Trial Outcomes & Findings for Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer. (NCT NCT00471146)

Last Updated: 2012-07-16

Results Overview

Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

630 participants

Primary outcome timeframe

Baseline until death or at least 1 year after the randomization of last participant

Results posted on

2012-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) in cycles of 4 weeks. Gemcitabine 1000 mg per square meter (mg/m\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Overall Study STARTED	314	316
Overall Study Treated	305	308
Overall Study COMPLETED	142	142
Overall Study NOT COMPLETED	172	174

Reasons for withdrawal

Reasons for withdrawal
Measure	Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) in cycles of 4 weeks. Gemcitabine 1000 mg per square meter (mg/m\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Overall Study Adverse Event	32	33
Overall Study Withdrawal by Subject	14	11
Overall Study Death	11	12
Overall Study Lost to Follow-up	4	2
Overall Study Protocol Violation	2	2
Overall Study Objective progression or relapse	84	87
Overall Study Global deterioration of health status	12	14
Overall Study Randomized but not treated	9	8
Overall Study Other	4	5

Baseline Characteristics

Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Axitinib + Gemcitabine n=314 Participants Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=316 Participants Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Total n=630 Participants Total of all reporting groups
Age, Customized Less than 65 years	203 Participants n=5 Participants	179 Participants n=7 Participants	382 Participants n=5 Participants
Age, Customized Greater than or equal to 65 years	111 Participants n=5 Participants	137 Participants n=7 Participants	248 Participants n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	128 Participants n=7 Participants	251 Participants n=5 Participants
Sex: Female, Male Male	191 Participants n=5 Participants	188 Participants n=7 Participants	379 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline until death or at least 1 year after the randomization of last participant

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 + Gemcitabine n=314 Participants Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=316 Participants Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Overall Survival (OS)	36.9 Weeks Interval 30.1 to 41.1	35.8 Weeks Interval 30.0 to 44.8

SECONDARY outcome

Timeframe: Baseline until disease progression or at least 1 year after the randomization of last participant

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 weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. 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").

Outcome measures

Outcome measures
Measure	Axitinib + Gemcitabine n=314 Participants Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=316 Participants Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Progression Free Survival (PFS)	19.1 Weeks Interval 17.1 to 24.4	18.9 Weeks Interval 16.2 to 22.6

SECONDARY outcome

Timeframe: Baseline, every 8 weeks until tumor progression or death

Percentage of participants with 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 was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

Outcome measures

Outcome measures
Measure	Axitinib + Gemcitabine n=314 Participants Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=316 Participants Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Percentage of Participants With Objective Response (OR)	4.9 Percentage of participants Interval 2.5 to 8.3	1.6 Percentage of participants Interval 0.4 to 4.0

SECONDARY outcome

Timeframe: Baseline until death or at least 1 year after the randomization of last participant

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

Time in weeks from the first documentation of objective tumor response 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 cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.

Outcome measures

Outcome measures
Measure	Axitinib + Gemcitabine n=12 Participants Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=4 Participants Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Duration of Response (DR)	33.1 Weeks Interval 16.1 to 33.1	NA Weeks Median duration of response for placebo+gemcitabine arm did not reach at the time of data cut-off.

SECONDARY outcome

Timeframe: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, 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. Change from baseline=Cycle/Day score minus baseline score.

