Trial Outcomes & Findings for A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer. (NCT NCT00600821)

Last Updated: 2013-11-08

Results Overview

Time in months from start of study treatment to first randomization date of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was "Death").

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

118 participants

Primary outcome timeframe

Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years

Results posted on

2013-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Axitinib + Paclitaxel + Carboplatin Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) along with infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin area under the concentration-time curve (AUC) of 6 mg\minute/milliliter (mg\min/mL) infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin Bevacizumab 15 mg/kilogram (mg/kg) infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Overall Study STARTED	58	60
Overall Study Treated	58	59
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	58	60

Reasons for withdrawal

Reasons for withdrawal
Measure	Axitinib + Paclitaxel + Carboplatin Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) along with infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin area under the concentration-time curve (AUC) of 6 mg\minute/milliliter (mg\min/mL) infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin Bevacizumab 15 mg/kilogram (mg/kg) infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Overall Study Death	45	46
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	1	1
Overall Study Terminated by sponsor	8	6
Overall Study Objective progression or relapse	0	1
Overall Study Randomized but not treated	0	1
Overall Study Other	2	3

Baseline Characteristics

A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Axitinib + Paclitaxel + Carboplatin n=58 Participants Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=60 Participants Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.	Total n=118 Participants Total of all reporting groups
Age, Customized Less than 18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 18 to 44 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Customized 45 to 64 years	33 Participants n=5 Participants	44 Participants n=7 Participants	77 Participants n=5 Participants
Age, Customized Greater than or equal to 65 years	24 Participants n=5 Participants	14 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years

Population: Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Outcome measures

Outcome measures
Measure	Axitinib + Paclitaxel + Carboplatin n=58 Participants Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=60 Participants Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Progression Free Survival (PFS)	5.7 Months Interval 4.1 to 7.5	6.1 Months Interval 4.2 to 8.7

SECONDARY outcome

Timeframe: Baseline, every 6 weeks until death or bimonthly after final study visit (up to 2.75 years)

Population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Time in months from date of randomization to date of death due to any cause. OS was calculated as (the death date minus the first randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Outcome measures

Outcome measures
Measure	Axitinib + Paclitaxel + Carboplatin n=58 Participants Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=60 Participants Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Overall Survival (OS)	10.6 Months Interval 7.5 to 16.4	13.3 Months Interval 10.4 to 17.6

SECONDARY outcome

Timeframe: Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years

OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR: disappearance of all lesions (target and/or non target) and no appearance of new lesions. PR: at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, without progression of non target lesions and no appearance of new lesions.

Outcome measures

Outcome measures
Measure	Axitinib + Paclitaxel + Carboplatin n=58 Participants Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=60 Participants Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Percentage of Participants With Objective Response (OR)	29.3 Percentage of participants Interval 18.1 to 42.7	43.3 Percentage of participants Interval 30.6 to 56.8

SECONDARY outcome

Timeframe: Baseline, every 6 weeks until disease progression or initiation of subsequent anticancer therapy up to 2.75 years

Population: DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).

Time in months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Outcome measures

Outcome measures
Measure	Axitinib + Paclitaxel + Carboplatin n=17 Participants Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=26 Participants Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Duration of Response (DR)	4.4 Months Interval 4.2 to 6.7	7.0 Months Interval 4.8 to 8.3

SECONDARY outcome

Timeframe: Pre-dose, 1 to 2 hours post-dose on Cycle 2 of Day 1 and Cycle 3 of Day 1

Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day (D) 1 of every cycle (C) then every 3 weeks until final study visit (up to 2.75 years)

Population: ITT population included participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or different drug from which they were randomized. 'n' signifies those participants evaluated for this measure at specific time point for each group respectively.

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhoea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.

