Trial Outcomes & Findings for A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer (NCT NCT01774786)

Last Updated: 2020-12-30

Results Overview

Overall survival (OS) was defined as the time from randomization to death from any cause. For participants who were still alive on the date of clinical data cut-off for the OS analysis, the last date when the participant was known to be alive on, or prior to the clinical cut-off date, was used to determine the censoring date. Participants who did not have any post-baseline data (e.g., dosing records, imaging dates, visit dates) were censored at the date of randomization plus 1 day.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

780 participants

Primary outcome timeframe

From Baseline until death from any cause (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.4 [0-42] months vs. 25.0 [0-41] months; Final Analysis: 46.1 [0-70] months vs. 44.4 [0-68] months)

Results posted on

2020-12-30

Participant Flow

A total of 780 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	Pertuzumab + Trastuzumab + Chemotherapy Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Placebo + Trastuzumab + Chemotherapy Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Overall Study STARTED	388	392
Overall Study Did Not Receive Any Study Treatment	4	3
Overall Study Received at Least One Dose of Pertuzumab	384	1
Overall Study Received Placebo (No Pertuzumab)	0	388
Overall Study COMPLETED	60	46
Overall Study NOT COMPLETED	328	346

Reasons for withdrawal

Reasons for withdrawal
Measure	Pertuzumab + Trastuzumab + Chemotherapy Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Placebo + Trastuzumab + Chemotherapy Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Overall Study Death	300	319
Overall Study Lost to Follow-up	6	7
Overall Study Withdrawal by Subject	18	14
Overall Study Physician Decision	2	0
Overall Study Non-compliance	0	1
Overall Study Reason Not Specified	2	5

Baseline Characteristics

A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pertuzumab + Trastuzumab + Chemotherapy n=388 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Placebo + Trastuzumab + Chemotherapy n=392 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Total n=780 Participants Total of all reporting groups
Age, Continuous	60.9 Years STANDARD_DEVIATION 11.3 • n=5 Participants	60.1 Years STANDARD_DEVIATION 10.7 • n=7 Participants	60.5 Years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	69 Participants n=7 Participants	163 Participants n=5 Participants
Sex: Female, Male Male	294 Participants n=5 Participants	323 Participants n=7 Participants	617 Participants n=5 Participants
Geographic Region Asia (excluding Japan)	143 Participants n=5 Participants	146 Participants n=7 Participants	289 Participants n=5 Participants
Geographic Region Japan	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Geographic Region North America/Western Europe/Australia	133 Participants n=5 Participants	133 Participants n=7 Participants	266 Participants n=5 Participants
Geographic Region South America/Eastern Europe	72 Participants n=5 Participants	73 Participants n=7 Participants	145 Participants n=5 Participants
Prior Gastrectomy Prior Gastrectomy	105 Participants n=5 Participants	102 Participants n=7 Participants	207 Participants n=5 Participants
Prior Gastrectomy No Prior Gastrectomy	283 Participants n=5 Participants	290 Participants n=7 Participants	573 Participants n=5 Participants
Human Epidermal Growth Factor Receptor 2 (HER2) Status IHC 2+/ISH+	129 Participants n=5 Participants	130 Participants n=7 Participants	259 Participants n=5 Participants
Human Epidermal Growth Factor Receptor 2 (HER2) Status IHC 3+	259 Participants n=5 Participants	262 Participants n=7 Participants	521 Participants n=5 Participants
Measurability of Disease, per RECIST v1.1 Measurable Disease	351 Participants n=5 Participants	352 Participants n=7 Participants	703 Participants n=5 Participants
Measurability of Disease, per RECIST v1.1 Non-Measurable Evaluable Disease Only	37 Participants n=5 Participants	40 Participants n=7 Participants	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline until death from any cause (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.4 [0-42] months vs. 25.0 [0-41] months; Final Analysis: 46.1 [0-70] months vs. 44.4 [0-68] months)

Population: The intent-to-treat (ITT) population included all randomized participants, regardless of whether study medication was received.

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy n=392 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=388 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Overall Survival Primary Analysis	14.2 Months Interval 12.9 to 15.5	17.5 Months Interval 16.2 to 19.3
Overall Survival Final Analysis	14.2 Months Interval 12.9 to 15.7	18.1 Months Interval 16.2 to 19.5

SECONDARY outcome

Timeframe: Baseline to death or progressive disease (PD), whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] vs. 21.3 [0-39] months; Final Analysis: 50.4 [0-70] vs. 47.4 [0-66] months)

Population: The ITT population included all randomized participants, regardless of whether study medication was received.

Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of progressive disease (PD), as determined by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Tumor assessments with CT or MRI scans of the chest, abdomen, and pelvis were performed every 9 weeks. Participants without documented PD or death were censored at the tumor assessment date for which the participant was last known to be progression-free. Participants who did not have any post-baseline tumor assessment data were censored at the date of randomization plus 1 day. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 millimeters (mm) in the sum of diameters of target lesions; the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy n=392 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=388 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria Primary Analysis	7.0 months Interval 6.4 to 8.2	8.5 months Interval 8.2 to 9.7
Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria Final Analysis	7.2 months Interval 6.4 to 8.2	8.5 months Interval 8.3 to 9.7

SECONDARY outcome

Timeframe: Baseline up to death or progressive disease, whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Primary Analysis: 24.9 [0-41] months vs. 21.3 [0-39] months)

Population: The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria.

The overall objective response rate was defined as the percentage of participants with partial response (PR) or complete response (CR) occurring on two consecutive occasions ≥4 weeks apart, as determined by the investigator using RECIST v1.1. Tumor assessments with computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest, abdomen, and pelvis were performed every 9 weeks. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be greater than or equal to (≥) 15 mm in short axis when assessed by CT scan.

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy n=352 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=351 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Objective Response (CR + PR)	48.3 Percentage of participants Interval 42.97 to 53.65	56.7 Percentage of participants Interval 51.33 to 61.95
Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Complete Response (CR)	0.9 Percentage of participants Interval 0.18 to 2.47	5.1 Percentage of participants Interval 3.07 to 7.98
Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Partial Response (PR)	47.4 Percentage of participants Interval 42.13 to 52.8	51.6 Percentage of participants Interval 46.2 to 56.91
Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Stable Disease (SD)	33.0 Percentage of participants Interval 28.06 to 38.14	27.9 Percentage of participants Interval 23.29 to 32.93
Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Progressive Disease (PD)	8.0 Percentage of participants Interval 5.35 to 11.29	4.8 Percentage of participants Interval 2.85 to 7.64
Primary Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Not Evaluable/Missing	10.8 Percentage of participants Interval 7.75 to 14.52	10.5 Percentage of participants Interval 7.53 to 14.24

SECONDARY outcome

Timeframe: Baseline up to death or progressive disease, whichever occurred first (Median [full range] duration of follow-up in Pertuzumab vs. Placebo arms for Final Analysis: 50.4 [0-70] months vs. 47.4 [0-66] months)

Population: The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria.

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy n=352 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=351 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Objective Response (CR + PR)	48.6 Percentage of participants Interval 43.25 to 53.94	57.0 Percentage of participants Interval 51.62 to 62.22
Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Complete Response (CR)	2.0 Percentage of participants Interval 0.8 to 4.05	5.7 Percentage of participants Interval 3.51 to 8.66
Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Partial Response (PR)	46.6 Percentage of participants Interval 41.29 to 51.95	51.3 Percentage of participants Interval 45.92 to 56.62
Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Stable Disease (SD)	32.7 Percentage of participants Interval 27.79 to 37.84	27.6 Percentage of participants Interval 23.02 to 32.63
Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Progressive Disease (PD)	8.2 Percentage of participants Interval 5.59 to 11.62	4.8 Percentage of participants Interval 2.85 to 7.64
Final Analysis of the Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria Not Evaluable/Missing	10.5 Percentage of participants Interval 7.51 to 14.2	10.5 Percentage of participants Interval 7.53 to 14.24

SECONDARY outcome

Population: The participants with measurable disease at baseline who achieved a documented objective response, according to RECIST v1.1 criteria.

