Trial Outcomes & Findings for Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (NCT NCT00588770)

NCT ID: NCT00588770

Last Updated: 2025-11-10

Results Overview

Overall survival (OS) was defined as time from randomization to death from any course. Patients who were alive were censored at the last contact date. Median OS was estimated using the Kaplan-Meier method.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 403 participants
• Primary outcome timeframe: assessed every 3 months within 2 years from study entry, then every 6 months up to 5 years from study entry
• Results posted on: 2025-11-10

Participant Flow

E1305 was activated on August 8, 2008 and closed on February 11,2015, with final accrual of 403 patients.

Participant milestones

Measure	Chemotherapy Arm (Arm A) ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Chemotherapy+Bevacizumab (Arm B) ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
Overall Study STARTED	200	203
Overall Study Eligible	188	183
Overall Study Start Protocol Therapy	200	194
Overall Study COMPLETED	41	3
Overall Study NOT COMPLETED	159	200

Reasons for withdrawal

Measure	Chemotherapy Arm (Arm A) ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Chemotherapy+Bevacizumab (Arm B) ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
Overall Study Disease progression	85	68
Overall Study Adverse Event	29	58
Overall Study Death	13	22
Overall Study Withdrawal by Subject	15	25
Overall Study Alternative therapy	2	4
Overall Study Other complicating disease	3	2
Overall Study Not start protocol therapy	0	9
Overall Study Lack of Efficacy	8	10
Overall Study Physician discretion	2	0
Overall Study Patient non-compliance	2	2

Baseline Characteristics

Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Baseline characteristics by cohort

Measure	Chemotherapy Arm (Arm A) n=200 Participants ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Chemotherapy+Bevacizumab (Arm B) n=203 Participants ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.	Total n=403 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	58 years n=20 Participants	58 years n=40 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	27 Participants n=20 Participants	59 Participants n=40 Participants
Sex: Female, Male Male	168 Participants n=5 Participants	176 Participants n=20 Participants	344 Participants n=40 Participants
Race/Ethnicity, Customized White	168 Participants n=5 Participants	179 Participants n=20 Participants	347 Participants n=40 Participants
Race/Ethnicity, Customized Black	21 Participants n=5 Participants	18 Participants n=20 Participants	39 Participants n=40 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	2 Participants n=20 Participants	6 Participants n=40 Participants
Race/Ethnicity, Customized Not reported	7 Participants n=5 Participants	4 Participants n=20 Participants	11 Participants n=40 Participants

PRIMARY outcome

Timeframe: assessed every 3 months within 2 years from study entry, then every 6 months up to 5 years from study entry

Population: All randomized patients

Overall survival (OS) was defined as time from randomization to death from any course. Patients who were alive were censored at the last contact date. Median OS was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Chemotherapy Arm (Arm A) n=200 Participants ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Chemotherapy+Bevacizumab (Arm B) n=203 Participants ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. Regimen 2: ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. Regimen 2 carbo: ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
Overall Survival (OS)	11.0 months Interval 9.5 to 13.0	12.6 months Interval 10.3 to 15.8

SECONDARY outcome

Timeframe: on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks

Population: All randomized patients

Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Progression-free survival (PFS) was defined as the time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who were still alive and progression free were censored at last disease assessment date. Median PFS was estimated using Kaplan-Meier method.

Outcome measures

Measure	Chemotherapy Arm (Arm A) n=200 Participants ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Chemotherapy+Bevacizumab (Arm B) n=203 Participants ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. Regimen 2: ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. Regimen 2 carbo: ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
Progression-free Survival (PFS)	4.3 months Interval 3.8 to 5.2	6.0 months Interval 4.9 to 6.7

SECONDARY outcome

Timeframe: on both arms, assessed every 2 cycles during chemotherapy treatment, then assessed every 9 weeks until progression up to 5 years from study entry; patients on arm B were assessed every 2 cycles for additional 12 weeks before changing to every 9 weeks

Population: All randomized patients

Overall response rate is defined as number of patients with complete response (CR) or partial response (PR) divided by all patients. Responses are evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR is defined as disappearance of all target and non-target lesions. PR is defined as disappearance of target lesions or at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and persistence of one or more non-target lesion(s).