Outcome measures

Outcome measures
Measure	Axitinib + Paclitaxel + Carboplatin n=58 Participants Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=60 Participants Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C13 D1 (n=8, 14)	50.00 Units on a scale Standard Deviation 24.49	26.19 Units on a scale Standard Deviation 22.05
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: EOT (n=27, 38)	51.03 Units on a scale Standard Deviation 24.51	43.13 Units on a scale Standard Deviation 27.57
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: Baseline (n=57, 59)	8.77 Units on a scale Standard Deviation 17.85	9.89 Units on a scale Standard Deviation 21.91
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C2 D1 (n=51, 53)	7.19 Units on a scale Standard Deviation 13.02	5.35 Units on a scale Standard Deviation 12.56
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C3 D1 (n=45, 47)	11.11 Units on a scale Standard Deviation 17.77	5.67 Units on a scale Standard Deviation 11.67
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C4 D1 (n=37, 48)	10.81 Units on a scale Standard Deviation 16.77	7.29 Units on a scale Standard Deviation 11.86
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C5 D1 (n=34, 38)	13.24 Units on a scale Standard Deviation 21.63	7.46 Units on a scale Standard Deviation 14.34
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C6 D1 (n=31, 33)	13.44 Units on a scale Standard Deviation 21.26	10.61 Units on a scale Standard Deviation 17.59
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C7 D1 (n=28, 30)	15.48 Units on a scale Standard Deviation 22.65	9.44 Units on a scale Standard Deviation 14.31
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C8 D1 (n=22, 28)	14.40 Units on a scale Standard Deviation 22.00	5.95 Units on a scale Standard Deviation 12.18
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C9 D1 (n=18, 23)	9.26 Units on a scale Standard Deviation 13.06	5.07 Units on a scale Standard Deviation 20.98
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C10 D1 (n=17, 20)	11.77 Units on a scale Standard Deviation 15.33	8.33 Units on a scale Standard Deviation 16.67
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C11 D1 (n=15, 19)	14.45 Units on a scale Standard Deviation 17.67	5.26 Units on a scale Standard Deviation 9.71
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C12 D1 (n=10, 17)	15.00 Units on a scale Standard Deviation 16.57	6.68 Units on a scale Standard Deviation 14.50
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: C13 D1 (n=8, 14)	12.50 Units on a scale Standard Deviation 17.25	5.95 Units on a scale Standard Deviation 14.03
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Nausea and vomiting: EOT (n=27, 38)	16.05 Units on a scale Standard Deviation 22.40	7.90 Units on a scale Standard Deviation 14.36
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: Baseline (n=57, 59)	31.29 Units on a scale Standard Deviation 31.82	35.31 Units on a scale Standard Deviation 30.02
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C2 D1 (n=51, 53)	29.74 Units on a scale Standard Deviation 29.87	28.30 Units on a scale Standard Deviation 29.16
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C3 D1 (n=45, 48)	30.00 Units on a scale Standard Deviation 27.43	18.75 Units on a scale Standard Deviation 18.07
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C4 D1 (n=37, 48)	26.58 Units on a scale Standard Deviation 18.62	25.35 Units on a scale Standard Deviation 27.29
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C5 D1 (n=34, 38)	25.00 Units on a scale Standard Deviation 18.91	24.12 Units on a scale Standard Deviation 24.72
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C6 D1 (n=31, 33)	31.18 Units on a scale Standard Deviation 18.63	25.25 Units on a scale Standard Deviation 28.90
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C7 D1 (n=28, 30)	28.57 Units on a scale Standard Deviation 28.99	27.22 Units on a scale Standard Deviation 26.07
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C8 D1 (n=22, 28)	28.03 Units on a scale Standard Deviation 25.91	22.62 Units on a scale Standard Deviation 23.66
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C9 D1 (n=18, 23)	33.33 Units on a scale Standard Deviation 22.14	27.54 Units on a scale Standard Deviation 31.22
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C10 D1 (n=17, 20)	30.39 Units on a scale Standard Deviation 26.51	24.17 Units on a scale Standard Deviation 24.47
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C11 D1 (n=15, 19)	43.33 Units on a scale Standard Deviation 28.03	18.42 Units on a scale Standard Deviation 21.44
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C12 D1 (n=10, 17)	35.00 Units on a scale Standard Deviation 21.45	23.53 Units on a scale Standard Deviation 29.50
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: C13 D1 (n=8, 14)	35.42 Units on a scale Standard Deviation 24.30	16.67 Units on a scale Standard Deviation 21.68
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Pain: EOT (n=27, 38)	38.27 Units on a scale Standard Deviation 33.27	34.65 Units on a scale Standard Deviation 30.36
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: Baseline (n=56, 58)	32.74 Units on a scale Standard Deviation 30.15	36.21 Units on a scale Standard Deviation 33.21
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C2 D1 (n=51, 52)	32.03 Units on a scale Standard Deviation 28.25	24.36 Units on a scale Standard Deviation 31.04
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C3 D1 (n=45, 47)	38.52 Units on a scale Standard Deviation 28.39	19.15 Units on a scale Standard Deviation 23.82
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C4 D1 (n=37, 48)	33.33 Units on a scale Standard Deviation 30.43	21.53 Units on a scale Standard Deviation 25.25
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C5 D1 (n=34, 38)	36.27 Units on a scale Standard Deviation 33.20	23.68 Units on a scale Standard Deviation 27.84
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C6 D1 (n=31, 33)	36.56 Units on a scale Standard Deviation 31.45	20.20 Units on a scale Standard Deviation 23.48
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C12 D1 (n=10, 17)	75.00 Units on a scale Standard Deviation 21.15	70.59 Units on a scale Standard Deviation 21.67
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C13 D1 (n=8, 14)	62.50 Units on a scale Standard Deviation 33.04	80.95 Units on a scale Standard Deviation 20.52
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C7 D1 (n=28, 30)	38.09 Units on a scale Standard Deviation 31.05	21.11 Units on a scale Standard Deviation 20.50
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C8 D1 (n=22, 28)	27.27 Units on a scale Standard Deviation 28.43	16.67 Units on a scale Standard Deviation 19.24
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C9 D1 (n=18, 23)	25.93 Units on a scale Standard Deviation 33.44	21.74 Units on a scale Standard Deviation 21.58
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C10 D1 (n=17, 20)	27.45 Units on a scale Standard Deviation 31.70	18.33 Units on a scale Standard Deviation 17.01
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C11 D1 (n=15, 19)	37.78 Units on a scale Standard Deviation 33.01	17.54 Units on a scale Standard Deviation 23.22
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C12 D1 (n=10, 17)	23.33 Units on a scale Standard Deviation 27.44	21.57 Units on a scale Standard Deviation 23.40
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Physical functioning (PF): Baseline (n=58, 59)	66.29 Units on a scale Standard Deviation 22.04	75.00 Units on a scale Standard Deviation 22.21
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C2 D1 (n=51, 53)	67.45 Units on a scale Standard Deviation 23.48	75.47 Units on a scale Standard Deviation 20.24
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C3 D1 (n=45, 47)	65.78 Units on a scale Standard Deviation 24.40	78.16 Units on a scale Standard Deviation 18.43
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C4 D1 (n=37, 48)	67.88 Units on a scale Standard Deviation 20.01	73.78 Units on a scale Standard Deviation 19.14
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C5 D1 (n=34, 38)	61.18 Units on a scale Standard Deviation 24.09	75.09 Units on a scale Standard Deviation 16.38
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C6 D1 (n=31, 33)	65.86 Units on a scale Standard Deviation 19.17	73.94 Units on a scale Standard Deviation 18.66
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C7 D1 (n=27, 30)	66.42 Units on a scale Standard Deviation 22.15	74.89 Units on a scale Standard Deviation 18.67
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C8 D1 (n=22, 28)	67.27 Units on a scale Standard Deviation 22.44	77.14 Units on a scale Standard Deviation 18.98
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C9 D1 (n=18, 23)	66.30 Units on a scale Standard Deviation 27.77	74.57 Units on a scale Standard Deviation 19.02
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C10 D1 (n=17, 20)	68.63 Units on a scale Standard Deviation 25.36	81.33 Units on a scale Standard Deviation 14.92
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C11 D1 (n=15, 19)	60.67 Units on a scale Standard Deviation 23.58	78.25 Units on a scale Standard Deviation 16.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C12 D1 (n=10, 17)	71.33 Units on a scale Standard Deviation 20.86	78.43 Units on a scale Standard Deviation 19.65
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: C13 D1 (n=8, 14)	66.67 Units on a scale Standard Deviation 25.94	79.05 Units on a scale Standard Deviation 21.22
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score PF: End of treatment (EOT) (n=27, 38)	62.96 Units on a scale Standard Deviation 21.11	64.91 Units on a scale Standard Deviation 24.83
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: Baseline (n=58, 58)	60.92 Units on a scale Standard Deviation 31.15	60.63 Units on a scale Standard Deviation 31.79
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C2 D1 (n=51, 53)	64.38 Units on a scale Standard Deviation 31.98	65.41 Units on a scale Standard Deviation 29.02
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C3 D1 (n=45, 47)	58.15 Units on a scale Standard Deviation 34.01	70.92 Units on a scale Standard Deviation 28.55
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C4 D1 (n=37, 48)	67.12 Units on a scale Standard Deviation 26.49	67.36 Units on a scale Standard Deviation 25.02
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C5 D1 (n=34, 38)	57.35 Units on a scale Standard Deviation 29.64	66.23 Units on a scale Standard Deviation 29.12
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C6 D1 (n=31, 33)	62.90 Units on a scale Standard Deviation 30.34	67.68 Units on a scale Standard Deviation 29.15
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C7 D1 (n=28, 30)	55.36 Units on a scale Standard Deviation 32.41	63.89 Units on a scale Standard Deviation 27.01
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C8 D1 (n=22, 28)	65.15 Units on a scale Standard Deviation 29.05	71.43 Units on a scale Standard Deviation 19.70
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C9 D1 (n=18, 23)	63.89 Units on a scale Standard Deviation 37.60	70.29 Units on a scale Standard Deviation 18.77
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C10 D1 (n=17, 20)	66.67 Units on a scale Standard Deviation 28.87	70.83 Units on a scale Standard Deviation 20.14
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: C11 D1 (n=15, 19)	60.00 Units on a scale Standard Deviation 29.41	71.93 Units on a scale Standard Deviation 21.55
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Role functioning: EOT (n=27, 38)	57.41 Units on a scale Standard Deviation 32.47	57.90 Units on a scale Standard Deviation 31.18
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: Baseline (n=57, 57)	69.74 Units on a scale Standard Deviation 23.45	63.74 Units on a scale Standard Deviation 27.44
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C13 D1 (n=8, 14)	77.08 Units on a scale Standard Deviation 22.60	83.93 Units on a scale Standard Deviation 14.79
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C2 D1 (n=50, 53)	78.33 Units on a scale Standard Deviation 21.76	73.64 Units on a scale Standard Deviation 22.81
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C3 D1 (n=45, 48)	75.19 Units on a scale Standard Deviation 21.36	78.76 Units on a scale Standard Deviation 20.69
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C4 D1 (n=37, 48)	75.75 Units on a scale Standard Deviation 20.17	76.04 Units on a scale Standard Deviation 23.23
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C5 D1 (n=32, 38)	77.60 Units on a scale Standard Deviation 18.38	78.51 Units on a scale Standard Deviation 21.37
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C6 D1 (n=29, 32)	78.74 Units on a scale Standard Deviation 18.97	77.35 Units on a scale Standard Deviation 23.40
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C7 D1 (n=28, 30)	78.57 Units on a scale Standard Deviation 22.62	79.45 Units on a scale Standard Deviation 20.50
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C8 D1 (n=22, 28)	77.65 Units on a scale Standard Deviation 19.14	81.25 Units on a scale Standard Deviation 18.09
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C9 D1 (n=18, 23)	74.07 Units on a scale Standard Deviation 19.78	78.50 Units on a scale Standard Deviation 23.39
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C10 D1 (n=17, 20)	77.94 Units on a scale Standard Deviation 18.85	78.33 Units on a scale Standard Deviation 13.36
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C11 D1 (n=15, 19)	70.00 Units on a scale Standard Deviation 21.32	82.46 Units on a scale Standard Deviation 18.61
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: C12 D1 (n=10, 17)	74.17 Units on a scale Standard Deviation 27.90	77.45 Units on a scale Standard Deviation 20.57
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Emotional functioning: EOT (n=27, 38)	68.52 Units on a scale Standard Deviation 26.39	70.18 Units on a scale Standard Deviation 25.60
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: Baseline (n=57, 57)	80.12 Units on a scale Standard Deviation 24.28	83.33 Units on a scale Standard Deviation 19.16
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C2 D1 (n=50, 53)	84.00 Units on a scale Standard Deviation 20.47	84.28 Units on a scale Standard Deviation 21.29
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C3 D1 (n=45, 48)	85.19 Units on a scale Standard Deviation 22.81	85.42 Units on a scale Standard Deviation 20.81
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C4 D1 (n=37, 48)	84.68 Units on a scale Standard Deviation 18.99	82.64 Units on a scale Standard Deviation 20.03
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C5 D1 (n=32, 38)	84.37 Units on a scale Standard Deviation 19.83	83.33 Units on a scale Standard Deviation 24.51
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C6 D1 (n=29, 32)	86.78 Units on a scale Standard Deviation 18.03	81.25 Units on a scale Standard Deviation 21.06
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C7 D1 (n=28, 30)	79.76 Units on a scale Standard Deviation 19.43	85.56 Units on a scale Standard Deviation 18.94
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C8 D1 (n=22, 28)	89.39 Units on a scale Standard Deviation 17.48	88.69 Units on a scale Standard Deviation 17.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C9 D1 (n=18, 23)	84.26 Units on a scale Standard Deviation 15.63	86.23 Units on a scale Standard Deviation 20.51
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C10 D1 (n=17, 20)	88.23 Units on a scale Standard Deviation 12.86	90.00 Units on a scale Standard Deviation 13.68
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C11 D1 (n=15, 19)	82.22 Units on a scale Standard Deviation 18.33	85.96 Units on a scale Standard Deviation 18.64
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C12 D1 (n=10, 17)	90.00 Units on a scale Standard Deviation 14.05	87.25 Units on a scale Standard Deviation 20.01
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: C13 D1 (n=8, 14)	85.42 Units on a scale Standard Deviation 13.91	95.24 Units on a scale Standard Deviation 12.10
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Cognitive Functioning: EOT (n=27, 38)	77.78 Units on a scale Standard Deviation 23.57	78.95 Units on a scale Standard Deviation 22.82
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: Baseline (n=57, 57)	71.35 Units on a scale Standard Deviation 27.59	65.50 Units on a scale Standard Deviation 32.25
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C2 D1 (n=50, 52)	69.67 Units on a scale Standard Deviation 30.06	75.32 Units on a scale Standard Deviation 25.24
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C3 D1 (n=45, 48)	71.11 Units on a scale Standard Deviation 27.62	74.65 Units on a scale Standard Deviation 24.79
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C4 D1 (n=37, 48)	73.42 Units on a scale Standard Deviation 24.99	71.53 Units on a scale Standard Deviation 29.77
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C5 D1 (n=32, 38)	65.10 Units on a scale Standard Deviation 26.22	75.88 Units on a scale Standard Deviation 27.04
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C6 D1 (n=29, 32)	70.11 Units on a scale Standard Deviation 26.49	71.88 Units on a scale Standard Deviation 26.92
