Trial Outcomes & Findings for A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma (NCT NCT01667419)

Last Updated: 2019-07-23

Results Overview

DFS was defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

498 participants

Primary outcome timeframe

From randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)

Results posted on

2019-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 Vemurafenib Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 milligrams (mg) twice daily, in 28-day cycles, for up to 52 weeks	Cohort 1 Placebo Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Vemurafenib Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Placebo Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Overall Study STARTED	157	157	93	91
Overall Study COMPLETED	114	110	57	52
Overall Study NOT COMPLETED	43	47	36	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Vemurafenib Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 milligrams (mg) twice daily, in 28-day cycles, for up to 52 weeks	Cohort 1 Placebo Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Vemurafenib Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Placebo Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Overall Study Reason Not Specified	1	0	0	0
Overall Study Withdrawal by Subject	16	8	9	8
Overall Study Non-compliance	0	0	0	1
Overall Study Protocol Violation	1	0	0	0
Overall Study Lost to Follow-up	7	6	2	4
Overall Study Death	18	33	25	26

Baseline Characteristics

The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 Vemurafenib n=157 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 1 Placebo n=157 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Vemurafenib n=93 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Placebo n=91 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks	Total n=498 Participants Total of all reporting groups
Age, Continuous	50.7 years STANDARD_DEVIATION 12.4 • n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	49.6 years STANDARD_DEVIATION 12.7 • n=7 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	51.6 years STANDARD_DEVIATION 14.1 • n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	49.1 years STANDARD_DEVIATION 12.9 • n=4 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	50.2 years STANDARD_DEVIATION 12.9 • n=21 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Sex: Female, Male Female	73 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	69 Participants n=7 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	41 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	32 Participants n=4 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	215 Participants n=21 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Sex: Female, Male Male	84 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	88 Participants n=7 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	52 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	59 Participants n=4 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	283 Participants n=21 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	2 Participants n=7 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	8 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	3 Participants n=4 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	25 Participants n=21 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	148 Participants n=7 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	79 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	80 Participants n=4 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	445 Participants n=21 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	7 Participants n=7 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	6 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	8 Participants n=4 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	28 Participants n=21 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Race/Ethnicity, Customized White	150 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	150 Participants n=7 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	84 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	81 Participants n=4 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	465 Participants n=21 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Race/Ethnicity, Customized Other	1 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	2 Participants n=7 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	1 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	2 Participants n=4 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	6 Participants n=21 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	0 Participants n=7 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	1 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	0 Participants n=4 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	1 Participants n=21 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Race/Ethnicity, Customized Unknown	6 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	5 Participants n=7 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	7 Participants n=5 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	8 Participants n=4 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.	26 Participants n=21 Participants • The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.

PRIMARY outcome

Timeframe: From randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)

Population: The ITT population included all participants enrolled in the study, whether or not they had received study medication.

DFS was defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 1 Vemurafenib n=157 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 1 Placebo n=157 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Vemurafenib n=93 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Placebo n=91 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT)	NA months Not estimable due to low number of events.	36.9 months Interval 21.4 to Not estimable due to low number of events.	23.1 months Interval 18.6 to 26.5	15.4 months Interval 11.1 to 35.9

SECONDARY outcome

Timeframe: From randomization until the date of diagnosis of distant (i.e., non-locoregional) metastases or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)

Population: The ITT population included all participants enrolled in the study, whether or not they had received study medication.

DMFS was defined as the time from randomization until the date of diagnosis of distant (i.e. non-locoregional) metastases or death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 1 Vemurafenib n=157 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 1 Placebo n=157 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Vemurafenib n=93 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Placebo n=91 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT	NA months Not estimable due to low number of events.	NA months Interval 36.9 to Not estimable due to low number of events.	37.2 months Interval 22.1 to Not estimable due to low number of events.	30.7 months Interval 24.5 to Not estimable due to low number of events.

SECONDARY outcome

Timeframe: From randomization until the date of death from any cause (up until 13-July-2018, approximately 6 years)

Population: The ITT population included all participants enrolled in the study, whether or not they had received study medication.

OS is defined as the time from randomization until the date of death from any cause.

Outcome measures

Outcome measures
Measure	Cohort 1 Vemurafenib n=157 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 1 Placebo n=157 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Vemurafenib n=93 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Placebo n=91 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Overall Survival (OS)	NA months Interval 60.0 to Not estimable due to low number of events.	NA months Not estimable due to low number of events.	59.9 months Interval 54.6 to 59.9	NA months Interval 52.6 to Not estimable due to low number of events.

SECONDARY outcome

Timeframe: From randomization up to study completion or discontinuation (up until 13-July-2018, approximately 6 years)

Population: The safety population included all participants who received at least one dose of study medication.

An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.

Outcome measures

Outcome measures
Measure	Cohort 1 Vemurafenib n=154 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 1 Placebo n=156 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Vemurafenib n=93 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Placebo n=91 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Percentage of Participants With Adverse Events	99.4 percentage of participants	88.5 percentage of participants	100.0 percentage of participants	89.0 percentage of participants

SECONDARY outcome

Timeframe: Day 1, Day 8, Day 15, Day 22 of Cycle 1;Day 1, Day 15 of Cycle 2;Day 1 Cycles 3-13;end of treatment(up to 13 months);every 13 weeks thereafter until recurrence or occurrence of a new primary melanoma (up to 17-Apr-17 data cut-off,approximately 4.5 years)

Population: The patient-reported outcome (PRO)-evaluable population included all participants who received at least one dose of vemurafenib and who had both a baseline assessment and at least one post-baseline QLQ-C30 assessment that generated a score.

European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire assesses 8 symptoms, function, financial difficulties, and a global health status/health-related quality of life (HRQoL). Most questions use a 4-point scale (1 'Not at all' to 4 'Very much';2 questions use a 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. Higher scores for the function and HRQoL represent higher levels of functioning and HRQoL, higher scores for the symptom represent higher levels of symptoms/problems, higher score for financial difficulty represent higher level of perceived financial burden of treatment. Changes of 5-10 points are considered to represent a minimally important difference to participants. A positive value means an increase, and negative value means a decrease in score at the indicated time-point relative to the score at baseline (Cycle 1 Day 1).