Outcome measures

Outcome measures
Measure	Axitinib + Gemcitabine n=314 Participants Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=316 Participants Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C8 D1 (n=17, 17)	-8.8 Units on a scale Standard Deviation 22.15	-2.9 Units on a scale Standard Deviation 23.74
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C10 D1 (n=3, 4)	-11.1 Units on a scale Standard Deviation 50.92	0.0 Units on a scale Standard Deviation 27.19
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL: Change at C10 D1 (n=3, 4)	22.3 Units on a scale Standard Deviation 19.28	-0.0 Units on a scale Standard Deviation 32.59
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C6 D1 (n=60, 57)	5.0 Units on a scale Standard Deviation 21.31	0.0 Units on a scale Standard Deviation 21.22
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C7 D1 (n=38, 36)	1.8 Units on a scale Standard Deviation 20.61	2.2 Units on a scale Standard Deviation 19.12
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C8 D1 (n=17, 20)	7.2 Units on a scale Standard Deviation 22.89	4.4 Units on a scale Standard Deviation 22.05
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C9 D1 (n=9, 9)	-6.2 Units on a scale Standard Deviation 21.63	14.8 Units on a scale Standard Deviation 24.21
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C10 D1 (n=3, 4)	-11.1 Units on a scale Standard Deviation 19.28	-5.5 Units on a scale Standard Deviation 27.98
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	11.1 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C6 D1 (n=60, 59)	6.9 Units on a scale Standard Deviation 22.61	2.8 Units on a scale Standard Deviation 20.33
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Baseline (n=295, 289)	77.445 Units on a scale Standard Deviation 20.3052	78.546 Units on a scale Standard Deviation 18.9192
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C2 D1 (n=233, 233)	-2.713 Units on a scale Standard Deviation 16.7682	-3.261 Units on a scale Standard Deviation 15.0742
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C3 D1 (n=173, 179)	-5.897 Units on a scale Standard Deviation 19.3522	-1.565 Units on a scale Standard Deviation 16.2738
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C4 D1 (n=134, 133)	-5.671 Units on a scale Standard Deviation 18.8623	-1.453 Units on a scale Standard Deviation 17.1209
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C5 D1 (n=96, 82)	-2.498 Units on a scale Standard Deviation 21.8687	-0.076 Units on a scale Standard Deviation 16.9709
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C6 D1 (n=59, 58)	-5.193 Units on a scale Standard Deviation 19.6995	-1.719 Units on a scale Standard Deviation 15.5260
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C7 D1 (n=38, 37)	-1.924 Units on a scale Standard Deviation 14.2726	0.011 Units on a scale Standard Deviation 18.9261
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C8 D1 (n=15, 21)	-4.000 Units on a scale Standard Deviation 16.8759	0.014 Units on a scale Standard Deviation 13.8428
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C9 D1 (n=9, 9)	0.033 Units on a scale Standard Deviation 15.2534	-12.578 Units on a scale Standard Deviation 20.9490
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C10 D1 (n=3, 4)	6.667 Units on a scale Standard Deviation 17.5754	-1.675 Units on a scale Standard Deviation 22.0563
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C11 D1 (n=1, 1)	0.000 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-6.600 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C12 D1 (n=1, 0)	0.000 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning: Change at C13 D1 (n=1, 0)	0.000 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Physical functioning:Change at followup (n=67, 70)	-17.713 Units on a scale Standard Deviation 23.8263	-11.523 Units on a scale Standard Deviation 21.0513
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Baseline (n=297, 295)	66.3 Units on a scale Standard Deviation 30.09	68.1 Units on a scale Standard Deviation 30.72
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C2 D1 (n=239, 242)	-2.2 Units on a scale Standard Deviation 30.95	-2.8 Units on a scale Standard Deviation 25.75
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C3 D1 (n=177, 185)	-4.6 Units on a scale Standard Deviation 32.65	1.5 Units on a scale Standard Deviation 26.90
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C4 D1 (n=135, 136)	-4.3 Units on a scale Standard Deviation 32.13	1.2 Units on a scale Standard Deviation 27.18
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C5 D1 (n=99, 81)	-0.5 Units on a scale Standard Deviation 34.95	-2.7 Units on a scale Standard Deviation 29.63
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C6 D1 (n=60, 58)	-4.4 Units on a scale Standard Deviation 29.25	-2.3 Units on a scale Standard Deviation 24.27
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C7 D1 (n=38, 37)	-3.1 Units on a scale Standard Deviation 25.07	-1.3 Units on a scale Standard Deviation 26.75
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C8 D1 (n=16, 21)	-6.2 Units on a scale Standard Deviation 20.05	0.0 Units on a scale Standard Deviation 31.63
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C9 D1 (n=9, 9)	1.9 Units on a scale Standard Deviation 28.21	-20.4 Units on a scale Standard Deviation 33.11
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C10 D1 (n=3, 4)	5.6 Units on a scale Standard Deviation 9.64	-4.2 Units on a scale Standard Deviation 28.46
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-50.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Role functioning: Change at follow-up (n=66, 72)	-20.0 Units on a scale Standard Deviation 31.52	-14.1 Units on a scale Standard Deviation 32.34
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Emotional functioning (EF): Baseline (n=294, 287)	70.8 Units on a scale Standard Deviation 22.01	71.7 Units on a scale Standard Deviation 22.47
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C2 D1 (n=233, 229)	5.0 Units on a scale Standard Deviation 21.48	5.0 Units on a scale Standard Deviation 18.92
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C3 D1 (n=170, 180)	3.7 Units on a scale Standard Deviation 20.19	3.4 Units on a scale Standard Deviation 18.95
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C4 D1 (n=134, 131)	3.0 Units on a scale Standard Deviation 22.54	5.2 Units on a scale Standard Deviation 21.12
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C5 D1 (n=96, 80)	4.3 Units on a scale Standard Deviation 21.09	5.9 Units on a scale Standard Deviation 17.24
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C6 D1 (n=60, 56)	4.0 Units on a scale Standard Deviation 19.31	6.7 Units on a scale Standard Deviation 17.43
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C7 D1 (n=37, 34)	0.0 Units on a scale Standard Deviation 18.84	3.2 Units on a scale Standard Deviation 16.28
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C8 D1 (n=17, 19)	-2.9 Units on a scale Standard Deviation 22.05	5.3 Units on a scale Standard Deviation 14.74
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C9 D1 (n=9, 9)	3.7 Units on a scale Standard Deviation 16.72	-4.6 Units on a scale Standard Deviation 15.07
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C10 D1 (n=3, 4)	13.9 Units on a scale Standard Deviation 12.73	2.1 Units on a scale Standard Deviation 18.50
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-16.6 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score EF: Change at follow-up (n=65, 71)	-7.3 Units on a scale Standard Deviation 23.51	-2.7 Units on a scale Standard Deviation 23.14
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Cognitive Functioning (CF): Baseline (n=293, 288)	78.7 Units on a scale Standard Deviation 22.26	80.9 Units on a scale Standard Deviation 21.50
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C2 D1 (n=234, 234)	-1.1 Units on a scale Standard Deviation 19.86	-0.3 Units on a scale Standard Deviation 17.74
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C3 D1 (n=172, 179)	-2.1 Units on a scale Standard Deviation 20.43	-0.9 Units on a scale Standard Deviation 18.67
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C4 D1 (n=134, 134)	-4.2 Units on a scale Standard Deviation 19.98	2.0 Units on a scale Standard Deviation 18.62
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C5 D1 (n=97, 80)	-1.4 Units on a scale Standard Deviation 20.21	1.7 Units on a scale Standard Deviation 18.86
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C6 D1 (n=60, 56)	-3.1 Units on a scale Standard Deviation 19.27	-4.5 Units on a scale Standard Deviation 19.97
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C7 D1 (n=38, 34)	-4.4 Units on a scale Standard Deviation 18.45	0.5 Units on a scale Standard Deviation 14.50
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C9 D1 (n=9, 9)	-0.0 Units on a scale Standard Deviation 25.03	-1.8 Units on a scale Standard Deviation 24.22
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C10 D1 (n=3, 4)	-5.6 Units on a scale Standard Deviation 9.64	8.3 Units on a scale Standard Deviation 28.88
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score CF: Change at follow-up (n=65, 71)	-12.6 Units on a scale Standard Deviation 25.01	-7.5 Units on a scale Standard Deviation 25.47
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Baseline (n=289, 286)	68.9 Units on a scale Standard Deviation 27.98	69.7 Units on a scale Standard Deviation 28.83
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C2 D1 (n=232, 230)	1.3 Units on a scale Standard Deviation 24.73	0.9 Units on a scale Standard Deviation 26.35
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C3 D1 (n=169, 178)	-1.3 Units on a scale Standard Deviation 29.38	3.2 Units on a scale Standard Deviation 27.31
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C4 D1 (n=132, 134)	0.1 Units on a scale Standard Deviation 25.51	0.6 Units on a scale Standard Deviation 26.83
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C5 D1 (n=95, 80)	2.1 Units on a scale Standard Deviation 27.31	0.8 Units on a scale Standard Deviation 27.93
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C6 D1 (n=58, 56)	-4.9 Units on a scale Standard Deviation 28.79	1.5 Units on a scale Standard Deviation 29.52
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C7 D1 (n=37, 35)	-5.4 Units on a scale Standard Deviation 20.05	2.4 Units on a scale Standard Deviation 29.47
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C8 D1 (n=17, 19)	4.9 Units on a scale Standard Deviation 29.91	-1.7 Units on a scale Standard Deviation 27.72
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C9 D1 (n=9, 9)	-0.0 Units on a scale Standard Deviation 32.29	-1.8 Units on a scale Standard Deviation 28.20
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C10 D1 (n=3, 4)	5.6 Units on a scale Standard Deviation 9.64	12.5 Units on a scale Standard Deviation 43.83
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	33.4 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Social functioning: Change at follow-up (n=64, 70)	-13.3 Units on a scale Standard Deviation 33.75	-2.6 Units on a scale Standard Deviation 33.88
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Baseline (n=293, 289)	41.0 Units on a scale Standard Deviation 23.87	40.1 Units on a scale Standard Deviation 25.12
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C2 D1 (n=227, 228)	2.8 Units on a scale Standard Deviation 21.15	2.1 Units on a scale Standard Deviation 20.12
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C3 D1 (n=170, 181)	3.4 Units on a scale Standard Deviation 21.94	-0.9 Units on a scale Standard Deviation 21.76
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C4 D1 (n=132, 132)	5.6 Units on a scale Standard Deviation 23.97	-1.1 Units on a scale Standard Deviation 22.77
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at C5 D1 (n=97, 80)	-0.0 Units on a scale Standard Deviation 24.39	1.1 Units on a scale Standard Deviation 21.92
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Fatigue: Change at follow-up (n=63, 71)	13.1 Units on a scale Standard Deviation 25.93	12.1 Units on a scale Standard Deviation 25.95
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Baseline (n=295, 294)	12.9 Units on a scale Standard Deviation 19.19	13.1 Units on a scale Standard Deviation 19.75
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C2 D1 (n=238, 239)	3.7 Units on a scale Standard Deviation 20.69	2.9 Units on a scale Standard Deviation 22.93
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C3 D1 (n=176, 185)	1.9 Units on a scale Standard Deviation 20.38	-0.4 Units on a scale Standard Deviation 19.54
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C4 D1 (n=133, 135)	3.5 Units on a scale Standard Deviation 20.82	0.4 Units on a scale Standard Deviation 19.68
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C5 D1 (n=98, 81)	4.6 Units on a scale Standard Deviation 22.16	1.0 Units on a scale Standard Deviation 18.88
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C7 D1 (n=38, 37)	1.3 Units on a scale Standard Deviation 19.52	2.7 Units on a scale Standard Deviation 20.24
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C8 D1 (n=17, 21)	-4.9 Units on a scale Standard Deviation 18.41	0.8 Units on a scale Standard Deviation 22.66
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C9 D1 (n=9, 9)	-13.0 Units on a scale Standard Deviation 32.02	-5.6 Units on a scale Standard Deviation 18.64
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C10 D1 (n=3, 4)	-11.1 Units on a scale Standard Deviation 19.23	8.3 Units on a scale Standard Deviation 9.58
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Nausea and vomiting: Change at followup (n=68, 73)	9.8 Units on a scale Standard Deviation 25.63	7.5 Units on a scale Standard Deviation 22.40
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Baseline (n=291, 291)	40.7 Units on a scale Standard Deviation 30.16	36.9 Units on a scale Standard Deviation 29.57
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C2 D1 (n=231, 234)	-10.1 Units on a scale Standard Deviation 29.47	-7.9 Units on a scale Standard Deviation 25.28
