9.140	62.92 score on a scale Standard Deviation 11.105
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 48: FACT-L Score (n=12,29)	96.19 score on a scale Standard Deviation 14.394	106.33 score on a scale Standard Deviation 18.701
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 60: Physical Well-Being (n=9,17)	22.67 score on a scale Standard Deviation 4.664	23.65 score on a scale Standard Deviation 4.212
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 60: Social Well-Being (n=9,17)	17.78 score on a scale Standard Deviation 6.405	21.31 score on a scale Standard Deviation 6.530
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 60: Emotional Well-Being (n=9,17)	16.78 score on a scale Standard Deviation 3.232	19.12 score on a scale Standard Deviation 3.638
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 60: Functional Well-Being (n=9,17)	15.11 score on a scale Standard Deviation 3.408	18.65 score on a scale Standard Deviation 6.828
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 60: FACT-L Subscale Score (n=9,17)	23.43 score on a scale Standard Deviation 5.010	25.99 score on a scale Standard Deviation 6.844
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 60: Lung Cancer Subscale Score (n=9,17)	17.89 score on a scale Standard Deviation 3.919	20.47 score on a scale Standard Deviation 5.959
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 60: Total FACT-G Score (n=9,17)	72.34 score on a scale Standard Deviation 11.607	82.73 score on a scale Standard Deviation 17.803
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 60: Trial Outcome Index (n=9,17)	55.67 score on a scale Standard Deviation 9.695	62.76 score on a scale Standard Deviation 14.316
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 60: Total FACT-L Score (n=9,17)	95.77 score on a scale Standard Deviation 15.703	108.71 score on a scale Standard Deviation 23.069
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 72: Physical Well-Being (n=6,8)	22.17 score on a scale Standard Deviation 4.997	23.25 score on a scale Standard Deviation 4.097
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 72: Social Well-Being (n=6,8)	19.00 score on a scale Standard Deviation 7.251	21.44 score on a scale Standard Deviation 5.852
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 72: Emotional Well-Being (n=6,8)	17.17 score on a scale Standard Deviation 2.401	18.25 score on a scale Standard Deviation 5.007
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 72: Functional Well-Being (n=6,8)	15.22 score on a scale Standard Deviation 4.457	16.50 score on a scale Standard Deviation 5.855
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 72: FACT-L Subscale Score (n=6,8)	21.23 score on a scale Standard Deviation 5.154	26.48 score on a scale Standard Deviation 6.185
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 72: Lung Cancer Subscale Score (n=6,8)	17.17 score on a scale Standard Deviation 4.021	21.40 score on a scale Standard Deviation 5.724
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 72: Total FACT-G Score (n=6,8)	73.67 score on a scale Standard Deviation 14.820	79.44 score on a scale Standard Deviation 16.176
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 72: Trial Outcome Index (n=6,8)	54.67 score on a scale Standard Deviation 11.911	61.15 score on a scale Standard Deviation 14.343
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 72: Total FACT-L Score (n=6,8)	94.90 score on a scale Standard Deviation 18.833	105.92 score on a scale Standard Deviation 21.282
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 84: Physical Well-Being (n=1,0)	20.00 score on a scale Standard Deviation NA Standard deviation (SD) not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants analyzed
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 84: Social Well-Being (n=1,0)	14.00 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants analyzed
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 84: Emotional Well-Being (n=1,0)	13.00 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants analyzed
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 84: Functional Well-Being (n=1,0)	18.00 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants analyzed
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 84: FACT-L Subscale Score (n=1,0)	17.00 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants analyzed
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 84: Lung Cancer Subscale Score (n=1,0)	13.00 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants analyzed
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 84: Total FACT-G Score (n=1,0)	65.00 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants analyzed
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 84: Trial Outcome Index (n=1,0)	51.00 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants analyzed
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Week 84: Total FACT-L Score (n=1,0)	82.00 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants analyzed
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Off Trtmt: Physical Well-Being (n=265,215)	19.57 score on a scale Standard Deviation 5.668	18.50 score on a scale Standard Deviation 5.534
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Off Trtmt: Social Well-Being (n=263,216)	20.01 score on a scale Standard Deviation 5.380	20.68 score on a scale Standard Deviation 5.265
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Off Trtmt: Emotional Well-Being (n=265,216)	14.76 score on a scale Standard Deviation 5.157	15.11 score on a scale Standard Deviation 5.183
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Off Trtmt: Functional Well-Being (n=265,216)	14.90 score on a scale Standard Deviation 5.893	14.58 score on a scale Standard Deviation 5.934
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Off Trtmt: FACT-L Subscale Score (n=264,214)	22.80 score on a scale Standard Deviation 5.268	22.88 score on a scale Standard Deviation 4.911
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Off Trtmt: Lung Cancer Subscale Score (n=264,214)	18.06 score on a scale Standard Deviation 4.629	18.16 score on a scale Standard Deviation 4.383
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Off Trtmt:Total FACT-G Score (n=261,214)	69.29 score on a scale Standard Deviation 15.730	68.94 score on a scale Standard Deviation 15.669
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Off Trtmt:Trial Outcome Index (n=263,213)	52.61 score on a scale Standard Deviation 13.475	51.34 score on a scale Standard Deviation 12.974
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) Off Trtmt:Total FACT-L Score (n=260,212)	92.14 score on a scale Standard Deviation 19.324	91.89 score on a scale Standard Deviation 18.738