Outcome measures

Outcome measures
Measure	Cohort 1 Vemurafenib n=138 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 1 Placebo n=147 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Vemurafenib n=87 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Placebo n=89 Participants Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 1 Day 15	16.7 score on a scale Standard Deviation 26.5	1.4 score on a scale Standard Deviation 12.0	12.2 score on a scale Standard Deviation 22.8	1.2 score on a scale Standard Deviation 17.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 2 Day 1	9.5 score on a scale Standard Deviation 21.0	1.2 score on a scale Standard Deviation 10.1	12.2 score on a scale Standard Deviation 23.7	1.6 score on a scale Standard Deviation 15.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 4 Day 1	9.5 score on a scale Standard Deviation 20.9	1.3 score on a scale Standard Deviation 12.1	10.3 score on a scale Standard Deviation 20.3	2.6 score on a scale Standard Deviation 15.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 52 Weeks	0.4 score on a scale Standard Deviation 17.6	0.0 score on a scale Standard Deviation 12.1	-1.3 score on a scale Standard Deviation 6.5	2.7 score on a scale Standard Deviation 9.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 104 Weeks	-1.2 score on a scale Standard Deviation 11.3	-1.3 score on a scale Standard Deviation 6.7	0.0 score on a scale Standard Deviation 0.0	-3.7 score on a scale Standard Deviation 11.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 2 Day 15	1.7 score on a scale Standard Deviation 21.2	-1.5 score on a scale Standard Deviation 19.1	0.4 score on a scale Standard Deviation 17.2	0.0 score on a scale Standard Deviation 16.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 5 Day 1	7.6 score on a scale Standard Deviation 23.7	-1.4 score on a scale Standard Deviation 20.3	2.8 score on a scale Standard Deviation 20.0	-3.6 score on a scale Standard Deviation 18.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 6 Day 1	7.2 score on a scale Standard Deviation 25.2	-0.6 score on a scale Standard Deviation 20.0	7.2 score on a scale Standard Deviation 24.8	-2.6 score on a scale Standard Deviation 19.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at End of Treatment	4.1 score on a scale Standard Deviation 14.5	2.4 score on a scale Standard Deviation 19.9	3.0 score on a scale Standard Deviation 18.1	6.2 score on a scale Standard Deviation 16.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 26 Weeks	4.8 score on a scale Standard Deviation 16.2	1.4 score on a scale Standard Deviation 16.3	3.5 score on a scale Standard Deviation 19.9	-1.0 score on a scale Standard Deviation 5.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 39 Weeks	1.7 score on a scale Standard Deviation 14.0	2.5 score on a scale Standard Deviation 13.3	4.8 score on a scale Standard Deviation 18.9	3.0 score on a scale Standard Deviation 12.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 52 Weeks	1.8 score on a scale Standard Deviation 15.3	3.8 score on a scale Standard Deviation 16.1	2.5 score on a scale Standard Deviation 15.8	5.3 score on a scale Standard Deviation 15.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 78 Weeks	4.3 score on a scale Standard Deviation 13.3	7.1 score on a scale Standard Deviation 18.2	0.0 score on a scale Standard Deviation 21.8	0.0 score on a scale Standard Deviation 16.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 104 Weeks	0.0 score on a scale Standard Deviation 16.0	6.7 score on a scale Standard Deviation 16.7	0.0 score on a scale Standard Deviation 22.2	8.3 score on a scale Standard Deviation 15.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 130 Weeks	-2.0 score on a scale Standard Deviation 8.1	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 23.6	13.3 score on a scale Standard Deviation 18.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 2 Day 1	-1.2 score on a scale Standard Deviation 16.0	2.5 score on a scale Standard Deviation 13.2	-1.0 score on a scale Standard Deviation 17.5	4.0 score on a scale Standard Deviation 12.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 12 Day 1	-2.3 score on a scale Standard Deviation 20.0	-2.2 score on a scale Standard Deviation 16.4	1.1 score on a scale Standard Deviation 14.6	-1.6 score on a scale Standard Deviation 14.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 78 Weeks	2.9 score on a scale Standard Deviation 14.6	-1.8 score on a scale Standard Deviation 22.1	8.9 score on a scale Standard Deviation 16.2	1.9 score on a scale Standard Deviation 10.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 5 Day 1	14.2 score on a scale Standard Deviation 23.7	1.9 score on a scale Standard Deviation 16.1	13.6 score on a scale Standard Deviation 18.9	4.7 score on a scale Standard Deviation 17.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 9 Day 1	16.3 score on a scale Standard Deviation 25.3	2.7 score on a scale Standard Deviation 20.5	13.7 score on a scale Standard Deviation 24.1	6.0 score on a scale Standard Deviation 21.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 12 Day 1	10.3 score on a scale Standard Deviation 23.8	2.1 score on a scale Standard Deviation 16.2	10.7 score on a scale Standard Deviation 22.5	3.2 score on a scale Standard Deviation 17.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 26 Weeks	2.5 score on a scale Standard Deviation 18.4	1.0 score on a scale Standard Deviation 15.5	0.5 score on a scale Standard Deviation 21.6	-1.3 score on a scale Standard Deviation 18.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 117 Weeks	-3.0 score on a scale Standard Deviation 13.4	4.2 score on a scale Standard Deviation 19.2	-7.4 score on a scale Standard Deviation 15.7	0.0 score on a scale Standard Deviation 28.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 143 Weeks	-1.6 score on a scale Standard Deviation 14.9	5.6 score on a scale Standard Deviation 7.9	-3.7 score on a scale Standard Deviation 17.0	16.7 score on a scale Standard Deviation 23.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 156 Weeks	-11.1 score on a scale Standard Deviation 11.1	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	33.3 score on a scale Standard Deviation 15.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 169 Weeks	-16.7 score on a scale Standard Deviation 7.9	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 1 Day 22	-1.5 score on a scale Standard Deviation 26.2	-3.2 score on a scale Standard Deviation 14.5	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 20.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 3 Day 1	0.3 score on a scale Standard Deviation 21.5	-5.2 score on a scale Standard Deviation 24.1	1.3 score on a scale Standard Deviation 20.2	-5.6 score on a scale Standard Deviation 19.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 10 Day 1	1.0 score on a scale Standard Deviation 23.4	-8.6 score on a scale Standard Deviation 25.1	2.6 score on a scale Standard Deviation 22.6	-6.4 score on a scale Standard Deviation 20.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 143 Weeks	4.8 score on a scale Standard Deviation 40.5	16.7 score on a scale Standard Deviation 23.6	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 156 Weeks	-22.2 score on a scale Standard Deviation 38.5	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	-16.7 score on a scale Standard Deviation 23.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 169 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 8 Day 1	4.6 score on a scale Standard Deviation 11.9	1.1 score on a scale Standard Deviation 9.0	5.9 score on a scale Standard Deviation 15.7	2.5 score on a scale Standard Deviation 12.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 10 Day 1	5.2 score on a scale Standard Deviation 13.1	0.9 score on a scale Standard Deviation 10.3	4.8 score on a scale Standard Deviation 10.6	0.4 score on a scale Standard Deviation 6.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 11 Day 1	3.4 score on a scale Standard Deviation 10.9	2.0 score on a scale Standard Deviation 8.5	3.2 score on a scale Standard Deviation 8.6	-0.3 score on a scale Standard Deviation 5.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 13 Day 1	2.8 score on a scale Standard Deviation 11.7	1.7 score on a scale Standard Deviation 7.1	3.4 score on a scale Standard Deviation 9.9	2.2 score on a scale Standard Deviation 9.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 130 Weeks	0.0 score on a scale Standard Deviation 5.9	4.2 score on a scale Standard Deviation 10.4	-3.3 score on a scale Standard Deviation 7.5	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 7 Day 1	8.2 score on a scale Standard Deviation 21.4	0.9 score on a scale Standard Deviation 16.6	8.3 score on a scale Standard Deviation 20.5	-2.0 score on a scale Standard Deviation 19.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Cycle 1 Day 1 (Baseline)	3.6 score on a scale Standard Deviation 11.2	3.9 score on a scale Standard Deviation 14.9	3.5 score on a scale Standard Deviation 10.3	3.4 score on a scale Standard Deviation 11.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 1 Day 8	2.8 score on a scale Standard Deviation 9.4	1.5 score on a scale Standard Deviation 7.1	10.4 score on a scale Standard Deviation 16.0	0.0 score on a scale Standard Deviation 11.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 91 Weeks	2.1 score on a scale Standard Deviation 16.8	2.3 score on a scale Standard Deviation 12.4	0.0 score on a scale Standard Deviation 0.0	2.8 score on a scale Standard Deviation 9.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 1 Day 22	7.6 score on a scale Standard Deviation 14.3	3.2 score on a scale Standard Deviation 10.0	11.1 score on a scale Standard Deviation 20.6	3.9 score on a scale Standard Deviation 20.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 2 Day 15	9.5 score on a scale Standard Deviation 22.2	1.0 score on a scale Standard Deviation 12.2	6.8 score on a scale Standard Deviation 16.3	0.8 score on a scale Standard Deviation 14.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 3 Day 1	10.4 score on a scale Standard Deviation 20.7	1.6 score on a scale Standard Deviation 10.1	8.3 score on a scale Standard Deviation 18.0	0.4 score on a scale Standard Deviation 14.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 5 Day 1	13.3 score on a scale Standard Deviation 23.5	1.4 score on a scale Standard Deviation 12.7	7.4 score on a scale Standard Deviation 15.0	-0.5 score on a scale Standard Deviation 12.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 6 Day 1	9.7 score on a scale Standard Deviation 21.1	2.4 score on a scale Standard Deviation 12.4	13.0 score on a scale Standard Deviation 21.6	1.1 score on a scale Standard Deviation 17.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 7 Day 1	10.7 score on a scale Standard Deviation 22.8	1.5 score on a scale Standard Deviation 14.0	7.4 score on a scale Standard Deviation 16.1	4.0 score on a scale Standard Deviation 18.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 8 Day 1	10.2 score on a scale Standard Deviation 22.7	1.9 score on a scale Standard Deviation 13.7	10.8 score on a scale Standard Deviation 18.7	-0.6 score on a scale Standard Deviation 12.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 9 Day 1	9.7 score on a scale Standard Deviation 25.2	2.3 score on a scale Standard Deviation 13.5	7.9 score on a scale Standard Deviation 17.7	3.8 score on a scale Standard Deviation 15.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT/Discontinuation	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 117 Weeks	-1.5 score on a scale Standard Deviation 12.5	2.0 score on a scale Standard Deviation 14.3	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Cycle 1 Day 1 (Baseline)	93.0 score on a scale Standard Deviation 14.1	92.0 score on a scale Standard Deviation 16.2	91.4 score on a scale Standard Deviation 17.2	94.9 score on a scale Standard Deviation 11.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 1 Day 8	-2.1 score on a scale Standard Deviation 12.3	1.5 score on a scale Standard Deviation 14.5	0.0 score on a scale Standard Deviation 10.5	2.6 score on a scale Standard Deviation 6.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 1 Day 15	-4.3 score on a scale Standard Deviation 13.1	0.8 score on a scale Standard Deviation 12.6	-3.8 score on a scale Standard Deviation 13.4	-0.8 score on a scale Standard Deviation 11.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 1 Day 22	-0.8 score on a scale Standard Deviation 17.4	1.6 score on a scale Standard Deviation 11.7	-3.3 score on a scale Standard Deviation 9.3	-4.9 score on a scale Standard Deviation 14.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 2 Day 1	-2.4 score on a scale Standard Deviation 14.2	-2.5 score on a scale Standard Deviation 14.3	-2.2 score on a scale Standard Deviation 12.2	0.0 score on a scale Standard Deviation 13.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 2 Day 15	-3.8 score on a scale Standard Deviation 15.1	-1.1 score on a scale Standard Deviation 14.6	-3.1 score on a scale Standard Deviation 11.9	-0.4 score on a scale Standard Deviation 15.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 3 Day 1	-3.6 score on a scale Standard Deviation 13.4	-0.6 score on a scale Standard Deviation 12.0	-2.5 score on a scale Standard Deviation 12.4	-2.1 score on a scale Standard Deviation 13.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 4 Day 1	-3.8 score on a scale Standard Deviation 14.6	-1.3 score on a scale Standard Deviation 15.1	-4.9 score on a scale Standard Deviation 13.5	-2.9 score on a scale Standard Deviation 13.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 5 Day 1	-6.2 score on a scale Standard Deviation 17.3	-2.0 score on a scale Standard Deviation 14.9	-3.9 score on a scale Standard Deviation 12.7	-3.6 score on a scale Standard Deviation 15.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 6 Day 1	-5.7 score on a scale Standard Deviation 15.8	-2.1 score on a scale Standard Deviation 12.5	-4.1 score on a scale Standard Deviation 16.0	-3.4 score on a scale Standard Deviation 18.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 7 Day 1	-6.3 score on a scale Standard Deviation 17.3	-3.1 score on a scale Standard Deviation 13.3	-3.9 score on a scale Standard Deviation 15.5	-5.6 score on a scale Standard Deviation 15.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 8 Day 1	-7.4 score on a scale Standard Deviation 16.1	-3.6 score on a scale Standard Deviation 16.9	-5.1 score on a scale Standard Deviation 16.6	-4.7 score on a scale Standard Deviation 13.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 9 Day 1	-8.2 score on a scale Standard Deviation 18.1	-4.6 score on a scale Standard Deviation 17.3	-5.8 score on a scale Standard Deviation 17.7	-5.4 score on a scale Standard Deviation 12.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 10 Day 1	-9.0 score on a scale Standard Deviation 20.1	-3.6 score on a scale Standard Deviation 17.4	-4.5 score on a scale Standard Deviation 17.5	-8.2 score on a scale Standard Deviation 19.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 11 Day 1	-10.6 score on a scale Standard Deviation 20.1	-2.9 score on a scale Standard Deviation 15.9	-5.0 score on a scale Standard Deviation 15.1	-3.8 score on a scale Standard Deviation 12.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 12 Day 1	-8.7 score on a scale Standard Deviation 21.5	-4.0 score on a scale Standard Deviation 14.6	-3.9 score on a scale Standard Deviation 13.6	-4.5 score on a scale Standard Deviation 14.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at Cycle 13 Day 1	-7.7 score on a scale Standard Deviation 20.7	-3.9 score on a scale Standard Deviation 16.1	-6.5 score on a scale Standard Deviation 15.7	-5.2 score on a scale Standard Deviation 12.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at End of Treatment	-4.9 score on a scale Standard Deviation 17.3	-3.5 score on a scale Standard Deviation 19.5	-4.0 score on a scale Standard Deviation 17.2	-6.9 score on a scale Standard Deviation 14.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 13 Weeks	-4.4 score on a scale Standard Deviation 14.9	-1.6 score on a scale Standard Deviation 14.1	-1.5 score on a scale Standard Deviation 14.0	-3.5 score on a scale Standard Deviation 14.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 26 Weeks	-2.8 score on a scale Standard Deviation 16.2	-2.5 score on a scale Standard Deviation 14.2	-2.1 score on a scale Standard Deviation 15.4	-3.8 score on a scale Standard Deviation 13.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 39 Weeks	-2.1 score on a scale Standard Deviation 13.2	-1.0 score on a scale Standard Deviation 14.6	-2.0 score on a scale Standard Deviation 11.9	-3.0 score on a scale Standard Deviation 11.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 52 Weeks	-3.5 score on a scale Standard Deviation 17.3	-1.9 score on a scale Standard Deviation 9.1	1.2 score on a scale Standard Deviation 13.0	-7.3 score on a scale Standard Deviation 12.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 65 Weeks	-4.4 score on a scale Standard Deviation 17.3	-3.9 score on a scale Standard Deviation 15.2	-1.0 score on a scale Standard Deviation 12.5	-4.6 score on a scale Standard Deviation 11.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 78 Weeks	-2.5 score on a scale Standard Deviation 17.2	-3.5 score on a scale Standard Deviation 19.4	-1.1 score on a scale Standard Deviation 14.7	-7.4 score on a scale Standard Deviation 12.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 91 Weeks	-2.5 score on a scale Standard Deviation 16.2	-2.3 score on a scale Standard Deviation 15.9	3.3 score on a scale Standard Deviation 11.3	-5.6 score on a scale Standard Deviation 13.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 104 Weeks	1.2 score on a scale Standard Deviation 14.6	-4.0 score on a scale Standard Deviation 16.9	3.3 score on a scale Standard Deviation 13.1	-5.6 score on a scale Standard Deviation 11.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 117 Weeks	1.5 score on a scale Standard Deviation 12.5	0.0 score on a scale Standard Deviation 10.2	-2.1 score on a scale Standard Deviation 5.9	-6.7 score on a scale Standard Deviation 14.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 130 Weeks	-3.9 score on a scale Standard Deviation 15.1	-1.4 score on a scale Standard Deviation 15.0	0.0 score on a scale Standard Deviation 0.0	-6.7 score on a scale Standard Deviation 14.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 143 Weeks	4.8 score on a scale Standard Deviation 18.5	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	-8.3 score on a scale Standard Deviation 11.