Outcome measures

Measure	Chemotherapy Arm (Arm A) n=200 Participants ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Chemotherapy+Bevacizumab (Arm B) n=203 Participants ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. Regimen 2: ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. Regimen 2 carbo: ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
Overall Response Rate	0.245 proportion of participants Interval 0.187 to 0.311	0.355 proportion of participants Interval 0.289 to 0.425

OTHER_PRE_SPECIFIED outcome

Timeframe: Before and after therapy

These were blood and tissue samples collections and have no data to report.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

These were blood and tissue samples collections and have no data to report.

Outcome measures

Outcome data not reported

Adverse Events

Chemotherapy (Arm A)

Serious events: 135 serious events

Other events: 50 other events

Deaths: 182 deaths

Chemotherapy + Bevacizumab (Arm B)

Serious events: 162 serious events

Other events: 50 other events

Deaths: 175 deaths

Serious adverse events

Measure	Chemotherapy (Arm A) n=199 participants at risk ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Chemotherapy + Bevacizumab (Arm B) n=193 participants at risk ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
Ear and labyrinth disorders Hearing impaired	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Ear and labyrinth disorders Tinnitus	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Blood and lymphatic system disorders Anemia	8.5% 17/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	4.7% 9/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Blood and lymphatic system disorders Febrile neutropenia	9.5% 19/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	18.1% 35/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Cardiac disorders Asystole	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Cardiac disorders Atrial fibrillation	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Cardiac disorders Cardiac arrest	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Cardiac disorders Chest pain - cardiac	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Cardiac disorders Left ventricular systolic dysfunction	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Cardiac disorders Myocardial infarction	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Cardiac disorders Supraventricular tachycardia	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Cardiac disorders Ventricular arrhythmia	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
General disorders Death NOS	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
General disorders Edema face	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
General disorders Edema limbs	1.0% 2/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
General disorders Fatigue	10.1% 20/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	17.6% 34/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
General disorders Non-cardiac chest pain	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
General disorders Pain	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
General disorders Sudden death NOS	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Skin and subcutaneous tissue disorders Alopecia	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia	1.0% 2/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Abdominal pain	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	3.6% 7/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Colitis	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Colonic perforation	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Constipation	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Diarrhea	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	4.7% 9/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Dyspepsia	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Dysphagia	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	4.7% 9/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Esophageal fistula	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Esophagitis	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.6% 3/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Gastric perforation	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Mucositis oral	4.0% 8/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	19.2% 37/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Nausea	7.5% 15/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	11.4% 22/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Oral hemorrhage	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	2.1% 4/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Oral pain	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Small intestinal obstruction	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Stomach pain	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Vomiting	4.5% 9/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	7.3% 14/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Gastrointestinal disorders Gastrointestinal disorders - Other	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Immune system disorders Anaphylaxis	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Immune system disorders Immune system disorders - Other, specify	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Abdominal infection	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Cranial nerve infection	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Enterocolitis infectious	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Gum infection	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Kidney infection	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Lung infection	1.5% 3/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	2.6% 5/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Mucosal infection	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Salivary gland infection	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Sepsis	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.6% 3/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Skin infection	1.0% 2/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.6% 3/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Soft tissue infection	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Tracheitis	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Wound infection	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Infections and infestations Infections and infestations - Other	1.5% 3/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	3.1% 6/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Injury, poisoning and procedural complications Injury to carotid artery	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Injury, poisoning and procedural complications Tracheal hemorrhage	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Injury, poisoning and procedural complications Tracheostomy site bleeding	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Injury, poisoning and procedural complications Vascular access complication	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Investigations Alanine aminotransferase increased	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.6% 3/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Investigations Aspartate aminotransferase increased	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Investigations Creatinine increased	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Investigations Lymphocyte count decreased	6.0% 12/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	6.2% 12/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Investigations Neutrophil count decreased	26.6% 53/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	37.8% 73/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Investigations Platelet count decreased	6.5% 13/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	7.8% 15/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Investigations Weight loss	2.0% 4/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	2.6% 5/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Investigations White blood cell decreased	16.6% 33/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	26.4% 51/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Investigations Investigations - Other, specify	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Metabolism and nutrition disorders Anorexia	6.5% 13/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	6.2% 12/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Metabolism and nutrition disorders Dehydration	5.5% 11/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	15.5% 30/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Metabolism and nutrition disorders Hypocalcemia	1.0% 2/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Metabolism and nutrition disorders Hypokalemia	4.0% 8/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	2.6% 5/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Metabolism and nutrition disorders Hypomagnesemia	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Metabolism and nutrition disorders Hyponatremia	2.5% 5/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	3.6% 7/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Metabolism and nutrition disorders Hypophosphatemia	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	3.1% 6/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Metabolism and nutrition disorders Metabolism and nutrition - Other	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Musculoskeletal and connective tissue disorders Bone pain	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	2.1% 4/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Nervous system disorders Ataxia	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Nervous system disorders Dizziness	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Nervous system disorders Peripheral sensory neuropathy	2.0% 4/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	2.1% 4/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Nervous system disorders Reversible posterior leukoencephalopathy	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Nervous system disorders Seizure	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Nervous system disorders Syncope	1.5% 3/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	2.6% 5/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Nervous system disorders Nervous system disorders - Other	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms - Other	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Psychiatric disorders Confusion	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Psychiatric disorders Depression	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Hiccups	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Laryngeal edema	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Laryngeal mucositis	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Pharyngeal fistula	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Pharyngeal hemorrhage	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.0% 4/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	2.6% 5/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.0% 2/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Respiratory, thoracic and mediastinal disorders Respiratory thoracic mediastinal - Other	1.0% 2/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.00% 0/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Renal and urinary disorders Acute kidney injury	1.5% 3/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.6% 3/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Renal and urinary disorders Proteinuria	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	1.6% 3/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Renal and urinary disorders Renal and urinary disorders - Other	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	0.52% 1/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Vascular disorders Hypertension	0.00% 0/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	6.2% 12/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Vascular disorders Hypotension	1.5% 3/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	2.1% 4/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Vascular disorders Thromboembolic event	0.50% 1/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	5.2% 10/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.