SECONDARY outcome

Timeframe: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)

Population: FAS; n=number of participants assessed for the given parameter at the specified timepoint.

Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0="not at all" and 4="very much"). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0="not at all" and 4="very much"). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0="Not at all" to 4="Very much"; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL.

Outcome measures

Measure	Placebo n=274 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=303 Participants Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Off Trtmt: Physical Well-Being (n=264,214)	-1.07 score on a scale Standard Deviation 4.750	-2.19 score on a scale Standard Deviation 5.506
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Off Trtmt: Emotional Well-Being (n=264,216)	-2.04 score on a scale Standard Deviation 4.225	-1.56 score on a scale Standard Deviation 4.745
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Off Trtmt: FACT-L Subscale Score (n=263,212)	-1.27 score on a scale Standard Deviation 4.458	-1.32 score on a scale Standard Deviation 4.708
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Off Trtmt: Lung Cancer Subscale Score (n=263,212)	-1.74 score on a scale Standard Deviation 3.882	-1.78 score on a scale Standard Deviation 4.199
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 6: Physical Well-Being (n=274,303)	0.22 score on a scale Standard Deviation 4.235	-0.47 score on a scale Standard Deviation 4.729
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 6: Social Well-Being (n=274,303)	-0.24 score on a scale Standard Deviation 4.901	0.23 score on a scale Standard Deviation 4.202
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 6: Emotional Well-Being (n=274,302)	-0.41 score on a scale Standard Deviation 3.801	0.29 score on a scale Standard Deviation 3.916
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 6: Functional Well-Being (n=275,302)	0.24 score on a scale Standard Deviation 4.819	-0.09 score on a scale Standard Deviation 4.711
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 6: FACT-L Subscale Score (n=275,298)	-0.06 score on a scale Standard Deviation 4.899	0.24 score on a scale Standard Deviation 4.623
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 6: Lung Cancer Subscale Score (n=275,298)	-0.32 score on a scale Standard Deviation 4.148	-0.03 score on a scale Standard Deviation 4.160
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 6: Total FACT-G Score (n=273,299)	-0.20 score on a scale Standard Deviation 12.256	0.01 score on a scale Standard Deviation 11.453
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 6: Trial Outcome Index (n=274,296)	0.16 score on a scale Standard Deviation 10.276	-0.73 score on a scale Standard Deviation 10.201
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 6: Total FACT-L Score (n=273,294)	-0.20 score on a scale Standard Deviation 15.133	0.14 score on a scale Standard Deviation 14.155
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 12: Physical Well-Being (n=144,193)	1.00 score on a scale Standard Deviation 4.036	-0.14 score on a scale Standard Deviation 4.908
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 12: Social Well-Being (n=143,194)	-0.43 score on a scale Standard Deviation 4.918	-0.43 score on a scale Standard Deviation 5.566
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 12: Emotional Well-Being (n=144,194)	0.25 score on a scale Standard Deviation 3.728	0.20 score on a scale Standard Deviation 4.115
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 12: Functional Well-Being (n=144,196)	1.00 score on a scale Standard Deviation 4.707	-0.38 score on a scale Standard Deviation 4.806
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 12: FACT-L Subscale Score (n=144,196)	0.88 score on a scale Standard Deviation 4.501	-0.06 score on a scale Standard Deviation 4.570
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 12: Lung Cancer Subscale Score (n=144,196)	0.19 score on a scale Standard Deviation 3.666	-0.48 score on a scale Standard Deviation 4.004
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 12: Total FACT-G Score (n=144,191)	1.83 score on a scale Standard Deviation 11.637	-0.84 score on a scale Standard Deviation 12.145
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 12: Trial Outcome Index (n=144,193)	2.20 score on a scale Standard Deviation 9.362	-1.04 score on a scale Standard Deviation 10.051
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 12: Total FACT-L Score (n=144,191)	2.72 score on a scale Standard Deviation 14.226	-0.90 score on a scale Standard Deviation 14.536
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 18: Physical Well-Being (n=86,143)	1.31 score on a scale Standard Deviation 4.798	0.40 score on a scale Standard Deviation 4.890
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 18: Social Well-Being (n=86,143)	-0.01 score on a scale Standard Deviation 4.454	-0.51 score on a scale Standard Deviation 5.894