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C7 D1 (n=28, 30)	64.88 Units on a scale Standard Deviation 32.50	72.22 Units on a scale Standard Deviation 23.71
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C8 D1 (n=22, 28)	71.97 Units on a scale Standard Deviation 24.87	72.02 Units on a scale Standard Deviation 24.45
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C9 D1 (n=18, 23)	74.07 Units on a scale Standard Deviation 29.83	81.16 Units on a scale Standard Deviation 16.13
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C10 D1 (n=17, 20)	72.55 Units on a scale Standard Deviation 32.24	79.17 Units on a scale Standard Deviation 20.14
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C11 D1 (n=15, 19)	66.67 Units on a scale Standard Deviation 28.17	78.95 Units on a scale Standard Deviation 16.52
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C12 D1 (n=10, 17)	71.67 Units on a scale Standard Deviation 20.86	80.39 Units on a scale Standard Deviation 20.61
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: C13 D1 (n=8, 14)	56.25 Units on a scale Standard Deviation 28.08	80.95 Units on a scale Standard Deviation 18.32
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Social functioning: EOT (n=27, 38)	69.14 Units on a scale Standard Deviation 26.03	65.79 Units on a scale Standard Deviation 26.83
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: Baseline (n=57, 58)	40.45 Units on a scale Standard Deviation 23.94	38.89 Units on a scale Standard Deviation 28.02
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C2 D1 (n=51, 53)	43.57 Units on a scale Standard Deviation 21.98	36.48 Units on a scale Standard Deviation 25.26
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C3 D1 (n=45, 47)	47.41 Units on a scale Standard Deviation 22.77	33.80 Units on a scale Standard Deviation 19.38
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C4 D1 (n=37, 48)	42.34 Units on a scale Standard Deviation 19.22	37.85 Units on a scale Standard Deviation 19.40
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C5 D1 (n=34, 38)	44.61 Units on a scale Standard Deviation 21.73	36.84 Units on a scale Standard Deviation 22.83
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C6 D1 (n=31, 33)	45.16 Units on a scale Standard Deviation 23.65	33.50 Units on a scale Standard Deviation 21.45
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C7 D1 (n=28, 30)	47.82 Units on a scale Standard Deviation 27.27	40.74 Units on a scale Standard Deviation 21.11
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C8 D1 (n=22, 28)	44.95 Units on a scale Standard Deviation 24.84	32.14 Units on a scale Standard Deviation 20.14
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C9 D1 (n=18, 23)	40.12 Units on a scale Standard Deviation 29.80	28.98 Units on a scale Standard Deviation 20.03
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C10 D1 (n=17, 20)	41.83 Units on a scale Standard Deviation 25.62	30.00 Units on a scale Standard Deviation 19.78
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C11 D1 (n=15, 19)	47.78 Units on a scale Standard Deviation 32.52	28.07 Units on a scale Standard Deviation 14.52
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Fatigue: C12 D1 (n=10, 17)	37.78 Units on a scale Standard Deviation 19.74	29.41 Units on a scale Standard Deviation 18.82
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: C13 D1 (n=8, 14)	37.50 Units on a scale Standard Deviation 37.53	19.05 Units on a scale Standard Deviation 17.12
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Dyspnoea: EOT (n=27, 38)	35.80 Units on a scale Standard Deviation 27.62	33.33 Units on a scale Standard Deviation 33.78
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: Baseline (n=57, 58)	46.20 Units on a scale Standard Deviation 33.19	37.93 Units on a scale Standard Deviation 31.50
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C2 D1 (n=51, 53)	36.60 Units on a scale Standard Deviation 36.06	28.30 Units on a scale Standard Deviation 33.59
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C3 D1 (n=45, 47)	30.37 Units on a scale Standard Deviation 33.20	29.08 Units on a scale Standard Deviation 33.06
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C4 D1 (n=37, 48)	24.32 Units on a scale Standard Deviation 26.81	27.08 Units on a scale Standard Deviation 28.89
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C5 D1 (n=34, 38)	28.43 Units on a scale Standard Deviation 24.80	23.68 Units on a scale Standard Deviation 31.87
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C6 D1 (n=31, 33)	24.73 Units on a scale Standard Deviation 25.77	24.24 Units on a scale Standard Deviation 29.19
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C7 D1 (n=28, 30)	23.81 Units on a scale Standard Deviation 28.48	25.55 Units on a scale Standard Deviation 24.26
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C8 D1 (n=22, 28)	21.21 Units on a scale Standard Deviation 26.32	19.05 Units on a scale Standard Deviation 23.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C9 D1 (n=18, 23)	25.93 Units on a scale Standard Deviation 31.43	23.19 Units on a scale Standard Deviation 27.40
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C10 D1 (n=17, 20)	27.45 Units on a scale Standard Deviation 26.97	20.00 Units on a scale Standard Deviation 25.13
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C11 D1 (n=15, 19)	33.33 Units on a scale Standard Deviation 28.17	22.81 Units on a scale Standard Deviation 24.97
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C12 D1 (n=10, 17)	26.67 Units on a scale Standard Deviation 21.08	23.53 Units on a scale Standard Deviation 28.30
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: C13 D1 (n=8, 14)	12.50 Units on a scale Standard Deviation 17.25	16.67 Units on a scale Standard Deviation 17.29
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Insomnia: EOT (n=27, 37)	28.39 Units on a scale Standard Deviation 27.28	36.94 Units on a scale Standard Deviation 30.21
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: Baseline (n=57, 59)	29.82 Units on a scale Standard Deviation 28.65	31.64 Units on a scale Standard Deviation 34.14
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C2 D1 (n=51, 53)	23.53 Units on a scale Standard Deviation 26.91	20.75 Units on a scale Standard Deviation 29.40
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C3 D1 (n=44, 47)	33.33 Units on a scale Standard Deviation 32.94	17.02 Units on a scale Standard Deviation 25.89
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C4 D1 (n=37, 48)	26.13 Units on a scale Standard Deviation 26.22	23.61 Units on a scale Standard Deviation 27.47
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C5 D1 (n=34, 38)	30.39 Units on a scale Standard Deviation 33.20	21.05 Units on a scale Standard Deviation 29.43
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C6 D1 (n=31, 33)	27.96 Units on a scale Standard Deviation 31.15	23.23 Units on a scale Standard Deviation 26.98
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C7 D1 (n=28, 30)	39.29 Units on a scale Standard Deviation 34.01	24.44 Units on a scale Standard Deviation 23.05
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C8 D1 (n=22, 28)	36.36 Units on a scale Standard Deviation 28.93	19.05 Units on a scale Standard Deviation 21.14
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C9 D1 (n=18, 23)	31.48 Units on a scale Standard Deviation 26.75	13.04 Units on a scale Standard Deviation 24.08
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C10 D1 (n=17, 20)	39.22 Units on a scale Standard Deviation 31.70	20.00 Units on a scale Standard Deviation 25.13
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C11 D1 (n=15, 19)	33.33 Units on a scale Standard Deviation 35.64	15.79 Units on a scale Standard Deviation 17.10
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C12 D1 (n=10, 17)	16.67 Units on a scale Standard Deviation 23.57	23.53 Units on a scale Standard Deviation 30.65
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: C13 D1 (n=8, 14)	29.17 Units on a scale Standard Deviation 21.36	16.67 Units on a scale Standard Deviation 28.49
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Loss of appetite: EOT (n=27, 38)	39.51 Units on a scale Standard Deviation 34.64	37.72 Units on a scale Standard Deviation 33.93
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: Baseline (n=56, 57)	15.48 Units on a scale Standard Deviation 23.75	21.05 Units on a scale Standard Deviation 31.89
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C2 D1 (n=50, 53)	21.33 Units on a scale Standard Deviation 28.38	20.13 Units on a scale Standard Deviation 26.43
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C3 D1 (n=45, 47)	18.52 Units on a scale Standard Deviation 24.16	14.89 Units on a scale Standard Deviation 23.88
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C4 D1 (n=36, 48)	18.52 Units on a scale Standard Deviation 26.96	13.19 Units on a scale Standard Deviation 21.46
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C5 D1 (n=32, 38)	18.75 Units on a scale Standard Deviation 22.30	21.05 Units on a scale Standard Deviation 27.31
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C6 D1 (n=28, 33)	22.62 Units on a scale Standard Deviation 25.75	19.19 Units on a scale Standard Deviation 28.90
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C7 D1 (n=28, 30)	25.00 Units on a scale Standard Deviation 26.64	7.78 Units on a scale Standard Deviation 14.34
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C8 D1 (n=22, 28)	19.70 Units on a scale Standard Deviation 19.68	2.38 Units on a scale Standard Deviation 8.74
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C9 D1 (n=18, 23)	9.26 Units on a scale Standard Deviation 19.15	5.80 Units on a scale Standard Deviation 12.92
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C10 D1 (n=17, 20)	17.65 Units on a scale Standard Deviation 20.81	5.00 Units on a scale Standard Deviation 12.21
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C11 D1 (n=15, 19)	22.22 Units on a scale Standard Deviation 20.57	8.77 Units on a scale Standard Deviation 18.73
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C12 D1 (n=10, 17)	20.00 Units on a scale Standard Deviation 23.31	5.88 Units on a scale Standard Deviation 17.62
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: C13 D1 (n=8, 14)	16.67 Units on a scale Standard Deviation 25.20	4.76 Units on a scale Standard Deviation 12.10
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Constipation: EOT (n=27, 38)	20.99 Units on a scale Standard Deviation 29.45	14.03 Units on a scale Standard Deviation 24.05
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: Baseline (n=55, 57)	6.67 Units on a scale Standard Deviation 17.45	5.85 Units on a scale Standard Deviation 14.26
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C2 D1 (n=50, 53)	11.33 Units on a scale Standard Deviation 17.31	10.06 Units on a scale Standard Deviation 21.27
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C3 D1 (n=45, 48)	15.55 Units on a scale Standard Deviation 18.26	9.72 Units on a scale Standard Deviation 21.70
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C4 D1 (n=37, 47)	13.51 Units on a scale Standard Deviation 19.97	5.67 Units on a scale Standard Deviation 12.66
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C5 D1 (n=32, 38)	22.92 Units on a scale Standard Deviation 32.17	7.89 Units on a scale Standard Deviation 18.07
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C6 D1 (n=29, 32)	21.84 Units on a scale Standard Deviation 28.56	10.42 Units on a scale Standard Deviation 19.74
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C7 D1 (n=28, 30)	16.67 Units on a scale Standard Deviation 26.45	11.11 Units on a scale Standard Deviation 15.98
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C8 D1 (n=22, 28)	24.24 Units on a scale Standard Deviation 31.17	4.76 Units on a scale Standard Deviation 11.88
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C9 D1 (n=18, 23)	27.78 Units on a scale Standard Deviation 28.58	5.80 Units on a scale Standard Deviation 12.92
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C10 D1 (n=17, 20)	23.53 Units on a scale Standard Deviation 30.65	10.00 Units on a scale Standard Deviation 19.04
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C11 D1 (n=15, 19)	31.11 Units on a scale Standard Deviation 34.43	0.00 Units on a scale Standard Deviation 0.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C12 D1 (n=10, 17)	43.33 Units on a scale Standard Deviation 16.10	0.00 Units on a scale Standard Deviation 0.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: C13 D1 (n=8, 14)	33.33 Units on a scale Standard Deviation 25.20	7.14 Units on a scale Standard Deviation 14.19
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Diarrhoea: EOT (n=27, 38)	23.46 Units on a scale Standard Deviation 28.96	3.51 Units on a scale Standard Deviation 12.94
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: Baseline (n=56, 57)	22.62 Units on a scale Standard Deviation 31.85	21.64 Units on a scale Standard Deviation 27.09
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C2 D1 (n=49, 53)	21.77 Units on a scale Standard Deviation 31.59	20.12 Units on a scale Standard Deviation 27.22
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C3 D1 (n=45, 48)	25.93 Units on a scale Standard Deviation 30.89	18.05 Units on a scale Standard Deviation 23.78
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C4 D1 (n=37, 48)	21.62 Units on a scale Standard Deviation 27.46	20.83 Units on a scale Standard Deviation 30.46
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C5 D1 (n=32, 38)	26.04 Units on a scale Standard Deviation 30.21	21.05 Units on a scale Standard Deviation 28.39
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C6 D1 (n=29, 32)	26.44 Units on a scale Standard Deviation 28.70	20.83 Units on a scale Standard Deviation 29.02
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C7 D1 (n=28, 30)	26.19 Units on a scale Standard Deviation 31.89	26.67 Units on a scale Standard Deviation 30.83
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C8 D1 (n=21, 28)	28.57 Units on a scale Standard Deviation 35.41	21.43 Units on a scale Standard Deviation 32.98
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C9 D1 (n=18, 23)	27.78 Units on a scale Standard Deviation 36.60	17.39 Units on a scale Standard Deviation 29.93
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C10 D1 (n=17, 19)	27.45 Units on a scale Standard Deviation 33.82	24.56 Units on a scale Standard Deviation 33.04
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C11 D1 (n=15, 19)	20.00 Units on a scale Standard Deviation 30.34	19.30 Units on a scale Standard Deviation 27.92
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C12 D1 (n=10, 17)	13.33 Units on a scale Standard Deviation 23.31	17.65 Units on a scale Standard Deviation 26.66
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: C13 D1 (n=8, 14)	20.83 Units on a scale Standard Deviation 35.36	16.67 Units on a scale Standard Deviation 28.49
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Financial difficulties: EOT (n=27, 37)	23.46 Units on a scale Standard Deviation 27.45	28.83 Units on a scale Standard Deviation 32.55
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: Baseline (n=57, 57)	53.22 Units on a scale Standard Deviation 22.03	54.97 Units on a scale Standard Deviation 21.06
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C2 D1 (n=49, 53)	58.16 Units on a scale Standard Deviation 20.38	59.59 Units on a scale Standard Deviation 17.78
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C3 D1 (n=45, 48)	56.67 Units on a scale Standard Deviation 20.07	59.72 Units on a scale Standard Deviation 16.34
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C4 D1 (n=37, 47)	57.21 Units on a scale Standard Deviation 18.02	57.80 Units on a scale Standard Deviation 18.17
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C5 D1 (n=32, 38)	58.07 Units on a scale Standard Deviation 21.94	61.84 Units on a scale Standard Deviation 17.61
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C6 D1 (n=29, 32)	53.45 Units on a scale Standard Deviation 17.75	60.94 Units on a scale Standard Deviation 17.51
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C7 D1 (n=28, 30)	55.65 Units on a scale Standard Deviation 20.17	58.61 Units on a scale Standard Deviation 15.39
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C8 D1 (n=22, 28)	56.82 Units on a scale Standard Deviation 17.18	60.71 Units on a scale Standard Deviation 15.36
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C9 D1 (n=18, 22)	56.48 Units on a scale Standard Deviation 23.14	64.40 Units on a scale Standard Deviation 15.89
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C10 D1 (n=17, 20)	55.39 Units on a scale Standard Deviation 17.91	62.50 Units on a scale Standard Deviation 14.93
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C11 D1 (n=15, 19)	47.78 Units on a scale Standard Deviation 19.02	63.60 Units on a scale Standard Deviation 15.52
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C12 D1 (n=10, 17)	54.17 Units on a scale Standard Deviation 19.35	63.73 Units on a scale Standard Deviation 12.48
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: C13 D1 (n=8, 14)	53.13 Units on a scale Standard Deviation 19.89	58.33 Units on a scale Standard Deviation 15.68
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) Score Global health status/QoL: EOT (n=27, 38)	49.38 Units on a scale Standard Deviation 20.92	50.22 Units on a scale Standard Deviation 21.62