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C3 D1 (n=169, 181)	-13.6 Units on a scale Standard Deviation 29.81	-11.2 Units on a scale Standard Deviation 26.63
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C4 D1 (n=131, 135)	-12.2 Units on a scale Standard Deviation 32.48	-7.8 Units on a scale Standard Deviation 27.14
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C5 D1 (n=97, 80)	-10.5 Units on a scale Standard Deviation 32.75	-6.9 Units on a scale Standard Deviation 26.21
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C6 D1 (n=59, 58)	-11.9 Units on a scale Standard Deviation 27.51	-7.5 Units on a scale Standard Deviation 29.48
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C7 D1 (n=38, 35)	-14.0 Units on a scale Standard Deviation 27.81	-9.5 Units on a scale Standard Deviation 24.67
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C8 D1 (n=17, 20)	-9.8 Units on a scale Standard Deviation 26.39	-6.7 Units on a scale Standard Deviation 29.32
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C9 D1 (n=9, 9)	-22.2 Units on a scale Standard Deviation 43.29	-5.6 Units on a scale Standard Deviation 39.08
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C10 D1 (n=3, 4)	-33.3 Units on a scale Standard Deviation 33.30	-4.2 Units on a scale Standard Deviation 45.88
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-33.3 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Pain: Change at follow-up (n=66, 72)	3.3 Units on a scale Standard Deviation 37.01	3.5 Units on a scale Standard Deviation 31.14
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Baseline (n=295, 295)	16.1 Units on a scale Standard Deviation 22.30	14.8 Units on a scale Standard Deviation 23.55
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C2 D1 (n=238, 240)	5.5 Units on a scale Standard Deviation 23.58	2.1 Units on a scale Standard Deviation 20.91
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C3 D1 (n=175, 186)	5.7 Units on a scale Standard Deviation 26.84	3.9 Units on a scale Standard Deviation 24.67
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C4 D1 (n=135, 135)	7.7 Units on a scale Standard Deviation 26.99	4.4 Units on a scale Standard Deviation 21.08
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C5 D1 (n=98, 82)	4.4 Units on a scale Standard Deviation 26.05	2.8 Units on a scale Standard Deviation 18.29
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C6 D1 (n=60, 59)	9.4 Units on a scale Standard Deviation 26.09	-0.0 Units on a scale Standard Deviation 16.37
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C7 D1 (n=37, 37)	6.3 Units on a scale Standard Deviation 24.63	5.4 Units on a scale Standard Deviation 20.05
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C8 D1 (n=16, 21)	4.2 Units on a scale Standard Deviation 20.62	12.7 Units on a scale Standard Deviation 24.66
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C9 D1 (n=9, 9)	11.1 Units on a scale Standard Deviation 47.14	14.8 Units on a scale Standard Deviation 29.39
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Dyspnoea: Change at follow-up (n=68, 73)	13.2 Units on a scale Standard Deviation 28.30	8.7 Units on a scale Standard Deviation 24.23
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Baseline (n=297, 295)	36.8 Units on a scale Standard Deviation 31.95	32.2 Units on a scale Standard Deviation 32.17
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C2 D1 (n=240, 241)	-13.6 Units on a scale Standard Deviation 33.55	-7.3 Units on a scale Standard Deviation 33.16
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C3 D1 (n=178, 185)	-13.5 Units on a scale Standard Deviation 33.33	-8.7 Units on a scale Standard Deviation 33.30
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C4 D1 (n=134, 134)	-12.7 Units on a scale Standard Deviation 38.52	-11.2 Units on a scale Standard Deviation 27.41
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C5 D1 (n=99, 82)	-14.5 Units on a scale Standard Deviation 33.05	-7.3 Units on a scale Standard Deviation 28.70
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C6 D1 (n=60, 59)	-8.3 Units on a scale Standard Deviation 30.46	-2.3 Units on a scale Standard Deviation 30.86
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C7 D1 (n=37, 37)	-11.7 Units on a scale Standard Deviation 36.19	-2.7 Units on a scale Standard Deviation 19.84
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C8 D1 (n=17, 21)	5.9 Units on a scale Standard Deviation 35.82	-3.2 Units on a scale Standard Deviation 20.82
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C9 D1 (n=9, 9)	-14.8 Units on a scale Standard Deviation 24.23	-0.0 Units on a scale Standard Deviation 23.56
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C10 D1 (n=3, 4)	11.1 Units on a scale Standard Deviation 19.23	-0.0 Units on a scale Standard Deviation 27.23
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	33.3 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Insomnia: Change at follow-up (n=68, 73)	1.5 Units on a scale Standard Deviation 36.63	1.4 Units on a scale Standard Deviation 28.02
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Baseline (n=297, 295)	39.6 Units on a scale Standard Deviation 35.49	37.5 Units on a scale Standard Deviation 33.36
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C2 D1 (n=240, 240)	-2.1 Units on a scale Standard Deviation 34.24	-2.6 Units on a scale Standard Deviation 27.91
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C3 D1 (n=178, 186)	-1.3 Units on a scale Standard Deviation 31.57	-5.9 Units on a scale Standard Deviation 31.50
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C4 D1 (n=135, 135)	0.0 Units on a scale Standard Deviation 35.27	-6.7 Units on a scale Standard Deviation 29.88
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C5 D1 (n=99, 82)	1.7 Units on a scale Standard Deviation 35.76	-4.5 Units on a scale Standard Deviation 30.44
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C6 D1 (n=60, 59)	2.8 Units on a scale Standard Deviation 33.22	-4.5 Units on a scale Standard Deviation 29.34
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C7 D1 (n=38, 37)	0.9 Units on a scale Standard Deviation 35.92	-7.2 Units on a scale Standard Deviation 27.37
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C8 D1 (n=17, 20)	7.8 Units on a scale Standard Deviation 25.07	-1.7 Units on a scale Standard Deviation 29.57
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C9 D1 (n=9, 9)	-14.8 Units on a scale Standard Deviation 29.41	-7.4 Units on a scale Standard Deviation 36.44
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C10 D1 (n=3, 4)	-22.2 Units on a scale Standard Deviation 19.23	0.0 Units on a scale Standard Deviation 38.48
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	33.3 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Loss of appetite: Change at follow-up (n=67, 73)	7.0 Units on a scale Standard Deviation 39.17	7.8 Units on a scale Standard Deviation 36.24
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Baseline (n=293, 289)	30.7 Units on a scale Standard Deviation 32.13	29.6 Units on a scale Standard Deviation 32.66
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C2 D1 (n=234, 235)	-4.8 Units on a scale Standard Deviation 32.18	-2.8 Units on a scale Standard Deviation 33.21
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C3 D1 (n =173, 181)	-7.3 Units on a scale Standard Deviation 32.12	-6.1 Units on a scale Standard Deviation 36.43
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C4 D1 (n=134, 135)	-6.5 Units on a scale Standard Deviation 35.99	-10.6 Units on a scale Standard Deviation 36.80
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C5 D1 (n=97, 80)	-11.0 Units on a scale Standard Deviation 33.59	-8.7 Units on a scale Standard Deviation 29.88
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C6 D1 (n=60, 58)	-5.6 Units on a scale Standard Deviation 37.42	-9.8 Units on a scale Standard Deviation 32.45
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C7 D1 (n=38, 36)	-2.6 Units on a scale Standard Deviation 31.37	-13.0 Units on a scale Standard Deviation 32.15
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C8 D1 (n=17, 20)	0.0 Units on a scale Standard Deviation 28.87	-16.7 Units on a scale Standard Deviation 39.74
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C9 D1 (n=9, 9)	-18.5 Units on a scale Standard Deviation 33.79	-29.6 Units on a scale Standard Deviation 35.14
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C10 D1 (n=3, 4)	-11.1 Units on a scale Standard Deviation 19.23	-50.0 Units on a scale Standard Deviation 43.04
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-66.7 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Constipation: Change at follow-up (n=66, 71)	5.1 Units on a scale Standard Deviation 42.27	-6.1 Units on a scale Standard Deviation 35.77
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Baseline (n=294, 290)	14.3 Units on a scale Standard Deviation 21.68	13.7 Units on a scale Standard Deviation 24.19
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C2 D1 (n=235, 235)	1.7 Units on a scale Standard Deviation 25.73	0.3 Units on a scale Standard Deviation 21.78
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C3 D1 (n=173, 182)	9.4 Units on a scale Standard Deviation 28.66	0.2 Units on a scale Standard Deviation 23.10
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C4 D1 (n=134, 136)	7.7 Units on a scale Standard Deviation 28.00	-1.5 Units on a scale Standard Deviation 22.53
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C5 D1 (n=96, 81)	11.8 Units on a scale Standard Deviation 27.35	1.2 Units on a scale Standard Deviation 27.10
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C6 D1 (n=60, 58)	20.0 Units on a scale Standard Deviation 33.72	1.7 Units on a scale Standard Deviation 28.22
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C7 D1 (n=38, 36)	14.9 Units on a scale Standard Deviation 32.60	2.8 Units on a scale Standard Deviation 23.05
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C8 D1 (n=17, 20)	25.5 Units on a scale Standard Deviation 38.24	1.7 Units on a scale Standard Deviation 27.52
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C9 D1 (n=9, 9)	37.0 Units on a scale Standard Deviation 45.47	22.2 Units on a scale Standard Deviation 33.35
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C10 D1 (n=3, 4)	22.2 Units on a scale Standard Deviation 50.91	16.7 Units on a scale Standard Deviation 19.23
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Diarrhoea: Change at follow-up (n=66, 71)	2.5 Units on a scale Standard Deviation 29.41	2.8 Units on a scale Standard Deviation 25.03
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score Financial difficulties (FD): Baseline (n=292, 285)	24.7 Units on a scale Standard Deviation 30.41	23.0 Units on a scale Standard Deviation 30.83
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD:Change at C2 D1 (n=233, 228)	-3.1 Units on a scale Standard Deviation 22.95	-4.5 Units on a scale Standard Deviation 23.29
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at C3 D1 (n=171, 176)	-7.2 Units on a scale Standard Deviation 26.94	-3.4 Units on a scale Standard Deviation 23.39
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at C4 D1 (n=133, 133)	-5.5 Units on a scale Standard Deviation 26.33	-3.3 Units on a scale Standard Deviation 23.52
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at C5 D1 (n=96, 80)	-4.9 Units on a scale Standard Deviation 21.62	1.3 Units on a scale Standard Deviation 25.68
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at C6 D1 (n=60, 56)	-3.9 Units on a scale Standard Deviation 24.61	-1.8 Units on a scale Standard Deviation 28.02
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at C7 D1 (n=37, 34)	-2.7 Units on a scale Standard Deviation 24.06	-3.9 Units on a scale Standard Deviation 32.60
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at C8 D1 (n=17, 17)	2.0 Units on a scale Standard Deviation 14.28	2.0 Units on a scale Standard Deviation 34.31
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at C9 D1 (n=9, 9)	7.4 Units on a scale Standard Deviation 22.23	3.7 Units on a scale Standard Deviation 45.49
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at C10 D1 (n=3, 4)	0.0 Units on a scale Standard Deviation 0.00	25.0 Units on a scale Standard Deviation 41.94
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	66.7 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score FD: Change at follow-up (n=65, 70)	6.7 Units on a scale Standard Deviation 29.59	-0.5 Units on a scale Standard Deviation 21.61
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/Quality of Life (QoL): Baseline (n=292, 288)	54.2 Units on a scale Standard Deviation 22.34	57.1 Units on a scale Standard Deviation 23.14
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL:Change at C2 D1 (n=234, 233)	2.2 Units on a scale Standard Deviation 23.36	1.9 Units on a scale Standard Deviation 22.39
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL:Change at C3 D1 (n=168, 180)	-0.3 Units on a scale Standard Deviation 25.42	5.7 Units on a scale Standard Deviation 21.45
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL:Change at C4 D1(n=132, 132)	0.1 Units on a scale Standard Deviation 23.79	2.8 Units on a scale Standard Deviation 21.54
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL:Change at C5 D1 (n=96, 81)	1.5 Units on a scale Standard Deviation 22.63	2.7 Units on a scale Standard Deviation 18.35
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL:Change at C6 D1 (n=60, 57)	0.8 Units on a scale Standard Deviation 21.41	3.2 Units on a scale Standard Deviation 23.40
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL:Change at C7 D1 (n=38, 35)	2.6 Units on a scale Standard Deviation 23.01	2.1 Units on a scale Standard Deviation 22.35
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL:Change at C8 D1 (n=17, 19)	-1.0 Units on a scale Standard Deviation 23.73	1.3 Units on a scale Standard Deviation 23.76
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL:Change at C9 D1 (n=9, 9)	7.4 Units on a scale Standard Deviation 16.89	-8.3 Units on a scale Standard Deviation 20.39
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score GHS/QoL:Change at follow-up (n=65, 71)	-9.1 Units on a scale Standard Deviation 26.06	-6.7 Units on a scale Standard Deviation 24.50