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 18: Emotional Well-Being (n=86,143)	0.59 score on a scale Standard Deviation 3.984	0.60 score on a scale Standard Deviation 3.723
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 18: Functional Well-Being (n=86,143)	1.06 score on a scale Standard Deviation 4.353	0.18 score on a scale Standard Deviation 4.903
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 18: FACT-L Subscale Score (n=86,143)	1.48 score on a scale Standard Deviation 4.171	0.27 score on a scale Standard Deviation 4.587
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 18: Lung Cancer Subscale Score (n=86,143)	0.49 score on a scale Standard Deviation 3.550	-0.26 score on a scale Standard Deviation 4.125
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 18: Total FACT-G Score (n=86,143)	2.95 score on a scale Standard Deviation 12.047	0.68 score on a scale Standard Deviation 12.668
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 18: Trial Outcome Index (n=86,143)	2.86 score on a scale Standard Deviation 9.638	0.32 score on a scale Standard Deviation 10.350
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 18: Total FACT-L Score (n=86,143)	4.43 score on a scale Standard Deviation 14.523	0.95 score on a scale Standard Deviation 15.386
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 24: Physical Well-Being (n=59,101)	1.29 score on a scale Standard Deviation 4.358	0.16 score on a scale Standard Deviation 4.881
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 24: Social Well-Being (n=59,101)	-0.25 score on a scale Standard Deviation 4.804	0.04 score on a scale Standard Deviation 6.092
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 24: Emotional Well-Being (n=59,100)	0.21 score on a scale Standard Deviation 5.118	-0.05 score on a scale Standard Deviation 4.169
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 24: Functional Well-Being (n=59,100)	1.64 score on a scale Standard Deviation 4.550	0.42 score on a scale Standard Deviation 4.373
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 24: FACT-L Subscale Score (n=59,101)	1.45 score on a scale Standard Deviation 5.018	0.50 score on a scale Standard Deviation 5.048
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 24: Lung Cancer Subscale Score (n=59,101)	0.48 score on a scale Standard Deviation 4.051	-0.12 score on a scale Standard Deviation 4.321
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 24: Total FACT-G Score (n=59,99)	2.89 score on a scale Standard Deviation 13.739	0.52 score on a scale Standard Deviation 12.753
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 24: Trial Outcome Index (n=59,100)	3.42 score on a scale Standard Deviation 9.606	0.43 score on a scale Standard Deviation 10.348
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 24: Total FACT-L Score (n=59,99)	4.34 score on a scale Standard Deviation 16.354	1.10 score on a scale Standard Deviation 15.954
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 30: Physical Well-Being (n=37,66)	1.61 score on a scale Standard Deviation 4.205	0.49 score on a scale Standard Deviation 5.129
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 30: Social Well-Being (n=37,66)	0.00 score on a scale Standard Deviation 5.510	-0.19 score on a scale Standard Deviation 6.676
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 30: Emotional Well-Being (n=37,66)	-0.07 score on a scale Standard Deviation 4.902	0.74 score on a scale Standard Deviation 4.775
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 30: Functional Well-Being (n=37,66)	2.17 score on a scale Standard Deviation 5.028	0.83 score on a scale Standard Deviation 5.243
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 30: FACT-L Subscale Score (n=37,66)	1.79 score on a scale Standard Deviation 4.616	0.99 score on a scale Standard Deviation 4.863
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 30: Lung Cancer Subscale Score (n=37,66)	0.69 score on a scale Standard Deviation 3.818	0.38 score on a scale Standard Deviation 4.454
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 30: Total FACT-G Score (n=37,66)	3.71 score on a scale Standard Deviation 13.827	1.88 score on a scale Standard Deviation 14.268
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 30: Trial Outcome Index (n=37,66)	4.47 score on a scale Standard Deviation 9.551	1.70 score on a scale Standard Deviation 11.108
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 30: Total FACT-L Score (n=37,66)	5.50 score on a scale Standard Deviation 15.828	2.86 score on a scale Standard Deviation 16.864
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 36: Physical Well-Being (n=25,47)	2.21 score on a scale Standard Deviation 4.791	0.77 score on a scale Standard Deviation 5.093
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 36: Social Well-Being (n=25,47)	-0.36 score on a scale Standard Deviation 5.659	-0.16 score on a scale Standard Deviation 7.053
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 36: Emotional Well-Being (n=25,47)	0.86 score on a scale Standard Deviation 4.892	0.65 score on a scale Standard Deviation 3.717