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 156 Weeks	11.1 score on a scale Standard Deviation 19.2	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	-16.7 score on a scale Standard Deviation 23.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 169 Weeks	16.7 score on a scale Standard Deviation 23.6	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT 182 Weeks	11.1 score on a scale Standard Deviation 19.2	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Cognitive Functioning: Change at PT/Discontin.	-2.1 score on a scale Standard Deviation 16.5	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	-5.6 score on a scale Standard Deviation 8.6	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Cycle 1 Day 1 (Baseline)	3.1 score on a scale Standard Deviation 10.6	5.7 score on a scale Standard Deviation 16.3	4.6 score on a scale Standard Deviation 12.6	5.7 score on a scale Standard Deviation 15.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 1 Day 8	-2.9 score on a scale Standard Deviation 13.9	0.0 score on a scale Standard Deviation 0.0	-2.1 score on a scale Standard Deviation 8.3	-5.3 score on a scale Standard Deviation 12.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 1 Day 15	2.1 score on a scale Standard Deviation 17.0	0.7 score on a scale Standard Deviation 13.0	1.7 score on a scale Standard Deviation 13.9	-0.4 score on a scale Standard Deviation 16.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 1 Day 22	-1.6 score on a scale Standard Deviation 19.7	1.6 score on a scale Standard Deviation 7.3	0.0 score on a scale Standard Deviation 12.6	-3.9 score on a scale Standard Deviation 16.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 2 Day 1	1.1 score on a scale Standard Deviation 12.7	1.4 score on a scale Standard Deviation 10.4	1.6 score on a scale Standard Deviation 13.8	-0.4 score on a scale Standard Deviation 16.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 2 Day 15	1.4 score on a scale Standard Deviation 14.8	0.0 score on a scale Standard Deviation 13.0	0.0 score on a scale Standard Deviation 11.9	-1.3 score on a scale Standard Deviation 15.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 3 Day 1	-1.2 score on a scale Standard Deviation 12.4	1.0 score on a scale Standard Deviation 13.9	0.4 score on a scale Standard Deviation 12.5	-1.7 score on a scale Standard Deviation 18.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 4 Day 1	0.6 score on a scale Standard Deviation 11.5	0.5 score on a scale Standard Deviation 16.8	0.0 score on a scale Standard Deviation 10.7	-2.2 score on a scale Standard Deviation 14.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 5 Day 1	-0.6 score on a scale Standard Deviation 9.1	0.3 score on a scale Standard Deviation 16.7	3.8 score on a scale Standard Deviation 14.4	-3.1 score on a scale Standard Deviation 17.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 6 Day 1	0.6 score on a scale Standard Deviation 13.1	1.8 score on a scale Standard Deviation 16.6	5.4 score on a scale Standard Deviation 16.9	-3.7 score on a scale Standard Deviation 20.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 7 Day 1	3.1 score on a scale Standard Deviation 18.1	1.5 score on a scale Standard Deviation 19.0	3.0 score on a scale Standard Deviation 12.6	-4.0 score on a scale Standard Deviation 15.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 8 Day 1	1.9 score on a scale Standard Deviation 14.6	1.6 score on a scale Standard Deviation 16.2	4.2 score on a scale Standard Deviation 15.1	-1.9 score on a scale Standard Deviation 17.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 9 Day 1	1.4 score on a scale Standard Deviation 11.7	-2.3 score on a scale Standard Deviation 13.5	3.2 score on a scale Standard Deviation 14.4	-0.6 score on a scale Standard Deviation 20.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 10 Day 1	1.4 score on a scale Standard Deviation 10.7	-1.4 score on a scale Standard Deviation 12.7	1.6 score on a scale Standard Deviation 11.2	-4.3 score on a scale Standard Deviation 17.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 11 Day 1	2.2 score on a scale Standard Deviation 14.7	0.0 score on a scale Standard Deviation 16.3	2.4 score on a scale Standard Deviation 14.0	-4.9 score on a scale Standard Deviation 15.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 12 Day 1	4.8 score on a scale Standard Deviation 19.1	-1.8 score on a scale Standard Deviation 14.4	3.1 score on a scale Standard Deviation 13.4	-3.5 score on a scale Standard Deviation 14.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at Cycle 13 Day 1	4.1 score on a scale Standard Deviation 18.5	0.0 score on a scale Standard Deviation 18.8	0.0 score on a scale Standard Deviation 11.2	-3.7 score on a scale Standard Deviation 19.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at End of Treatment	3.3 score on a scale Standard Deviation 15.1	2.4 score on a scale Standard Deviation 19.1	4.5 score on a scale Standard Deviation 17.3	-1.4 score on a scale Standard Deviation 17.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 13 Weeks	0.4 score on a scale Standard Deviation 17.1	-0.5 score on a scale Standard Deviation 17.0	6.0 score on a scale Standard Deviation 16.9	0.9 score on a scale Standard Deviation 21.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 26 Weeks	-0.4 score on a scale Standard Deviation 13.8	-0.9 score on a scale Standard Deviation 13.8	2.8 score on a scale Standard Deviation 9.4	-1.0 score on a scale Standard Deviation 18.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 39 Weeks	0.4 score on a scale Standard Deviation 14.8	-0.5 score on a scale Standard Deviation 13.6	2.4 score on a scale Standard Deviation 13.7	-4.0 score on a scale Standard Deviation 16.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 52 Weeks	0.0 score on a scale Standard Deviation 13.4	0.0 score on a scale Standard Deviation 14.8	0.0 score on a scale Standard Deviation 9.2	0.0 score on a scale Standard Deviation 13.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 10 Day 1	7.3 score on a scale Standard Deviation 18.9	1.7 score on a scale Standard Deviation 15.5	4.8 score on a scale Standard Deviation 15.7	0.0 score on a scale Standard Deviation 12.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 65 Weeks	3.8 score on a scale Standard Deviation 14.1	3.6 score on a scale Standard Deviation 21.9	2.0 score on a scale Standard Deviation 14.3	0.0 score on a scale Standard Deviation 11.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 78 Weeks	-1.4 score on a scale Standard Deviation 9.8	6.1 score on a scale Standard Deviation 25.6	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 130 Weeks	0.0 score on a scale Standard Deviation 0.0	2.8 score on a scale Standard Deviation 17.2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 11 Day 1	5.4 score on a scale Standard Deviation 19.2	1.8 score on a scale Standard Deviation 14.2	4.7 score on a scale Standard Deviation 13.3	0.7 score on a scale Standard Deviation 12.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 143 Weeks	-4.8 score on a scale Standard Deviation 12.6	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 156 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	16.7 score on a scale Standard Deviation 23.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 169 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 91 Weeks	-4.3 score on a scale Standard Deviation 11.4	6.0 score on a scale Standard Deviation 18.3	2.2 score on a scale Standard Deviation 8.6	0.0 score on a scale Standard Deviation 14.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 104 Weeks	1.3 score on a scale Standard Deviation 14.8	4.0 score on a scale Standard Deviation 14.7	-3.3 score on a scale Standard Deviation 10.5	0.0 score on a scale Standard Deviation 16.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 117 Weeks	-6.7 score on a scale Standard Deviation 13.7	9.8 score on a scale Standard Deviation 19.6	0.0 score on a scale Standard Deviation 0.0	-6.7 score on a scale Standard Deviation 14.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 130 Weeks	-8.3 score on a scale Standard Deviation 14.9	5.6 score on a scale Standard Deviation 13.0	0.0 score on a scale Standard Deviation 23.6	-6.7 score on a scale Standard Deviation 14.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 143 Weeks	-9.5 score on a scale Standard Deviation 16.3	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 156 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	-16.7 score on a scale Standard Deviation 23.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 169 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT 182 Weeks	-11.1 score on a scale Standard Deviation 19.2	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Constipation: Change at PT/Discontinuation	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Cycle 1 Day 1 (Baseline)	4.1 score on a scale Standard Deviation 13.0	5.4 score on a scale Standard Deviation 17.5	3.8 score on a scale Standard Deviation 13.9	4.1 score on a scale Standard Deviation 16.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 1 Day 8	4.2 score on a scale Standard Deviation 11.3	0.0 score on a scale Standard Deviation 10.3	-4.2 score on a scale Standard Deviation 20.6	-8.8 score on a scale Standard Deviation 24.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 1 Day 15	2.5 score on a scale Standard Deviation 21.3	-0.7 score on a scale Standard Deviation 14.7	1.7 score on a scale Standard Deviation 19.4	-1.6 score on a scale Standard Deviation 17.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 1 Day 22	3.0 score on a scale Standard Deviation 9.8	-1.6 score on a scale Standard Deviation 16.6	-2.2 score on a scale Standard Deviation 23.5	-9.8 score on a scale Standard Deviation 25.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 2 Day 1	1.3 score on a scale Standard Deviation 19.9	-0.9 score on a scale Standard Deviation 16.3	4.9 score on a scale Standard Deviation 21.7	0.0 score on a scale Standard Deviation 20.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 3 Day 1	3.4 score on a scale Standard Deviation 21.9	-0.3 score on a scale Standard Deviation 18.4	3.3 score on a scale Standard Deviation 19.4	-0.9 score on a scale Standard Deviation 15.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 4 Day 1	3.9 score on a scale Standard Deviation 23.0	0.3 score on a scale Standard Deviation 19.8	5.6 score on a scale Standard Deviation 18.2	-2.6 score on a scale Standard Deviation 18.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 12 Day 1	8.5 score on a scale Standard Deviation 20.9	1.5 score on a scale Standard Deviation 14.0	7.3 score on a scale Standard Deviation 15.3	0.0 score on a scale Standard Deviation 11.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at Cycle 13 Day 1	5.7 score on a scale Standard Deviation 17.2	1.9 score on a scale Standard Deviation 13.6	6.2 score on a scale Standard Deviation 14.6	0.7 score on a scale Standard Deviation 11.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at End of Treatment	2.7 score on a scale Standard Deviation 16.3	0.8 score on a scale Standard Deviation 20.1	5.1 score on a scale Standard Deviation 18.7	2.7 score on a scale Standard Deviation 18.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 13 Weeks	0.0 score on a scale Standard Deviation 13.2	1.8 score on a scale Standard Deviation 16.5	-1.2 score on a scale Standard Deviation 6.3	1.8 score on a scale Standard Deviation 10.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 26 Weeks	0.7 score on a scale Standard Deviation 16.6	-1.4 score on a scale Standard Deviation 15.3	3.5 score on a scale Standard Deviation 17.4	1.0 score on a scale Standard Deviation 12.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 39 Weeks	-0.4 score on a scale Standard Deviation 12.5	-0.5 score on a scale Standard Deviation 7.0	-0.8 score on a scale Standard Deviation 9.0	2.0 score on a scale Standard Deviation 14.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 65 Weeks	-1.9 score on a scale Standard Deviation 12.1	0.9 score on a scale Standard Deviation 14.5	0.0 score on a scale Standard Deviation 0.0	5.6 score on a scale Standard Deviation 17.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 78 Weeks	-0.7 score on a scale Standard Deviation 11.1	2.0 score on a scale Standard Deviation 14.3	0.0 score on a scale Standard Deviation 0.0	3.7 score on a scale Standard Deviation 11.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 130 Weeks	-2.0 score on a scale Standard Deviation 8.1	-2.8 score on a scale Standard Deviation 43.7	6.7 score on a scale Standard Deviation 14.9	13.3 score on a scale Standard Deviation 18.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 143 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 156 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 169 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 182 Weeks	0.0 score on a scale Standard Deviation 0.0	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT/Discontinuation	0.0 score on a scale Standard Deviation 17.8	-33.3 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Cycle 1 Day 1 (Baseline)	3.6 score on a scale Standard Deviation 10.4	4.8 score on a scale Standard Deviation 12.9	5.0 score on a scale Standard Deviation 12.0	3.0 score on a scale Standard Deviation 10.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 7 Day 1	9.4 score on a scale Standard Deviation 24.2	-1.5 score on a scale Standard Deviation 21.6	4.9 score on a scale Standard Deviation 22.5	-4.5 score on a scale Standard Deviation 18.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 8 Day 1	5.1 score on a scale Standard Deviation 19.6	-0.9 score on a scale Standard Deviation 21.3	5.6 score on a scale Standard Deviation 20.9	-3.2 score on a scale Standard Deviation 16.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 9 Day 1	7.7 score on a scale Standard Deviation 25.0	0.7 score on a scale Standard Deviation 24.5	4.3 score on a scale Standard Deviation 19.5	-1.9 score on a scale Standard Deviation 23.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 10 Day 1	6.9 score on a scale Standard Deviation 21.6	-0.3 score on a scale Standard Deviation 22.3	5.9 score on a scale Standard Deviation 23.8	-2.1 score on a scale Standard Deviation 18.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 11 Day 1	6.1 score on a scale Standard Deviation 19.6	1.1 score on a scale Standard Deviation 23.3	4.7 score on a scale Standard Deviation 23.1	-0.7 score on a scale Standard Deviation 20.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 12 Day 1	7.4 score on a scale Standard Deviation 25.4	-0.7 score on a scale Standard Deviation 23.3	7.9 score on a scale Standard Deviation 24.8	-0.7 score on a scale Standard Deviation 19.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at Cycle 13 Day 1	8.5 score on a scale Standard Deviation 24.5	0.4 score on a scale Standard Deviation 25.4	8.0 score on a scale Standard Deviation 28.9	-1.5 score on a scale Standard Deviation 20.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at End of Treatment	0.8 score on a scale Standard Deviation 21.5	0.0 score on a scale Standard Deviation 20.7	-1.0 score on a scale Standard Deviation 16.4	-1.8 score on a scale Standard Deviation 18.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 13 Weeks	-0.4 score on a scale Standard Deviation 15.4	-1.8 score on a scale Standard Deviation 24.0	0.0 score on a scale Standard Deviation 18.0	0.0 score on a scale Standard Deviation 15.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 26 Weeks	-2.2 score on a scale Standard Deviation 16.5	-3.2 score on a scale Standard Deviation 24.5	0.7 score on a scale Standard Deviation 8.5	-1.9 score on a scale Standard Deviation 19.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 39 Weeks	-1.7 score on a scale Standard Deviation 15.9	-4.9 score on a scale Standard Deviation 23.2	1.6 score on a scale Standard Deviation 14.8	0.0 score on a scale Standard Deviation 18.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 52 Weeks	-1.8 score on a scale Standard Deviation 17.2	-3.8 score on a scale Standard Deviation 23.5	-1.2 score on a scale Standard Deviation 21.6	0.0 score on a scale Standard Deviation 19.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 65 Weeks	0.0 score on a scale Standard Deviation 19.6	-6.1 score on a scale Standard Deviation 29.9	2.0 score on a scale Standard Deviation 8.1	-7.4 score on a scale Standard Deviation 24.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 78 Weeks	-0.7 score on a scale Standard Deviation 20.5	-7.1 score on a scale Standard Deviation 29.8	0.0 score on a scale Standard Deviation 0.0	-3.7 score on a scale Standard Deviation 11.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 91 Weeks	4.0 score on a scale Standard Deviation 16.2	-9.2 score on a scale Standard Deviation 25.0	0.0 score on a scale Standard Deviation 0.0	-8.3 score on a scale Standard Deviation 28.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 104 Weeks	0.0 score on a scale Standard Deviation 9.2	-5.3 score on a scale Standard Deviation 28.3	3.3 score on a scale Standard Deviation 10.5	-11.1 score on a scale Standard Deviation 33.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Diarrhoea: Change at PT 117 Weeks	0.0 score on a scale Standard Deviation 10.3	-11.8 score on a scale Standard Deviation 31.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 9 Day 1	5.5 score on a scale Standard Deviation 15.7	2.5 score on a scale Standard Deviation 10.4	4.0 score on a scale Standard Deviation 10.2	0.3 score on a scale Standard Deviation 7.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 12 Day 1	4.3 score on a scale Standard Deviation 12.6	1.3 score on a scale Standard Deviation 7.9	4.8 score on a scale Standard Deviation 10.5	3.5 score on a scale Standard Deviation 13.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at End of Treatment	0.9 score on a scale Standard Deviation 6.5	0.3 score on a scale Standard Deviation 12.5	1.5 score on a scale Standard Deviation 11.9	3.8 score on a scale Standard Deviation 13.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 13 Weeks	0.2 score on a scale Standard Deviation 6.4	1.8 score on a scale Standard Deviation 8.5	0.6 score on a scale Standard Deviation 6.3	0.9 score on a scale Standard Deviation 6.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 26 Weeks	2.2 score on a scale Standard Deviation 8.7	0.7 score on a scale Standard Deviation 15.7	0.7 score on a scale Standard Deviation 10.4	-1.0 score on a scale Standard Deviation 3.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 39 Weeks	0.2 score on a scale Standard Deviation 5.7	0.2 score on a scale Standard Deviation 6.1	1.6 score on a scale Standard Deviation 8.1	1.5 score on a scale Standard Deviation 6.