SECONDARY outcome

Timeframe: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.

Outcome measures

Outcome measures
Measure	Axitinib + Gemcitabine n=314 Participants Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=316 Participants Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C3 D1 (n=143, 156)	6.2 Units on a scale Standard Deviation 26.37	2.5 Units on a scale Standard Deviation 24.67
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Baseline (n=246, 250)	41.6 Units on a scale Standard Deviation 27.16	40.0 Units on a scale Standard Deviation 25.54
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C2 D1 (n=191, 197)	-10.9 Units on a scale Standard Deviation 24.38	-10.1 Units on a scale Standard Deviation 22.93
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C3 D1 (n=141, 153)	-16.3 Units on a scale Standard Deviation 25.51	-11.2 Units on a scale Standard Deviation 24.92
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C4 D1 (n=99, 111)	-13.2 Units on a scale Standard Deviation 28.70	-11.4 Units on a scale Standard Deviation 26.16
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C5 D1 (n=67, 64)	-15.8 Units on a scale Standard Deviation 28.06	-13.0 Units on a scale Standard Deviation 23.85
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C6 D1 (n=41, 43)	-15.9 Units on a scale Standard Deviation 25.47	-13.0 Units on a scale Standard Deviation 24.62
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C7 D1 (n=25, 25)	-15.3 Units on a scale Standard Deviation 28.02	-15.0 Units on a scale Standard Deviation 25.69
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C8 D1 (n=11, 11)	-7.6 Units on a scale Standard Deviation 27.76	-9.8 Units on a scale Standard Deviation 30.01
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C9 D1 (n=6, 6)	-29.2 Units on a scale Standard Deviation 31.06	0.0 Units on a scale Standard Deviation 15.81
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C10 D1 (n=2, 3)	-20.9 Units on a scale Standard Deviation 29.49	5.6 Units on a scale Standard Deviation 26.79
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Pancreatic Pain: Change at follow-up (n=47, 46)	-3.5 Units on a scale Standard Deviation 29.59	-3.6 Units on a scale Standard Deviation 28.80
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Baseline (n=245, 254)	10.2 Units on a scale Standard Deviation 17.21	10.8 Units on a scale Standard Deviation 17.59
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C2 D1 (n=193, 205)	0.3 Units on a scale Standard Deviation 18.24	-2.0 Units on a scale Standard Deviation 17.67
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C3 D1 (n=142, 157)	-1.4 Units on a scale Standard Deviation 16.78	-2.5 Units on a scale Standard Deviation 18.60
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C4 D1 (n=99, 112)	-2.5 Units on a scale Standard Deviation 18.34	-2.4 Units on a scale Standard Deviation 18.15
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C5 D1 (n=68, 64)	1.0 Units on a scale Standard Deviation 17.49	-2.6 Units on a scale Standard Deviation 16.60
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C6 D1 (n=40, 41)	0.4 Units on a scale Standard Deviation 15.34	-3.2 Units on a scale Standard Deviation 17.57
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C7 D1 (n=25, 24)	-0.7 Units on a scale Standard Deviation 16.30	-4.9 Units on a scale Standard Deviation 18.70
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C8 D1 (n=11, 12)	-4.5 Units on a scale Standard Deviation 13.10	-4.2 Units on a scale Standard Deviation 12.57
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C9 D1 (n=6, 5)	-11.1 Units on a scale Standard Deviation 13.60	-13.3 Units on a scale Standard Deviation 13.94
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C10 D1 (n=2, 2)	-16.7 Units on a scale Standard Deviation 23.55	-8.4 Units on a scale Standard Deviation 11.81
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Hepatic: Change at follow-up (n=47, 48)	2.8 Units on a scale Standard Deviation 23.38	-1.4 Units on a scale Standard Deviation 23.27
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Baseline (n=250, 255)	34.3 Units on a scale Standard Deviation 30.78	33.9 Units on a scale Standard Deviation 31.05
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C2 D1 (n=195, 206)	2.8 Units on a scale Standard Deviation 29.15	0.6 Units on a scale Standard Deviation 26.72
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C3 D1 (n=144, 159)	-1.2 Units on a scale Standard Deviation 31.58	-4.3 Units on a scale Standard Deviation 32.97
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C4 D1 (n=100, 114)	0.5 Units on a scale Standard Deviation 30.57	-4.5 Units on a scale Standard Deviation 30.90
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C5 D1 (n=69, 65)	1.4 Units on a scale Standard Deviation 32.80	-3.6 Units on a scale Standard Deviation 36.14
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C6 D1 (n=40, 45)	3.3 Units on a scale Standard Deviation 30.23	0.4 Units on a scale Standard Deviation 35.97
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C7 D1 (n=25, 26)	-6.0 Units on a scale Standard Deviation 30.76	-1.3 Units on a scale Standard Deviation 24.91
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C8 D1 (n=11, 14)	4.5 Units on a scale Standard Deviation 42.87	17.9 Units on a scale Standard Deviation 23.07
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C9 D1 (n=6, 6)	-13.9 Units on a scale Standard Deviation 46.44	22.2 Units on a scale Standard Deviation 25.10
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C10 D1 (n=2, 3)	-33.3 Units on a scale Standard Deviation 47.09	11.1 Units on a scale Standard Deviation 19.23
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	66.7 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Digestive Symptom: Change at follow-up (n=47, 47)	6.0 Units on a scale Standard Deviation 38.14	2.8 Units on a scale Standard Deviation 35.83
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Baseline (n=217, 232)	56.8 Units on a scale Standard Deviation 36.90	55.5 Units on a scale Standard Deviation 38.04
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at C2 D1 (n=157, 181)	-0.5 Units on a scale Standard Deviation 37.81	-4.0 Units on a scale Standard Deviation 33.17
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at C3 D1 (n=118, 139)	-4.9 Units on a scale Standard Deviation 37.70	-3.0 Units on a scale Standard Deviation 32.25
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at C4 D1 (n=85, 100)	-4.1 Units on a scale Standard Deviation 38.40	3.0 Units on a scale Standard Deviation 29.90
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at C5 D1 (n=55, 58)	-1.5 Units on a scale Standard Deviation 34.30	-5.2 Units on a scale Standard Deviation 29.32
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at C6 D1 (n=30, 38)	12.2 Units on a scale Standard Deviation 29.67	-11.4 Units on a scale Standard Deviation 33.58
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at C7 D1 (n=19, 21)	4.4 Units on a scale Standard Deviation 35.06	-7.1 Units on a scale Standard Deviation 31.88
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at C8 D1 (n=8, 10)	12.5 Units on a scale Standard Deviation 24.82	-15.0 Units on a scale Standard Deviation 26.59
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at C9 D1 (n=4, 6)	25.0 Units on a scale Standard Deviation 31.93	0.0 Units on a scale Standard Deviation 23.55
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at C10 D1 (n=0, 3)	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.	11.1 Units on a scale Standard Deviation 19.28
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at C11 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.	33.3 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at C12 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.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at 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.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Sexuality: Change at follow-up (n=36, 41)	-3.2 Units on a scale Standard Deviation 41.18	-23.2 Units on a scale Standard Deviation 42.31
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Health care(HC)satisfaction: Baseline (n=241, 247)	78.0 Units on a scale Standard Deviation 26.66	78.3 Units on a scale Standard Deviation 23.94
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C2 D1 (n=182, 194)	0.1 Units on a scale Standard Deviation 27.73	1.8 Units on a scale Standard Deviation 24.13
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C3 D1 (n=135, 149)	0.2 Units on a scale Standard Deviation 31.54	5.4 Units on a scale Standard Deviation 24.98
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C4 D1 (n=97, 108)	-4.3 Units on a scale Standard Deviation 34.88	-0.2 Units on a scale Standard Deviation 26.52
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C5 D1 (n=66, 59)	1.0 Units on a scale Standard Deviation 29.66	0.8 Units on a scale Standard Deviation 28.77
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C6 D1 (n=40, 39)	-6.7 Units on a scale Standard Deviation 26.91	-0.4 Units on a scale Standard Deviation 27.96
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C7 D1 (n=27, 20)	-4.3 Units on a scale Standard Deviation 22.44	6.7 Units on a scale Standard Deviation 33.06
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C8 D1 (n=12, 11)	-16.7 Units on a scale Standard Deviation 52.23	7.6 Units on a scale Standard Deviation 20.22
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C9 D1 (n=6, 6)	16.7 Units on a scale Standard Deviation 47.14	-5.6 Units on a scale Standard Deviation 17.23
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C10 D1 (n=2, 3)	-33.3 Units on a scale Standard Deviation 0.0	5.6 Units on a scale Standard Deviation 9.64
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C11 D1 (n=1, 1)	-33.3 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C12 D1 (n=1, 0)	-33.3 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at C13 D1(n=1, 0)	-33.3 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score HC satisfaction: Change at follow-up (n=46, 45)	-0.7 Units on a scale Standard Deviation 29.39	-2.2 Units on a scale Standard Deviation 31.50
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Baseline (n=249, 251)	28.5 Units on a scale Standard Deviation 28.46	28.8 Units on a scale Standard Deviation 28.67
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C2 D1 (n=189, 200)	4.9 Units on a scale Standard Deviation 23.11	-0.2 Units on a scale Standard Deviation 26.78
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C3 D1 (n=142, 149)	4.9 Units on a scale Standard Deviation 22.26	2.1 Units on a scale Standard Deviation 26.16
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C4 D1 (n=97, 111)	6.7 Units on a scale Standard Deviation 26.20	0.9 Units on a scale Standard Deviation 26.48
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C5 D1 (n=70, 62)	4.8 Units on a scale Standard Deviation 26.33	-0.3 Units on a scale Standard Deviation 25.87
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C6 D1 (n=40, 42)	8.3 Units on a scale Standard Deviation 28.24	-0.8 Units on a scale Standard Deviation 33.92
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C7 D1 (n=25, 24)	12.0 Units on a scale Standard Deviation 27.43	-5.6 Units on a scale Standard Deviation 33.22
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C8 D1 (n=11, 12)	21.2 Units on a scale Standard Deviation 42.23	11.1 Units on a scale Standard Deviation 32.04
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C9 D1 (n=6, 6)	33.3 Units on a scale Standard Deviation 52.69	8.3 Units on a scale Standard Deviation 46.87
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C10 D1 (n=2, 3)	-8.3 Units on a scale Standard Deviation 11.74	5.6 Units on a scale Standard Deviation 78.77
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-50.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Body Image: Change at follow-up (n=47, 45)	13.1 Units on a scale Standard Deviation 30.67	11.5 Units on a scale Standard Deviation 24.56
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Baseline (n=250, 255)	20.3 Units on a scale Standard Deviation 22.92	21.2 Units on a scale Standard Deviation 25.72
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C2 D1 (n=193, 204)	3.0 Units on a scale Standard Deviation 24.19	1.5 Units on a scale Standard Deviation 22.21
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C4 D1 (n=98, 114)	6.6 Units on a scale Standard Deviation 25.52	4.8 Units on a scale Standard Deviation 22.14
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C5 D1 (n=68, 63)	8.3 Units on a scale Standard Deviation 33.15	1.3 Units on a scale Standard Deviation 24.56
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C6 D1 (n=40, 43)	9.6 Units on a scale Standard Deviation 30.63	2.3 Units on a scale Standard Deviation 28.07
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C7 D1 (n=25, 25)	6.0 Units on a scale Standard Deviation 25.40	1.3 Units on a scale Standard Deviation 30.77
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C8 D1 (n=11, 13)	1.5 Units on a scale Standard Deviation 29.29	7.7 Units on a scale Standard Deviation 38.86
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C9 D1 (n=6, 6)	13.9 Units on a scale Standard Deviation 32.35	-5.6 Units on a scale Standard Deviation 51.27
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C10 D1 (n=2, 3)	-8.3 Units on a scale Standard Deviation 35.36	-16.7 Units on a scale Standard Deviation 72.62
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C11 D1 (n=1, 1)	16.7 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-100.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C12 D1 (n=1, 0)	16.7 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Altered Bowel Habit: Change at followup (n=47, 48)	6.0 Units on a scale Standard Deviation 29.36	5.9 Units on a scale Standard Deviation 21.33
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Baseline (n=250, 256)	38.7 Units on a scale Standard Deviation 32.98	32.9 Units on a scale Standard Deviation 30.61