Duration of objective response is defined as the time from first occurrence of documented objective response to documented disease progression, as determined by the investigator using RECIST v1.1, or death from any cause. Objective response: PR or CR occurring on 2 consecutive occasions ≥4 weeks apart. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR: disappearance of all target lesions. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; the appearance of one or more new lesions. Measurable disease defined as tumor lesions with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node, it must be ≥15 mm in short axis when assessed by CT scan.

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy n=171 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=200 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria Primary Analysis	8.4 months Interval 6.8 to 8.7	10.2 months Interval 8.4 to 10.7
Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria Final Analysis	8.4 months Interval 6.7 to 9.0	10.2 months Interval 8.5 to 11.6

SECONDARY outcome

Population: The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria.

The clinical benefit rate was defined as best response of complete response (CR) or partial response (PR) or stable disease (SD) for 6 weeks or longer, as determined by the investigator using RECIST v1.1. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters while on study. Measurable disease is defined as tumor lesions measured in at least one dimension (longest diameter in plane of measurement) with a minimum size of: 10 mm by CT or MRI scan; 10 mm caliper measurement by clinical examination; 20 mm by chest X-ray. For a malignant lymph node to be considered pathologically enlarged and measurable, it must be \>/=15 mm in short axis when assessed by CT scan. The clinical benefit rate was not updated at the final analysis.

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy n=352 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=351 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria	81.3 percentage of participants Interval 76.77 to 85.19	84.6 percentage of participants Interval 80.41 to 88.23

SECONDARY outcome

Timeframe: From Baseline until end of post-treatment follow-up (up to 70 months)

Population: The safety population included all participants who received any amount of any study medication. Those who received any amount of pertuzumab were included in the pertuzumab arm; all other treated participants were included in the placebo arm.

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. The investigator graded all AEs for severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE.

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy n=388 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=385 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Overview of Safety: Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 Any Adverse Event (AE)	385 Participants	381 Participants
Overview of Safety: Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 AE with Fatal Outcome	31 Participants	27 Participants
Overview of Safety: Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 Serious AE	156 Participants	178 Participants
Overview of Safety: Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 Grade 3-5 AE	288 Participants	310 Participants
Overview of Safety: Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 AE Leading to Pertuz/Pbo & Trastuz Discontinuation	46 Participants	48 Participants
Overview of Safety: Number of Participants With at Least One Adverse Event, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03 AE Leading to Dose Interruption &/or Dose Delay	94 Participants	110 Participants

SECONDARY outcome

Timeframe: From Baseline until end of post-treatment follow-up (up to 70 months)

The number and percentage of participants with symptomatic left ventricular systolic dysfunction (LVSD) and asymptomatic LVSD events (defined as a left ventricular ejection fraction \[LVEF\] ≥10% decrease from baseline to an absolute value \<50%) at any time during the study was summarized by treatment arm.

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy n=388 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=385 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Number of Participants With Symptomatic or Asymptomatic Left Ventricular Systolic Dysfunction (LVSD) Symptomatic LVSD	1 Participants	3 Participants
Number of Participants With Symptomatic or Asymptomatic Left Ventricular Systolic Dysfunction (LVSD) Asymptomatic LVSD	18 Participants	20 Participants

SECONDARY outcome

Timeframe: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years)

Population: Participants in the ITT population (includes all randomized participants, regardless of whether study medication was received) with both a baseline assessment and at least 1 post-treatment assessment are included in the analysis.