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 52 Weeks	0.9 score on a scale Standard Deviation 6.0	0.3 score on a scale Standard Deviation 4.8	0.0 score on a scale Standard Deviation 4.6	0.7 score on a scale Standard Deviation 3.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 65 Weeks	0.0 score on a scale Standard Deviation 5.7	3.5 score on a scale Standard Deviation 12.9	-1.0 score on a scale Standard Deviation 4.0	2.8 score on a scale Standard Deviation 8.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 78 Weeks	0.4 score on a scale Standard Deviation 5.5	2.0 score on a scale Standard Deviation 11.6	-1.1 score on a scale Standard Deviation 4.3	1.9 score on a scale Standard Deviation 5.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 91 Weeks	1.6 score on a scale Standard Deviation 6.5	2.3 score on a scale Standard Deviation 8.6	-1.1 score on a scale Standard Deviation 4.3	1.4 score on a scale Standard Deviation 4.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 104 Weeks	1.9 score on a scale Standard Deviation 10.7	0.0 score on a scale Standard Deviation 4.8	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 1 Day 8	4.2 score on a scale Standard Deviation 11.3	-1.5 score on a scale Standard Deviation 7.1	4.2 score on a scale Standard Deviation 16.7	-1.8 score on a scale Standard Deviation 7.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 117 Weeks	-1.5 score on a scale Standard Deviation 4.9	4.9 score on a scale Standard Deviation 9.8	-1.9 score on a scale Standard Deviation 5.6	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 1 Day 15	6.3 score on a scale Standard Deviation 18.9	0.2 score on a scale Standard Deviation 8.5	2.9 score on a scale Standard Deviation 15.2	1.2 score on a scale Standard Deviation 12.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 1 Day 22	4.8 score on a scale Standard Deviation 12.0	-1.6 score on a scale Standard Deviation 7.3	0.0 score on a scale Standard Deviation 17.8	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 143 Weeks	-2.4 score on a scale Standard Deviation 6.3	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 156 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	8.3 score on a scale Standard Deviation 11.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 2 Day 1	1.9 score on a scale Standard Deviation 13.5	0.2 score on a scale Standard Deviation 11.6	4.8 score on a scale Standard Deviation 20.9	3.2 score on a scale Standard Deviation 14.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 169 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 2 Day 15	2.8 score on a scale Standard Deviation 16.0	1.0 score on a scale Standard Deviation 13.5	4.6 score on a scale Standard Deviation 18.9	4.1 score on a scale Standard Deviation 17.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 3 Day 1	3.4 score on a scale Standard Deviation 17.0	1.8 score on a scale Standard Deviation 13.4	3.7 score on a scale Standard Deviation 18.3	3.8 score on a scale Standard Deviation 12.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 4 Day 1	3.1 score on a scale Standard Deviation 15.6	3.1 score on a scale Standard Deviation 14.7	3.0 score on a scale Standard Deviation 18.8	1.8 score on a scale Standard Deviation 14.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 5 Day 1	5.2 score on a scale Standard Deviation 14.4	4.0 score on a scale Standard Deviation 14.7	3.7 score on a scale Standard Deviation 19.0	3.1 score on a scale Standard Deviation 15.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 6 Day 1	3.8 score on a scale Standard Deviation 16.8	2.4 score on a scale Standard Deviation 13.9	3.9 score on a scale Standard Deviation 19.4	2.1 score on a scale Standard Deviation 15.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 7 Day 1	5.3 score on a scale Standard Deviation 16.7	3.7 score on a scale Standard Deviation 17.3	3.9 score on a scale Standard Deviation 17.8	2.8 score on a scale Standard Deviation 12.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 8 Day 1	4.2 score on a scale Standard Deviation 16.5	4.1 score on a scale Standard Deviation 17.6	2.6 score on a scale Standard Deviation 14.8	3.1 score on a scale Standard Deviation 13.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 9 Day 1	5.7 score on a scale Standard Deviation 17.1	5.3 score on a scale Standard Deviation 16.8	2.1 score on a scale Standard Deviation 16.8	4.5 score on a scale Standard Deviation 18.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 10 Day 1	5.2 score on a scale Standard Deviation 20.1	4.5 score on a scale Standard Deviation 16.4	6.3 score on a scale Standard Deviation 18.8	3.5 score on a scale Standard Deviation 12.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 11 Day 1	5.7 score on a scale Standard Deviation 19.4	5.0 score on a scale Standard Deviation 19.0	7.0 score on a scale Standard Deviation 20.6	3.5 score on a scale Standard Deviation 14.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 12 Day 1	6.7 score on a scale Standard Deviation 24.1	5.5 score on a scale Standard Deviation 18.1	3.6 score on a scale Standard Deviation 18.9	5.6 score on a scale Standard Deviation 15.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at Cycle 13 Day 1	6.5 score on a scale Standard Deviation 19.2	4.9 score on a scale Standard Deviation 15.5	4.9 score on a scale Standard Deviation 19.9	5.9 score on a scale Standard Deviation 14.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 13 Weeks	3.0 score on a scale Standard Deviation 17.1	3.2 score on a scale Standard Deviation 16.7	3.0 score on a scale Standard Deviation 16.1	2.6 score on a scale Standard Deviation 12.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 65 Weeks	3.8 score on a scale Standard Deviation 14.1	6.1 score on a scale Standard Deviation 15.2	-3.9 score on a scale Standard Deviation 11.1	1.9 score on a scale Standard Deviation 7.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 91 Weeks	3.0 score on a scale Standard Deviation 9.7	5.7 score on a scale Standard Deviation 12.8	-2.2 score on a scale Standard Deviation 15.3	0.0 score on a scale Standard Deviation 14.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 117 Weeks	0.0 score on a scale Standard Deviation 14.5	5.9 score on a scale Standard Deviation 13.1	-3.7 score on a scale Standard Deviation 20.0	6.7 score on a scale Standard Deviation 14.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 143 Weeks	9.5 score on a scale Standard Deviation 25.2	0.0 score on a scale Standard Deviation 0.0	-11.1 score on a scale Standard Deviation 19.2	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 156 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	16.7 score on a scale Standard Deviation 23.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 169 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT 182 Weeks	0.0 score on a scale Standard Deviation 0.0	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Dyspnoea: Change at PT/Discontinuation	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Cycle 1 Day 1 (Baseline)	83.8 score on a scale Standard Deviation 15.1	86.1 score on a scale Standard Deviation 16.4	81.6 score on a scale Standard Deviation 21.5	84.5 score on a scale Standard Deviation 17.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 1 Day 8	-4.5 score on a scale Standard Deviation 15.5	1.9 score on a scale Standard Deviation 12.0	3.6 score on a scale Standard Deviation 11.4	1.8 score on a scale Standard Deviation 14.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 1 Day 15	-5.2 score on a scale Standard Deviation 18.0	1.9 score on a scale Standard Deviation 12.3	-1.0 score on a scale Standard Deviation 16.6	3.8 score on a scale Standard Deviation 12.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 1 Day 22	-6.4 score on a scale Standard Deviation 20.6	2.4 score on a scale Standard Deviation 9.9	-0.6 score on a scale Standard Deviation 12.8	-0.5 score on a scale Standard Deviation 17.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 2 Day 15	0.2 score on a scale Standard Deviation 18.7	2.0 score on a scale Standard Deviation 15.4	-0.5 score on a scale Standard Deviation 11.7	3.8 score on a scale Standard Deviation 13.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 3 Day 1	-0.1 score on a scale Standard Deviation 17.3	2.3 score on a scale Standard Deviation 13.2	-0.8 score on a scale Standard Deviation 16.8	3.5 score on a scale Standard Deviation 13.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 4 Day 1	-2.7 score on a scale Standard Deviation 18.9	1.8 score on a scale Standard Deviation 15.1	-1.2 score on a scale Standard Deviation 15.9	2.4 score on a scale Standard Deviation 14.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 5 Day 1	-3.5 score on a scale Standard Deviation 19.8	-0.2 score on a scale Standard Deviation 18.4	-0.8 score on a scale Standard Deviation 15.4	3.0 score on a scale Standard Deviation 14.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 6 Day 1	-2.8 score on a scale Standard Deviation 17.5	-0.7 score on a scale Standard Deviation 16.7	-2.6 score on a scale Standard Deviation 16.0	1.4 score on a scale Standard Deviation 18.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 7 Day 1	-3.0 score on a scale Standard Deviation 18.5	0.5 score on a scale Standard Deviation 16.4	-2.3 score on a scale Standard Deviation 16.1	-0.5 score on a scale Standard Deviation 14.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 8 Day 1	-3.5 score on a scale Standard Deviation 20.0	-0.9 score on a scale Standard Deviation 15.5	-1.9 score on a scale Standard Deviation 15.9	0.2 score on a scale Standard Deviation 13.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 9 Day 1	-1.6 score on a scale Standard Deviation 22.1	-0.9 score on a scale Standard Deviation 17.0	0.1 score on a scale Standard Deviation 15.8	-0.2 score on a scale Standard Deviation 16.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 10 Day 1	-1.0 score on a scale Standard Deviation 20.5	-1.1 score on a scale Standard Deviation 14.3	-0.1 score on a scale Standard Deviation 16.5	0.0 score on a scale Standard Deviation 14.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 11 Day 1	0.0 score on a scale Standard Deviation 19.6	0.5 score on a scale Standard Deviation 14.1	1.2 score on a scale Standard Deviation 15.7	0.7 score on a scale Standard Deviation 14.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at Cycle 13 Day 1	-2.0 score on a scale Standard Deviation 20.4	-2.5 score on a scale Standard Deviation 18.6	0.2 score on a scale Standard Deviation 16.5	0.2 score on a scale Standard Deviation 13.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at End of Treatment	1.5 score on a scale Standard Deviation 18.8	-2.0 score on a scale Standard Deviation 19.6	2.2 score on a scale Standard Deviation 22.2	-4.4 score on a scale Standard Deviation 19.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 13 Weeks	3.2 score on a scale Standard Deviation 17.4	-1.0 score on a scale Standard Deviation 19.5	6.4 score on a scale Standard Deviation 16.7	3.5 score on a scale Standard Deviation 13.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 26 Weeks	4.9 score on a scale Standard Deviation 18.3	-1.4 score on a scale Standard Deviation 14.1	3.0 score on a scale Standard Deviation 18.2	1.2 score on a scale Standard Deviation 16.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 39 Weeks	2.5 score on a scale Standard Deviation 15.5	-0.2 score on a scale Standard Deviation 14.9	4.1 score on a scale Standard Deviation 19.0	2.3 score on a scale Standard Deviation 12.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 52 Weeks	2.4 score on a scale Standard Deviation 17.8	-0.7 score on a scale Standard Deviation 16.3	9.0 score on a scale Standard Deviation 16.8	1.7 score on a scale Standard Deviation 14.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 65 Weeks	1.1 score on a scale Standard Deviation 17.9	-2.0 score on a scale Standard Deviation 17.5	10.3 score on a scale Standard Deviation 17.1	3.7 score on a scale Standard Deviation 16.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 91 Weeks	1.8 score on a scale Standard Deviation 16.8	0.0 score on a scale Standard Deviation 17.3	13.3 score on a scale Standard Deviation 16.6	-0.7 score on a scale Standard Deviation 20.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 104 Weeks	6.5 score on a scale Standard Deviation 14.3	-7.0 score on a scale Standard Deviation 21.9	4.2 score on a scale Standard Deviation 13.2	1.9 score on a scale Standard Deviation 20.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 117 Weeks	7.2 score on a scale Standard Deviation 12.7	-2.9 score on a scale Standard Deviation 14.7	0.0 score on a scale Standard Deviation 16.7	3.3 score on a scale Standard Deviation 29.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 130 Weeks	8.7 score on a scale Standard Deviation 12.8	-4.9 score on a scale Standard Deviation 15.3	3.3 score on a scale Standard Deviation 20.1	1.7 score on a scale Standard Deviation 32.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 143 Weeks	0.0 score on a scale Standard Deviation 18.0	-4.2 score on a scale Standard Deviation 5.9	0.0 score on a scale Standard Deviation 25.0	-16.7 score on a scale Standard Deviation 23.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 156 Weeks	22.2 score on a scale Standard Deviation 9.6	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable	—	4.2 score on a scale Standard Deviation 53.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 169 Weeks	25.0 score on a scale Standard Deviation 11.8	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT 182 Weeks	16.7 score on a scale Standard Deviation 16.7	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Emotional functioning: Change at PT/Discont.	-5.2 score on a scale Standard Deviation 28.1	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	1.4 score on a scale Standard Deviation 11.1	8.3 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Cycle 1 Day 1 (Baseline)	13.2 score on a scale Standard Deviation 14.7	16.1 score on a scale Standard Deviation 19.4	15.5 score on a scale Standard Deviation 18.2	14.7 score on a scale Standard Deviation 18.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 1 Day 8	7.9 score on a scale Standard Deviation 19.0	-0.3 score on a scale Standard Deviation 9.8	7.6 score on a scale Standard Deviation 13.3	5.3 score on a scale Standard Deviation 10.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 1 Day 15	22.6 score on a scale Standard Deviation 26.1	2.3 score on a scale Standard Deviation 14.2	18.2 score on a scale Standard Deviation 27.0	3.4 score on a scale Standard Deviation 13.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 1 Day 22	15.2 score on a scale Standard Deviation 21.3	-1.9 score on a scale Standard Deviation 14.4	17.0 score on a scale Standard Deviation 21.4	9.2 score on a scale Standard Deviation 15.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 2 Day 1	13.2 score on a scale Standard Deviation 22.0	2.5 score on a scale Standard Deviation 15.2	13.7 score on a scale Standard Deviation 24.2	2.5 score on a scale Standard Deviation 14.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 2 Day 15	15.2 score on a scale Standard Deviation 23.5	1.5 score on a scale Standard Deviation 18.2	10.7 score on a scale Standard Deviation 19.9	2.1 score on a scale Standard Deviation 16.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 3 Day 1	14.1 score on a scale Standard Deviation 22.5	1.5 score on a scale Standard Deviation 16.4	12.6 score on a scale Standard Deviation 23.1	4.7 score on a scale Standard Deviation 15.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 4 Day 1	12.6 score on a scale Standard Deviation 21.7	2.0 score on a scale Standard Deviation 18.4	13.3 score on a scale Standard Deviation 23.1	3.2 score on a scale Standard Deviation 18.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT 182 Weeks	0.0 score on a scale Standard Deviation 0.0	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at PT/Discont.	4.2 score on a scale Standard Deviation 11.8	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	8.3 score on a scale Standard Deviation 13.9	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 6 Day 1	11.9 score on a scale Standard Deviation 21.6	1.5 score on a scale Standard Deviation 17.4	13.8 score on a scale Standard Deviation 22.2	3.0 score on a scale Standard Deviation 18.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Cycle 1 Day 1 (Baseline)	11.6 score on a scale Standard Deviation 17.5	12.8 score on a scale Standard Deviation 21.6	10.9 score on a scale Standard Deviation 19.0	14.6 score on a scale Standard Deviation 23.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 7 Day 1	13.1 score on a scale Standard Deviation 21.0	0.2 score on a scale Standard Deviation 18.3	13.2 score on a scale Standard Deviation 23.2	6.0 score on a scale Standard Deviation 17.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 8 Day 1	14.1 score on a scale Standard Deviation 23.9	3.9 score on a scale Standard Deviation 21.9	12.7 score on a scale Standard Deviation 22.7	5.0 score on a scale Standard Deviation 15.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 1 Day 8	9.7 score on a scale Standard Deviation 22.5	-1.5 score on a scale Standard Deviation 15.4	10.4 score on a scale Standard Deviation 14.8	-3.5 score on a scale Standard Deviation 8.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 10 Day 1	11.3 score on a scale Standard Deviation 22.6	3.4 score on a scale Standard Deviation 18.7	11.3 score on a scale Standard Deviation 25.0	3.3 score on a scale Standard Deviation 16.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 11 Day 1	11.5 score on a scale Standard Deviation 22.7	2.7 score on a scale Standard Deviation 18.2	10.7 score on a scale Standard Deviation 20.9	7.6 score on a scale Standard Deviation 18.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 1 Day 15	20.8 score on a scale Standard Deviation 28.5	0.5 score on a scale Standard Deviation 12.4	16.3 score on a scale Standard Deviation 28.1	-1.4 score on a scale Standard Deviation 14.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 1 Day 22	15.9 score on a scale Standard Deviation 28.9	-3.2 score on a scale Standard Deviation 13.6	22.2 score on a scale Standard Deviation 18.5	9.8 score on a scale Standard Deviation 21.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 2 Day 1	12.9 score on a scale Standard Deviation 26.5	0.5 score on a scale Standard Deviation 15.1	15.1 score on a scale Standard Deviation 28.9	-3.8 score on a scale Standard Deviation 18.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 2 Day 15	14.3 score on a scale Standard Deviation 27.5	2.4 score on a scale Standard Deviation 17.2	12.7 score on a scale Standard Deviation 23.3	-3.5 score on a scale Standard Deviation 18.