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C2 D1 (n=197, 207)	-8.6 Units on a scale Standard Deviation 33.32	-3.4 Units on a scale Standard Deviation 29.65
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C3 D1 (n=144, 158)	-8.3 Units on a scale Standard Deviation 33.34	-5.1 Units on a scale Standard Deviation 28.70
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C4 D1 (n=101, 114)	-5.0 Units on a scale Standard Deviation 36.64	-0.3 Units on a scale Standard Deviation 26.05
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C5 D1 (n=71, 65)	-8.5 Units on a scale Standard Deviation 34.15	-0.5 Units on a scale Standard Deviation 29.17
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C6 D1 (n=42, 45)	-3.2 Units on a scale Standard Deviation 31.08	-2.2 Units on a scale Standard Deviation 32.10
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C7 D1 (n=26, 26)	-14.1 Units on a scale Standard Deviation 32.91	-12.8 Units on a scale Standard Deviation 23.25
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C8 D1 (n=11, 14)	-18.2 Units on a scale Standard Deviation 43.12	-11.9 Units on a scale Standard Deviation 28.05
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C9 D1 (n=6, 6)	-11.1 Units on a scale Standard Deviation 34.42	-16.7 Units on a scale Standard Deviation 34.95
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C10 D1 (n=2, 3)	-16.7 Units on a scale Standard Deviation 23.55	22.2 Units on a scale Standard Deviation 38.51
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	33.3 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Ascites: Change at follow-up (n=48, 48)	5.6 Units on a scale Standard Deviation 35.96	-2.1 Units on a scale Standard Deviation 26.11
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Baseline (n=252, 257)	29.4 Units on a scale Standard Deviation 30.38	24.0 Units on a scale Standard Deviation 28.55
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C2 D1 (n=198, 208)	-0.3 Units on a scale Standard Deviation 26.87	-2.4 Units on a scale Standard Deviation 24.29
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C3 D1 (n=144, 159)	0.2 Units on a scale Standard Deviation 30.16	-5.2 Units on a scale Standard Deviation 25.59
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C4 D1 (n=101, 115)	-4.0 Units on a scale Standard Deviation 24.63	-4.1 Units on a scale Standard Deviation 25.80
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C5 D1 (n=71, 65)	0.5 Units on a scale Standard Deviation 29.01	-4.6 Units on a scale Standard Deviation 22.72
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C6 D1 (n=41, 45)	1.6 Units on a scale Standard Deviation 31.58	-1.5 Units on a scale Standard Deviation 24.57
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C7 D1 (n=26, 26)	-3.8 Units on a scale Standard Deviation 19.60	-1.3 Units on a scale Standard Deviation 17.59
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C8 D1 (n=11, 14)	0.0 Units on a scale Standard Deviation 21.06	2.4 Units on a scale Standard Deviation 20.53
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C9 D1 (n=6, 6)	-5.6 Units on a scale Standard Deviation 25.07	11.1 Units on a scale Standard Deviation 27.23
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C10 D1 (n=2, 3)	-16.7 Units on a scale Standard Deviation 23.55	22.2 Units on a scale Standard Deviation 19.23
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Indigestion: Change at follow-up (n=48, 48)	7.6 Units on a scale Standard Deviation 30.94	1.4 Units on a scale Standard Deviation 30.73
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Baseline (n=249, 256)	37.9 Units on a scale Standard Deviation 32.34	34.0 Units on a scale Standard Deviation 31.31
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at C2 D1 (n=197, 206)	1.2 Units on a scale Standard Deviation 29.81	2.6 Units on a scale Standard Deviation 31.82
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at C3 D1 (n=146, 159)	3.2 Units on a scale Standard Deviation 33.07	0.2 Units on a scale Standard Deviation 34.48
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at C4 D1 (n=101, 115)	-1.3 Units on a scale Standard Deviation 33.65	2.3 Units on a scale Standard Deviation 32.07
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at C5 D1 (n=70, 65)	-1.0 Units on a scale Standard Deviation 32.60	1.0 Units on a scale Standard Deviation 31.17
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at C6 D1 (n=41, 45)	-1.6 Units on a scale Standard Deviation 26.83	-1.5 Units on a scale Standard Deviation 29.27
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at C7 D1 (n=25, 26)	-1.3 Units on a scale Standard Deviation 26.31	-3.8 Units on a scale Standard Deviation 23.71
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at C8 D1 (n=10, 14)	-10.0 Units on a scale Standard Deviation 35.34	2.4 Units on a scale Standard Deviation 27.62
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at C9 D1 (n=5, 6)	0.0 Units on a scale Standard Deviation 0.00	5.6 Units on a scale Standard Deviation 13.59
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at C10 D1 (n=1, 3)	33.3 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-11.1 Units on a scale Standard Deviation 19.23
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at C11 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at C12 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.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at 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.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Flatulence: Change at follow-up (n=48, 46)	-0.7 Units on a scale Standard Deviation 35.41	2.2 Units on a scale Standard Deviation 34.00
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Baseline (n=251, 253)	33.1 Units on a scale Standard Deviation 27.62	33.6 Units on a scale Standard Deviation 26.84
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at C2 D1 (n=197, 205)	4.2 Units on a scale Standard Deviation 24.26	0.6 Units on a scale Standard Deviation 21.63
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at C3 D1 (n=145, 157)	4.6 Units on a scale Standard Deviation 25.87	-3.3 Units on a scale Standard Deviation 21.13
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at C4 D1 (n=101, 112)	1.2 Units on a scale Standard Deviation 26.37	-6.2 Units on a scale Standard Deviation 24.82
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at C5 D1 (n=70, 64)	0.5 Units on a scale Standard Deviation 28.37	-8.3 Units on a scale Standard Deviation 24.48
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at C6 D1 (n=40, 44)	-2.1 Units on a scale Standard Deviation 24.80	-5.3 Units on a scale Standard Deviation 24.84
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at C7 D1 (n=24, 26)	-0.7 Units on a scale Standard Deviation 24.31	-5.1 Units on a scale Standard Deviation 25.27
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at C8 D1 (n=10, 14)	15.0 Units on a scale Standard Deviation 34.64	-4.7 Units on a scale Standard Deviation 21.12
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at C9 D1 (n=5, 6)	16.7 Units on a scale Standard Deviation 31.16	2.8 Units on a scale Standard Deviation 19.47
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at C10 D1 (n=1, 3)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation 28.87
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at C11 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.	-16.6 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at C12 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.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at 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.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Cachexia: Change at follow-up (n=48, 47)	8.0 Units on a scale Standard Deviation 31.69	6.4 Units on a scale Standard Deviation 30.79
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Baseline (n=209, 226)	24.9 Units on a scale Standard Deviation 21.21	27.4 Units on a scale Standard Deviation 23.08
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at C2 D1 (n=159, 181)	11.2 Units on a scale Standard Deviation 23.11	5.8 Units on a scale Standard Deviation 22.06
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at C3 D1 (n=113, 137)	13.0 Units on a scale Standard Deviation 24.67	4.7 Units on a scale Standard Deviation 22.18
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at C4 D1 (n=80, 102)	10.1 Units on a scale Standard Deviation 20.64	4.9 Units on a scale Standard Deviation 22.48
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at C5 D1 (n=54, 59)	7.4 Units on a scale Standard Deviation 25.55	3.6 Units on a scale Standard Deviation 23.84
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at C6 D1 (n=29, 40)	8.1 Units on a scale Standard Deviation 26.72	-1.4 Units on a scale Standard Deviation 25.32
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at C7 D1 (n=17, 22)	15.0 Units on a scale Standard Deviation 20.77	-1.0 Units on a scale Standard Deviation 19.38
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at C8 D1 (n=8, 11)	9.7 Units on a scale Standard Deviation 19.19	-3.0 Units on a scale Standard Deviation 22.83
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at C9 D1 (n=3, 6)	14.8 Units on a scale Standard Deviation 23.15	-1.9 Units on a scale Standard Deviation 27.60
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at C10 D1 (n=0, 3)	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.	0.0 Units on a scale Standard Deviation 40.12
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at C11 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.	-33.4 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at C12 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.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at 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.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Side Effects: Change at follow-up (n=42, 42)	18.8 Units on a scale Standard Deviation 24.37	13.2 Units on a scale Standard Deviation 27.80
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of Future Health (FH): Baseline (n=252, 250))	59.3 Units on a scale Standard Deviation 31.33	61.1 Units on a scale Standard Deviation 33.07
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C2 D1 (n=192, 201)	-3.5 Units on a scale Standard Deviation 31.82	-9.6 Units on a scale Standard Deviation 28.80
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C3 D1 (n=145, 155)	-0.9 Units on a scale Standard Deviation 34.02	-11.6 Units on a scale Standard Deviation 30.07
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C4 D1 (n=103, 113)	-4.5 Units on a scale Standard Deviation 32.70	-15.9 Units on a scale Standard Deviation 30.90
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C5 D1 (n=71, 64)	-0.5 Units on a scale Standard Deviation 31.12	-10.9 Units on a scale Standard Deviation 29.74
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C6 D1 (n=42, 44)	-4.8 Units on a scale Standard Deviation 30.86	-14.4 Units on a scale Standard Deviation 32.47
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C7 D1 (n=27, 25)	-6.2 Units on a scale Standard Deviation 22.72	-13.3 Units on a scale Standard Deviation 33.34
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C8 D1 (n=12, 12)	2.8 Units on a scale Standard Deviation 30.02	5.6 Units on a scale Standard Deviation 27.84
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C9 D1 (n=6, 6)	16.7 Units on a scale Standard Deviation 27.90	16.7 Units on a scale Standard Deviation 34.96
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C10 D1 (n=2, 3)	-16.7 Units on a scale Standard Deviation 23.62	11.1 Units on a scale Standard Deviation 50.96
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Fear of FH:Change at follow-up (n=48, 45)	5.6 Units on a scale Standard Deviation 28.63	-4.4 Units on a scale Standard Deviation 38.67
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability: Baseline (n=250, 249)	34.3 Units on a scale Standard Deviation 33.59	38.0 Units on a scale Standard Deviation 34.40
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability: Change at C2 D1 (n=192, 198)	6.1 Units on a scale Standard Deviation 38.19	-0.3 Units on a scale Standard Deviation 34.58
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability:Change at C3 D1 (n=142, 153)	3.5 Units on a scale Standard Deviation 39.65	0.4 Units on a scale Standard Deviation 36.68
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability:Change at C4 D1 (n=101, 112)	5.6 Units on a scale Standard Deviation 36.55	0.3 Units on a scale Standard Deviation 37.04
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability:Change at C5 D1 (n=70, 62)	0.9 Units on a scale Standard Deviation 34.05	-3.8 Units on a scale Standard Deviation 39.17
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability:Change at C6 D1 (n=42, 42)	4.8 Units on a scale Standard Deviation 34.99	0.8 Units on a scale Standard Deviation 46.27
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability: Change at C7 D1 (n=26, 24)	2.6 Units on a scale Standard Deviation 28.18	-7.0 Units on a scale Standard Deviation 36.76
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability: Change at C8 D1 (n=11, 11)	6.1 Units on a scale Standard Deviation 32.74	3.0 Units on a scale Standard Deviation 43.36
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability: Change at C9 D1 (n=5, 6)	0.0 Units on a scale Standard Deviation 23.55	0.0 Units on a scale Standard Deviation 55.78
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability: Change at C10 D1 (n=1, 3)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-11.1 Units on a scale Standard Deviation 69.43
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-66.7 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability: Change at C13 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score Future Plan ability: Change at followup (n=48, 45)	21.5 Units on a scale Standard Deviation 35.40	5.2 Units on a scale Standard Deviation 38.25