SECONDARY outcome

Timeframe: Day 1 of every cycle then every 3 weeks until final study visit (up to 2.75 years)

QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnoea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

Outcome measures

Outcome measures
Measure	Axitinib + Paclitaxel + Carboplatin n=58 Participants Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=60 Participants Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C7 D1 (n=28, 28)	39.29 Units on a scale Standard Deviation 46.31	40.48 Units on a scale Standard Deviation 45.68
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C8 D1 (n=21, 27)	42.86 Units on a scale Standard Deviation 44.90	44.44 Units on a scale Standard Deviation 48.92
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: Baseline (n=56, 59)	37.50 Units on a scale Standard Deviation 31.18	38.42 Units on a scale Standard Deviation 24.62
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C2 D1 (n=50, 53)	30.67 Units on a scale Standard Deviation 24.13	30.19 Units on a scale Standard Deviation 20.94
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C3 D1 (n=46, 47)	28.98 Units on a scale Standard Deviation 25.92	28.37 Units on a scale Standard Deviation 23.03
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C4 D1 (n=37, 48)	29.73 Units on a scale Standard Deviation 25.80	27.08 Units on a scale Standard Deviation 20.23
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C5 D1 (n=33, 38)	22.22 Units on a scale Standard Deviation 18.00	28.07 Units on a scale Standard Deviation 23.92
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C6 D1 (n=29, 33)	26.44 Units on a scale Standard Deviation 24.20	26.26 Units on a scale Standard Deviation 23.21
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C7 D1 (n=28, 29)	25.00 Units on a scale Standard Deviation 21.52	25.29 Units on a scale Standard Deviation 24.65
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C8 D1 (n=22, 27)	21.21 Units on a scale Standard Deviation 19.37	19.75 Units on a scale Standard Deviation 21.20
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C9 D1 (n=18, 23)	20.37 Units on a scale Standard Deviation 20.26	24.64 Units on a scale Standard Deviation 25.06
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C10 D1 (n=17, 20)	23.53 Units on a scale Standard Deviation 25.73	21.67 Units on a scale Standard Deviation 22.36
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C11 D1 (n=15, 19)	24.44 Units on a scale Standard Deviation 23.46	26.31 Units on a scale Standard Deviation 23.78
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C12 D1 (n=10, 17)	26.66 Units on a scale Standard Deviation 14.05	29.41 Units on a scale Standard Deviation 30.92
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: C13 D1 (n=8, 14)	33.33 Units on a scale Standard Deviation 25.20	21.43 Units on a scale Standard Deviation 21.11
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Cough: End of treatment (EOT) (n=26, 38)	33.33 Units on a scale Standard Deviation 21.08	33.33 Units on a scale Standard Deviation 29.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: Baseline (n=56, 59)	2.98 Units on a scale Standard Deviation 11.51	3.39 Units on a scale Standard Deviation 10.16
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C2 D1 (n=50, 53)	2.67 Units on a scale Standard Deviation 9.13	1.89 Units on a scale Standard Deviation 7.78
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C3 D1 (n=44, 47)	0.76 Units on a scale Standard Deviation 5.02	5.67 Units on a scale Standard Deviation 14.44
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C4 D1 (n=36, 48)	0.93 Units on a scale Standard Deviation 5.56	3.47 Units on a scale Standard Deviation 10.29
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C5 D1 (n=33, 38)	1.01 Units on a scale Standard Deviation 5.80	3.51 Units on a scale Standard Deviation 12.94
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C6 D1 (n=29, 33)	3.45 Units on a scale Standard Deviation 13.64	3.03 Units on a scale Standard Deviation 12.81
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C7 D1 (n=27, 29)	0.00 Units on a scale Standard Deviation 0.00	3.45 Units on a scale Standard Deviation 10.33
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C8 D1 (n=22, 27)	0.00 Units on a scale Standard Deviation 0.00	1.23 Units on a scale Standard Deviation 6.41
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C9 D1 (n=18, 23)	0.00 Units on a scale Standard Deviation 0.00	0.00 Units on a scale Standard Deviation 0.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C10 D1 (n=17, 20)	0.00 Units on a scale Standard Deviation 0.00	0.00 Units on a scale Standard Deviation 0.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C11 D1 (n=15, 19)	0.00 Units on a scale Standard Deviation 0.00	0.00 Units on a scale Standard Deviation 0.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C12 D1 (n=10, 17)	0.00 Units on a scale Standard Deviation 0.00	0.00 Units on a scale Standard Deviation 0.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: C13 D1 (n=8, 14)	4.17 Units on a scale Standard Deviation 11.78	0.00 Units on a scale Standard Deviation 0.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Haemoptysis: EOT (n=26, 38)	0.00 Units on a scale Standard Deviation 0.00	5.26 Units on a scale Standard Deviation 16.49
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: Baseline (n=56, 58)	29.17 Units on a scale Standard Deviation 20.60	31.42 Units on a scale Standard Deviation 28.85
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C2 D1 (n=48, 53)	29.86 Units on a scale Standard Deviation 25.23	23.90 Units on a scale Standard Deviation 21.51
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C3 D1 (n=45, 43)	33.83 Units on a scale Standard Deviation 22.09	20.41 Units on a scale Standard Deviation 18.61
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C4 D1 (n=36, 45)	32.10 Units on a scale Standard Deviation 20.01	24.69 Units on a scale Standard Deviation 21.57
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C5 D1 (n=33, 37)	30.30 Units on a scale Standard Deviation 21.21	23.12 Units on a scale Standard Deviation 19.84
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C6 D1 (n=28, 31)	35.32 Units on a scale Standard Deviation 24.76	21.86 Units on a scale Standard Deviation 18.70
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C7 D1 (n=27, 27)	30.45 Units on a scale Standard Deviation 25.52	20.16 Units on a scale Standard Deviation 16.02
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C8 D1 (n=22, 26)	24.75 Units on a scale Standard Deviation 21.94	21.37 Units on a scale Standard Deviation 16.61
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C9 D1 (n=18, 22)	27.78 Units on a scale Standard Deviation 29.83	18.69 Units on a scale Standard Deviation 14.70
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C10 D1 (n=17, 19)	28.76 Units on a scale Standard Deviation 27.80	19.88 Units on a scale Standard Deviation 15.08
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C11 D1 (n=15, 18)	27.41 Units on a scale Standard Deviation 24.80	19.75 Units on a scale Standard Deviation 15.51
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C12 D1 (n=10, 17)	23.33 Units on a scale Standard Deviation 22.50	22.22 Units on a scale Standard Deviation 19.25
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: C13 D1 (n=8, 14)	37.50 Units on a scale Standard Deviation 31.95	16.67 Units on a scale Standard Deviation 16.16
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dyspnoea: EOT (n=25, 37)	34.22 Units on a scale Standard Deviation 23.33	33.63 Units on a scale Standard Deviation 28.39
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: Baseline (n=56, 58)	3.57 Units on a scale Standard Deviation 12.19	1.15 Units on a scale Standard Deviation 6.13
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C2 D1 (n=51, 53)	18.95 Units on a scale Standard Deviation 26.88	9.43 Units on a scale Standard Deviation 23.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C3 D1 (n=45, 47)	18.52 Units on a scale Standard Deviation 28.03	9.22 Units on a scale Standard Deviation 21.65
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C4 D1 (n=37, 48)	21.62 Units on a scale Standard Deviation 31.64	8.33 Units on a scale Standard Deviation 21.19
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C5 D1 (n=33, 38)	23.23 Units on a scale Standard Deviation 36.79	11.40 Units on a scale Standard Deviation 23.60
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C6 D1 (n=28, 33)	16.67 Units on a scale Standard Deviation 30.77	6.06 Units on a scale Standard Deviation 19.46
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C7 D1 (n=28, 29)	17.86 Units on a scale Standard Deviation 27.94	6.90 Units on a scale Standard Deviation 16.38
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C8 D1 (n=22, 27)	16.67 Units on a scale Standard Deviation 30.43	3.70 Units on a scale Standard Deviation 10.67
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C9 D1 (n=18, 23)	9.26 Units on a scale Standard Deviation 15.36	5.80 Units on a scale Standard Deviation 16.37
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C10 D1 (n=17, 20)	19.61 Units on a scale Standard Deviation 33.46	10.00 Units on a scale Standard Deviation 26.71
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C11 D1 (n=15, 19)	22.22 Units on a scale Standard Deviation 37.09	8.77 Units on a scale Standard Deviation 24.45
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C12 D1 (n=10, 17)	16.67 Units on a scale Standard Deviation 23.57	7.84 Units on a scale Standard Deviation 18.74
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: C13 D1 (n=8, 14)	25.00 Units on a scale Standard Deviation 38.83	4.76 Units on a scale Standard Deviation 12.10
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Sore Mouth: EOT (n=26, 38)	8.97 Units on a scale Standard Deviation 24.14	4.39 Units on a scale Standard Deviation 13.80
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: Baseline (n=56, 59)	6.55 Units on a scale Standard Deviation 17.31	6.78 Units on a scale Standard Deviation 14.88
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C2 D1 (n=51, 53)	11.76 Units on a scale Standard Deviation 22.92	6.92 Units on a scale Standard Deviation 17.73
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C3 D1 (n=46, 47)	13.77 Units on a scale Standard Deviation 20.58	4.96 Units on a scale Standard Deviation 11.99
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C4 D1 (n=37, 48)	9.91 Units on a scale Standard Deviation 20.59	2.78 Units on a scale Standard Deviation 9.31
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C5 D1 (n=32, 38)	12.50 Units on a scale Standard Deviation 26.44	4.39 Units on a scale Standard Deviation 11.42
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C6 D1 (n=28, 33)	13.10 Units on a scale Standard Deviation 27.73	7.07 Units on a scale Standard Deviation 16.15
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C7 D1 (n=28, 28)	11.90 Units on a scale Standard Deviation 26.00	5.95 Units on a scale Standard Deviation 15.85
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C8 D1 (n=22, 27)	16.67 Units on a scale Standard Deviation 26.73	1.23 Units on a scale Standard Deviation 6.41
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C9 D1 (n=18, 23)	9.26 Units on a scale Standard Deviation 15.36	1.45 Units on a scale Standard Deviation 6.95
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C10 D1 (n=17, 20)	21.57 Units on a scale Standard Deviation 26.20	6.67 Units on a scale Standard Deviation 17.44
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C11 D1 (n=15, 19)	24.44 Units on a scale Standard Deviation 29.46	1.75 Units on a scale Standard Deviation 7.65
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C12 D1 (n=10, 17)	6.67 Units on a scale Standard Deviation 14.05	3.92 Units on a scale Standard Deviation 16.17
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: C13 D1 (n=8, 14)	20.83 Units on a scale Standard Deviation 24.80	4.76 Units on a scale Standard Deviation 17.82
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Dysphagia: EOT (n=26, 38)	7.69 Units on a scale Standard Deviation 21.72	7.89 Units on a scale Standard Deviation 19.66
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: Baseline (n=56, 59)	9.52 Units on a scale Standard Deviation 19.81	15.25 Units on a scale Standard Deviation 26.50
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C2 D1 (n=51, 53)	24.84 Units on a scale Standard Deviation 30.44	33.96 Units on a scale Standard Deviation 33.01
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C3 D1 (n=46, 47)	37.68 Units on a scale Standard Deviation 34.15	34.75 Units on a scale Standard Deviation 36.09
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C4 D1 (n=37, 48)	45.05 Units on a scale Standard Deviation 37.86	38.19 Units on a scale Standard Deviation 32.97