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 3 Day 1	11.8 score on a scale Standard Deviation 20.2	1.2 score on a scale Standard Deviation 16.3	13.2 score on a scale Standard Deviation 25.6	-0.6 score on a scale Standard Deviation 17.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 4 Day 1	9.0 score on a scale Standard Deviation 22.1	4.0 score on a scale Standard Deviation 19.7	12.0 score on a scale Standard Deviation 25.9	-2.4 score on a scale Standard Deviation 19.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 5 Day 1	12.7 score on a scale Standard Deviation 24.3	1.9 score on a scale Standard Deviation 17.6	14.6 score on a scale Standard Deviation 21.1	-4.9 score on a scale Standard Deviation 20.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 6 Day 1	8.8 score on a scale Standard Deviation 22.7	2.2 score on a scale Standard Deviation 18.9	14.5 score on a scale Standard Deviation 22.9	-3.7 score on a scale Standard Deviation 20.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 8 Day 1	11.0 score on a scale Standard Deviation 24.9	3.6 score on a scale Standard Deviation 20.1	12.1 score on a scale Standard Deviation 23.7	-1.6 score on a scale Standard Deviation 18.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 9 Day 1	12.8 score on a scale Standard Deviation 27.5	3.6 score on a scale Standard Deviation 21.2	10.3 score on a scale Standard Deviation 23.5	-0.3 score on a scale Standard Deviation 23.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 10 Day 1	8.9 score on a scale Standard Deviation 22.0	1.9 score on a scale Standard Deviation 17.5	11.6 score on a scale Standard Deviation 24.6	-3.2 score on a scale Standard Deviation 16.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 11 Day 1	10.0 score on a scale Standard Deviation 25.0	2.7 score on a scale Standard Deviation 21.3	13.5 score on a scale Standard Deviation 26.1	-0.7 score on a scale Standard Deviation 24.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 12 Day 1	12.2 score on a scale Standard Deviation 24.6	1.3 score on a scale Standard Deviation 19.8	12.7 score on a scale Standard Deviation 19.5	-2.1 score on a scale Standard Deviation 20.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at Cycle 13 Day 1	11.6 score on a scale Standard Deviation 23.5	3.4 score on a scale Standard Deviation 21.2	16.4 score on a scale Standard Deviation 27.4	-1.9 score on a scale Standard Deviation 22.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at End of Treatment	4.9 score on a scale Standard Deviation 23.4	4.1 score on a scale Standard Deviation 23.3	6.7 score on a scale Standard Deviation 21.1	1.6 score on a scale Standard Deviation 21.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 13 Weeks	-0.6 score on a scale Standard Deviation 17.6	-0.2 score on a scale Standard Deviation 18.2	4.2 score on a scale Standard Deviation 19.7	-4.8 score on a scale Standard Deviation 23.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 26 Weeks	1.1 score on a scale Standard Deviation 21.8	-1.2 score on a scale Standard Deviation 16.6	7.1 score on a scale Standard Deviation 24.0	-4.3 score on a scale Standard Deviation 19.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at Cycle 13 Day 1	11.1 score on a scale Standard Deviation 23.1	4.0 score on a scale Standard Deviation 19.0	13.4 score on a scale Standard Deviation 26.6	4.7 score on a scale Standard Deviation 15.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 39 Weeks	0.6 score on a scale Standard Deviation 19.9	2.2 score on a scale Standard Deviation 22.1	7.5 score on a scale Standard Deviation 23.0	-7.6 score on a scale Standard Deviation 23.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at End of Treatment	6.5 score on a scale Standard Deviation 21.3	2.2 score on a scale Standard Deviation 24.2	3.3 score on a scale Standard Deviation 21.9	6.4 score on a scale Standard Deviation 20.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 13 Weeks	1.6 score on a scale Standard Deviation 18.4	0.7 score on a scale Standard Deviation 19.8	-1.2 score on a scale Standard Deviation 19.0	1.5 score on a scale Standard Deviation 14.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 52 Weeks	2.0 score on a scale Standard Deviation 18.0	0.0 score on a scale Standard Deviation 16.3	9.3 score on a scale Standard Deviation 21.8	-1.3 score on a scale Standard Deviation 20.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 39 Weeks	-1.0 score on a scale Standard Deviation 16.9	0.7 score on a scale Standard Deviation 17.2	-0.5 score on a scale Standard Deviation 18.2	-0.3 score on a scale Standard Deviation 12.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 65 Weeks	-0.3 score on a scale Standard Deviation 19.7	0.9 score on a scale Standard Deviation 21.2	6.9 score on a scale Standard Deviation 15.7	-4.6 score on a scale Standard Deviation 12.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 78 Weeks	0.7 score on a scale Standard Deviation 20.2	2.5 score on a scale Standard Deviation 19.6	1.1 score on a scale Standard Deviation 14.7	-5.6 score on a scale Standard Deviation 8.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 52 Weeks	1.6 score on a scale Standard Deviation 16.7	1.7 score on a scale Standard Deviation 17.6	-1.2 score on a scale Standard Deviation 14.6	1.3 score on a scale Standard Deviation 20.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 65 Weeks	1.3 score on a scale Standard Deviation 16.5	4.4 score on a scale Standard Deviation 18.5	-4.6 score on a scale Standard Deviation 11.8	-1.2 score on a scale Standard Deviation 17.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 78 Weeks	2.4 score on a scale Standard Deviation 16.2	4.7 score on a scale Standard Deviation 20.8	-4.4 score on a scale Standard Deviation 10.1	-4.9 score on a scale Standard Deviation 18.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 91 Weeks	-2.5 score on a scale Standard Deviation 18.7	4.6 score on a scale Standard Deviation 25.9	4.4 score on a scale Standard Deviation 14.7	-9.7 score on a scale Standard Deviation 21.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 91 Weeks	-0.8 score on a scale Standard Deviation 16.3	3.8 score on a scale Standard Deviation 18.8	-3.7 score on a scale Standard Deviation 15.5	-2.8 score on a scale Standard Deviation 26.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 104 Weeks	-1.2 score on a scale Standard Deviation 17.9	11.3 score on a scale Standard Deviation 22.4	3.3 score on a scale Standard Deviation 13.1	-13.0 score on a scale Standard Deviation 21.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 104 Weeks	-1.2 score on a scale Standard Deviation 14.6	8.9 score on a scale Standard Deviation 18.7	-1.1 score on a scale Standard Deviation 17.7	-1.2 score on a scale Standard Deviation 29.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 117 Weeks	-4.5 score on a scale Standard Deviation 18.0	8.8 score on a scale Standard Deviation 22.9	1.9 score on a scale Standard Deviation 13.0	-10.0 score on a scale Standard Deviation 25.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 130 Weeks	2.9 score on a scale Standard Deviation 19.8	6.9 score on a scale Standard Deviation 31.3	6.7 score on a scale Standard Deviation 27.9	-13.3 score on a scale Standard Deviation 32.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 143 Weeks	-2.4 score on a scale Standard Deviation 20.2	8.3 score on a scale Standard Deviation 11.8	5.6 score on a scale Standard Deviation 25.5	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 130 Weeks	-0.7 score on a scale Standard Deviation 15.5	6.5 score on a scale Standard Deviation 19.2	-4.4 score on a scale Standard Deviation 16.9	0.0 score on a scale Standard Deviation 33.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 156 Weeks	-22.2 score on a scale Standard Deviation 19.2	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	8.3 score on a scale Standard Deviation 11.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 169 Weeks	-8.3 score on a scale Standard Deviation 11.8	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT 182 Weeks	-22.2 score on a scale Standard Deviation 19.2	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Pain: Change at PT/Discontin.	12.5 score on a scale Standard Deviation 14.8	-33.3 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	-2.8 score on a scale Standard Deviation 19.5	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 9 Day 1	-11.0 score on a scale Standard Deviation 26.2	1.7 score on a scale Standard Deviation 19.7	-8.2 score on a scale Standard Deviation 22.8	-3.8 score on a scale Standard Deviation 21.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Cycle 1 Day 1 (Baseline)	92.7 score on a scale Standard Deviation 11.0	92.3 score on a scale Standard Deviation 11.6	91.3 score on a scale Standard Deviation 13.6	92.7 score on a scale Standard Deviation 13.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT 182 Weeks	-14.8 score on a scale Standard Deviation 6.4	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 1 Day 8	-4.4 score on a scale Standard Deviation 8.7	0.3 score on a scale Standard Deviation 4.4	-5.0 score on a scale Standard Deviation 6.7	-2.5 score on a scale Standard Deviation 11.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Fatigue: Change at PT/Discontinuation	6.9 score on a scale Standard Deviation 16.7	-22.2 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	-11.1 score on a scale Standard Deviation 25.3	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 1 Day 15	-9.7 score on a scale Standard Deviation 17.4	-0.2 score on a scale Standard Deviation 8.2	-7.4 score on a scale Standard Deviation 15.0	-1.5 score on a scale Standard Deviation 6.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Cycle 1 Day 1 (Baseline)	12.4 score on a scale Standard Deviation 25.2	20.9 score on a scale Standard Deviation 30.0	16.5 score on a scale Standard Deviation 30.4	15.9 score on a scale Standard Deviation 26.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 1 Day 22	-10.3 score on a scale Standard Deviation 16.6	-0.6 score on a scale Standard Deviation 7.0	-10.2 score on a scale Standard Deviation 15.3	-2.7 score on a scale Standard Deviation 9.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 1 Day 8	-9.7 score on a scale Standard Deviation 25.0	-3.0 score on a scale Standard Deviation 14.2	2.1 score on a scale Standard Deviation 8.3	-7.0 score on a scale Standard Deviation 17.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 2 Day 1	-6.2 score on a scale Standard Deviation 14.4	-0.3 score on a scale Standard Deviation 9.1	-9.2 score on a scale Standard Deviation 16.9	-1.8 score on a scale Standard Deviation 8.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 2 Day 15	-7.1 score on a scale Standard Deviation 16.4	-0.7 score on a scale Standard Deviation 10.8	-7.6 score on a scale Standard Deviation 13.9	-1.4 score on a scale Standard Deviation 9.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 3 Day 1	-6.6 score on a scale Standard Deviation 14.8	-0.7 score on a scale Standard Deviation 11.0	-7.3 score on a scale Standard Deviation 15.0	-2.7 score on a scale Standard Deviation 10.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 4 Day 1	-4.9 score on a scale Standard Deviation 13.1	-0.2 score on a scale Standard Deviation 10.8	-7.4 score on a scale Standard Deviation 13.8	-1.0 score on a scale Standard Deviation 10.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 5 Day 1	-6.1 score on a scale Standard Deviation 14.7	-1.0 score on a scale Standard Deviation 11.3	-5.6 score on a scale Standard Deviation 13.3	-1.8 score on a scale Standard Deviation 12.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 6 Day 1	-4.7 score on a scale Standard Deviation 14.5	-0.8 score on a scale Standard Deviation 12.1	-7.5 score on a scale Standard Deviation 15.2	-0.6 score on a scale Standard Deviation 10.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 7 Day 1	-4.7 score on a scale Standard Deviation 13.6	0.4 score on a scale Standard Deviation 11.2	-8.0 score on a scale Standard Deviation 12.7	0.2 score on a scale Standard Deviation 9.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 8 Day 1	-5.2 score on a scale Standard Deviation 13.6	-0.8 score on a scale Standard Deviation 13.1	-6.7 score on a scale Standard Deviation 12.6	-0.3 score on a scale Standard Deviation 11.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 1 Day 15	1.5 score on a scale Standard Deviation 17.5	-1.9 score on a scale Standard Deviation 20.0	0.0 score on a scale Standard Deviation 15.2	-4.4 score on a scale Standard Deviation 21.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 9 Day 1	-6.7 score on a scale Standard Deviation 18.2	-0.5 score on a scale Standard Deviation 12.2	-5.5 score on a scale Standard Deviation 10.6	-1.5 score on a scale Standard Deviation 14.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 2 Day 1	0.0 score on a scale Standard Deviation 17.9	-3.1 score on a scale Standard Deviation 21.0	0.8 score on a scale Standard Deviation 16.5	-4.4 score on a scale Standard Deviation 19.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 2 Day 15	1.1 score on a scale Standard Deviation 20.8	-2.2 score on a scale Standard Deviation 20.1	-0.4 score on a scale Standard Deviation 17.2	-7.2 score on a scale Standard Deviation 20.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 4 Day 1	-0.8 score on a scale Standard Deviation 23.6	-2.8 score on a scale Standard Deviation 24.3	-0.4 score on a scale Standard Deviation 19.7	-5.8 score on a scale Standard Deviation 18.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 10 Day 1	-4.9 score on a scale Standard Deviation 14.0	-1.6 score on a scale Standard Deviation 11.8	-6.5 score on a scale Standard Deviation 13.2	-1.7 score on a scale Standard Deviation 9.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 5 Day 1	1.2 score on a scale Standard Deviation 23.0	-5.5 score on a scale Standard Deviation 26.7	2.3 score on a scale Standard Deviation 18.0	-7.8 score on a scale Standard Deviation 23.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 6 Day 1	-0.6 score on a scale Standard Deviation 22.5	-7.4 score on a scale Standard Deviation 26.4	2.9 score on a scale Standard Deviation 20.4	-5.8 score on a scale Standard Deviation 22.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 7 Day 1	1.9 score on a scale Standard Deviation 26.8	-5.6 score on a scale Standard Deviation 26.1	4.9 score on a scale Standard Deviation 27.2	-5.6 score on a scale Standard Deviation 21.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 11 Day 1	-4.2 score on a scale Standard Deviation 14.4	-1.3 score on a scale Standard Deviation 10.8	-6.0 score on a scale Standard Deviation 12.8	-3.3 score on a scale Standard Deviation 13.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 12 Day 1	-5.4 score on a scale Standard Deviation 15.7	-1.6 score on a scale Standard Deviation 11.5	-4.8 score on a scale Standard Deviation 11.9	-0.6 score on a scale Standard Deviation 10.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at Cycle 13 Day 1	-4.5 score on a scale Standard Deviation 15.0	-3.0 score on a scale Standard Deviation 14.7	-5.6 score on a scale Standard Deviation 12.4	-1.9 score on a scale Standard Deviation 12.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at End of Treatment	-2.8 score on a scale Standard Deviation 13.3	-2.9 score on a scale Standard Deviation 16.0	-5.8 score on a scale Standard Deviation 13.8	-5.1 score on a scale Standard Deviation 14.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 13 Weeks	0.5 score on a scale Standard Deviation 11.3	0.1 score on a scale Standard Deviation 9.8	-0.8 score on a scale Standard Deviation 10.9	-0.5 score on a scale Standard Deviation 12.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 26 Weeks	-1.9 score on a scale Standard Deviation 12.5	0.0 score on a scale Standard Deviation 8.5	-4.1 score on a scale Standard Deviation 10.5	0.6 score on a scale Standard Deviation 12.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 39 Weeks	0.4 score on a scale Standard Deviation 10.7	-1.7 score on a scale Standard Deviation 13.5	-3.3 score on a scale Standard Deviation 13.4	0.6 score on a scale Standard Deviation 8.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 52 Weeks	-1.4 score on a scale Standard Deviation 10.0	-0.5 score on a scale Standard Deviation 11.7	-1.4 score on a scale Standard Deviation 9.6	-1.1 score on a scale Standard Deviation 14.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Appetite Loss: Change at PT 182 Weeks	0.0 score on a scale Standard Deviation 0.0	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 8 Day 1	-0.6 score on a scale Standard Deviation 23.2	-4.7 score on a scale Standard Deviation 27.0	4.1 score on a scale Standard Deviation 26.7	-3.1 score on a scale Standard Deviation 20.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 9 Day 1	2.0 score on a scale Standard Deviation 24.1	-8.9 score on a scale Standard Deviation 23.0	4.2 score on a scale Standard Deviation 23.6	-5.8 score on a scale Standard Deviation 20.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 65 Weeks	-0.9 score on a scale Standard Deviation 8.6	-2.6 score on a scale Standard Deviation 13.6	2.7 score on a scale Standard Deviation 9.7	-0.4 score on a scale Standard Deviation 10.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 78 Weeks	-0.5 score on a scale Standard Deviation 8.6	-1.0 score on a scale Standard Deviation 10.8	2.7 score on a scale Standard Deviation 10.0	-3.7 score on a scale Standard Deviation 11.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 11 Day 1	1.4 score on a scale Standard Deviation 21.4	-7.5 score on a scale Standard Deviation 21.5	0.6 score on a scale Standard Deviation 20.4	-8.3 score on a scale Standard Deviation 22.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 91 Weeks	0.2 score on a scale Standard Deviation 7.2	-3.4 score on a scale Standard Deviation 12.9	-0.9 score on a scale Standard Deviation 10.3	0.0 score on a scale Standard Deviation 17.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 12 Day 1	-0.4 score on a scale Standard Deviation 24.4	-6.3 score on a scale Standard Deviation 23.9	0.0 score on a scale Standard Deviation 26.4	-6.3 score on a scale Standard Deviation 23.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 104 Weeks	2.5 score on a scale Standard Deviation 8.3	-4.9 score on a scale Standard Deviation 10.3	1.3 score on a scale Standard Deviation 11.2	1.5 score on a scale Standard Deviation 18.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 117 Weeks	1.2 score on a scale Standard Deviation 8.1	-7.1 score on a scale Standard Deviation 14.2	0.7 score on a scale Standard Deviation 13.1	2.7 score on a scale Standard Deviation 19.