SECONDARY outcome

Timeframe: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.

Outcome measures

Outcome measures
Measure	Axitinib + Gemcitabine n=314 Participants Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=316 Participants Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C8 D1 (n=12, 12)	0.8 Units on a scale Standard Deviation 2.98	-0.8 Units on a scale Standard Deviation 2.53
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Baseline (n=247, 250)	3.8 Units on a scale Standard Deviation 2.84	3.7 Units on a scale Standard Deviation 2.96
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C2 D1 (n=192, 200)	-0.7 Units on a scale Standard Deviation 3.04	-0.9 Units on a scale Standard Deviation 2.84
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C3 D1 (n=138, 151)	-1.5 Units on a scale Standard Deviation 3.09	-0.9 Units on a scale Standard Deviation 2.83
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C4 D1 (n=99, 113)	-1.0 Units on a scale Standard Deviation 3.41	-0.9 Units on a scale Standard Deviation 3.09
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C5 D1 (n=69, 64)	-1.1 Units on a scale Standard Deviation 3.43	-1.2 Units on a scale Standard Deviation 3.08
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C6 D1 (n=41, 43)	-0.9 Units on a scale Standard Deviation 2.98	-1.0 Units on a scale Standard Deviation 3.17
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C7 D1 (n=25, 26)	-0.8 Units on a scale Standard Deviation 2.27	-0.9 Units on a scale Standard Deviation 3.50
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C8 D1 (n=12, 13)	0.8 Units on a scale Standard Deviation 2.56	-1.5 Units on a scale Standard Deviation 3.20
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C9 D1(n=6, 6)	-1.8 Units on a scale Standard Deviation 1.94	-1.3 Units on a scale Standard Deviation 1.51
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C10 D1 (n=2, 3)	-2.0 Units on a scale Standard Deviation 2.83	-0.3 Units on a scale Standard Deviation 2.31
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-4.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Worst Pain: Change at follow-up (n=47, 46)	0.5 Units on a scale Standard Deviation 3.08	0.0 Units on a scale Standard Deviation 3.21
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 Hours (hrs): Baseline (n=246, 248)	1.8 Units on a scale Standard Deviation 1.92	1.7 Units on a scale Standard Deviation 1.93
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C2 D1 (n=193, 197)	-0.2 Units on a scale Standard Deviation 2.21	-0.3 Units on a scale Standard Deviation 1.92
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C3 D1 (n=138, 150)	-0.6 Units on a scale Standard Deviation 2.01	-0.3 Units on a scale Standard Deviation 1.88
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C4 D1 (n=99, 112)	-0.3 Units on a scale Standard Deviation 2.15	-0.0 Units on a scale Standard Deviation 1.96
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C5 D1 (n=69, 63)	-0.3 Units on a scale Standard Deviation 2.41	-0.2 Units on a scale Standard Deviation 2.04
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C6 D1 (n=40, 43)	-0.2 Units on a scale Standard Deviation 2.07	-0.1 Units on a scale Standard Deviation 1.64
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C7 D1 (n=25, 26)	0.4 Units on a scale Standard Deviation 1.47	-0.0 Units on a scale Standard Deviation 2.46
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C8 D1 (n=12, 13)	1.3 Units on a scale Standard Deviation 2.34	-0.2 Units on a scale Standard Deviation 1.41
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C9 D1 (n=6, 6)	-0.3 Units on a scale Standard Deviation 1.37	0.2 Units on a scale Standard Deviation 1.60
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C10 D1 (n=2, 3)	-1.5 Units on a scale Standard Deviation 2.12	0.3 Units on a scale Standard Deviation 0.58
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	4.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain in Last 24 hrs: Change at followup (n=48, 45)	0.4 Units on a scale Standard Deviation 2.70	0.8 Units on a scale Standard Deviation 2.58
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Baseline (n=246, 248)	2.9 Units on a scale Standard Deviation 2.16	2.8 Units on a scale Standard Deviation 2.27
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C2 D1 (n=195, 198)	-0.5 Units on a scale Standard Deviation 2.02	-0.5 Units on a scale Standard Deviation 2.29
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C3 D1 (n=140, 149)	-0.8 Units on a scale Standard Deviation 2.48	-0.5 Units on a scale Standard Deviation 2.10
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C4 D1 (n=99, 113)	-0.7 Units on a scale Standard Deviation 2.44	-0.6 Units on a scale Standard Deviation 2.03
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C5 D1 (n=69, 63)	-0.7 Units on a scale Standard Deviation 2.48	-0.6 Units on a scale Standard Deviation 2.29
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C6 D1 (n=40, 43)	-0.5 Units on a scale Standard Deviation 2.07	-0.9 Units on a scale Standard Deviation 2.12
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C7 D1 (n=25, 26)	-0.3 Units on a scale Standard Deviation 1.46	-0.5 Units on a scale Standard Deviation 2.97
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C8 D1 (n=12, 13)	1.0 Units on a scale Standard Deviation 2.00	-1.4 Units on a scale Standard Deviation 1.94
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C9 D1 (n=6, 6)	-1.7 Units on a scale Standard Deviation 1.51	-1.7 Units on a scale Standard Deviation 1.86
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C10 D1 (n=2, 3)	-2.0 Units on a scale Standard Deviation 2.83	-1.0 Units on a scale Standard Deviation 2.65
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-3.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-2.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain on the Average: Change at followup (n=48, 45)	0.6 Units on a scale Standard Deviation 2.70	0.4 Units on a scale Standard Deviation 2.74
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Baseline (n=248, 249)	2.1 Units on a scale Standard Deviation 2.13	2.1 Units on a scale Standard Deviation 2.36
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C2 D1 (n=196, 200)	-0.4 Units on a scale Standard Deviation 2.23	-0.5 Units on a scale Standard Deviation 2.37
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C3 D1 (n=140, 150)	-0.8 Units on a scale Standard Deviation 2.31	-0.6 Units on a scale Standard Deviation 2.06
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C4 D1 (n=99, 113)	-0.6 Units on a scale Standard Deviation 2.26	-0.5 Units on a scale Standard Deviation 2.45
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C5 D1 (n=68, 63)	-0.5 Units on a scale Standard Deviation 2.76	-0.3 Units on a scale Standard Deviation 2.65
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C6 D1 (n=40, 43)	-0.5 Units on a scale Standard Deviation 1.96	-0.5 Units on a scale Standard Deviation 2.14
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C7 D1 (n=25, 26)	0.1 Units on a scale Standard Deviation 1.66	-0.2 Units on a scale Standard Deviation 3.26
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C8 D1 (n=12, 13)	1.1 Units on a scale Standard Deviation 1.93	-0.6 Units on a scale Standard Deviation 1.56
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C9 D1 (n=6, 6)	-1.5 Units on a scale Standard Deviation 1.76	-0.3 Units on a scale Standard Deviation 0.52
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C10 D1 (n=2, 3)	-2.0 Units on a scale Standard Deviation 2.83	0.7 Units on a scale Standard Deviation 1.15
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	5.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-5.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Pain Right Now: Change at follow-up (n=48, 46)	0.4 Units on a scale Standard Deviation 2.64	-0.0 Units on a scale Standard Deviation 2.67
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Treatment (Tx): Baseline (n=226, 221)	7.8 Units on a scale Standard Deviation 12.09	6.9 Units on a scale Standard Deviation 9.71
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at C2 D1 (n=164, 165)	0.6 Units on a scale Standard Deviation 13.96	0.4 Units on a scale Standard Deviation 11.48
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at C3 D1 (n=122, 124)	-2.1 Units on a scale Standard Deviation 13.10	0.1 Units on a scale Standard Deviation 9.16
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at C4 D1 (n=88, 92)	-1.7 Units on a scale Standard Deviation 13.51	-0.9 Units on a scale Standard Deviation 17.56
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at C5 D1 (n=59, 51)	-2.9 Units on a scale Standard Deviation 16.35	1.8 Units on a scale Standard Deviation 11.62
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at C6 D1 (n=34, 33)	-1.6 Units on a scale Standard Deviation 11.90	0.5 Units on a scale Standard Deviation 4.28
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at C7 D1 (n=21, 18)	1.0 Units on a scale Standard Deviation 2.78	-3.2 Units on a scale Standard Deviation 19.65
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at C8 D1 (n=10, 8)	-5.0 Units on a scale Standard Deviation 21.20	-11.6 Units on a scale Standard Deviation 28.16
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at C9 D1 (n=5, 5)	-14.0 Units on a scale Standard Deviation 28.99	-16.6 Units on a scale Standard Deviation 35.44
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at C10 D1 (n=1, 2)	6.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation 1.41
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at C11 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at C12 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.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at 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.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relief Pain Tx: Change at follow-up (n=43, 36)	0.2 Units on a scale Standard Deviation 3.82	-0.4 Units on a scale Standard Deviation 5.08
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Baseline (n=243, 243)	3.2 Units on a scale Standard Deviation 3.11	3.0 Units on a scale Standard Deviation 3.01
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C2 D1 (n=190, 193)	-0.6 Units on a scale Standard Deviation 2.96	-0.7 Units on a scale Standard Deviation 2.55
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C3 D1 (n=135, 143)	-1.1 Units on a scale Standard Deviation 3.47	-0.7 Units on a scale Standard Deviation 2.61
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C4 D1 (n=97, 109)	-0.4 Units on a scale Standard Deviation 3.10	-0.8 Units on a scale Standard Deviation 2.53
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C5 D1 (n=66, 62)	-0.8 Units on a scale Standard Deviation 3.64	-0.5 Units on a scale Standard Deviation 2.51
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C6 D1 (n=40, 41)	-0.6 Units on a scale Standard Deviation 3.82	-0.7 Units on a scale Standard Deviation 2.62
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C7 D1 (n=25, 25)	-0.5 Units on a scale Standard Deviation 2.87	-0.4 Units on a scale Standard Deviation 2.84
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C8 D1 (n=12, 12)	0.1 Units on a scale Standard Deviation 2.07	-0.8 Units on a scale Standard Deviation 2.70
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C9 D1 (n=6, 6)	-2.2 Units on a scale Standard Deviation 2.71	0.3 Units on a scale Standard Deviation 3.72
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C10 D1 (n=2, 3)	-2.5 Units on a scale Standard Deviation 3.54	3.0 Units on a scale Standard Deviation 5.29
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score General Activity: Change at follow-up (n=47, 44)	1.0 Units on a scale Standard Deviation 4.32	0.0 Units on a scale Standard Deviation 3.63
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Baseline (n=243, 241)	3.0 Units on a scale Standard Deviation 2.92	2.8 Units on a scale Standard Deviation 2.77
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C2 D1 (n=191, 191)	-0.6 Units on a scale Standard Deviation 2.74	-0.2 Units on a scale Standard Deviation 2.46
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C3 D1 (n=135, 141)	-1.0 Units on a scale Standard Deviation 3.39	-0.5 Units on a scale Standard Deviation 2.51
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C4 D1 (n=98, 106)	-0.3 Units on a scale Standard Deviation 3.22	-0.9 Units on a scale Standard Deviation 2.81
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C5 D1 (n=66, 61)	-0.7 Units on a scale Standard Deviation 3.66	-0.9 Units on a scale Standard Deviation 2.59
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C6 D1 (n=40, 41)	-0.6 Units on a scale Standard Deviation 3.23	-0.8 Units on a scale Standard Deviation 2.93
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C7 D1 (n=25, 25)	0.0 Units on a scale Standard Deviation 2.54	-0.2 Units on a scale Standard Deviation 3.18
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C8 D1 (n=12, 12)	0.6 Units on a scale Standard Deviation 1.31	-1.1 Units on a scale Standard Deviation 3.12
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C9 D1 (n=6, 6)	-1.3 Units on a scale Standard Deviation 1.97	-0.8 Units on a scale Standard Deviation 3.31
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C10 D1 (n=2, 3)	-1.0 Units on a scale Standard Deviation 1.41	3.3 Units on a scale Standard Deviation 1.53