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C5 D1 (n=33, 38)	50.51 Units on a scale Standard Deviation 39.19	42.11 Units on a scale Standard Deviation 33.50
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C6 D1 (n=29, 33)	55.17 Units on a scale Standard Deviation 39.11	52.53 Units on a scale Standard Deviation 33.37
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C7 D1 (n=28, 29)	48.81 Units on a scale Standard Deviation 37.93	54.02 Units on a scale Standard Deviation 33.82
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C8 D1 (n=22, 27)	57.58 Units on a scale Standard Deviation 40.08	50.62 Units on a scale Standard Deviation 36.25
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C9 D1 (n=17, 23)	45.10 Units on a scale Standard Deviation 40.73	56.52 Units on a scale Standard Deviation 36.84
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C10 D1 (n=17, 20)	45.10 Units on a scale Standard Deviation 42.40	48.33 Units on a scale Standard Deviation 38.20
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C11 D1 (n=14, 19)	50.00 Units on a scale Standard Deviation 42.87	49.12 Units on a scale Standard Deviation 35.78
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C12 D1 (n=9, 17)	55.56 Units on a scale Standard Deviation 40.83	54.90 Units on a scale Standard Deviation 38.98
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: C13 D1 (n=8, 14)	58.33 Units on a scale Standard Deviation 42.73	47.62 Units on a scale Standard Deviation 38.60
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Peripheral neuropathy: EOT (n=25, 38)	37.33 Units on a scale Standard Deviation 35.12	40.35 Units on a scale Standard Deviation 38.87
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: Baseline (n=56, 59)	2.98 Units on a scale Standard Deviation 11.51	2.26 Units on a scale Standard Deviation 10.48
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C2 D1 (n=50, 53)	69.33 Units on a scale Standard Deviation 33.56	71.70 Units on a scale Standard Deviation 32.29
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C3 D1 (n=46, 45)	73.91 Units on a scale Standard Deviation 37.13	68.89 Units on a scale Standard Deviation 38.53
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C4 D1 (n=37, 45)	65.77 Units on a scale Standard Deviation 40.43	60.00 Units on a scale Standard Deviation 42.40
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C5 D1 (n=33, 35)	61.62 Units on a scale Standard Deviation 44.19	64.76 Units on a scale Standard Deviation 44.24
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C6 D1 (n=28, 32)	69.05 Units on a scale Standard Deviation 42.48	61.46 Units on a scale Standard Deviation 45.68
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C9 D1 (n=18, 23)	27.78 Units on a scale Standard Deviation 43.16	31.88 Units on a scale Standard Deviation 44.36
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C10 D1 (n=17, 20)	31.37 Units on a scale Standard Deviation 43.25	11.67 Units on a scale Standard Deviation 29.17
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C11 D1 (n=14, 18)	16.67 Units on a scale Standard Deviation 36.40	16.67 Units on a scale Standard Deviation 34.77
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C12 D1 (n=10, 17)	13.33 Units on a scale Standard Deviation 28.11	9.80 Units on a scale Standard Deviation 28.30
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: C13 D1 (n=8, 14)	8.33 Units on a scale Standard Deviation 23.57	7.14 Units on a scale Standard Deviation 26.73
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Alopecia: EOT (n=26, 37)	33.33 Units on a scale Standard Deviation 42.16	27.03 Units on a scale Standard Deviation 39.94
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: Baseline (n=56, 59)	23.81 Units on a scale Standard Deviation 28.93	20.90 Units on a scale Standard Deviation 25.45
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C2 D1 (n=51, 53)	18.95 Units on a scale Standard Deviation 27.69	10.06 Units on a scale Standard Deviation 18.00
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C3 D1 (n=45, 47)	14.81 Units on a scale Standard Deviation 25.18	5.67 Units on a scale Standard Deviation 12.66
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C4 D1 (n=36, 48)	14.81 Units on a scale Standard Deviation 24.49	9.03 Units on a scale Standard Deviation 19.13
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C5 D1 (n=33, 38)	11.11 Units on a scale Standard Deviation 19.84	3.51 Units on a scale Standard Deviation 10.37
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C6 D1 (n=28, 33)	15.48 Units on a scale Standard Deviation 21.24	1.01 Units on a scale Standard Deviation 5.80
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C7 D1 (n=28, 28)	11.90 Units on a scale Standard Deviation 18.62	3.57 Units on a scale Standard Deviation 10.50
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C8 D1 (n=22, 27)	13.64 Units on a scale Standard Deviation 16.77	3.70 Units on a scale Standard Deviation 10.67
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C9 D1 (n=18, 23)	12.96 Units on a scale Standard Deviation 20.26	7.25 Units on a scale Standard Deviation 14.06
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C10 D1 (n=17, 20)	13.72 Units on a scale Standard Deviation 16.91	8.33 Units on a scale Standard Deviation 18.34
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C11 D1 (n=15, 19)	24.44 Units on a scale Standard Deviation 29.46	7.02 Units on a scale Standard Deviation 13.96
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C12 D1 (n=10, 16)	13.33 Units on a scale Standard Deviation 17.21	2.08 Units on a scale Standard Deviation 8.33
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: C13 D1 (n=7, 14)	19.05 Units on a scale Standard Deviation 26.23	4.76 Units on a scale Standard Deviation 12.10
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Chest pain: EOT (n=26, 37)	30.77 Units on a scale Standard Deviation 33.89	15.31 Units on a scale Standard Deviation 24.34
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: Baseline (n=56, 59)	20.83 Units on a scale Standard Deviation 27.39	20.34 Units on a scale Standard Deviation 29.04
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C2 D1 (n=51, 53)	20.91 Units on a scale Standard Deviation 28.25	20.75 Units on a scale Standard Deviation 24.66
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C3 D1 (n=45, 47)	14.81 Units on a scale Standard Deviation 25.18	5.67 Units on a scale Standard Deviation 12.66
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C4 D1 (n=37, 47)	18.92 Units on a scale Standard Deviation 25.51	17.02 Units on a scale Standard Deviation 30.19
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C5 D1 (n=33, 38)	14.14 Units on a scale Standard Deviation 26.39	14.91 Units on a scale Standard Deviation 26.51
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C6 D1 (n=29, 33)	16.09 Units on a scale Standard Deviation 26.16	5.05 Units on a scale Standard Deviation 12.14
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C7 D1 (n=28, 29)	15.48 Units on a scale Standard Deviation 23.10	14.94 Units on a scale Standard Deviation 22.86
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C8 D1 (n=22, 26)	16.67 Units on a scale Standard Deviation 26.73	14.10 Units on a scale Standard Deviation 19.26
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C9 D1 (n=18, 23)	14.81 Units on a scale Standard Deviation 23.49	13.04 Units on a scale Standard Deviation 19.43
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C10 D1 (n=17, 20)	13.73 Units on a scale Standard Deviation 23.74	20.00 Units on a scale Standard Deviation 27.36
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C11 D1 (n=14, 19)	26.19 Units on a scale Standard Deviation 29.75	15.79 Units on a scale Standard Deviation 23.22
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C12 D1 (n=10, 17)	23.33 Units on a scale Standard Deviation 22.50	25.49 Units on a scale Standard Deviation 32.34
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: C13 D1 (n=8, 14)	20.83 Units on a scale Standard Deviation 24.80	19.05 Units on a scale Standard Deviation 25.20
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Arm/shoulder pain: EOT (n=26, 38)	21.80 Units on a scale Standard Deviation 33.92	23.68 Units on a scale Standard Deviation 31.87
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: Baseline (n=52, 57)	28.85 Units on a scale Standard Deviation 32.36	25.15 Units on a scale Standard Deviation 34.09
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C2 D1 (n=49, 50)	26.53 Units on a scale Standard Deviation 28.85	32.67 Units on a scale Standard Deviation 31.94
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C3 D1 (n=46, 47)	34.06 Units on a scale Standard Deviation 31.81	23.40 Units on a scale Standard Deviation 31.79
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C4 D1 (n=36, 45)	25.93 Units on a scale Standard Deviation 27.73	28.15 Units on a scale Standard Deviation 30.11
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C5 D1 (n=32, 38)	25.00 Units on a scale Standard Deviation 29.33	26.32 Units on a scale Standard Deviation 33.02
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C6 D1 (n=28, 33)	29.76 Units on a scale Standard Deviation 26.20	27.27 Units on a scale Standard Deviation 33.80
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C7 D1 (n=28, 28)	32.14 Units on a scale Standard Deviation 35.70	35.71 Units on a scale Standard Deviation 36.21
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C8 D1 (n=22, 26)	16.67 Units on a scale Standard Deviation 28.64	25.64 Units on a scale Standard Deviation 33.08
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C9 D1 (n=15, 23)	31.11 Units on a scale Standard Deviation 34.43	31.88 Units on a scale Standard Deviation 34.05
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C10 D1 (n=16, 19)	25.00 Units on a scale Standard Deviation 28.55	22.81 Units on a scale Standard Deviation 31.53
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C11 D1 (n=14, 18)	42.86 Units on a scale Standard Deviation 33.15	25.93 Units on a scale Standard Deviation 33.44
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C12 D1 (n=10, 17)	33.33 Units on a scale Standard Deviation 27.22	27.45 Units on a scale Standard Deviation 33.82
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: C13 D1 (n=8, 14)	29.17 Units on a scale Standard Deviation 27.82	26.19 Units on a scale Standard Deviation 29.75
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Other pain: EOT (n=25, 37)	34.67 Units on a scale Standard Deviation 32.60	29.73 Units on a scale Standard Deviation 36.67
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: Baseline (n=37, 35)	60.36 Units on a scale Standard Deviation 29.23	66.67 Units on a scale Standard Deviation 28.01
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C3 D1 (n=29, 24)	65.52 Units on a scale Standard Deviation 31.48	68.06 Units on a scale Standard Deviation 31.82
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C4 D1 (n=19, 29)	63.16 Units on a scale Standard Deviation 26.98	72.41 Units on a scale Standard Deviation 23.69
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C5 D1 (n=17, 22)	70.59 Units on a scale Standard Deviation 26.04	72.73 Units on a scale Standard Deviation 22.15
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C6 D1 (n=16, 17)	66.67 Units on a scale Standard Deviation 29.81	72.55 Units on a scale Standard Deviation 24.25
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C7 D1 (n=15, 14)	75.56 Units on a scale Standard Deviation 26.63	66.67 Units on a scale Standard Deviation 29.24
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C8 D1 (n=13, 16)	66.67 Units on a scale Standard Deviation 27.22	75.00 Units on a scale Standard Deviation 25.82
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C9 D1 (n=6, 14)	72.23 Units on a scale Standard Deviation 13.61	69.05 Units on a scale Standard Deviation 20.52
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C10 D1 (n=10, 10)	73.34 Units on a scale Standard Deviation 14.05	60.00 Units on a scale Standard Deviation 26.30
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C11 D1 (n=9, 9)	48.15 Units on a scale Standard Deviation 17.57	81.48 Units on a scale Standard Deviation 17.57
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C12 D1 (n=6, 9)	55.56 Units on a scale Standard Deviation 17.22	70.37 Units on a scale Standard Deviation 20.03
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C13 D1 (n=0, 0)	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: EOT (n=15, 19)	60.00 Units on a scale Standard Deviation 22.54	66.67 Units on a scale Standard Deviation 29.40
European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Lung Cancer-13 (QLQ- LC13) Score Medicine for pain: C2 D1 (n=30, 35)	62.22 Units on a scale Standard Deviation 22.72	71.43 Units on a scale Standard Deviation 26.99