Other adverse events

Measure	Chemotherapy (Arm A) n=199 participants at risk ARM A: Patients receive one of the four chemotherapy regimens ARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Chemotherapy + Bevacizumab (Arm B) n=193 participants at risk ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A ARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA. ARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA. ARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA. ARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.
General disorders Fatigue	6.5% 13/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	9.8% 19/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Skin and subcutaneous tissue disorders Alopecia	9.5% 19/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	5.7% 11/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Investigations Platelet count decreased	4.5% 9/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	5.2% 10/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Metabolism and nutrition disorders Anorexia	3.0% 6/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	6.7% 13/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.
Nervous system disorders Peripheral sensory neuropathy	14.1% 28/199 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.	12.4% 24/193 • Assessed at the end of each cycle (1 cycle=21 days) while on treatment and at 3 months post treatment (to report late adverse events) At Risk for All-Cause Mortality includes all enrolled participants; at Risk for all other Adverse Events includes the safety population. A total of four chemotherapy regimen choices were allowed for the platinum-doublet treatment, and chemotherapy regimen choice was at the discretion of the treating physician and was made prior to randomization. The trial did not intent to look at the four chemotherapy regimens separately in terms of safety and efficacy.

Additional Information

Study statistician

ECOG-ACRIN Cancer Reserch Group Statistical Office

Phone: 6176323012

Email: eatrials@jimmy.harvard.edu

Results disclosure agreements

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

Restriction type: LTE60