The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 5 - 10 points considered to be a minimally important difference to participants. A positive value means an increase, while a 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	Placebo + Trastuzumab + Chemotherapy n=392 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=388 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 21	5.86 score on a scale Standard Deviation 22.00	1.27 score on a scale Standard Deviation 28.09
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 22	2.84 score on a scale Standard Deviation 24.16	1.24 score on a scale Standard Deviation 27.72
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 23	1.89 score on a scale Standard Deviation 22.51	6.08 score on a scale Standard Deviation 27.32
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Cycle 1 (Baseline)	23.72 score on a scale Standard Deviation 24.82	23.92 score on a scale Standard Deviation 25.92
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 13	3.83 score on a scale Standard Deviation 23.78	3.51 score on a scale Standard Deviation 23.82
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at PT Visit 1	-6.14 score on a scale Standard Deviation 24.97	-7.24 score on a scale Standard Deviation 27.24
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at PT Visit 2	-5.68 score on a scale Standard Deviation 26.57	-2.72 score on a scale Standard Deviation 27.46
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 27	-1.72 score on a scale Standard Deviation 26.85	5.81 score on a scale Standard Deviation 24.37
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 22	-7.80 score on a scale Standard Deviation 19.92	-10.95 score on a scale Standard Deviation 31.46
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 23	-6.06 score on a scale Standard Deviation 23.04	-10.58 score on a scale Standard Deviation 34.82
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 24	-7.50 score on a scale Standard Deviation 21.99	-9.44 score on a scale Standard Deviation 31.94
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 25	-8.33 score on a scale Standard Deviation 26.87	-10.26 score on a scale Standard Deviation 28.42
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 26	-4.17 score on a scale Standard Deviation 20.30	-9.52 score on a scale Standard Deviation 32.63
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 27	-4.60 score on a scale Standard Deviation 19.36	-13.18 score on a scale Standard Deviation 30.11
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 28	-1.28 score on a scale Standard Deviation 22.07	-11.67 score on a scale Standard Deviation 31.62
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at PT Visit 1	-1.32 score on a scale Standard Deviation 30.81	2.81 score on a scale Standard Deviation 29.19
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at PT Visit 2	3.03 score on a scale Standard Deviation 31.13	5.67 score on a scale Standard Deviation 29.23
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 24	-1.67 score on a scale Standard Deviation 12.96	1.11 score on a scale Standard Deviation 22.10
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 25	-3.70 score on a scale Standard Deviation 15.49	0.64 score on a scale Standard Deviation 21.38
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 26	1.04 score on a scale Standard Deviation 23.16	0.00 score on a scale Standard Deviation 22.57
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 27	3.45 score on a scale Standard Deviation 22.44	0.78 score on a scale Standard Deviation 21.19
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 28	3.85 score on a scale Standard Deviation 17.20	1.67 score on a scale Standard Deviation 21.28
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at PT Visit 1	6.77 score on a scale Standard Deviation 23.82	6.97 score on a scale Standard Deviation 26.98
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at PT Visit 2	9.39 score on a scale Standard Deviation 26.76	3.30 score on a scale Standard Deviation 23.81
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Cycle 1 (Baseline)	76.56 score on a scale Standard Deviation 19.84	76.90 score on a scale Standard Deviation 20.21
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 2	3.05 score on a scale Standard Deviation 18.49	3.53 score on a scale Standard Deviation 16.84
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 3	3.96 score on a scale Standard Deviation 19.95	2.65 score on a scale Standard Deviation 18.63
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 4	3.67 score on a scale Standard Deviation 20.44	3.10 score on a scale Standard Deviation 21.11
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 5	2.74 score on a scale Standard Deviation 21.72	2.62 score on a scale Standard Deviation 19.97
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 6	4.93 score on a scale Standard Deviation 21.00	1.01 score on a scale Standard Deviation 19.64
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 7	4.41 score on a scale Standard Deviation 20.18	1.72 score on a scale Standard Deviation 21.09
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 8	5.66 score on a scale Standard Deviation 19.63	3.43 score on a scale Standard Deviation 20.66
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 9	4.78 score on a scale Standard Deviation 19.45	4.72 score on a scale Standard Deviation 20.10
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 10	6.74 score on a scale Standard Deviation 18.13	3.72 score on a scale Standard Deviation 21.76
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 11	4.96 score on a scale Standard Deviation 19.21	5.85 score on a scale Standard Deviation 19.64
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 12	5.24 score on a scale Standard Deviation 19.14	4.93 score on a scale Standard Deviation 21.38
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 13	5.18 score on a scale Standard Deviation 17.95	5.00 score on a scale Standard Deviation 23.07
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 14	6.29 score on a scale Standard Deviation 19.03	5.93 score on a scale Standard Deviation 22.90
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 15	5.19 score on a scale Standard Deviation 19.61	6.03 score on a scale Standard Deviation 22.13
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 16	5.29 score on a scale Standard Deviation 20.81	5.17 score on a scale Standard Deviation 23.20
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 17	6.31 score on a scale Standard Deviation 18.70	6.01 score on a scale Standard Deviation 23.55
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 18	5.87 score on a scale Standard Deviation 19.39	3.68 score on a scale Standard Deviation 24.11
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 19	5.56 score on a scale Standard Deviation 18.68	4.69 score on a scale Standard Deviation 26.01
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 20	5.42 score on a scale Standard Deviation 17.91	3.47 score on a scale Standard Deviation 26.92
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 21	6.48 score on a scale Standard Deviation 22.00	4.54 score on a scale Standard Deviation 26.55
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 22	6.91 score on a scale Standard Deviation 18.66	5.35 score on a scale Standard Deviation 28.67
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 23	6.63 score on a scale Standard Deviation 21.00	5.82 score on a scale Standard Deviation 28.42
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 24	8.54 score on a scale Standard Deviation 19.57	5.28 score on a scale Standard Deviation 26.22
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 25	8.80 score on a scale Standard Deviation 20.89	5.93 score on a scale Standard Deviation 25.48
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 26	5.99 score on a scale Standard Deviation 16.15	5.44 score on a scale Standard Deviation 27.77
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 27	5.75 score on a scale Standard Deviation 18.51	7.56 score on a scale Standard Deviation 28.34
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at Cycle 28	7.05 score on a scale Standard Deviation 18.96	7.08 score on a scale Standard Deviation 25.43
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at PT Visit 1	-3.92 score on a scale Standard Deviation 23.28	-5.48 score on a scale Standard Deviation 23.16
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Emotional Functional Scale: Change at PT Visit 2	-4.47 score on a scale Standard Deviation 23.34	-2.64 score on a scale Standard Deviation 23.33
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Cycle 1 (Baseline)	32.27 score on a scale Standard Deviation 21.92	31.96 score on a scale Standard Deviation 23.46
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 2	2.32 score on a scale Standard Deviation 21.57	3.13 score on a scale Standard Deviation 19.80
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 3	3.19 score on a scale Standard Deviation 22.97	1.41 score on a scale Standard Deviation 22.65
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 4	1.58 score on a scale Standard Deviation 24.04	2.77 score on a scale Standard Deviation 23.14
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 5	3.05 score on a scale Standard Deviation 24.29	3.87 score on a scale Standard Deviation 25.75
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 6	2.62 score on a scale Standard Deviation 23.68	4.37 score on a scale Standard Deviation 25.64
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 7	0.97 score on a scale Standard Deviation 23.44	2.36 score on a scale Standard Deviation 26.79
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 8	-1.18 score on a scale Standard Deviation 22.74	-0.19 score on a scale Standard Deviation 25.00
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 9	-2.01 score on a scale Standard Deviation 22.84	-2.38 score on a scale Standard Deviation 22.69
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 10	-3.08 score on a scale Standard Deviation 22.41	-3.41 score on a scale Standard Deviation 24.69
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 11	-3.44 score on a scale Standard Deviation 21.21	-4.35 score on a scale Standard Deviation 22.66
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 12	-4.60 score on a scale Standard Deviation 24.39	-3.14 score on a scale Standard Deviation 24.56
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 13	-4.50 score on a scale Standard Deviation 21.47	-4.57 score on a scale Standard Deviation 23.31
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 14	-6.54 score on a scale Standard Deviation 22.89	-6.75 score on a scale Standard Deviation 24.32