SECONDARY outcome

Timeframe: Baseline, C1 D1, C1 D15, C2 D1, C3 D1, C4 D1 and C5 D1

Population: Data was not generated but sample was collected for banking and moved to a separate exploratory research database for future research.

RNA expression profiles of genes which were associated with tumor growth, angiogenesis and metastases were collected and correlated with efficacy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1

Population: ITT population: participants randomized with study drug designated according to initial randomization, regardless of whether participants received study drug or different drug. 'n': participants evaluated at specific time point for each group respectively. 'N' (Number of participants analyzed) signifies participants evaluable for the measure.

Circulating endothelial cells (CECs) are noninvasive marker of vascular damage, remodeling, and dysfunction. Total CEC, plasma-vascular endothelial growth factor receptor-2 (pVEGFR2), VEGFR2, p-Beta-type platelet-derived growth factor receptor (pPDGFRB+) and PDGFRB+ were explored using CECs. Blood was collected to analyze effects of therapy on the number, viability/apoptotic state, and/or target activity/expression in CECs.

Outcome measures

Outcome measures
Measure	Axitinib + Paclitaxel + Carboplatin n=58 Participants Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=59 Participants Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Circulating Endothelial Cells (CEC) in Blood: Total CEC C7 D1 (n=11, 14)	71770.91 Cells/milliliter (cells/mL) Standard Deviation 94182.032	36964.36 Cells/milliliter (cells/mL) Standard Deviation 60577.084
Circulating Endothelial Cells (CEC) in Blood: Total CEC Baseline (n=39, 37)	46815.38 Cells/milliliter (cells/mL) Standard Deviation 131531.755	16960.41 Cells/milliliter (cells/mL) Standard Deviation 25527.526
Circulating Endothelial Cells (CEC) in Blood: Total CEC C1 D15 (n=27, 29)	11780.15 Cells/milliliter (cells/mL) Standard Deviation 13127.847	21882.41 Cells/milliliter (cells/mL) Standard Deviation 67578.781
Circulating Endothelial Cells (CEC) in Blood: Total CEC C2 D1 (n=32, 28)	29229.09 Cells/milliliter (cells/mL) Standard Deviation 55724.997	40507.36 Cells/milliliter (cells/mL) Standard Deviation 82161.060
Circulating Endothelial Cells (CEC) in Blood: Total CEC C3 D1 (n=24, 30)	19517.50 Cells/milliliter (cells/mL) Standard Deviation 19793.722	25215.70 Cells/milliliter (cells/mL) Standard Deviation 42932.747
Circulating Endothelial Cells (CEC) in Blood: Total CEC C4 D1 (n=20, 27)	24556.05 Cells/milliliter (cells/mL) Standard Deviation 22434.011	41944.59 Cells/milliliter (cells/mL) Standard Deviation 70239.938
Circulating Endothelial Cells (CEC) in Blood: Total CEC C5 D1 (n=18, 23)	28266.22 Cells/milliliter (cells/mL) Standard Deviation 39480.209	37468.13 Cells/milliliter (cells/mL) Standard Deviation 82647.380
Circulating Endothelial Cells (CEC) in Blood: Total CEC C9 D1 (n=7, 7)	58680.00 Cells/milliliter (cells/mL) Standard Deviation 78138.794	107978.14 Cells/milliliter (cells/mL) Standard Deviation 206314.489
Circulating Endothelial Cells (CEC) in Blood: Total CEC C11 D1 (n=6, 6)	116620.83 Cells/milliliter (cells/mL) Standard Deviation 129577.280	120847.67 Cells/milliliter (cells/mL) Standard Deviation 140674.394

SECONDARY outcome

Timeframe: Baseline (C1 D1), C1 D15, C2 D1, C3 D1, C4 D1, C5 D1, C7 D1, C9 D1 and C11 D1

Outcome measures

SECONDARY outcome

Timeframe: Baseline, C1D1, C1D15, C2D1, C3D1, C4D1, C5D1, C7D1, C9D1 and C11D1

Plasma concentrations of soluble proteins (soluble- stem-cell factor receptor (sKIT) vascular endothelial growth factor \[VEGF\], and vascular endothelial growth factor receptor-2 \[VEGFR2\], VEGFR3) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.

Outcome measures

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1 of Cycle 1)

Population: Data was reported in listings but not summarized due to statistical constraints.

UGT1A1 an enzyme of the glucuronidation pathway that transforms small lipophilic molecules, such as steroids, bilirubin, hormones, and drugs, into water-soluble, excretable metabolites.