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at Cycle 13 Day 1	1.2 score on a scale Standard Deviation 23.7	-6.0 score on a scale Standard Deviation 22.2	-1.9 score on a scale Standard Deviation 27.8	-8.1 score on a scale Standard Deviation 24.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 91 Weeks	2.6 score on a scale Standard Deviation 21.6	1.7 score on a scale Standard Deviation 20.1	2.2 score on a scale Standard Deviation 13.9	2.8 score on a scale Standard Deviation 12.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 104 Weeks	2.5 score on a scale Standard Deviation 18.3	0.0 score on a scale Standard Deviation 19.2	3.3 score on a scale Standard Deviation 10.5	1.9 score on a scale Standard Deviation 13.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 117 Weeks	9.1 score on a scale Standard Deviation 15.2	2.0 score on a scale Standard Deviation 21.1	-2.1 score on a scale Standard Deviation 5.9	3.3 score on a scale Standard Deviation 18.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 130 Weeks	-1.2 score on a scale Standard Deviation 4.2	-5.0 score on a scale Standard Deviation 11.4	-2.7 score on a scale Standard Deviation 10.1	5.3 score on a scale Standard Deviation 20.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 130 Weeks	9.8 score on a scale Standard Deviation 15.7	6.9 score on a scale Standard Deviation 16.6	0.0 score on a scale Standard Deviation 0.0	10.0 score on a scale Standard Deviation 32.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 143 Weeks	7.1 score on a scale Standard Deviation 18.9	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	-8.3 score on a scale Standard Deviation 11.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 156 Weeks	27.8 score on a scale Standard Deviation 9.6	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 143 Weeks	0.0 score on a scale Standard Deviation 8.6	0.0 score on a scale Standard Deviation 0.0	-4.4 score on a scale Standard Deviation 20.4	-3.3 score on a scale Standard Deviation 4.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 169 Weeks	25.0 score on a scale Standard Deviation 11.8	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 182 Weeks	27.8 score on a scale Standard Deviation 9.6	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT/Discontinuation	-4.2 score on a scale Standard Deviation 21.4	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	0.0 score on a scale Standard Deviation 10.5	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Cycle 1 Day 1 (Baseline)	18.4 score on a scale Standard Deviation 23.2	17.0 score on a scale Standard Deviation 25.4	17.2 score on a scale Standard Deviation 23.2	18.7 score on a scale Standard Deviation 24.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 156 Weeks	2.2 score on a scale Standard Deviation 3.8	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	-6.7 score on a scale Standard Deviation 9.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at End of Treatment	2.5 score on a scale Standard Deviation 23.1	-3.7 score on a scale Standard Deviation 26.5	-2.5 score on a scale Standard Deviation 23.4	-0.9 score on a scale Standard Deviation 23.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 169 Weeks	3.3 score on a scale Standard Deviation 4.7	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT 182 Weeks	2.2 score on a scale Standard Deviation 3.8	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Physical functioning: Change at PT/Discontin.	-0.8 score on a scale Standard Deviation 8.3	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable	10.0 score on a scale Standard Deviation 15.6	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Cycle 1 Day 1 (Baseline)	79.0 score on a scale Standard Deviation 16.7	77.9 score on a scale Standard Deviation 18.4	76.5 score on a scale Standard Deviation 20.6	78.8 score on a scale Standard Deviation 17.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 1 Day 8	-9.4 score on a scale Standard Deviation 20.5	0.4 score on a scale Standard Deviation 7.5	-9.9 score on a scale Standard Deviation 15.9	1.3 score on a scale Standard Deviation 6.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 1 Day 15	-19.1 score on a scale Standard Deviation 24.2	-0.4 score on a scale Standard Deviation 11.4	-14.5 score on a scale Standard Deviation 20.4	-0.3 score on a scale Standard Deviation 11.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 1 Day 22	-17.8 score on a scale Standard Deviation 27.0	1.2 score on a scale Standard Deviation 10.3	-16.7 score on a scale Standard Deviation 19.9	0.5 score on a scale Standard Deviation 11.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 2 Day 1	-9.8 score on a scale Standard Deviation 19.7	-1.2 score on a scale Standard Deviation 14.5	-10.9 score on a scale Standard Deviation 17.6	1.0 score on a scale Standard Deviation 10.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 2 Day 15	-11.5 score on a scale Standard Deviation 21.0	0.2 score on a scale Standard Deviation 13.5	-9.5 score on a scale Standard Deviation 18.0	-1.4 score on a scale Standard Deviation 14.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 3 Day 1	-10.6 score on a scale Standard Deviation 19.0	-1.0 score on a scale Standard Deviation 14.6	-9.4 score on a scale Standard Deviation 17.0	-0.9 score on a scale Standard Deviation 14.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 4 Day 1	-10.2 score on a scale Standard Deviation 19.6	-1.0 score on a scale Standard Deviation 14.9	-8.4 score on a scale Standard Deviation 18.9	-1.8 score on a scale Standard Deviation 15.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 5 Day 1	-12.0 score on a scale Standard Deviation 20.4	-0.1 score on a scale Standard Deviation 15.1	-8.9 score on a scale Standard Deviation 17.3	0.4 score on a scale Standard Deviation 16.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 6 Day 1	-8.9 score on a scale Standard Deviation 18.9	-2.2 score on a scale Standard Deviation 16.1	-12.4 score on a scale Standard Deviation 19.3	-0.5 score on a scale Standard Deviation 16.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 7 Day 1	-10.7 score on a scale Standard Deviation 19.4	-1.6 score on a scale Standard Deviation 16.8	-11.8 score on a scale Standard Deviation 17.9	-2.3 score on a scale Standard Deviation 15.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 8 Day 1	-10.3 score on a scale Standard Deviation 18.3	-1.6 score on a scale Standard Deviation 17.6	-11.2 score on a scale Standard Deviation 20.5	-3.3 score on a scale Standard Deviation 17.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 9 Day 1	-11.3 score on a scale Standard Deviation 21.9	-0.5 score on a scale Standard Deviation 16.9	-8.3 score on a scale Standard Deviation 19.7	-1.6 score on a scale Standard Deviation 16.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 10 Day 1	-7.6 score on a scale Standard Deviation 19.1	-0.7 score on a scale Standard Deviation 15.9	-9.8 score on a scale Standard Deviation 18.7	0.2 score on a scale Standard Deviation 15.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 11 Day 1	-7.8 score on a scale Standard Deviation 19.5	-0.8 score on a scale Standard Deviation 15.3	-8.8 score on a scale Standard Deviation 18.9	-3.1 score on a scale Standard Deviation 18.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 12 Day 1	-9.3 score on a scale Standard Deviation 20.2	-0.8 score on a scale Standard Deviation 16.0	-10.5 score on a scale Standard Deviation 17.4	-3.6 score on a scale Standard Deviation 18.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at Cycle 13 Day 1	-7.5 score on a scale Standard Deviation 17.5	-3.4 score on a scale Standard Deviation 19.4	-9.4 score on a scale Standard Deviation 18.9	-3.9 score on a scale Standard Deviation 15.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at EOT	-5.2 score on a scale Standard Deviation 19.0	-3.6 score on a scale Standard Deviation 19.0	-3.0 score on a scale Standard Deviation 18.4	-7.4 score on a scale Standard Deviation 21.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 13 Weeks	0.1 score on a scale Standard Deviation 16.0	-0.1 score on a scale Standard Deviation 15.7	-1.0 score on a scale Standard Deviation 18.1	0.2 score on a scale Standard Deviation 20.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 1 Day 8	11.1 score on a scale Standard Deviation 18.8	-3.0 score on a scale Standard Deviation 14.2	2.1 score on a scale Standard Deviation 22.7	1.8 score on a scale Standard Deviation 20.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 1 Day 15	6.8 score on a scale Standard Deviation 29.6	1.0 score on a scale Standard Deviation 19.6	9.6 score on a scale Standard Deviation 26.1	-4.4 score on a scale Standard Deviation 21.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 1 Day 22	9.1 score on a scale Standard Deviation 27.6	-3.2 score on a scale Standard Deviation 23.3	6.7 score on a scale Standard Deviation 18.7	-7.8 score on a scale Standard Deviation 22.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 2 Day 1	0.8 score on a scale Standard Deviation 23.9	-1.2 score on a scale Standard Deviation 22.6	2.4 score on a scale Standard Deviation 24.8	-5.6 score on a scale Standard Deviation 19.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 2 Day 15	5.9 score on a scale Standard Deviation 27.7	0.5 score on a scale Standard Deviation 25.2	2.1 score on a scale Standard Deviation 28.7	-3.7 score on a scale Standard Deviation 23.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 3 Day 1	0.6 score on a scale Standard Deviation 25.7	-1.3 score on a scale Standard Deviation 23.0	-0.4 score on a scale Standard Deviation 28.1	-2.6 score on a scale Standard Deviation 22.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 4 Day 1	2.2 score on a scale Standard Deviation 25.6	-1.0 score on a scale Standard Deviation 25.0	3.4 score on a scale Standard Deviation 26.1	-4.9 score on a scale Standard Deviation 23.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 5 Day 1	2.4 score on a scale Standard Deviation 27.4	0.3 score on a scale Standard Deviation 23.8	3.2 score on a scale Standard Deviation 26.9	-5.7 score on a scale Standard Deviation 22.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 6 Day 1	3.1 score on a scale Standard Deviation 28.6	1.8 score on a scale Standard Deviation 25.6	3.4 score on a scale Standard Deviation 26.5	-4.2 score on a scale Standard Deviation 24.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 7 Day 1	4.7 score on a scale Standard Deviation 26.6	-0.3 score on a scale Standard Deviation 25.6	3.4 score on a scale Standard Deviation 23.8	-2.3 score on a scale Standard Deviation 17.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 8 Day 1	4.2 score on a scale Standard Deviation 28.5	0.6 score on a scale Standard Deviation 29.1	7.7 score on a scale Standard Deviation 29.9	-6.3 score on a scale Standard Deviation 18.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 9 Day 1	3.3 score on a scale Standard Deviation 27.8	0.7 score on a scale Standard Deviation 27.1	6.3 score on a scale Standard Deviation 28.6	0.0 score on a scale Standard Deviation 21.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 10 Day 1	1.7 score on a scale Standard Deviation 22.9	0.7 score on a scale Standard Deviation 22.0	4.2 score on a scale Standard Deviation 27.1	-1.4 score on a scale Standard Deviation 19.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 11 Day 1	0.7 score on a scale Standard Deviation 25.0	-0.7 score on a scale Standard Deviation 25.5	5.3 score on a scale Standard Deviation 32.0	1.4 score on a scale Standard Deviation 18.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 12 Day 1	0.7 score on a scale Standard Deviation 24.6	0.0 score on a scale Standard Deviation 27.7	3.6 score on a scale Standard Deviation 29.2	0.0 score on a scale Standard Deviation 23.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at Cycle 13 Day 1	4.1 score on a scale Standard Deviation 26.4	3.8 score on a scale Standard Deviation 31.7	6.2 score on a scale Standard Deviation 29.0	-1.5 score on a scale Standard Deviation 22.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at End Of Treatment	-3.0 score on a scale Standard Deviation 25.3	1.3 score on a scale Standard Deviation 28.8	3.5 score on a scale Standard Deviation 32.4	0.4 score on a scale Standard Deviation 26.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 13 Weeks	-4.4 score on a scale Standard Deviation 21.9	-1.8 score on a scale Standard Deviation 25.2	-2.4 score on a scale Standard Deviation 24.5	-0.9 score on a scale Standard Deviation 22.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 26 Weeks	-2.6 score on a scale Standard Deviation 21.9	0.5 score on a scale Standard Deviation 28.2	-1.4 score on a scale Standard Deviation 23.0	-3.8 score on a scale Standard Deviation 22.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 39 Weeks	-5.9 score on a scale Standard Deviation 23.7	-0.5 score on a scale Standard Deviation 29.6	-2.4 score on a scale Standard Deviation 27.9	-5.1 score on a scale Standard Deviation 23.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 52 Weeks	-3.9 score on a scale Standard Deviation 24.3	0.5 score on a scale Standard Deviation 26.6	-2.5 score on a scale Standard Deviation 26.0	-8.0 score on a scale Standard Deviation 26.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 65 Weeks	-6.3 score on a scale Standard Deviation 23.6	1.8 score on a scale Standard Deviation 21.8	-3.9 score on a scale Standard Deviation 33.1	-3.7 score on a scale Standard Deviation 22.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 78 Weeks	-2.2 score on a scale Standard Deviation 28.5	1.0 score on a scale Standard Deviation 30.6	-4.4 score on a scale Standard Deviation 27.8	-3.7 score on a scale Standard Deviation 26.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 91 Weeks	-4.0 score on a scale Standard Deviation 16.2	-1.1 score on a scale Standard Deviation 25.9	-4.4 score on a scale Standard Deviation 21.3	-2.8 score on a scale Standard Deviation 26.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 104 Weeks	-4.9 score on a scale Standard Deviation 17.8	4.0 score on a scale Standard Deviation 27.8	0.0 score on a scale Standard Deviation 22.2	-3.7 score on a scale Standard Deviation 11.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 117 Weeks	-9.1 score on a scale Standard Deviation 18.3	-7.8 score on a scale Standard Deviation 30.1	0.0 score on a scale Standard Deviation 16.7	-13.3 score on a scale Standard Deviation 29.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 130 Weeks	-7.8 score on a scale Standard Deviation 22.1	-8.3 score on a scale Standard Deviation 20.7	6.7 score on a scale Standard Deviation 27.9	-6.7 score on a scale Standard Deviation 14.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 143 Weeks	-14.3 score on a scale Standard Deviation 17.8	-16.7 score on a scale Standard Deviation 23.6	0.0 score on a scale Standard Deviation 33.3	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 156 Weeks	-11.1 score on a scale Standard Deviation 19.2	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	0.0 score on a scale Standard Deviation 0.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 169 Weeks	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT 182 Weeks	-11.1 score on a scale Standard Deviation 19.2	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Insomnia: Change at PT/Discont.	0.0 score on a scale Standard Deviation 17.8	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	5.6 score on a scale Standard Deviation 25.1	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 26 Weeks	-2.2 score on a scale Standard Deviation 16.2	0.5 score on a scale Standard Deviation 14.8	0.4 score on a scale Standard Deviation 19.5	0.0 score on a scale Standard Deviation 19.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 39 Weeks	-4.1 score on a scale Standard Deviation 21.6	-0.9 score on a scale Standard Deviation 15.2	-0.4 score on a scale Standard Deviation 16.9	-1.3 score on a scale Standard Deviation 19.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 52 Weeks	-2.3 score on a scale Standard Deviation 15.6	-0.7 score on a scale Standard Deviation 15.3	2.2 score on a scale Standard Deviation 13.2	-2.0 score on a scale Standard Deviation 23.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 65 Weeks	-0.9 score on a scale Standard Deviation 17.7	-2.0 score on a scale Standard Deviation 15.1	1.5 score on a scale Standard Deviation 15.1	-0.5 score on a scale Standard Deviation 17.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 78 Weeks	-0.9 score on a scale Standard Deviation 15.6	-1.5 score on a scale Standard Deviation 15.8	1.7 score on a scale Standard Deviation 14.8	-0.9 score on a scale Standard Deviation 13.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 91 Weeks	0.3 score on a scale Standard Deviation 17.4	-2.6 score on a scale Standard Deviation 17.6	6.1 score on a scale Standard Deviation 15.3	-2.1 score on a scale Standard Deviation 24.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 104 Weeks	1.2 score on a scale Standard Deviation 14.9	-4.7 score on a scale Standard Deviation 19.4	-3.3 score on a scale Standard Deviation 19.3	0.0 score on a scale Standard Deviation 29.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 117 Weeks	0.4 score on a scale Standard Deviation 20.5	2.5 score on a scale Standard Deviation 15.0	-1.0 score on a scale Standard Deviation 13.7	6.7 score on a scale Standard Deviation 21.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 130 Weeks	2.1 score on a scale Standard Deviation 7.1	-3.5 score on a scale Standard Deviation 16.8	-3.3 score on a scale Standard Deviation 12.6	5.0 score on a scale Standard Deviation 24.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 143 Weeks	-1.2 score on a scale Standard Deviation 18.9	-4.2 score on a scale Standard Deviation 5.9	-11.1 score on a scale Standard Deviation 9.6	-8.3 score on a scale Standard Deviation 11.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 156 Weeks	11.1 score on a scale Standard Deviation 4.8	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable	—	12.5 score on a scale Standard Deviation 5.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 169 Weeks	8.3 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT 182 Weeks	19.4 score on a scale Standard Deviation 12.7	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Global health status/QoL: Change at PT/Discontin.	