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 15	-4.99 score on a scale Standard Deviation 22.40	-5.47 score on a scale Standard Deviation 24.68
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 16	-6.93 score on a scale Standard Deviation 21.89	-3.54 score on a scale Standard Deviation 24.81
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 17	-3.45 score on a scale Standard Deviation 21.91	-4.27 score on a scale Standard Deviation 25.50
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 18	-8.92 score on a scale Standard Deviation 20.54	-4.14 score on a scale Standard Deviation 24.42
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 19	-9.01 score on a scale Standard Deviation 20.71	-5.32 score on a scale Standard Deviation 27.83
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 20	-6.53 score on a scale Standard Deviation 21.83	-5.56 score on a scale Standard Deviation 26.64
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 21	-7.41 score on a scale Standard Deviation 23.45	-3.94 score on a scale Standard Deviation 25.97
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 22	-10.64 score on a scale Standard Deviation 22.22	-1.49 score on a scale Standard Deviation 25.58
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 23	-9.60 score on a scale Standard Deviation 28.01	-5.82 score on a scale Standard Deviation 25.23
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 24	-12.50 score on a scale Standard Deviation 24.29	-1.67 score on a scale Standard Deviation 27.05
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 25	-12.35 score on a scale Standard Deviation 22.03	-4.70 score on a scale Standard Deviation 26.16
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 26	-11.46 score on a scale Standard Deviation 22.84	-4.99 score on a scale Standard Deviation 24.85
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 27	-5.36 score on a scale Standard Deviation 23.87	-6.98 score on a scale Standard Deviation 23.76
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at Cycle 28	-4.70 score on a scale Standard Deviation 26.14	-6.39 score on a scale Standard Deviation 18.98
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at PT Visit 1	5.25 score on a scale Standard Deviation 24.00	10.02 score on a scale Standard Deviation 28.48
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Fatigue Symptom Scale: Change at PT Visit 2	9.70 score on a scale Standard Deviation 25.01	7.70 score on a scale Standard Deviation 27.65
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Cycle 1 (Baseline)	26.21 score on a scale Standard Deviation 29.78	26.67 score on a scale Standard Deviation 30.32
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 2	-2.46 score on a scale Standard Deviation 25.46	-0.90 score on a scale Standard Deviation 26.85
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 3	0.00 score on a scale Standard Deviation 26.33	0.31 score on a scale Standard Deviation 27.62
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 4	0.11 score on a scale Standard Deviation 25.10	0.89 score on a scale Standard Deviation 25.95
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 5	2.58 score on a scale Standard Deviation 26.46	1.75 score on a scale Standard Deviation 27.71
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 6	0.92 score on a scale Standard Deviation 26.36	1.11 score on a scale Standard Deviation 27.62
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 7	0.30 score on a scale Standard Deviation 26.41	1.11 score on a scale Standard Deviation 31.08
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 8	0.47 score on a scale Standard Deviation 25.27	1.15 score on a scale Standard Deviation 30.21
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 9	-0.51 score on a scale Standard Deviation 24.75	1.11 score on a scale Standard Deviation 29.78
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 10	-2.42 score on a scale Standard Deviation 24.30	0.90 score on a scale Standard Deviation 30.10
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 11	-0.22 score on a scale Standard Deviation 24.84	0.39 score on a scale Standard Deviation 29.37
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 12	-0.97 score on a scale Standard Deviation 26.39	-1.05 score on a scale Standard Deviation 28.91
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 13	0.30 score on a scale Standard Deviation 24.82	-0.95 score on a scale Standard Deviation 28.82
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 14	-0.98 score on a scale Standard Deviation 25.02	-1.73 score on a scale Standard Deviation 29.74
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 15	1.36 score on a scale Standard Deviation 26.18	-1.81 score on a scale Standard Deviation 28.96
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 16	0.39 score on a scale Standard Deviation 25.97	-3.16 score on a scale Standard Deviation 30.13
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 17	1.35 score on a scale Standard Deviation 27.28	-3.87 score on a scale Standard Deviation 29.59
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 18	2.35 score on a scale Standard Deviation 26.02	-2.29 score on a scale Standard Deviation 27.46
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 19	-0.51 score on a scale Standard Deviation 27.73	-0.35 score on a scale Standard Deviation 28.41
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 20	1.59 score on a scale Standard Deviation 27.71	1.19 score on a scale Standard Deviation 29.47
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 21	-4.94 score on a scale Standard Deviation 27.78	1.27 score on a scale Standard Deviation 28.96
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 22	-4.26 score on a scale Standard Deviation 23.69	2.49 score on a scale Standard Deviation 26.79
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 23	-2.27 score on a scale Standard Deviation 29.11	-0.53 score on a scale Standard Deviation 26.43
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 24	-5.83 score on a scale Standard Deviation 26.03	1.11 score on a scale Standard Deviation 24.52
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 25	-4.63 score on a scale Standard Deviation 25.39	3.21 score on a scale Standard Deviation 27.42
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 26	-2.22 score on a scale Standard Deviation 26.16	2.72 score on a scale Standard Deviation 28.74
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 27	1.15 score on a scale Standard Deviation 24.37	-3.10 score on a scale Standard Deviation 23.92
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at Cycle 28	-1.28 score on a scale Standard Deviation 24.00	-1.67 score on a scale Standard Deviation 23.81
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at PT Visit 1	1.33 score on a scale Standard Deviation 26.21	1.70 score on a scale Standard Deviation 29.66
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Financial Difficulties Scale: Change at PT Visit 2	4.24 score on a scale Standard Deviation 31.32	1.98 score on a scale Standard Deviation 26.17
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea and Vomiting Scale: Cycle 1 (Baseline)	11.92 score on a scale Standard Deviation 18.76	11.14 score on a scale Standard Deviation 19.11
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 2	4.08 score on a scale Standard Deviation 22.25	5.85 score on a scale Standard Deviation 22.65
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 3	5.06 score on a scale Standard Deviation 21.14	5.12 score on a scale Standard Deviation 23.62
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 4	3.56 score on a scale Standard Deviation 23.76	4.10 score on a scale Standard Deviation 21.85
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 5	5.15 score on a scale Standard Deviation 23.81	5.13 score on a scale Standard Deviation 22.58
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 6	2.59 score on a scale Standard Deviation 21.24	4.11 score on a scale Standard Deviation 23.36
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 7	2.49 score on a scale Standard Deviation 22.31	2.07 score on a scale Standard Deviation 23.58
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 8	-0.77 score on a scale Standard Deviation 20.21	-0.86 score on a scale Standard Deviation 20.80
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 9	-2.98 score on a scale Standard Deviation 19.78	-2.54 score on a scale Standard Deviation 20.85
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 10	-2.81 score on a scale Standard Deviation 20.57	-4.30 score on a scale Standard Deviation 18.81
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 11	-3.66 score on a scale Standard Deviation 20.04	-3.51 score on a scale Standard Deviation 18.01
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 12	-3.45 score on a scale Standard Deviation 20.34	-3.04 score on a scale Standard Deviation 18.07
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 13	-3.60 score on a scale Standard Deviation 19.25	-4.02 score on a scale Standard Deviation 16.29
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 14	-5.72 score on a scale Standard Deviation 18.54	-3.46 score on a scale Standard Deviation 19.54
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 15	-3.91 score on a scale Standard Deviation 16.55	-3.59 score on a scale Standard Deviation 16.34
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 16	-2.55 score on a scale Standard Deviation 20.00	-0.43 score on a scale Standard Deviation 20.32
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 17	-3.15 score on a scale Standard Deviation 16.48	-0.60 score on a scale Standard Deviation 17.46
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 18	-3.52 score on a scale Standard Deviation 18.24	-0.65 score on a scale Standard Deviation 16.90
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 19	-4.04 score on a scale Standard Deviation 19.62	-0.87 score on a scale Standard Deviation 18.32
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 20	-3.97 score on a scale Standard Deviation 17.89	-1.79 score on a scale Standard Deviation 18.48
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 21	-6.48 score on a scale Standard Deviation 19.80	-1.05 score on a scale Standard Deviation 20.03
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 22	-8.16 score on a scale Standard Deviation 18.99	-3.48 score on a scale Standard Deviation 19.14
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 23	-6.44 score on a scale Standard Deviation 24.70	-4.23 score on a scale Standard Deviation 17.70
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 24	-7.92 score on a scale Standard Deviation 17.70	-4.72 score on a scale Standard Deviation 16.26