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 36: Functional Well-Being (n=25,47)	1.31 score on a scale Standard Deviation 5.551	1.10 score on a scale Standard Deviation 5.280
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 36: FACT-L Subscale Score (n=25,47)	0.67 score on a scale Standard Deviation 4.864	0.43 score on a scale Standard Deviation 5.459
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 36: Lung Cancer Subscale Score (n=25,47)	-0.10 score on a scale Standard Deviation 3.963	-0.06 score on a scale Standard Deviation 4.535
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 36: Total FACT-G Score (n=25,47)	4.02 score on a scale Standard Deviation 14.439	2.37 score on a scale Standard Deviation 13.991
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 36: Trial Outcome Index (n=25,47)	3.42 score on a scale Standard Deviation 11.186	1.82 score on a scale Standard Deviation 10.443
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 36: Total Fact-L Score (n=25,47)	4.68 score on a scale Standard Deviation 17.636	2.79 score on a scale Standard Deviation 16.662
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 42: Physical Well-Being (n=19,35)	1.82 score on a scale Standard Deviation 3.936	0.27 score on a scale Standard Deviation 5.835
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 42: Social Well-Being (n=19,35)	-1.14 score on a scale Standard Deviation 6.006	0.28 score on a scale Standard Deviation 7.784
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 42: Emotional Well-Being (n=19,35)	-0.11 score on a scale Standard Deviation 3.573	0.59 score on a scale Standard Deviation 3.741
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 42: Functional Well-Being (n=19,35)	0.05 score on a scale Standard Deviation 3.582	0.65 score on a scale Standard Deviation 5.580
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 42: FACT-L Subscale Score (n=19,35)	1.40 score on a scale Standard Deviation 4.321	0.87 score on a scale Standard Deviation 4.974
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 42: Lung Cancer Subscale Score (n=19,35)	0.42 score on a scale Standard Deviation 2.858	0.51 score on a scale Standard Deviation 4.301
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 42: FACT-G Score (n=19,35)	0.62 score on a scale Standard Deviation 10.871	1.80 score on a scale Standard Deviation 15.245
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 42: Trial Outcome Index (n=19,35)	2.29 score on a scale Standard Deviation 7.037	1.44 score on a scale Standard Deviation 12.405
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 42: FACT-L Score (n=19,35)	2.03 score on a scale Standard Deviation 12.466	2.67 score on a scale Standard Deviation 18.499
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 48: Physical Well-Being (n=13,29)	0.46 score on a scale Standard Deviation 3.497	1.37 score on a scale Standard Deviation 6.388
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 48: Social Well-Being (n=13,29)	-1.96 score on a scale Standard Deviation 7.987	-0.68 score on a scale Standard Deviation 6.851
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 48: Emotional Well-Being (n=13,29)	-0.08 score on a scale Standard Deviation 3.095	0.41 score on a scale Standard Deviation 4.166
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 48: Functional Well-Being (n=13,29)	-2.00 score on a scale Standard Deviation 3.894	0.55 score on a scale Standard Deviation 5.448
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 48: FACT-L Subscale Score (n=12,29)	0.03 score on a scale Standard Deviation 4.445	0.82 score on a scale Standard Deviation 5.967
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 48: Lung Cancer Subscale Score (n=12,29)	-0.79 score on a scale Standard Deviation 3.100	0.34 score on a scale Standard Deviation 5.150
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 48: Total FACT-G Score (n=13,29)	-3.57 score on a scale Standard Deviation 12.233	1.64 score on a scale Standard Deviation 14.463
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 48: Trial Outcome Index (n=12,29)	-1.79 score on a scale Standard Deviation 7.570	2.26 score on a scale Standard Deviation 13.247
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 48: Total FACT-L Score (n=12,29)	-1.60 score on a scale Standard Deviation 11.354	2.46 score on a scale Standard Deviation 18.177
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 60: Physical Well-Being (n=9,17)	1.89 score on a scale Standard Deviation 5.383	1.82 score on a scale Standard Deviation 6.307
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 60: Social Well-Being (n=9,17)	-0.57 score on a scale Standard Deviation 7.368	0.06 score on a scale Standard Deviation 9.116
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 60: Emotional Well-Being (n=9,17)	-1.56 score on a scale Standard Deviation 2.789	0.28 score on a scale Standard Deviation 4.478
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 60: Functional Well-Being (n=9,17)	-0.56 score on a scale Standard Deviation 3.877	-0.53 score on a scale Standard Deviation 7.434