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	5.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-3.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Mood: Change at follow-up (n=47, 44)	0.9 Units on a scale Standard Deviation 3.65	0.2 Units on a scale Standard Deviation 3.62
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Baseline (n=242, 243)	2.2 Units on a scale Standard Deviation 2.78	2.3 Units on a scale Standard Deviation 2.81
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C2 D1 (n=189, 194)	0.1 Units on a scale Standard Deviation 2.84	-0.1 Units on a scale Standard Deviation 2.61
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C3 D1 (n=133, 143)	-0.2 Units on a scale Standard Deviation 3.41	-0.3 Units on a scale Standard Deviation 2.52
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C4 D1 (n=97, 108)	0.3 Units on a scale Standard Deviation 3.32	-0.4 Units on a scale Standard Deviation 2.64
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C5 D1 (n=66, 62)	0.1 Units on a scale Standard Deviation 3.49	-0.3 Units on a scale Standard Deviation 2.37
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C6 D1 (n=41, 41)	0.5 Units on a scale Standard Deviation 2.86	-0.2 Units on a scale Standard Deviation 2.24
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C7 D1 (n=25, 25)	1.1 Units on a scale Standard Deviation 2.67	-0.1 Units on a scale Standard Deviation 2.42
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C8 D1 (n=12, 12)	0.7 Units on a scale Standard Deviation 2.46	-1.3 Units on a scale Standard Deviation 2.42
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C9 D1 (n=6, 6)	-1.0 Units on a scale Standard Deviation 3.52	0.2 Units on a scale Standard Deviation 4.62
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C10 D1 (n=2, 3)	-2.0 Units on a scale Standard Deviation 2.83	1.3 Units on a scale Standard Deviation 5.51
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-2.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Walking Ability: Change at follow-up (n=47, 45)	0.9 Units on a scale Standard Deviation 4.13	0.7 Units on a scale Standard Deviation 3.27
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Baseline (n=240, 240)	3.5 Units on a scale Standard Deviation 3.34	3.2 Units on a scale Standard Deviation 3.23
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C2 D1 (n=187, 191)	-0.4 Units on a scale Standard Deviation 3.24	-0.1 Units on a scale Standard Deviation 3.16
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C3 D1 (n=133, 139)	-0.6 Units on a scale Standard Deviation 3.33	-0.4 Units on a scale Standard Deviation 2.67
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C4 D1 (n=96, 107)	-0.2 Units on a scale Standard Deviation 3.15	-0.7 Units on a scale Standard Deviation 2.90
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C5 D1 (n=65, 61)	-0.7 Units on a scale Standard Deviation 3.86	-0.6 Units on a scale Standard Deviation 2.71
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C6 D1 (n=39, 41)	0.2 Units on a scale Standard Deviation 3.62	-0.2 Units on a scale Standard Deviation 3.12
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C7 D1 (n=25, 24)	0.5 Units on a scale Standard Deviation 2.76	-0.4 Units on a scale Standard Deviation 2.52
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C8 D1 (n=12, 12)	-0.3 Units on a scale Standard Deviation 3.70	-0.1 Units on a scale Standard Deviation 3.37
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C9 D1 (n=6, 6)	-1.5 Units on a scale Standard Deviation 3.51	3.5 Units on a scale Standard Deviation 4.32
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C10 D1 (n=2, 3)	-0.5 Units on a scale Standard Deviation 0.71	1.3 Units on a scale Standard Deviation 3.51
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	2.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-2.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Normal Work: Change at follow-up (n=46, 43)	1.0 Units on a scale Standard Deviation 4.54	0.3 Units on a scale Standard Deviation 3.90
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Baseline (n=244, 242)	2.3 Units on a scale Standard Deviation 2.93	1.9 Units on a scale Standard Deviation 2.44
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C2 D1 (n=190, 193)	-0.3 Units on a scale Standard Deviation 2.82	0.0 Units on a scale Standard Deviation 2.18
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C3 D1 (n=136, 142)	-0.4 Units on a scale Standard Deviation 3.81	-0.0 Units on a scale Standard Deviation 2.16
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C4 D1 (n=98, 108)	-0.2 Units on a scale Standard Deviation 3.36	-0.1 Units on a scale Standard Deviation 2.52
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C5 D1 (n=66, 62)	-0.6 Units on a scale Standard Deviation 3.11	-0.1 Units on a scale Standard Deviation 2.27
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C6 D1 (n=40, 41)	-0.3 Units on a scale Standard Deviation 4.01	-0.1 Units on a scale Standard Deviation 2.76
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C7 D1 (n=25, 25)	0.8 Units on a scale Standard Deviation 3.32	-0.7 Units on a scale Standard Deviation 2.44
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C8 D1 (n=12, 12)	0.6 Units on a scale Standard Deviation 2.61	-0.9 Units on a scale Standard Deviation 2.35
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C9 D1 (n=6, 6)	-1.2 Units on a scale Standard Deviation 2.93	0.8 Units on a scale Standard Deviation 4.88
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C10 D1 (n=2, 3)	1.0 Units on a scale Standard Deviation 1.41	2.7 Units on a scale Standard Deviation 2.52
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	2.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-2.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Relations: Change at follow-up (n=47, 45)	0.7 Units on a scale Standard Deviation 3.94	0.8 Units on a scale Standard Deviation 3.56
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Baseline (n=244, 242)	3.3 Units on a scale Standard Deviation 3.16	3.2 Units on a scale Standard Deviation 3.17
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C2 D1 (n=191, 193)	-1.1 Units on a scale Standard Deviation 3.36	-0.9 Units on a scale Standard Deviation 2.73
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C3 D1 (n=136, 142)	-1.6 Units on a scale Standard Deviation 3.52	-1.1 Units on a scale Standard Deviation 2.89
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C4 D1 (n=98, 107)	-1.2 Units on a scale Standard Deviation 3.29	-1.2 Units on a scale Standard Deviation 3.02
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C5 D1 (n=66, 62)	-1.3 Units on a scale Standard Deviation 4.06	-0.8 Units on a scale Standard Deviation 3.37
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C6 D1(n=39, 41)	-1.5 Units on a scale Standard Deviation 3.22	-0.8 Units on a scale Standard Deviation 3.62
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C7 D1 (n=25, 25)	-0.2 Units on a scale Standard Deviation 3.61	-0.6 Units on a scale Standard Deviation 2.81
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C8 D1 (n=12, 12)	0.6 Units on a scale Standard Deviation 2.71	-1.2 Units on a scale Standard Deviation 3.51
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C9 D1 (n=6, 6)	-2.3 Units on a scale Standard Deviation 3.20	0.3 Units on a scale Standard Deviation 2.07
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C10 D1 (n=2, 3)	1.0 Units on a scale Standard Deviation 1.41	0.7 Units on a scale Standard Deviation 3.51
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	4.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-5.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Sleep: Change at follow-up (n=47, 44)	0.5 Units on a scale Standard Deviation 3.65	-0.3 Units on a scale Standard Deviation 3.54
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Baseline (n=242, 240)	3.5 Units on a scale Standard Deviation 3.34	3.4 Units on a scale Standard Deviation 3.17
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C2 D1 (n=191, 191)	-0.6 Units on a scale Standard Deviation 2.99	-0.5 Units on a scale Standard Deviation 2.89
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C3 D1 (n=134, 142)	-0.7 Units on a scale Standard Deviation 3.64	-0.7 Units on a scale Standard Deviation 2.77
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C4 D1 (n=98, 107)	-0.6 Units on a scale Standard Deviation 3.58	-0.9 Units on a scale Standard Deviation 2.70
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C5 D1 (n=66, 62)	-0.6 Units on a scale Standard Deviation 4.03	-0.8 Units on a scale Standard Deviation 3.07
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C6 D1 (n=40, 41)	-0.4 Units on a scale Standard Deviation 3.87	-1.0 Units on a scale Standard Deviation 3.17
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C7 D1 (n=25, 25)	0.4 Units on a scale Standard Deviation 3.53	-0.9 Units on a scale Standard Deviation 2.28
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C9 D1 (n=6, 6)	-0.5 Units on a scale Standard Deviation 5.01	0.2 Units on a scale Standard Deviation 2.86
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C10 D1 (n=2, 3)	0.5 Units on a scale Standard Deviation 0.71	2.3 Units on a scale Standard Deviation 5.51
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-4.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Enjoyment of Life: Change at follow-up (n=47, 43)	0.2 Units on a scale Standard Deviation 3.68	-0.2 Units on a scale Standard Deviation 3.99
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pain Intensity(PI): Baseline (n=248, 251)	2.7 Units on a scale Standard Deviation 1.98	2.6 Units on a scale Standard Deviation 2.12
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C2 D1 (n=196, 202)	-0.4 Units on a scale Standard Deviation 1.97	-0.5 Units on a scale Standard Deviation 1.97
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C3 D1 (n=140, 151)	-0.9 Units on a scale Standard Deviation 2.15	-0.6 Units on a scale Standard Deviation 1.88
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C4 D1 (n=99, 114)	-0.6 Units on a scale Standard Deviation 2.19	-0.5 Units on a scale Standard Deviation 1.99
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C5 D1 (n=69, 64)	-0.6 Units on a scale Standard Deviation 2.46	-0.6 Units on a scale Standard Deviation 2.19
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C6 D1 (n=41, 43)	-0.5 Units on a scale Standard Deviation 1.92	-0.6 Units on a scale Standard Deviation 1.89
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C7 D1 (n=25, 27)	-0.1 Units on a scale Standard Deviation 1.48	-0.4 Units on a scale Standard Deviation 2.78
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C8 D1 (n=12, 13)	1.0 Units on a scale Standard Deviation 2.01	-0.9 Units on a scale Standard Deviation 1.76
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C9 D1 (n=6, 6)	-1.3 Units on a scale Standard Deviation 1.51	-0.8 Units on a scale Standard Deviation 1.11
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C10 D1 (n=2, 3)	-1.9 Units on a scale Standard Deviation 2.69	-0.1 Units on a scale Standard Deviation 1.44
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	1.5 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-3.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined PI:Change follow-up (n=48, 47)	0.5 Units on a scale Standard Deviation 2.34	0.2 Units on a scale Standard Deviation 2.56
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pain Interference(Pf):Baseline(n=244,243)	3.0 Units on a scale Standard Deviation 2.64	2.8 Units on a scale Standard Deviation 2.52
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C2 D1 (n=191, 194)	-0.5 Units on a scale Standard Deviation 2.44	-0.4 Units on a scale Standard Deviation 1.97
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C3 D1 (n=136,143)	-0.8 Units on a scale Standard Deviation 2.99	-0.5 Units on a scale Standard Deviation 2.01
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C4 D1 (n=98,109)	-0.4 Units on a scale Standard Deviation 2.62	-0.7 Units on a scale Standard Deviation 2.12
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C5 D1 (n=66, 62)	-0.6 Units on a scale Standard Deviation 3.18	-0.6 Units on a scale Standard Deviation 2.07
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C6 D1 (n=41, 41)	-0.4 Units on a scale Standard Deviation 2.92	-0.6 Units on a scale Standard Deviation 2.38
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C7 D1 (n=25, 25)	0.3 Units on a scale Standard Deviation 2.32	-0.5 Units on a scale Standard Deviation 2.10
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C8 D1 (n=12, 12)	0.4 Units on a scale Standard Deviation 1.84	-0.9 Units on a scale Standard Deviation 2.15
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C9 D1 (n=6, 6)	-1.4 Units on a scale Standard Deviation 2.69	0.7 Units on a scale Standard Deviation 2.86
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C10 D1 (n=2, 3)	-0.5 Units on a scale Standard Deviation 0.71	2.1 Units on a scale Standard Deviation 2.90
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C11 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	1.9 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C12 D1 (n=1, 0)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at C13 D1 (n=1, 1)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-2.7 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score Combined Pf: Change at follow-up (n=47, 45)	0.7 Units on a scale Standard Deviation 3.55	0.3 Units on a scale Standard Deviation 3.40