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 25	-7.41 score on a scale Standard Deviation 19.29	-4.17 score on a scale Standard Deviation 20.84
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 26	-9.38 score on a scale Standard Deviation 19.37	-3.40 score on a scale Standard Deviation 24.29
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 27	-7.47 score on a scale Standard Deviation 20.70	-5.04 score on a scale Standard Deviation 22.58
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea And Vomiting Scale: Change at Cycle 28	-6.41 score on a scale Standard Deviation 17.69	-1.25 score on a scale Standard Deviation 20.11
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea and Vomiting Scale: Change at PT Visit 1	4.13 score on a scale Standard Deviation 23.91	4.68 score on a scale Standard Deviation 22.20
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Nausea and Vomiting Scale: Change at PT Visit 2	2.73 score on a scale Standard Deviation 21.60	4.29 score on a scale Standard Deviation 23.05
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 2	-6.38 score on a scale Standard Deviation 23.58	-6.80 score on a scale Standard Deviation 24.69
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 3	-7.23 score on a scale Standard Deviation 25.78	-9.89 score on a scale Standard Deviation 25.16
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 4	-7.46 score on a scale Standard Deviation 26.06	-10.26 score on a scale Standard Deviation 24.78
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 5	-6.25 score on a scale Standard Deviation 25.42	-8.86 score on a scale Standard Deviation 25.88
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 6	-7.33 score on a scale Standard Deviation 24.85	-8.95 score on a scale Standard Deviation 25.73
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 7	-7.46 score on a scale Standard Deviation 24.79	-10.95 score on a scale Standard Deviation 26.13
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 8	-8.53 score on a scale Standard Deviation 22.86	-9.97 score on a scale Standard Deviation 25.80
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 9	-7.82 score on a scale Standard Deviation 22.98	-9.29 score on a scale Standard Deviation 24.83
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 10	-8.13 score on a scale Standard Deviation 22.75	-9.41 score on a scale Standard Deviation 26.10
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 11	-6.34 score on a scale Standard Deviation 22.97	-10.33 score on a scale Standard Deviation 25.77
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 12	-5.24 score on a scale Standard Deviation 25.29	-10.27 score on a scale Standard Deviation 23.10
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 13	-4.80 score on a scale Standard Deviation 20.27	-10.28 score on a scale Standard Deviation 25.79
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 14	-5.56 score on a scale Standard Deviation 23.37	-10.49 score on a scale Standard Deviation 25.49
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 15	-3.74 score on a scale Standard Deviation 22.77	-11.15 score on a scale Standard Deviation 22.86
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 16	-4.71 score on a scale Standard Deviation 23.66	-9.91 score on a scale Standard Deviation 22.94
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 17	-5.63 score on a scale Standard Deviation 22.63	-7.59 score on a scale Standard Deviation 25.00
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 18	-8.22 score on a scale Standard Deviation 20.68	-8.82 score on a scale Standard Deviation 23.42
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 19	-5.05 score on a scale Standard Deviation 21.48	-8.16 score on a scale Standard Deviation 25.13
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 20	-6.08 score on a scale Standard Deviation 19.24	-6.94 score on a scale Standard Deviation 25.90
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 21	-6.48 score on a scale Standard Deviation 23.44	-9.92 score on a scale Standard Deviation 27.15
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 22	-8.51 score on a scale Standard Deviation 19.62	-7.71 score on a scale Standard Deviation 26.96
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 23	-7.95 score on a scale Standard Deviation 26.29	-10.85 score on a scale Standard Deviation 22.03
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 24	-10.00 score on a scale Standard Deviation 17.21	-10.00 score on a scale Standard Deviation 24.39
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 25	-12.96 score on a scale Standard Deviation 19.96	-9.94 score on a scale Standard Deviation 24.09
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 26	-8.33 score on a scale Standard Deviation 18.45	-10.54 score on a scale Standard Deviation 22.49
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 27	-5.75 score on a scale Standard Deviation 21.95	-11.24 score on a scale Standard Deviation 22.34
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at Cycle 28	-9.62 score on a scale Standard Deviation 19.54	-10.42 score on a scale Standard Deviation 27.91
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at PT Visit 1	2.06 score on a scale Standard Deviation 28.70	1.13 score on a scale Standard Deviation 27.27
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Pain Symptom Scale: Change at PT Visit 2	5.45 score on a scale Standard Deviation 29.96	-1.49 score on a scale Standard Deviation 28.39
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Cycle 1 (Baseline)	82.05 score on a scale Standard Deviation 18.32	80.86 score on a scale Standard Deviation 19.53
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 2	-3.01 score on a scale Standard Deviation 15.34	-3.58 score on a scale Standard Deviation 14.56
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 3	-3.92 score on a scale Standard Deviation 17.03	-2.99 score on a scale Standard Deviation 17.19
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 4	-3.50 score on a scale Standard Deviation 17.99	-3.28 score on a scale Standard Deviation 18.87
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 5	-4.62 score on a scale Standard Deviation 17.62	-3.10 score on a scale Standard Deviation 19.35
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 6	-3.84 score on a scale Standard Deviation 18.65	-5.00 score on a scale Standard Deviation 20.30
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 7	-3.79 score on a scale Standard Deviation 19.82	-3.66 score on a scale Standard Deviation 20.75
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 8	-1.56 score on a scale Standard Deviation 18.55	-2.24 score on a scale Standard Deviation 21.14
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 9	-0.75 score on a scale Standard Deviation 18.44	-1.59 score on a scale Standard Deviation 20.21
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 10	-0.27 score on a scale Standard Deviation 17.16	0.11 score on a scale Standard Deviation 19.93
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 11	0.27 score on a scale Standard Deviation 17.09	0.35 score on a scale Standard Deviation 19.43
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 12	0.89 score on a scale Standard Deviation 16.35	-1.05 score on a scale Standard Deviation 20.06
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 13	0.27 score on a scale Standard Deviation 17.41	-0.80 score on a scale Standard Deviation 20.65
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 14	1.70 score on a scale Standard Deviation 18.09	-0.02 score on a scale Standard Deviation 20.14
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 15	-0.95 score on a scale Standard Deviation 17.99	0.41 score on a scale Standard Deviation 18.91
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 16	-0.08 score on a scale Standard Deviation 18.18	-1.08 score on a scale Standard Deviation 19.85
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 17	-0.81 score on a scale Standard Deviation 17.55	-0.46 score on a scale Standard Deviation 19.43
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 18	0.75 score on a scale Standard Deviation 16.85	0.13 score on a scale Standard Deviation 19.74
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 19	1.31 score on a scale Standard Deviation 14.38	1.39 score on a scale Standard Deviation 19.82
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 20	0.85 score on a scale Standard Deviation 16.74	0.71 score on a scale Standard Deviation 21.08
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 21	0.25 score on a scale Standard Deviation 18.18	0.42 score on a scale Standard Deviation 22.20
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 22	1.42 score on a scale Standard Deviation 16.79	-2.79 score on a scale Standard Deviation 21.90
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 23	0.61 score on a scale Standard Deviation 19.60	-1.48 score on a scale Standard Deviation 21.47
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 24	3.00 score on a scale Standard Deviation 16.47	-2.67 score on a scale Standard Deviation 22.27
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 25	4.81 score on a scale Standard Deviation 15.91	-2.18 score on a scale Standard Deviation 20.61
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 26	-1.88 score on a scale Standard Deviation 20.69	-1.90 score on a scale Standard Deviation 20.09
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 27	-3.68 score on a scale Standard Deviation 19.40	0.16 score on a scale Standard Deviation 18.66
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at Cycle 28	-2.82 score on a scale Standard Deviation 18.97	-1.17 score on a scale Standard Deviation 17.79
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at PT Visit 1	-7.51 score on a scale Standard Deviation 20.53	-11.37 score on a scale Standard Deviation 23.67
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Physical Functional Scale: Change at PT Visit 2	-11.82 score on a scale Standard Deviation 20.27	-11.49 score on a scale Standard Deviation 24.31
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Cycle 1 (Baseline)	59.90 score on a scale Standard Deviation 22.11	59.77 score on a scale Standard Deviation 22.88
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 2	4.29 score on a scale Standard Deviation 23.42	1.81 score on a scale Standard Deviation 23.35
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 3	2.86 score on a scale Standard Deviation 25.03	1.56 score on a scale Standard Deviation 25.05
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 4	4.15 score on a scale Standard Deviation 23.79	1.39 score on a scale Standard Deviation 25.26