Outcome measures

Outcome data not reported

Adverse Events

Axitinib + Paclitaxel + Carboplatin

Serious events: 31 serious events

Other events: 54 other events

Deaths: 0 deaths

Bevacizumab + Paclitaxel + Carboplatin

Serious events: 19 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Axitinib + Paclitaxel + Carboplatin n=58 Participants Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=59 Participants Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Circulating Endothelial Cells (CEC) in Blood Baseline (pVEGFR2+) (n=50, 42)	1936317.98 Flourescent Intensity Unit (FIU) Standard Deviation 1252665.900	1764577.67 Flourescent Intensity Unit (FIU) Standard Deviation 1331540.549
Circulating Endothelial Cells (CEC) in Blood C1 D15 (pVEGFR2+) (n=38, 37)	1822095.74 Flourescent Intensity Unit (FIU) Standard Deviation 1678888.153	1810049.32 Flourescent Intensity Unit (FIU) Standard Deviation 1330590.809
Circulating Endothelial Cells (CEC) in Blood C2 D1 (pVEGFR2+) (n=41, 35)	1767065.44 Flourescent Intensity Unit (FIU) Standard Deviation 1442193.213	2090673.60 Flourescent Intensity Unit (FIU) Standard Deviation 1659128.892
Circulating Endothelial Cells (CEC) in Blood C3 D1 (pVEGFR2+) (n=33, 34)	1715569.39 Flourescent Intensity Unit (FIU) Standard Deviation 1515661.662	1578940.53 Flourescent Intensity Unit (FIU) Standard Deviation 1274415.109
Circulating Endothelial Cells (CEC) in Blood C4 D1 (pVEGFR2+) (n=25, 32)	1472447.68 Flourescent Intensity Unit (FIU) Standard Deviation 970463.341	1815402.16 Flourescent Intensity Unit (FIU) Standard Deviation 1263516.725
Circulating Endothelial Cells (CEC) in Blood C5 D1 (pVEGFR2+) (n=24, 26)	2208801.96 Flourescent Intensity Unit (FIU) Standard Deviation 3098289.400	1794843.58 Flourescent Intensity Unit (FIU) Standard Deviation 1458412.725
Circulating Endothelial Cells (CEC) in Blood C7 D1 (pVEGFR2+) (n=16, 16)	1405048.00 Flourescent Intensity Unit (FIU) Standard Deviation 879770.893	1634128.00 Flourescent Intensity Unit (FIU) Standard Deviation 1443612.089
Circulating Endothelial Cells (CEC) in Blood C9 D1 (pVEGFR2+) (n=12, 11)	2280989.75 Flourescent Intensity Unit (FIU) Standard Deviation 1050678.808	2283985.00 Flourescent Intensity Unit (FIU) Standard Deviation 1093158.760
Circulating Endothelial Cells (CEC) in Blood C11 D1 (pVEGFR2+) (n=10, 9)	1828224.90 Flourescent Intensity Unit (FIU) Standard Deviation 1179020.490	2354939.11 Flourescent Intensity Unit (FIU) Standard Deviation 1116283.011
Circulating Endothelial Cells (CEC) in Blood Baseline (VEGFR2+) (n=50, 42)	1694522.56 Flourescent Intensity Unit (FIU) Standard Deviation 1534520.504	1841618.36 Flourescent Intensity Unit (FIU) Standard Deviation 1300088.201
Circulating Endothelial Cells (CEC) in Blood C1 D15 (VEGFR2+) (n=38, 37)	1634956.89 Flourescent Intensity Unit (FIU) Standard Deviation 1285333.248	1740268.05 Flourescent Intensity Unit (FIU) Standard Deviation 1444881.394
Circulating Endothelial Cells (CEC) in Blood C2 D1 (VEGFR2+) (n=41, 35)	1597041.59 Flourescent Intensity Unit (FIU) Standard Deviation 865675.123	1444404.94 Flourescent Intensity Unit (FIU) Standard Deviation 1097875.465
Circulating Endothelial Cells (CEC) in Blood C3 D1 (VEGFR2+) (n=33, 34)	1443986.61 Flourescent Intensity Unit (FIU) Standard Deviation 843071.909	1504595.71 Flourescent Intensity Unit (FIU) Standard Deviation 1163469.112
Circulating Endothelial Cells (CEC) in Blood C4 D1 (VEGFR2+) (n=25, 32)	1181666.88 Flourescent Intensity Unit (FIU) Standard Deviation 673860.407	1259913.44 Flourescent Intensity Unit (FIU) Standard Deviation 765707.741
Circulating Endothelial Cells (CEC) in Blood C5 D1 (VEGFR2+) (n=24, 25)	1371956.00 Flourescent Intensity Unit (FIU) Standard Deviation 948166.942	1447188.88 Flourescent Intensity Unit (FIU) Standard Deviation 885864.695
Circulating Endothelial Cells (CEC) in Blood C7 D1 (VEGFR2+) (n=16, 16)	1028231.44 Flourescent Intensity Unit (FIU) Standard Deviation 495059.378	1317560.13 Flourescent Intensity Unit (FIU) Standard Deviation 720095.027
Circulating Endothelial Cells (CEC) in Blood C9 D1 (VEGFR2+) (n=12, 11)	1485819.58 Flourescent Intensity Unit (FIU) Standard Deviation 953884.288	1476621.00 Flourescent Intensity Unit (FIU) Standard Deviation 1688887.819
Circulating Endothelial Cells (CEC) in Blood C11 D1 (VEGFR2+) (n=10, 9)	1573298.80 Flourescent Intensity Unit (FIU) Standard Deviation 1152155.993	1332064.78 Flourescent Intensity Unit (FIU) Standard Deviation 668964.428
Circulating Endothelial Cells (CEC) in Blood Baseline (pPDGFRB+) (n=50, 42)	1646702.34 Flourescent Intensity Unit (FIU) Standard Deviation 1482336.244	1734853.24 Flourescent Intensity Unit (FIU) Standard Deviation 1485338.326
Circulating Endothelial Cells (CEC) in Blood C1 D15 (pPDGFRB+) (n=38, 37)	1253893.97 Flourescent Intensity Unit (FIU) Standard Deviation 894629.298	1599671.65 Flourescent Intensity Unit (FIU) Standard Deviation 1669690.889
Circulating Endothelial Cells (CEC) in Blood C2 D1 (pPDGFRB+) (n=41, 35)	1395311.88 Flourescent Intensity Unit (FIU) Standard Deviation 1111766.454	1885684.31 Flourescent Intensity Unit (FIU) Standard Deviation 1356916.305
Circulating Endothelial Cells (CEC) in Blood C3 D1 (pPDGFRB+) (n=33, 34)	1470448.94 Flourescent Intensity Unit (FIU) Standard Deviation 841336.398	1285439.44 Flourescent Intensity Unit (FIU) Standard Deviation 1083860.541
Circulating Endothelial Cells (CEC) in Blood C4 D1 (pPDGFRB+) (n=25, 32)	1046445.72 Flourescent Intensity Unit (FIU) Standard Deviation 588769.375	1514713.97 Flourescent Intensity Unit (FIU) Standard Deviation 1150805.007
Circulating Endothelial Cells (CEC) in Blood C5 D1 (pPDGFRB+) (n=24, 26)	2253114.67 Flourescent Intensity Unit (FIU) Standard Deviation 3314986.569	2299459.38 Flourescent Intensity Unit (FIU) Standard Deviation 5140939.706
Circulating Endothelial Cells (CEC) in Blood C7 D1 (pPDGFRB+) (n=16, 16)	1380133.19 Flourescent Intensity Unit (FIU) Standard Deviation 1002147.826	2163313.88 Flourescent Intensity Unit (FIU) Standard Deviation 3720352.717
Circulating Endothelial Cells (CEC) in Blood C9 D1 (pPDGFRB+) (n=12, 11)	2172539.75 Flourescent Intensity Unit (FIU) Standard Deviation 2323386.087	2225289.18 Flourescent Intensity Unit (FIU) Standard Deviation 1126401.528
Circulating Endothelial Cells (CEC) in Blood C11 D1 (pPDGFRB+) (n=10, 9)	1580028.90 Flourescent Intensity Unit (FIU) Standard Deviation 927582.364	3127640.22 Flourescent Intensity Unit (FIU) Standard Deviation 2817719.865
Circulating Endothelial Cells (CEC) in Blood Baseline (PDGFRB+) (n=50, 42)	1775826.12 Flourescent Intensity Unit (FIU) Standard Deviation 1485762.540	3176459.69 Flourescent Intensity Unit (FIU) Standard Deviation 3222201.986
Circulating Endothelial Cells (CEC) in Blood C1 D15 (PDGFRB+) (n=38, 37)	1589914.37 Flourescent Intensity Unit (FIU) Standard Deviation 985828.939	1819988.05 Flourescent Intensity Unit (FIU) Standard Deviation 1807664.991
Circulating Endothelial Cells (CEC) in Blood C2 D1 (PDGFRB+) (n=41, 35)	1840677.73 Flourescent Intensity Unit (FIU) Standard Deviation 1315688.806	1586256.17 Flourescent Intensity Unit (FIU) Standard Deviation 1092406.544
Circulating Endothelial Cells (CEC) in Blood C3 D1 (PDGFRB+) (n=33, 34)	1690163.33 Flourescent Intensity Unit (FIU) Standard Deviation 1064816.034	1518360.71 Flourescent Intensity Unit (FIU) Standard Deviation 1286285.813
Circulating Endothelial Cells (CEC) in Blood C4 D1 (PDGFRB+) (n=25, 32)	1288624.64 Flourescent Intensity Unit (FIU) Standard Deviation 641546.254	1408366.91 Flourescent Intensity Unit (FIU) Standard Deviation 1013859.813
Circulating Endothelial Cells (CEC) in Blood C5 D1 (PDGFRB+) (n=24, 26)	1309639.50 Flourescent Intensity Unit (FIU) Standard Deviation 975890.557	1364500.50 Flourescent Intensity Unit (FIU) Standard Deviation 1058758.211
Circulating Endothelial Cells (CEC) in Blood C7 D1 (PDGFRB+) (n=16, 16)	1049351.00 Flourescent Intensity Unit (FIU) Standard Deviation 587546.139	1287039.25 Flourescent Intensity Unit (FIU) Standard Deviation 922009.811
Circulating Endothelial Cells (CEC) in Blood C9 D1 (PDGFRB+) (n=12, 11)	1666413.67 Flourescent Intensity Unit (FIU) Standard Deviation 1465165.325	1625161.64 Flourescent Intensity Unit (FIU) Standard Deviation 1467355.491
Circulating Endothelial Cells (CEC) in Blood C11 D1 (PDGFRB+) (n=10, 9)	1533606.00 Flourescent Intensity Unit (FIU) Standard Deviation 1258733.501	1959067.11 Flourescent Intensity Unit (FIU) Standard Deviation 1973194.943