-4.2 score on a scale Standard Deviation 19.9	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	0.0 score on a scale Standard Deviation 31.2	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Cycle 1 Day 1 (Baseline)	86.7 score on a scale Standard Deviation 21.9	87.2 score on a scale Standard Deviation 22.5	86.6 score on a scale Standard Deviation 22.0	88.6 score on a scale Standard Deviation 23.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 1 Day 8	-2.8 score on a scale Standard Deviation 15.3	-0.8 score on a scale Standard Deviation 10.9	-1.0 score on a scale Standard Deviation 16.6	4.4 score on a scale Standard Deviation 18.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 1 Day 15	-19.4 score on a scale Standard Deviation 29.1	0.2 score on a scale Standard Deviation 16.3	-15.2 score on a scale Standard Deviation 27.6	-2.4 score on a scale Standard Deviation 19.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 1 Day 22	-10.6 score on a scale Standard Deviation 28.4	1.6 score on a scale Standard Deviation 9.0	-16.7 score on a scale Standard Deviation 20.9	-1.0 score on a scale Standard Deviation 25.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 2 Day 1	-13.0 score on a scale Standard Deviation 26.6	0.2 score on a scale Standard Deviation 16.6	-13.3 score on a scale Standard Deviation 27.5	0.4 score on a scale Standard Deviation 17.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 2 Day 15	-11.1 score on a scale Standard Deviation 25.7	-0.6 score on a scale Standard Deviation 18.4	-9.6 score on a scale Standard Deviation 21.5	-0.4 score on a scale Standard Deviation 17.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 3 Day 1	-9.7 score on a scale Standard Deviation 25.4	0.4 score on a scale Standard Deviation 19.0	-8.2 score on a scale Standard Deviation 21.3	-2.1 score on a scale Standard Deviation 21.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 4 Day 1	-8.4 score on a scale Standard Deviation 23.8	0.3 score on a scale Standard Deviation 21.3	-9.0 score on a scale Standard Deviation 19.7	-1.3 score on a scale Standard Deviation 19.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 13 Weeks	0.4 score on a scale Standard Deviation 26.2	-5.9 score on a scale Standard Deviation 24.3	-10.1 score on a scale Standard Deviation 27.6	-8.8 score on a scale Standard Deviation 25.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 5 Day 1	-11.1 score on a scale Standard Deviation 26.0	0.6 score on a scale Standard Deviation 20.5	-10.4 score on a scale Standard Deviation 22.3	0.8 score on a scale Standard Deviation 22.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 6 Day 1	-5.8 score on a scale Standard Deviation 24.2	-0.5 score on a scale Standard Deviation 18.3	-11.6 score on a scale Standard Deviation 22.9	0.5 score on a scale Standard Deviation 20.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 7 Day 1	-9.9 score on a scale Standard Deviation 27.6	0.9 score on a scale Standard Deviation 21.5	-8.8 score on a scale Standard Deviation 24.0	0.3 score on a scale Standard Deviation 21.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 8 Day 1	-9.2 score on a scale Standard Deviation 26.5	-1.9 score on a scale Standard Deviation 23.0	-9.5 score on a scale Standard Deviation 24.5	-0.3 score on a scale Standard Deviation 21.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 9 Day 1	-11.2 score on a scale Standard Deviation 28.4	0.0 score on a scale Standard Deviation 20.7	-7.9 score on a scale Standard Deviation 23.5	-1.9 score on a scale Standard Deviation 25.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 10 Day 1	-8.5 score on a scale Standard Deviation 25.5	-1.7 score on a scale Standard Deviation 19.3	-7.7 score on a scale Standard Deviation 23.2	3.9 score on a scale Standard Deviation 22.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 11 Day 1	-6.6 score on a scale Standard Deviation 24.5	-1.3 score on a scale Standard Deviation 19.7	-10.2 score on a scale Standard Deviation 25.0	-3.5 score on a scale Standard Deviation 24.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 12 Day 1	-8.7 score on a scale Standard Deviation 26.2	-0.4 score on a scale Standard Deviation 17.2	-8.2 score on a scale Standard Deviation 25.2	0.3 score on a scale Standard Deviation 26.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at Cycle 13 Day 1	-8.1 score on a scale Standard Deviation 24.6	-4.5 score on a scale Standard Deviation 22.2	-8.3 score on a scale Standard Deviation 25.9	-2.2 score on a scale Standard Deviation 24.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at End Of Treatment	-4.7 score on a scale Standard Deviation 25.0	-1.3 score on a scale Standard Deviation 23.2	-4.2 score on a scale Standard Deviation 25.0	-6.0 score on a scale Standard Deviation 27.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 13 Weeks	2.0 score on a scale Standard Deviation 21.8	1.8 score on a scale Standard Deviation 17.6	1.2 score on a scale Standard Deviation 19.0	5.3 score on a scale Standard Deviation 26.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 26 Weeks	0.9 score on a scale Standard Deviation 24.7	3.0 score on a scale Standard Deviation 17.3	0.4 score on a scale Standard Deviation 20.1	5.2 score on a scale Standard Deviation 24.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 39 Weeks	2.7 score on a scale Standard Deviation 24.2	0.2 score on a scale Standard Deviation 21.1	0.4 score on a scale Standard Deviation 21.3	7.1 score on a scale Standard Deviation 28.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 26 Weeks	-3.0 score on a scale Standard Deviation 22.3	-6.0 score on a scale Standard Deviation 18.8	-5.7 score on a scale Standard Deviation 26.3	-7.6 score on a scale Standard Deviation 25.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 52 Weeks	2.4 score on a scale Standard Deviation 23.8	0.8 score on a scale Standard Deviation 20.3	0.6 score on a scale Standard Deviation 18.2	4.0 score on a scale Standard Deviation 29.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 65 Weeks	5.3 score on a scale Standard Deviation 19.3	-1.3 score on a scale Standard Deviation 16.6	3.9 score on a scale Standard Deviation 11.1	7.4 score on a scale Standard Deviation 29.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 78 Weeks	-1.4 score on a scale Standard Deviation 25.5	-4.0 score on a scale Standard Deviation 20.0	4.4 score on a scale Standard Deviation 11.7	-3.7 score on a scale Standard Deviation 13.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 39 Weeks	-1.7 score on a scale Standard Deviation 22.1	-7.8 score on a scale Standard Deviation 25.8	-2.4 score on a scale Standard Deviation 28.3	-8.1 score on a scale Standard Deviation 26.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 91 Weeks	3.5 score on a scale Standard Deviation 27.2	-1.7 score on a scale Standard Deviation 17.4	1.1 score on a scale Standard Deviation 14.7	16.7 score on a scale Standard Deviation 35.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 104 Weeks	6.2 score on a scale Standard Deviation 22.2	-7.3 score on a scale Standard Deviation 20.5	6.7 score on a scale Standard Deviation 14.1	14.8 score on a scale Standard Deviation 38.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 52 Weeks	-2.2 score on a scale Standard Deviation 21.5	-5.4 score on a scale Standard Deviation 21.1	-11.1 score on a scale Standard Deviation 24.5	-1.3 score on a scale Standard Deviation 32.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 117 Weeks	7.6 score on a scale Standard Deviation 26.6	-2.0 score on a scale Standard Deviation 10.0	5.6 score on a scale Standard Deviation 11.8	26.7 score on a scale Standard Deviation 41.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 65 Weeks	2.6 score on a scale Standard Deviation 26.3	-6.1 score on a scale Standard Deviation 30.9	-9.8 score on a scale Standard Deviation 19.6	-7.4 score on a scale Standard Deviation 31.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 130 Weeks	6.9 score on a scale Standard Deviation 21.3	-5.6 score on a scale Standard Deviation 14.8	3.3 score on a scale Standard Deviation 18.3	23.3 score on a scale Standard Deviation 43.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 143 Weeks	7.1 score on a scale Standard Deviation 18.9	0.0 score on a scale Standard Deviation 0.0	11.1 score on a scale Standard Deviation 19.2	8.3 score on a scale Standard Deviation 11.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 78 Weeks	2.2 score on a scale Standard Deviation 27.9	-8.1 score on a scale Standard Deviation 31.2	-11.1 score on a scale Standard Deviation 20.6	0.0 score on a scale Standard Deviation 16.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 156 Weeks	27.8 score on a scale Standard Deviation 25.5	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	16.7 score on a scale Standard Deviation 23.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 169 Weeks	16.7 score on a scale Standard Deviation 23.6	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT 182 Weeks	27.8 score on a scale Standard Deviation 25.5	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Role functioning: Change at PT/Discontin.	-8.3 score on a scale Standard Deviation 23.6	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	11.1 score on a scale Standard Deviation 17.2	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Cycle 1 Day 1 (Baseline)	89.6 score on a scale Standard Deviation 16.6	88.2 score on a scale Standard Deviation 20.8	87.7 score on a scale Standard Deviation 21.2	90.4 score on a scale Standard Deviation 19.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 1 Day 8	1.4 score on a scale Standard Deviation 18.3	0.8 score on a scale Standard Deviation 12.0	2.1 score on a scale Standard Deviation 14.8	0.9 score on a scale Standard Deviation 8.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 1 Day 15	-15.0 score on a scale Standard Deviation 26.9	0.8 score on a scale Standard Deviation 13.8	-7.5 score on a scale Standard Deviation 18.9	0.4 score on a scale Standard Deviation 13.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 1 Day 22	-9.1 score on a scale Standard Deviation 28.0	5.6 score on a scale Standard Deviation 13.3	-5.6 score on a scale Standard Deviation 17.4	-2.0 score on a scale Standard Deviation 20.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 2 Day 1	-8.0 score on a scale Standard Deviation 22.9	2.2 score on a scale Standard Deviation 16.6	-10.2 score on a scale Standard Deviation 23.8	3.0 score on a scale Standard Deviation 13.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 2 Day 15	-8.3 score on a scale Standard Deviation 21.5	2.7 score on a scale Standard Deviation 16.9	-7.7 score on a scale Standard Deviation 18.2	4.0 score on a scale Standard Deviation 17.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 3 Day 1	-8.1 score on a scale Standard Deviation 21.5	2.3 score on a scale Standard Deviation 17.8	-7.4 score on a scale Standard Deviation 21.1	1.5 score on a scale Standard Deviation 17.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 4 Day 1	-7.1 score on a scale Standard Deviation 21.5	1.7 score on a scale Standard Deviation 18.1	-7.5 score on a scale Standard Deviation 20.6	1.3 score on a scale Standard Deviation 13.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 5 Day 1	-9.4 score on a scale Standard Deviation 21.7	3.3 score on a scale Standard Deviation 17.6	-9.5 score on a scale Standard Deviation 18.5	2.6 score on a scale Standard Deviation 18.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 91 Weeks	0.0 score on a scale Standard Deviation 27.2	-10.3 score on a scale Standard Deviation 29.7	-11.1 score on a scale Standard Deviation 20.6	-11.1 score on a scale Standard Deviation 32.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 6 Day 1	-7.2 score on a scale Standard Deviation 22.2	1.9 score on a scale Standard Deviation 17.6	-11.4 score on a scale Standard Deviation 22.4	0.0 score on a scale Standard Deviation 17.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 7 Day 1	-8.0 score on a scale Standard Deviation 22.7	4.5 score on a scale Standard Deviation 17.0	-9.6 score on a scale Standard Deviation 22.9	0.0 score on a scale Standard Deviation 17.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 104 Weeks	-2.6 score on a scale Standard Deviation 18.7	-8.0 score on a scale Standard Deviation 30.9	-13.3 score on a scale Standard Deviation 23.3	-18.5 score on a scale Standard Deviation 37.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 8 Day 1	-8.3 score on a scale Standard Deviation 23.6	2.2 score on a scale Standard Deviation 17.7	-7.9 score on a scale Standard Deviation 23.0	0.6 score on a scale Standard Deviation 16.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 10 Day 1	-8.7 score on a scale Standard Deviation 24.9	0.0 score on a scale Standard Deviation 16.1	-8.7 score on a scale Standard Deviation 23.4	-0.7 score on a scale Standard Deviation 16.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 117 Weeks	-6.1 score on a scale Standard Deviation 22.1	-5.9 score on a scale Standard Deviation 24.3	-4.2 score on a scale Standard Deviation 11.8	-13.3 score on a scale Standard Deviation 18.3
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 130 Weeks	-7.8 score on a scale Standard Deviation 27.7	-5.6 score on a scale Standard Deviation 31.2	0.0 score on a scale Standard Deviation 0.0	-20.0 score on a scale Standard Deviation 29.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT 182 Weeks	-22.2 score on a scale Standard Deviation 38.5	—	—	—
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Financial difficulties: Change at PT/Discontin.	0.0 score on a scale Standard Deviation 17.8	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation NA 1 participant was analyzed, so standard deviation is not applicable.
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Cycle 1 Day 1 (Baseline)	1.4 score on a scale Standard Deviation 5.1	1.8 score on a scale Standard Deviation 9.6	1.9 score on a scale Standard Deviation 7.4	1.3 score on a scale Standard Deviation 5.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 1 Day 8	4.2 score on a scale Standard Deviation 8.9	0.8 score on a scale Standard Deviation 6.3	5.2 score on a scale Standard Deviation 8.0	3.5 score on a scale Standard Deviation 8.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 1 Day 15	9.8 score on a scale Standard Deviation 16.9	1.8 score on a scale Standard Deviation 6.9	8.8 score on a scale Standard Deviation 17.0	1.2 score on a scale Standard Deviation 7.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 1 Day 22	6.1 score on a scale Standard Deviation 12.1	0.8 score on a scale Standard Deviation 6.4	5.6 score on a scale Standard Deviation 10.3	2.9 score on a scale Standard Deviation 8.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 2 Day 1	5.2 score on a scale Standard Deviation 12.9	0.9 score on a scale Standard Deviation 5.9	4.6 score on a scale Standard Deviation 11.1	1.4 score on a scale Standard Deviation 7.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 2 Day 15	6.3 score on a scale Standard Deviation 14.1	1.1 score on a scale Standard Deviation 8.5	2.9 score on a scale Standard Deviation 9.1	1.6 score on a scale Standard Deviation 10.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 3 Day 1	5.7 score on a scale Standard Deviation 13.1	1.6 score on a scale Standard Deviation 7.3	4.5 score on a scale Standard Deviation 9.9	1.3 score on a scale Standard Deviation 8.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 4 Day 1	5.6 score on a scale Standard Deviation 13.6	1.9 score on a scale Standard Deviation 11.7	6.6 score on a scale Standard Deviation 14.3	1.3 score on a scale Standard Deviation 10.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 5 Day 1	7.3 score on a scale Standard Deviation 16.4	2.6 score on a scale Standard Deviation 9.2	5.1 score on a scale Standard Deviation 10.7	-0.5 score on a scale Standard Deviation 7.8
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 6 Day 1	5.3 score on a scale Standard Deviation 13.1	2.4 score on a scale Standard Deviation 9.7	6.3 score on a scale Standard Deviation 12.2	-0.5 score on a scale Standard Deviation 7.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Nausea and vomiting: Change at Cycle 7 Day 1	4.7 score on a scale Standard Deviation 11.7	2.0 score on a scale Standard Deviation 7.8	4.2 score on a scale Standard Deviation 11.3	0.6 score on a scale Standard Deviation 6.9
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 11 Day 1	-8.6 score on a scale Standard Deviation 24.4	1.4 score on a scale Standard Deviation 15.1	-9.9 score on a scale Standard Deviation 23.1	-2.1 score on a scale Standard Deviation 21.6
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 12 Day 1	-10.6 score on a scale Standard Deviation 24.2	-0.4 score on a scale Standard Deviation 15.7	-9.1 score on a scale Standard Deviation 22.2	0.0 score on a scale Standard Deviation 16.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at Cycle 13 Day 1	-8.3 score on a scale Standard Deviation 24.2	-1.9 score on a scale Standard Deviation 21.1	-10.2 score on a scale Standard Deviation 25.2	1.5 score on a scale Standard Deviation 17.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at End of Treatment	-6.1 score on a scale Standard Deviation 21.8	1.2 score on a scale Standard Deviation 25.8	-5.5 score on a scale Standard Deviation 23.3	-3.3 score on a scale Standard Deviation 21.2
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 13 Weeks	-1.7 score on a scale Standard Deviation 18.9	2.7 score on a scale Standard Deviation 15.4	1.2 score on a scale Standard Deviation 16.2	1.3 score on a scale Standard Deviation 19.5
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 26 Weeks	-2.6 score on a scale Standard Deviation 20.3	4.2 score on a scale Standard Deviation 15.0	0.0 score on a scale Standard Deviation 13.9	2.4 score on a scale Standard Deviation 14.1
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 39 Weeks	3.4 score on a scale Standard Deviation 16.5	2.7 score on a scale Standard Deviation 15.4	0.0 score on a scale Standard Deviation 18.3	5.1 score on a scale Standard Deviation 17.4
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 52 Weeks	-0.7 score on a scale Standard Deviation 18.9	1.6 score on a scale Standard Deviation 14.7	2.5 score on a scale Standard Deviation 13.6	-1.3 score on a scale Standard Deviation 18.0
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 65 Weeks	2.8 score on a scale Standard Deviation 18.7	0.9 score on a scale Standard Deviation 16.0	4.9 score on a scale Standard Deviation 11.4	0.9 score on a scale Standard Deviation 10.7
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score Social functioning: Change at PT 78 Weeks	0.7 score on a scale Standard Deviation 20.8	6.1 score on a scale Standard Deviation 14.3	4.4 score on a scale Standard Deviation 13.3	-1.9 score on a scale Standard Deviation 13.0