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 5	3.92 score on a scale Standard Deviation 23.05	1.17 score on a scale Standard Deviation 25.70
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 6	3.61 score on a scale Standard Deviation 23.13	0.68 score on a scale Standard Deviation 27.89
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 7	3.33 score on a scale Standard Deviation 22.77	1.83 score on a scale Standard Deviation 27.81
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 8	5.18 score on a scale Standard Deviation 23.18	3.06 score on a scale Standard Deviation 27.09
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 9	4.68 score on a scale Standard Deviation 22.99	4.39 score on a scale Standard Deviation 26.25
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 10	5.07 score on a scale Standard Deviation 22.77	4.80 score on a scale Standard Deviation 25.35
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 11	3.82 score on a scale Standard Deviation 23.75	5.78 score on a scale Standard Deviation 26.62
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 12	5.34 score on a scale Standard Deviation 24.47	3.11 score on a scale Standard Deviation 24.89
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 14	4.82 score on a scale Standard Deviation 24.86	5.97 score on a scale Standard Deviation 23.09
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 15	1.70 score on a scale Standard Deviation 24.46	4.26 score on a scale Standard Deviation 25.98
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 16	3.04 score on a scale Standard Deviation 23.77	3.12 score on a scale Standard Deviation 25.16
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 17	3.83 score on a scale Standard Deviation 24.84	2.93 score on a scale Standard Deviation 24.84
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 18	2.58 score on a scale Standard Deviation 27.08	3.02 score on a scale Standard Deviation 23.88
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 19	3.97 score on a scale Standard Deviation 25.43	3.25 score on a scale Standard Deviation 26.39
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 20	4.89 score on a scale Standard Deviation 25.69	5.12 score on a scale Standard Deviation 24.20
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 21	5.40 score on a scale Standard Deviation 24.72	5.38 score on a scale Standard Deviation 23.87
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 22	3.19 score on a scale Standard Deviation 25.57	3.79 score on a scale Standard Deviation 22.56
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 23	4.07 score on a scale Standard Deviation 27.18	4.03 score on a scale Standard Deviation 23.85
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 24	2.92 score on a scale Standard Deviation 30.58	4.24 score on a scale Standard Deviation 22.66
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 25	8.10 score on a scale Standard Deviation 25.39	3.59 score on a scale Standard Deviation 22.38
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 25	4.63 score on a scale Standard Deviation 26.91	-3.53 score on a scale Standard Deviation 29.21
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 26	5.47 score on a scale Standard Deviation 26.91	7.27 score on a scale Standard Deviation 24.55
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 27	1.72 score on a scale Standard Deviation 28.38	7.54 score on a scale Standard Deviation 23.19
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Global Health Status Scale: Change at Cycle 28	4.81 score on a scale Standard Deviation 28.98	4.49 score on a scale Standard Deviation 22.69
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Cycle 1 (Baseline)	79.33 score on a scale Standard Deviation 25.12	77.06 score on a scale Standard Deviation 27.02
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 2	-2.82 score on a scale Standard Deviation 24.35	-3.78 score on a scale Standard Deviation 24.99
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 3	-4.55 score on a scale Standard Deviation 28.00	-3.62 score on a scale Standard Deviation 25.96
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 4	-5.99 score on a scale Standard Deviation 26.87	-4.64 score on a scale Standard Deviation 27.69
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 5	-7.41 score on a scale Standard Deviation 27.25	-4.72 score on a scale Standard Deviation 27.68
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 6	-6.03 score on a scale Standard Deviation 28.51	-6.13 score on a scale Standard Deviation 28.94
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 7	-5.34 score on a scale Standard Deviation 26.31	-4.82 score on a scale Standard Deviation 29.75
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 8	-2.38 score on a scale Standard Deviation 26.41	-1.85 score on a scale Standard Deviation 28.87
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 9	-2.47 score on a scale Standard Deviation 27.29	-1.19 score on a scale Standard Deviation 28.57
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 10	0.90 score on a scale Standard Deviation 25.97	-1.79 score on a scale Standard Deviation 28.10
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 11	-2.69 score on a scale Standard Deviation 24.94	-0.78 score on a scale Standard Deviation 28.34
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 12	0.24 score on a scale Standard Deviation 24.07	-1.05 score on a scale Standard Deviation 27.28
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 13	-2.40 score on a scale Standard Deviation 24.91	-2.01 score on a scale Standard Deviation 26.61
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 14	-1.31 score on a scale Standard Deviation 25.66	-0.86 score on a scale Standard Deviation 27.27
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 15	-3.23 score on a scale Standard Deviation 25.40	-1.03 score on a scale Standard Deviation 27.51
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 16	-2.35 score on a scale Standard Deviation 25.48	-3.16 score on a scale Standard Deviation 28.73
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 17	-3.38 score on a scale Standard Deviation 25.88	-1.04 score on a scale Standard Deviation 26.69
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 18	0.23 score on a scale Standard Deviation 26.05	-0.16 score on a scale Standard Deviation 27.10
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 19	-0.25 score on a scale Standard Deviation 23.48	1.04 score on a scale Standard Deviation 27.55
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 20	0.79 score on a scale Standard Deviation 23.46	-1.19 score on a scale Standard Deviation 30.04
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 21	0.00 score on a scale Standard Deviation 27.47	-0.84 score on a scale Standard Deviation 28.98
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 22	1.06 score on a scale Standard Deviation 22.63	-2.24 score on a scale Standard Deviation 27.96
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 23	1.14 score on a scale Standard Deviation 25.01	-3.44 score on a scale Standard Deviation 30.11
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 24	2.08 score on a scale Standard Deviation 24.22	-4.44 score on a scale Standard Deviation 29.73
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 26	0.52 score on a scale Standard Deviation 26.60	-1.36 score on a scale Standard Deviation 28.02
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 27	-4.02 score on a scale Standard Deviation 29.77	-1.55 score on a scale Standard Deviation 30.82
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at Cycle 28	-3.85 score on a scale Standard Deviation 29.56	-0.42 score on a scale Standard Deviation 27.86
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at PT Visit 1	-9.49 score on a scale Standard Deviation 28.64	-14.61 score on a scale Standard Deviation 30.41
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Role Functional Scale: Change at PT Visit 2	-15.45 score on a scale Standard Deviation 31.82	-10.73 score on a scale Standard Deviation 31.94
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Cycle 1 (Baseline)	75.90 score on a scale Standard Deviation 24.69	77.96 score on a scale Standard Deviation 24.09
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 2	-0.44 score on a scale Standard Deviation 23.09	-3.45 score on a scale Standard Deviation 24.07
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 3	-2.07 score on a scale Standard Deviation 25.35	-4.62 score on a scale Standard Deviation 25.25
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 4	-1.70 score on a scale Standard Deviation 26.58	-2.59 score on a scale Standard Deviation 25.08
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 5	-3.26 score on a scale Standard Deviation 27.24	-5.54 score on a scale Standard Deviation 27.03
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 6	-1.04 score on a scale Standard Deviation 27.20	-5.72 score on a scale Standard Deviation 27.87
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 7	-0.15 score on a scale Standard Deviation 26.00	-2.69 score on a scale Standard Deviation 27.13
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 8	1.08 score on a scale Standard Deviation 26.49	-1.72 score on a scale Standard Deviation 26.93
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 9	0.77 score on a scale Standard Deviation 25.11	0.56 score on a scale Standard Deviation 27.59
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 10	2.31 score on a scale Standard Deviation 25.75	-0.81 score on a scale Standard Deviation 27.31
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 11	1.94 score on a scale Standard Deviation 24.39	0.58 score on a scale Standard Deviation 27.35
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 12	2.40 score on a scale Standard Deviation 24.70	0.52 score on a scale Standard Deviation 28.59
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 13	2.10 score on a scale Standard Deviation 25.73	0.83 score on a scale Standard Deviation 25.31
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 14	2.12 score on a scale Standard Deviation 24.89	1.98 score on a scale Standard Deviation 26.71
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 15	0.00 score on a scale Standard Deviation 27.08	1.79 score on a scale Standard Deviation 27.24
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 16	0.39 score on a scale Standard Deviation 25.84	-0.72 score on a scale Standard Deviation 25.76
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 17	1.58 score on a scale Standard Deviation 24.39	-0.45 score on a scale Standard Deviation 26.51
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 18	2.11 score on a scale Standard Deviation 26.42	-0.98 score on a scale Standard Deviation 25.99