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 60: FACT-L Subscale Score (n=9,17)	1.61 score on a scale Standard Deviation 5.882	0.43 score on a scale Standard Deviation 6.275
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 60: Lung Cancer Subscale Score (n=9,17)	-0.22 score on a scale Standard Deviation 4.438	0.47 score on a scale Standard Deviation 5.535
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 60: Total FACT-G Score (n=9,17)	-0.79 score on a scale Standard Deviation 12.270	1.64 score on a scale Standard Deviation 17.542
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 60: Trial Outcome Index (n=9,17)	1.11 score on a scale Standard Deviation 11.044	1.76 score on a scale Standard Deviation 14.316
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 60: Total FACT-L Score (n=9,17)	0.82 score on a scale Standard Deviation 15.700	2.07 score on a scale Standard Deviation 22.086
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 72: Physical Well-Being (n=6,8)	1.33 score on a scale Standard Deviation 6.318	2.63 score on a scale Standard Deviation 7.130
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 72: Social Well-Being (n=6,8)	0.31 score on a scale Standard Deviation 6.723	0.30 score on a scale Standard Deviation 3.733
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 72: Emotional Well-Being (n=6,8)	-1.50 score on a scale Standard Deviation 3.619	-0.13 score on a scale Standard Deviation 4.853
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 72: Functional Well-Being (n=6,8)	-1.67 score on a scale Standard Deviation 5.354	-1.13 score on a scale Standard Deviation 5.384
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 72: FACT-L Subscale Score (n=6,8)	-0.50 score on a scale Standard Deviation 7.396	1.03 score on a scale Standard Deviation 4.818
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 72: Lung Cancer Subscale Score (n=6,8)	-1.17 score on a scale Standard Deviation 5.193	1.78 score on a scale Standard Deviation 4.141
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 72: Total FACT-G Score (n=6,8)	-1.53 score on a scale Standard Deviation 11.929	1.67 score on a scale Standard Deviation 14.651
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 72: Trial Outcome Index (n=6,8)	-1.50 score on a scale Standard Deviation 13.097	3.28 score on a scale Standard Deviation 13.738
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 72: Total FACT-L Score (n=6,8)	-2.03 score on a scale Standard Deviation 16.140	2.70 score on a scale Standard Deviation 17.579
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 84: Physical Well-Being (n=1,0)	1.33 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants were analyzed
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 84: Social Well-Being (n=1,0)	-2.00 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants were analyzed
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 84: Emotional Well-Being (n=1,0)	-3.00 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants were analyzed
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 84: Functional Well-Being (n=1,0)	-1.00 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants were analyzed
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 84: FACT-L Subscale Score (n=1,0)	6.0 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants were analyzed
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 84: Lung Cancer Subscale Score (n=1,0)	2.0 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants were analyzed
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 84: Total FACT-G Score (n=1,0)	-4.67 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants were analyzed
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 84: Trial Outcome Index (n=1,0)	2.33 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants were analyzed
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Week 84: Total FACT-L Score (n=1,0)	1.33 score on a scale Standard Deviation NA SD not calculated as only 1 participant was analyzed.	NA score on a scale Standard Deviation NA Zero participants were analyzed
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Off Trtmt: Total FACT-G Score (n=260,213)	-4.91 score on a scale Standard Deviation 12.576	-5.71 score on a scale Standard Deviation 13.588
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Off Trtmt: Trial Outcome Index (n=261,210)	-4.03 score on a scale Standard Deviation 10.658	-6.05 score on a scale Standard Deviation 11.785
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Off Trtmt: Total FACT-L Score (n=258,209)	-6.26 score on a scale Standard Deviation 15.146	-7.10 score on a scale Standard Deviation 16.194
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Off Trtmt: Social Well-Being (n=263,216)	-0.66 score on a scale Standard Deviation 4.973	0.09 score on a scale Standard Deviation 4.824
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) Off Trtmt: Functional Well-Being (n=264,216)	-1.20 score on a scale Standard Deviation 5.170	-1.98 score on a scale Standard Deviation 5.355