Measure	Axitinib + Paclitaxel + Carboplatin n=57 Participants Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=58 Participants Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Plasma Concentration of Soluble Proteins Baseline (SKIT) (n=52, 47)	49740.29 Picogram/mL (pg/mL) Standard Deviation 16998.69	49544.15 Picogram/mL (pg/mL) Standard Deviation 14803.62
Plasma Concentration of Soluble Proteins C1 D15 (SKIT) (n=42, 36)	53095.48 Picogram/mL (pg/mL) Standard Deviation 18233.85	55801.39 Picogram/mL (pg/mL) Standard Deviation 22058.63
Plasma Concentration of Soluble Proteins C2 D1 (SKIT) (n=41, 43)	52979.39 Picogram/mL (pg/mL) Standard Deviation 18018.73	55729.65 Picogram/mL (pg/mL) Standard Deviation 21476.66
Plasma Concentration of Soluble Proteins C3 D1 (SKIT) (n=40, 38)	53817.75 Picogram/mL (pg/mL) Standard Deviation 19638.72	65634.14 Picogram/mL (pg/mL) Standard Deviation 27097.91
Plasma Concentration of Soluble Proteins C4 D1 (SKIT) (n=32, 38)	56961.41 Picogram/mL (pg/mL) Standard Deviation 20828.07	72671.32 Picogram/mL (pg/mL) Standard Deviation 33207.22
Plasma Concentration of Soluble Proteins C5 D1 (SKIT) (n=27, 34)	58305.00 Picogram/mL (pg/mL) Standard Deviation 20311.85	68677.21 Picogram/mL (pg/mL) Standard Deviation 30073.83
Plasma Concentration of Soluble Proteins C7 D1 (SKIT) (n=18, 23)	50701.11 Picogram/mL (pg/mL) Standard Deviation 17927.98	75547.61 Picogram/mL (pg/mL) Standard Deviation 24458.54
Plasma Concentration of Soluble Proteins C9 D1 (SKIT) (n=12, 16)	48680.42 Picogram/mL (pg/mL) Standard Deviation 14791.32	65990.78 Picogram/mL (pg/mL) Standard Deviation 17003.08
Plasma Concentration of Soluble Proteins C11 D1 (SKIT) (n=11, 13)	49251.82 Picogram/mL (pg/mL) Standard Deviation 19469.45	66920.38 Picogram/mL (pg/mL) Standard Deviation 12261.25
Plasma Concentration of Soluble Proteins Baseline (VEGF) (n=50, 48)	95.14 Picogram/mL (pg/mL) Standard Deviation 66.60	121.83 Picogram/mL (pg/mL) Standard Deviation 141.22
Plasma Concentration of Soluble Proteins C1 D15 (VEGF) (n=40, 37)	117.08 Picogram/mL (pg/mL) Standard Deviation 98.05	287.19 Picogram/mL (pg/mL) Standard Deviation 171.77
Plasma Concentration of Soluble Proteins C2 D1 (VEGF) (n=39, 43)	127.46 Picogram/mL (pg/mL) Standard Deviation 128.06	324.33 Picogram/mL (pg/mL) Standard Deviation 153.65
Plasma Concentration of Soluble Proteins C3 D1 (VEGF) (n=39, 38)	148.06 Picogram/mL (pg/mL) Standard Deviation 159.80	368.23 Picogram/mL (pg/mL) Standard Deviation 151.20
Plasma Concentration of Soluble Proteins C4 D1 (VEGF) (n=30, 38)	197.16 Picogram/mL (pg/mL) Standard Deviation 282.49	405.13 Picogram/mL (pg/mL) Standard Deviation 173.86
Plasma Concentration of Soluble Proteins C5 D1 (VEGF) (n=25, 34)	184.77 Picogram/mL (pg/mL) Standard Deviation 175.32	400.16 Picogram/mL (pg/mL) Standard Deviation 165.69
Plasma Concentration of Soluble Proteins C7 D1 (VEGF) (n=18, 23)	226.62 Picogram/mL (pg/mL) Standard Deviation 202.53	433.30 Picogram/mL (pg/mL) Standard Deviation 172.14
Plasma Concentration of Soluble Proteins C9 D1 (VEGF) (n=12, 16)	273.17 Picogram/mL (pg/mL) Standard Deviation 207.22	422.38 Picogram/mL (pg/mL) Standard Deviation 157.76
Plasma Concentration of Soluble Proteins C11 D1 (VEGF) (n=11, 13)	339.86 Picogram/mL (pg/mL) Standard Deviation 303.71	449.92 Picogram/mL (pg/mL) Standard Deviation 144.50
Plasma Concentration of Soluble Proteins Baseline (VEGFR2) (n=52, 48)	9587.31 Picogram/mL (pg/mL) Standard Deviation 1570.27	9995.00 Picogram/mL (pg/mL) Standard Deviation 2185.61
Plasma Concentration of Soluble Proteins C1 D15 (VEGFR2) (n=42, 37)	7828.10 Picogram/mL (pg/mL) Standard Deviation 1959.39	10781.35 Picogram/mL (pg/mL) Standard Deviation 2311.90
Plasma Concentration of Soluble Proteins C2 D1 (VEGFR2) (n=41, 43)	7477.80 Picogram/mL (pg/mL) Standard Deviation 2146.89	10330.00 Picogram/mL (pg/mL) Standard Deviation 2511.23
Plasma Concentration of Soluble Proteins C3 D1 (VEGFR2) (n=40, 38)	7058.50 Picogram/mL (pg/mL) Standard Deviation 2037.12	10129.47 Picogram/mL (pg/mL) Standard Deviation 2244.65
Plasma Concentration of Soluble Proteins C4 D1 (VEGFR2) (n=32, 38)	6885.94 Picogram/mL (pg/mL) Standard Deviation 1754.19	9934.21 Picogram/mL (pg/mL) Standard Deviation 1785.78
Plasma Concentration of Soluble Proteins C5 D1 (VEGFR2) (n=27, 34)	6565.93 Picogram/mL (pg/mL) Standard Deviation 1755.75	10140.59 Picogram/mL (pg/mL) Standard Deviation 2056.40
Plasma Concentration of Soluble Proteins C7 D1 (VEGFR2) (n=18, 23)	6401.11 Picogram/mL (pg/mL) Standard Deviation 2360.24	10339.57 Picogram/mL (pg/mL) Standard Deviation 1897.95
Plasma Concentration of Soluble Proteins C9 D1 (VEGFR2) (n=12, 16)	6291.67 Picogram/mL (pg/mL) Standard Deviation 2235.24	9421.25 Picogram/mL (pg/mL) Standard Deviation 2446.42
Plasma Concentration of Soluble Proteins C11 D1 (VEGFR2) (n=11, 13)	5696.36 Picogram/mL (pg/mL) Standard Deviation 2724.57	9222.31 Picogram/mL (pg/mL) Standard Deviation 2727.04
Plasma Concentration of Soluble Proteins Baseline (VEGFR3) (n=52, 48)	44390.77 Picogram/mL (pg/mL) Standard Deviation 75118.17	24718.33 Picogram/mL (pg/mL) Standard Deviation 12494.07
Plasma Concentration of Soluble Proteins C1 D15 (VEGFR3) (n=42, 37)	33684.29 Picogram/mL (pg/mL) Standard Deviation 52617.02	17693.51 Picogram/mL (pg/mL) Standard Deviation 9679.53
Plasma Concentration of Soluble Proteins C2 D1 (VEGFR3) (n=41, 43)	35780.49 Picogram/mL (pg/mL) Standard Deviation 68287.68	17798.37 Picogram/mL (pg/mL) Standard Deviation 9710.23
Plasma Concentration of Soluble Proteins C3 D1 (VEGFR3) (n=40, 38)	34147.00 Picogram/mL (pg/mL) Standard Deviation 74220.30	15901.32 Picogram/mL (pg/mL) Standard Deviation 8062.41
Plasma Concentration of Soluble Proteins C4 D1 (VEGFR3) (n=32, 38)	19730.94 Picogram/mL (pg/mL) Standard Deviation 9237.69	16307.37 Picogram/mL (pg/mL) Standard Deviation 7409.61
Plasma Concentration of Soluble Proteins C5 D1 (VEGFR3) (n=27, 34)	17452.59 Picogram/mL (pg/mL) Standard Deviation 8614.99	16381.47 Picogram/mL (pg/mL) Standard Deviation 6707.41
Plasma Concentration of Soluble Proteins C7 D1 (VEGFR3) (n=18, 23)	17896.67 Picogram/mL (pg/mL) Standard Deviation 8360.82	15626.30 Picogram/mL (pg/mL) Standard Deviation 8873.31
Plasma Concentration of Soluble Proteins C9 D1 (VEGFR3) (n=12, 16)	21449.17 Picogram/mL (pg/mL) Standard Deviation 12806.75	14733.44 Picogram/mL (pg/mL) Standard Deviation 6441.61
Plasma Concentration of Soluble Proteins C11 D1 (VEGFR3) (n=11, 13)	22332.73 Picogram/mL (pg/mL) Standard Deviation 12408.37	16048.46 Picogram/mL (pg/mL) Standard Deviation 7064.47

Serious adverse events
Measure	Axitinib + Paclitaxel + Carboplatin n=58 participants at risk Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=59 participants at risk Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Nervous system disorders Meningeal disorder	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	0.00% 0/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Confusional state	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Hallucination	0.00% 0/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 2/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Pancytopenia	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Acute myocardial infarction	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial fibrillation	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac arrest	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial infarction	3.4% 2/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Pericardial effusion	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Supraventricular tachycardia	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Tachycardia	0.00% 0/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Inappropriate antidiuretic hormone secretion	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Anal fissure	0.00% 0/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oesophagitis	0.00% 0/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 2/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	5.2% 3/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	0.00% 0/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chills	0.00% 0/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Death	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	12.1% 7/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.1% 3/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 2/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders General physical health deterioration	0.00% 0/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Immune system disorders Anaphylactic reaction	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Device related infection	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Diverticulitis	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Endocarditis bacterial	0.00% 0/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Lower respiratory tract infection	0.00% 0/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 2/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Neutropenic sepsis	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	3.4% 2/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Staphylococcal infection	1.7% 1/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events
Measure	Axitinib + Paclitaxel + Carboplatin n=58 participants at risk Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m\^2) over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.	Bevacizumab + Paclitaxel + Carboplatin n=59 participants at risk Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m\^2 over 3 hours and carboplatin AUC of 6 mg\*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
Nervous system disorders Lethargy	6.9% 4/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.5% 5/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia	20.7% 12/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	25.4% 15/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Leukopenia	12.1% 7/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.5% 5/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Neutropenia	31.0% 18/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	25.4% 15/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	20.7% 12/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	18.6% 11/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hypothyroidism	15.5% 9/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 2/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	10.3% 6/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.1% 3/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	5.2% 3/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 4/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	27.6% 16/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.8% 17/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	46.6% 27/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.9% 20/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	13.8% 8/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 2/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	36.2% 21/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	32.2% 19/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	13.8% 8/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.2% 6/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	24.1% 14/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	18.6% 11/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	29.3% 17/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.2% 6/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	13.8% 8/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.1% 3/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	34.5% 20/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	37.3% 22/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Malaise	5.2% 3/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	8.6% 5/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.1% 3/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	10.3% 6/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.2% 6/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	10.3% 6/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.3% 9/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Lower respiratory tract infection	6.9% 4/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.2% 6/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	6.9% 4/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.1% 3/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	17.2% 10/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.2% 6/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	43.1% 25/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.3% 12/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	5.2% 3/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	5.2% 3/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.1% 3/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyponatraemia	6.9% 4/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.1% 3/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	22.4% 13/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	18.6% 11/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	17.2% 10/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.5% 5/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	8.6% 5/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.9% 7/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	6.9% 4/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.2% 3/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 4/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	12.1% 7/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.9% 7/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	6.9% 4/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.7% 1/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	6.9% 4/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.9% 10/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	8.6% 5/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 4/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	6.9% 4/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.2% 6/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	19.0% 11/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.8% 4/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Neuropathy peripheral	25.9% 15/58 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	25.4% 15/59 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.