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 19	3.28 score on a scale Standard Deviation 21.53	2.26 score on a scale Standard Deviation 26.56
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 20	0.79 score on a scale Standard Deviation 22.88	1.59 score on a scale Standard Deviation 27.09
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 24	4.17 score on a scale Standard Deviation 24.39	5.83 score on a scale Standard Deviation 25.64
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 25	2.78 score on a scale Standard Deviation 23.40	1.60 score on a scale Standard Deviation 27.27
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 26	1.56 score on a scale Standard Deviation 24.45	3.74 score on a scale Standard Deviation 26.19
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at Cycle 28	-0.64 score on a scale Standard Deviation 24.26	6.25 score on a scale Standard Deviation 23.48
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at PT Visit 1	-3.80 score on a scale Standard Deviation 28.74	-9.13 score on a scale Standard Deviation 26.47
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Social Functional Scale: Change at PT Visit 2	-8.48 score on a scale Standard Deviation 28.98	-5.45 score on a scale Standard Deviation 28.49
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Cycle 1 (Baseline)	25.41 score on a scale Standard Deviation 28.81	22.94 score on a scale Standard Deviation 28.00
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 2	-0.39 score on a scale Standard Deviation 28.27	-0.69 score on a scale Standard Deviation 26.82
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 3	-3.48 score on a scale Standard Deviation 30.14	-3.53 score on a scale Standard Deviation 27.03
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 4	-3.62 score on a scale Standard Deviation 30.40	-2.88 score on a scale Standard Deviation 28.14
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 5	-2.66 score on a scale Standard Deviation 30.17	-2.21 score on a scale Standard Deviation 29.27
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 6	-5.58 score on a scale Standard Deviation 32.53	-2.94 score on a scale Standard Deviation 28.63
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 7	-4.82 score on a scale Standard Deviation 32.98	-4.56 score on a scale Standard Deviation 28.42
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 8	-6.45 score on a scale Standard Deviation 30.75	-6.13 score on a scale Standard Deviation 27.72
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 9	-6.12 score on a scale Standard Deviation 30.32	-8.97 score on a scale Standard Deviation 25.69
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 10	-4.42 score on a scale Standard Deviation 28.79	-8.24 score on a scale Standard Deviation 26.69
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 11	-5.81 score on a scale Standard Deviation 27.69	-8.97 score on a scale Standard Deviation 28.19
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 12	-6.43 score on a scale Standard Deviation 26.49	-8.81 score on a scale Standard Deviation 27.67
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 13	-5.11 score on a scale Standard Deviation 24.29	-10.17 score on a scale Standard Deviation 26.71
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 14	-7.84 score on a scale Standard Deviation 24.45	-9.14 score on a scale Standard Deviation 26.84
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 15	-5.10 score on a scale Standard Deviation 21.59	-9.74 score on a scale Standard Deviation 28.89
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 16	-4.31 score on a scale Standard Deviation 26.62	-8.91 score on a scale Standard Deviation 26.14
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 17	-5.41 score on a scale Standard Deviation 26.48	-11.01 score on a scale Standard Deviation 26.62
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 18	-8.45 score on a scale Standard Deviation 20.09	-8.82 score on a scale Standard Deviation 28.12
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 19	-7.58 score on a scale Standard Deviation 22.49	-11.46 score on a scale Standard Deviation 29.35
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 20	-5.29 score on a scale Standard Deviation 25.55	-10.32 score on a scale Standard Deviation 27.37
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Insomnia Symptom Scale: Change at Cycle 21	-4.94 score on a scale Standard Deviation 27.02	-11.81 score on a scale Standard Deviation 27.24
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Cycle 1 (Baseline)	27.59 score on a scale Standard Deviation 29.96	26.68 score on a scale Standard Deviation 28.65
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 2	0.97 score on a scale Standard Deviation 35.86	6.57 score on a scale Standard Deviation 33.18
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 3	3.81 score on a scale Standard Deviation 36.76	3.63 score on a scale Standard Deviation 36.19
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 4	0.79 score on a scale Standard Deviation 34.33	5.24 score on a scale Standard Deviation 34.20
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 5	2.90 score on a scale Standard Deviation 35.85	4.55 score on a scale Standard Deviation 36.50
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 6	-0.39 score on a scale Standard Deviation 36.86	3.94 score on a scale Standard Deviation 36.07
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 7	1.61 score on a scale Standard Deviation 35.98	2.07 score on a scale Standard Deviation 38.05
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 8	-3.69 score on a scale Standard Deviation 34.20	-2.42 score on a scale Standard Deviation 33.81
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 9	-4.76 score on a scale Standard Deviation 31.67	-6.67 score on a scale Standard Deviation 31.92
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 10	-6.63 score on a scale Standard Deviation 28.48	-8.06 score on a scale Standard Deviation 32.52
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 11	-9.68 score on a scale Standard Deviation 27.38	-9.36 score on a scale Standard Deviation 33.19
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 12	-9.05 score on a scale Standard Deviation 28.51	-9.22 score on a scale Standard Deviation 33.73
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 13	-10.81 score on a scale Standard Deviation 29.18	-10.17 score on a scale Standard Deviation 31.10
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 14	-12.09 score on a scale Standard Deviation 30.32	-12.10 score on a scale Standard Deviation 31.96
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 15	-9.18 score on a scale Standard Deviation 29.81	-8.21 score on a scale Standard Deviation 32.96
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 16	-10.59 score on a scale Standard Deviation 28.74	-6.03 score on a scale Standard Deviation 33.07
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 17	-9.91 score on a scale Standard Deviation 29.05	-6.55 score on a scale Standard Deviation 29.29
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 18	-14.08 score on a scale Standard Deviation 27.98	-4.90 score on a scale Standard Deviation 31.25
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 19	-13.13 score on a scale Standard Deviation 28.57	-8.33 score on a scale Standard Deviation 31.34
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 20	-13.23 score on a scale Standard Deviation 29.66	-3.97 score on a scale Standard Deviation 31.65
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 21	-14.20 score on a scale Standard Deviation 32.76	-5.91 score on a scale Standard Deviation 31.01
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 22	-16.31 score on a scale Standard Deviation 29.38	-4.98 score on a scale Standard Deviation 34.45
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 23	-11.36 score on a scale Standard Deviation 35.90	-6.35 score on a scale Standard Deviation 36.84
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 24	-13.33 score on a scale Standard Deviation 30.00	-7.78 score on a scale Standard Deviation 33.82
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 25	-12.04 score on a scale Standard Deviation 31.02	-7.05 score on a scale Standard Deviation 35.14
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 26	-12.50 score on a scale Standard Deviation 32.52	-7.48 score on a scale Standard Deviation 34.87
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 27	-9.20 score on a scale Standard Deviation 28.03	-10.08 score on a scale Standard Deviation 33.76
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at Cycle 28	-11.54 score on a scale Standard Deviation 29.73	-10.00 score on a scale Standard Deviation 32.20
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at PT Visit 1	2.64 score on a scale Standard Deviation 33.14	7.30 score on a scale Standard Deviation 36.86
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Appetite Loss: Change at PT Visit 2	4.55 score on a scale Standard Deviation 34.53	-0.33 score on a scale Standard Deviation 33.83
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Cycle 1 (Baseline)	88.22 score on a scale Standard Deviation 16.18	87.95 score on a scale Standard Deviation 17.32
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 2	-1.81 score on a scale Standard Deviation 16.93	-1.90 score on a scale Standard Deviation 17.82
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 3	-3.17 score on a scale Standard Deviation 18.30	-0.83 score on a scale Standard Deviation 17.11
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 4	-2.99 score on a scale Standard Deviation 19.28	-2.04 score on a scale Standard Deviation 17.78
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 5	-4.59 score on a scale Standard Deviation 19.59	-3.04 score on a scale Standard Deviation 19.09
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 6	-3.84 score on a scale Standard Deviation 19.00	-5.10 score on a scale Standard Deviation 19.23
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 7	-4.31 score on a scale Standard Deviation 19.09	-4.34 score on a scale Standard Deviation 19.52
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 8	-3.30 score on a scale Standard Deviation 17.59	-3.15 score on a scale Standard Deviation 17.90
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 9	-4.59 score on a scale Standard Deviation 18.53	-2.22 score on a scale Standard Deviation 18.53
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 10	-3.11 score on a scale Standard Deviation 18.50	-3.32 score on a scale Standard Deviation 19.44