Adverse Events

Placebo

Serious events: 34 serious events

Other events: 152 other events

Deaths: 0 deaths

Erlotinib, 150 mg/Day

Serious events: 49 serious events

Other events: 283 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=445 participants at risk Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=433 participants at risk Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Infections and infestations Pneumonia	0.90% 4/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	1.6% 7/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Bronchitis	0.45% 2/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Lower respiratory tract infection	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Respiratory tract infection	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Catheter sepsis	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Cellulitis	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.46% 2/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Empyema	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Lung abscess	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Nocardiosis	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Pyelonephritis acute	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Sepsis	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Staphylococcal abscess	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Upper respiratory tract infection	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Infections and infestations Colitis	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.45% 2/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.46% 2/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.45% 2/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.46% 2/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.45% 2/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Pleural fistula	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Gastrointestinal disorders Diarrhoea	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.92% 4/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Gastrointestinal disorders Vomiting	0.45% 2/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Gastrointestinal disorders Dysphagia	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Gastrointestinal disorders Gastric perforation	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Gastrointestinal disorders Haematemesis	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Musculoskeletal and connective tissue disorders Muscular weakness	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Renal and urinary disorders Renal failure acute	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Renal and urinary disorders Urogenital haemorrhage	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Skin and subcutaneous tissue disorders Rash	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.46% 2/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Investigations Alanine aminotransferase increased	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Investigations Aspartate aminotransferase increased	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Psychiatric disorders Depression	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Psychiatric disorders Panic attack	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Blood and lymphatic system disorders Anaemia	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Eye disorders Diplopia	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Hepatobiliary disorders Cholelithiasis	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Injury, poisoning and procedural complications Femur fracture	0.45% 2/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Metabolism and nutrition disorders Anorexia	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Metabolism and nutrition disorders Dehydration	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
General disorders Asthenia	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
General disorders Chest pain	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
General disorders Drowning	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
General disorders Pyrexia	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
General disorders Sudden death	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Nervous system disorders Cerebrovascular accident	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Nervous system disorders Dizziness	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Nervous system disorders Intracranial pressure increased	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Nervous system disorders Neuralgia	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Nervous system disorders Neuropathy peripheral	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Nervous system disorders Sciatica	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Nervous system disorders Syncope	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.46% 2/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Cardiac disorders Cardiac failure	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Cardiac disorders Cardiac tamponade	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Cardiac disorders Left ventricular dysfunction	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Cardiac disorders Myocardial infarction	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Cardiac disorders Aortic aneurysm	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Vascular disorders Peripheral ischaemia	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Vascular disorders Arterial thrombosis	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Vascular disorders Arteritis	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Vascular disorders Deep vein thrombosis	0.22% 1/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.00% 0/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Vascular disorders Iliac artery thrombosis	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	0.23% 1/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.

Other adverse events

Measure	Placebo n=445 participants at risk Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.	Erlotinib, 150 mg/Day n=433 participants at risk Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
Skin and subcutaneous tissue disorders Rash	5.8% 26/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	48.7% 211/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Skin and subcutaneous tissue disorders Pruritus	2.7% 12/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	7.4% 32/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Skin and subcutaneous tissue disorders Acne	0.00% 0/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	6.2% 27/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Gastrointestinal disorders Diarrhoea	4.5% 20/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	20.1% 87/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Gastrointestinal disorders Nausea	6.1% 27/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	7.6% 33/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Cough	8.5% 38/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	8.3% 36/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 37/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	7.6% 33/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Respiratory, thoracic and mediastinal disorders Haemoptysis	4.7% 21/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	5.1% 22/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
General disorders Fatigue	5.8% 26/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	9.0% 39/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
General disorders Chest pain	6.3% 28/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	3.2% 14/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.
Metabolism and nutrition disorders Anorexia	4.9% 22/445 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.	9.0% 39/433 • Adverse events (AEs) were recorded from Day 1 (after randomization) through the end of study, up to 27 months. Serious adverse events (SAEs) were recorded from Day 1 (after randomization) through the second data cut-off, up to 71 months. All participants who received at least 1 dose of investigational treatment and had at least 1 safety follow-up, whether prematurely withdrawn or not, were included in the safety analysis.

Additional Information

Medical Communications

Hoffman-LaRoche

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