SECONDARY outcome

Timeframe: Pre-morning dose (0 hour [hr]) and 1 to 4 hrs post-dose on Days 1, 8, 15, and 22 of Cycle 1; pre-morning dose (0 hr) on Days 1 and 15 of Cycle 2; pre-morning dose (0 hr) on Day 1 of Cycles 3-13; at end of treatment (up to 13 months)

Population: The pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of vemurafenib and had provided valid PK assessments.

Outcome measures

Adverse Events

Cohort 1 Vemurafenib

Serious events: 25 serious events

Other events: 150 other events

Deaths: 18 deaths

Cohort 1 Placebo

Serious events: 16 serious events

Other events: 117 other events

Deaths: 33 deaths

Cohort 2 Vemurafenib

Serious events: 15 serious events

Other events: 92 other events

Deaths: 25 deaths

Cohort 2 Placebo

Serious events: 9 serious events

Other events: 67 other events

Deaths: 26 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 1-800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort 1 Vemurafenib n=149 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 1 Placebo n=92 Participants Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Vemurafenib Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks	Cohort 2 Placebo Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Plasma Concentration of Vemurafenib Cycle 10 Day 1	41000 nanograms per milliliter (ng/mL) Standard Deviation 19000	43900 nanograms per milliliter (ng/mL) Standard Deviation 18500	—	—
Plasma Concentration of Vemurafenib Cycle 11 Day 1	45900 nanograms per milliliter (ng/mL) Standard Deviation 15300	39700 nanograms per milliliter (ng/mL) Standard Deviation 17600	—	—
Plasma Concentration of Vemurafenib Cycle 1 Day 1 (nominal Day 1)	2880 nanograms per milliliter (ng/mL) Standard Deviation 2770	3050 nanograms per milliliter (ng/mL) Standard Deviation 3010	—	—
Plasma Concentration of Vemurafenib Cycle 1 Day 8	49900 nanograms per milliliter (ng/mL) Standard Deviation 19800	43400 nanograms per milliliter (ng/mL) Standard Deviation 13600	—	—
Plasma Concentration of Vemurafenib Cycle 1 Day 15	45300 nanograms per milliliter (ng/mL) Standard Deviation 23000	50200 nanograms per milliliter (ng/mL) Standard Deviation 20500	—	—
Plasma Concentration of Vemurafenib Cycle 1 Day 22	44000 nanograms per milliliter (ng/mL) Standard Deviation 22400	48800 nanograms per milliliter (ng/mL) Standard Deviation 23700	—	—
Plasma Concentration of Vemurafenib Cycle 2 Day 1	40200 nanograms per milliliter (ng/mL) Standard Deviation 24100	43800 nanograms per milliliter (ng/mL) Standard Deviation 19400	—	—
Plasma Concentration of Vemurafenib Cycle 2 Day 15	42400 nanograms per milliliter (ng/mL) Standard Deviation 21700	44200 nanograms per milliliter (ng/mL) Standard Deviation 21200	—	—
Plasma Concentration of Vemurafenib Cycle 3 Day 1	46700 nanograms per milliliter (ng/mL) Standard Deviation 21500	43700 nanograms per milliliter (ng/mL) Standard Deviation 22000	—	—
Plasma Concentration of Vemurafenib Cycle 4 Day 1	44800 nanograms per milliliter (ng/mL) Standard Deviation 19300	47400 nanograms per milliliter (ng/mL) Standard Deviation 20100	—	—
Plasma Concentration of Vemurafenib Cycle 5 Day 1	43100 nanograms per milliliter (ng/mL) Standard Deviation 18800	43700 nanograms per milliliter (ng/mL) Standard Deviation 19400	—	—
Plasma Concentration of Vemurafenib Cycle 6 Day 1	46000 nanograms per milliliter (ng/mL) Standard Deviation 18900	42000 nanograms per milliliter (ng/mL) Standard Deviation 22000	—	—
Plasma Concentration of Vemurafenib Cycle 7 Day 1	42800 nanograms per milliliter (ng/mL) Standard Deviation 20500	45200 nanograms per milliliter (ng/mL) Standard Deviation 20500	—	—
Plasma Concentration of Vemurafenib Cycle 8 Day 1	43600 nanograms per milliliter (ng/mL) Standard Deviation 19900	42600 nanograms per milliliter (ng/mL) Standard Deviation 18900	—	—
Plasma Concentration of Vemurafenib Cycle 9 Day 1	42900 nanograms per milliliter (ng/mL) Standard Deviation 18400	43000 nanograms per milliliter (ng/mL) Standard Deviation 17700	—	—
Plasma Concentration of Vemurafenib Cycle 12 Day 1	43700 nanograms per milliliter (ng/mL) Standard Deviation 15200	46600 nanograms per milliliter (ng/mL) Standard Deviation 19800	—	—
Plasma Concentration of Vemurafenib Cycle 13 Day 1	44000 nanograms per milliliter (ng/mL) Standard Deviation 17200	42600 nanograms per milliliter (ng/mL) Standard Deviation 19900	—	—