SECONDARY outcome

Timeframe: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Outcome measures
Measure	Axitinib + Gemcitabine n=314 Participants Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=316 Participants Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Baseline (n=289, 290)	0.665 Units on a scale Standard Deviation 0.2709	0.690 Units on a scale Standard Deviation 0.2479
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C2 D1 (n=231, 240)	0.050 Units on a scale Standard Deviation 0.2699	0.020 Units on a scale Standard Deviation 0.2033
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C3 D1 (n=171, 178)	0.053 Units on a scale Standard Deviation 0.2528	0.028 Units on a scale Standard Deviation 0.2362
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C4 D1 (n=128, 131)	0.010 Units on a scale Standard Deviation 0.2730	0.050 Units on a scale Standard Deviation 0.2209
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C5 D1 (n=94, 80)	0.010 Units on a scale Standard Deviation 0.2889	0.044 Units on a scale Standard Deviation 0.2092
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C6 D1 (n=57, 57)	0.001 Units on a scale Standard Deviation 0.2489	0.058 Units on a scale Standard Deviation 0.2294
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C7 D1 (n=37, 36)	0.049 Units on a scale Standard Deviation 0.1891	0.075 Units on a scale Standard Deviation 0.1838
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C8 D1 (n=17, 20)	-0.021 Units on a scale Standard Deviation 0.2366	0.071 Units on a scale Standard Deviation 0.2188
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C9 D1 (n=9, 9)	0.049 Units on a scale Standard Deviation 0.1878	0.121 Units on a scale Standard Deviation 0.3006
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C10 D1 (n=3, 4)	0.181 Units on a scale Standard Deviation 0.2206	0.208 Units on a scale Standard Deviation 0.3034
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C11 D1 (n=1, 1)	0.000 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.058 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C12 D1 (n=1, 0)	0.000 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Units on a scale Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at C13 D1 (n=1, 1)	0.000 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.470 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile Change at follow-up (n=65, 73)	-0.148 Units on a scale Standard Deviation 0.3637	-0.080 Units on a scale Standard Deviation 0.3243

SECONDARY outcome

Timeframe: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.

Outcome measures

Outcome measures
Measure	Axitinib + Gemcitabine n=314 Participants Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=316 Participants Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Baseline (n= 277, 281)	60.6 Millimeter (mm) Standard Deviation 23.67	62.6 Millimeter (mm) Standard Deviation 23.09
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 2 Day 1 (n= 223, 226)	1.0 Millimeter (mm) Standard Deviation 19.64	-0.4 Millimeter (mm) Standard Deviation 20.42
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 3 Day 1 (n= 161, 171)	2.6 Millimeter (mm) Standard Deviation 22.30	1.1 Millimeter (mm) Standard Deviation 20.25
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 4 Day 1 (n=122, 128)	0.5 Millimeter (mm) Standard Deviation 22.38	3.2 Millimeter (mm) Standard Deviation 19.81
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 5 Day 1 (n= 90, 79)	-0.3 Millimeter (mm) Standard Deviation 22.83	1.9 Millimeter (mm) Standard Deviation 19.40
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 6 Day 1 (n= 56, 56)	1.0 Millimeter (mm) Standard Deviation 24.63	3.7 Millimeter (mm) Standard Deviation 21.84
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 7 Day 1 (n= 36, 35)	2.6 Millimeter (mm) Standard Deviation 25.82	4.1 Millimeter (mm) Standard Deviation 22.52
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 8 Day 1 (n= 16, 19)	3.8 Millimeter (mm) Standard Deviation 23.21	9.6 Millimeter (mm) Standard Deviation 28.55
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 9 Day 1 (n= 9, 9)	22.2 Millimeter (mm) Standard Deviation 24.93	7.7 Millimeter (mm) Standard Deviation 20.00
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 10 Day 1 (n= 3, 4)	20.0 Millimeter (mm) Standard Deviation 26.46	6.3 Millimeter (mm) Standard Deviation 24.62
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 11 Day 1 (n= 1, 1)	0.0 Millimeter (mm) Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	30.0 Millimeter (mm) Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 12 Day 1 (n= 1, 0)	0.0 Millimeter (mm) Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	NA Millimeter (mm) Standard Deviation NA Data was not analyzed as no participants were evaluable for the particular cycle.
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at Cycle 13 Day 1 (n= 1, 1)	0.0 Millimeter (mm) Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	36.0 Millimeter (mm) Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score Change at follow-up (n= 62, 68)	-6.3 Millimeter (mm) Standard Deviation 24.07	-4.8 Millimeter (mm) Standard Deviation 22.79

SECONDARY outcome

Timeframe: Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months

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

Adverse Events

Axitinib + Gemcitabine

Serious events: 108 serious events

Other events: 276 other events

Deaths: 0 deaths

Placebo + Gemcitabine

Serious events: 102 serious events

Other events: 276 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

Serious adverse events
Measure	Axitinib + Gemcitabine n=304 participants at risk Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=309 participants at risk Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Gastrointestinal disorders Enterocutaneous fistula	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.66% 2/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Gastrointestinal perforation	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Abdominal pain	4.6% 14/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	3.2% 10/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.65% 2/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Anal fistula	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Ascites	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Colonic obstruction	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Constipation	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	1.6% 5/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Diarrhoea	0.66% 2/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	1.3% 4/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Dysphagia	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Duodenal ulcer	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Anaemia	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	1.3% 4/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Febrile neutropenia	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Neutropenia	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Splenic vein thrombosis	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Thrombocytopenia	0.66% 2/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Acute myocardial infarction	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Angina pectoris	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Atrial fibrillation	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Cardiac arrest	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Cardiac failure	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Cardiac failure congestive	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.65% 2/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Tachycardia	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Congenital, familial and genetic disorders Pyloric stenosis	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Ear and labyrinth disorders Deafness	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Endocrine disorders Adrenal insufficiency	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Endocrine disorders Hypothyroidism	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Abdominal distension	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Haematemesis	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Ileus	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.97% 3/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Intestinal fistula	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Intestinal obstruction	0.66% 2/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Intestinal perforation	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Large intestinal obstruction	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Large intestine perforation	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Melaena	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.

Other adverse events
Measure	Axitinib + Gemcitabine n=304 participants at risk Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.	Placebo + Gemcitabine n=309 participants at risk Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Gastrointestinal disorders Abdominal mass	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Abdominal pain	17.8% 54/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	16.8% 52/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Abdominal pain lower	0.66% 2/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	1.6% 5/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Colitis	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Constipation	28.9% 88/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	29.4% 91/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Abdominal pain upper	7.9% 24/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	7.8% 24/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Dental caries	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Abdominal tenderness	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Aphthous stomatitis	0.66% 2/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Ascites	1.6% 5/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	2.9% 9/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Gastrointestinal disorders Cheilitis	1.3% 4/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Anaemia	8.2% 25/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	16.5% 51/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Eosinopenia	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Erythroblastosis	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Erythropenia	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Granulocytopenia	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Haemoglobinaemia	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.65% 2/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Leukocytosis	0.66% 2/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Leukopenia	7.6% 23/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	4.2% 13/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Lymphadenopathy	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Lymphocytosis	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Lymphopenia	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	2.3% 7/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Neutropenia	24.0% 73/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	17.2% 53/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Neutrophilia	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Thrombocytopenia	15.8% 48/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	11.0% 34/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Blood and lymphatic system disorders Thrombocytosis	1.3% 4/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.97% 3/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Atrial fibrillation	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Atrial flutter	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Bradycardia	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.65% 2/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Bundle branch block right	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Cardiovascular disorder	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Cyanosis	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Diastolic dysfunction	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Mitral valve incompetence	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Nodal rhythm	0.33% 1/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.00% 0/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Palpitations	1.3% 4/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.65% 2/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.
Cardiac disorders Pericardial effusion	0.00% 0/304 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.	0.32% 1/309 Same event may appear as both AE and SAE, both distinctly presented. An event may be categorized as SAE in 1 subject, AE in another or one subject may have experienced both serious and nonserious event. A participant randomized for Axitinib+Gemcitabine, received Gemcitabine only and was shifted to Placebo+Gemcitabine group for safety evaluation.