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 11	-3.44 score on a scale Standard Deviation 17.06	-2.83 score on a scale Standard Deviation 18.44
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 12	-2.52 score on a scale Standard Deviation 18.16	-3.35 score on a scale Standard Deviation 20.00
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 13	-3.60 score on a scale Standard Deviation 17.89	-1.79 score on a scale Standard Deviation 19.04
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 14	-2.29 score on a scale Standard Deviation 17.56	-1.98 score on a scale Standard Deviation 19.00
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 15	-2.38 score on a scale Standard Deviation 16.05	-1.15 score on a scale Standard Deviation 18.47
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 16	-2.55 score on a scale Standard Deviation 17.16	-2.73 score on a scale Standard Deviation 17.16
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 17	-1.13 score on a scale Standard Deviation 15.44	-2.53 score on a scale Standard Deviation 17.21
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 18	0.47 score on a scale Standard Deviation 16.42	-2.78 score on a scale Standard Deviation 18.18
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 19	0.00 score on a scale Standard Deviation 14.62	-1.04 score on a scale Standard Deviation 18.07
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 20	0.79 score on a scale Standard Deviation 15.68	-2.18 score on a scale Standard Deviation 19.67
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 21	0.62 score on a scale Standard Deviation 16.50	-2.11 score on a scale Standard Deviation 20.56
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 22	-0.71 score on a scale Standard Deviation 18.04	-4.73 score on a scale Standard Deviation 18.98
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 23	1.14 score on a scale Standard Deviation 17.75	-2.38 score on a scale Standard Deviation 19.60
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 24	1.25 score on a scale Standard Deviation 16.18	-2.78 score on a scale Standard Deviation 19.69
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 25	-0.93 score on a scale Standard Deviation 18.66	-5.45 score on a scale Standard Deviation 16.41
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 26	-1.56 score on a scale Standard Deviation 18.63	-2.38 score on a scale Standard Deviation 16.32
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 27	-1.15 score on a scale Standard Deviation 18.33	-3.88 score on a scale Standard Deviation 18.84
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at Cycle 28	0.00 score on a scale Standard Deviation 20.00	-3.75 score on a scale Standard Deviation 15.78
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at PT Visit 1	-9.16 score on a scale Standard Deviation 20.02	-9.13 score on a scale Standard Deviation 21.90
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Cognitive Functional Scale: Change at PT Visit 2	-11.21 score on a scale Standard Deviation 22.48	-8.42 score on a scale Standard Deviation 20.22
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Cycle 1 (Baseline)	18.41 score on a scale Standard Deviation 27.13	20.43 score on a scale Standard Deviation 28.45
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 2	0.29 score on a scale Standard Deviation 27.23	-5.39 score on a scale Standard Deviation 27.05
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 3	-2.11 score on a scale Standard Deviation 27.65	-7.48 score on a scale Standard Deviation 28.98
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 4	-3.73 score on a scale Standard Deviation 28.26	-5.32 score on a scale Standard Deviation 29.21
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 5	-1.28 score on a scale Standard Deviation 27.64	-5.94 score on a scale Standard Deviation 29.15
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 6	-2.33 score on a scale Standard Deviation 30.24	-7.13 score on a scale Standard Deviation 29.65
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 7	-4.09 score on a scale Standard Deviation 29.06	-8.13 score on a scale Standard Deviation 30.11
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 8	-4.45 score on a scale Standard Deviation 27.32	-8.05 score on a scale Standard Deviation 30.90
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 9	-5.61 score on a scale Standard Deviation 26.74	-10.00 score on a scale Standard Deviation 27.10
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 10	-7.43 score on a scale Standard Deviation 26.81	-9.32 score on a scale Standard Deviation 29.56
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 11	-6.88 score on a scale Standard Deviation 27.84	-9.16 score on a scale Standard Deviation 29.60
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 12	-7.25 score on a scale Standard Deviation 25.39	-10.27 score on a scale Standard Deviation 29.04
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 13	-5.76 score on a scale Standard Deviation 26.27	-11.19 score on a scale Standard Deviation 29.55
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 14	-6.21 score on a scale Standard Deviation 26.00	-11.60 score on a scale Standard Deviation 27.11
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 15	-7.14 score on a scale Standard Deviation 24.52	-10.51 score on a scale Standard Deviation 26.59
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 16	-7.45 score on a scale Standard Deviation 25.39	-8.62 score on a scale Standard Deviation 24.91
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 17	-5.86 score on a scale Standard Deviation 18.59	-8.33 score on a scale Standard Deviation 24.30
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 18	-6.57 score on a scale Standard Deviation 26.20	-7.52 score on a scale Standard Deviation 22.93
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 19	-3.03 score on a scale Standard Deviation 25.97	-3.47 score on a scale Standard Deviation 25.81
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 20	-4.76 score on a scale Standard Deviation 26.68	-3.97 score on a scale Standard Deviation 26.08
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 21	-9.26 score on a scale Standard Deviation 25.42	-3.80 score on a scale Standard Deviation 29.23
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 22	-8.51 score on a scale Standard Deviation 27.34	-4.98 score on a scale Standard Deviation 28.58
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 23	-8.33 score on a scale Standard Deviation 26.04	-6.35 score on a scale Standard Deviation 28.62
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 24	-10.00 score on a scale Standard Deviation 26.37	-7.78 score on a scale Standard Deviation 27.01
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 25	-9.26 score on a scale Standard Deviation 28.30	-7.05 score on a scale Standard Deviation 29.77
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 26	-6.25 score on a scale Standard Deviation 23.09	-6.12 score on a scale Standard Deviation 30.94
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 27	-10.34 score on a scale Standard Deviation 26.88	-7.75 score on a scale Standard Deviation 28.95
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at Cycle 28	-6.41 score on a scale Standard Deviation 21.12	-6.67 score on a scale Standard Deviation 26.37
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at PT Visit 1	-4.62 score on a scale Standard Deviation 26.19	-6.78 score on a scale Standard Deviation 31.45
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Constipation Symptom Scale: Change at PT Visit 2	-0.91 score on a scale Standard Deviation 31.11	-6.93 score on a scale Standard Deviation 28.41
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Cycle 1 (Baseline)	9.16 score on a scale Standard Deviation 18.87	8.87 score on a scale Standard Deviation 17.70
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 2	5.20 score on a scale Standard Deviation 23.79	15.12 score on a scale Standard Deviation 30.42
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 3	4.99 score on a scale Standard Deviation 26.10	14.64 score on a scale Standard Deviation 27.71
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 4	4.63 score on a scale Standard Deviation 24.07	14.13 score on a scale Standard Deviation 27.15
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 5	4.99 score on a scale Standard Deviation 23.70	13.17 score on a scale Standard Deviation 25.47
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 6	2.47 score on a scale Standard Deviation 23.76	14.81 score on a scale Standard Deviation 27.01
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 7	2.92 score on a scale Standard Deviation 23.44	12.26 score on a scale Standard Deviation 23.74
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 8	2.61 score on a scale Standard Deviation 23.53	8.91 score on a scale Standard Deviation 23.56
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 9	2.04 score on a scale Standard Deviation 21.25	6.83 score on a scale Standard Deviation 23.76
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 10	0.60 score on a scale Standard Deviation 20.91	6.63 score on a scale Standard Deviation 23.97
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 11	2.60 score on a scale Standard Deviation 20.36	5.26 score on a scale Standard Deviation 21.80
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 12	1.92 score on a scale Standard Deviation 19.97	3.98 score on a scale Standard Deviation 22.30
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 13	1.50 score on a scale Standard Deviation 19.27	4.29 score on a scale Standard Deviation 24.27
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 14	0.98 score on a scale Standard Deviation 20.15	3.95 score on a scale Standard Deviation 24.45
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 15	1.02 score on a scale Standard Deviation 19.42	3.33 score on a scale Standard Deviation 23.79
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 16	3.14 score on a scale Standard Deviation 15.10	5.46 score on a scale Standard Deviation 21.06
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 17	2.25 score on a scale Standard Deviation 14.94	2.68 score on a scale Standard Deviation 21.05
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 18	3.29 score on a scale Standard Deviation 17.95	3.59 score on a scale Standard Deviation 21.95
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 19	2.02 score on a scale Standard Deviation 16.41	3.82 score on a scale Standard Deviation 19.86
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 20	3.70 score on a scale Standard Deviation 17.05	5.95 score on a scale Standard Deviation 19.47
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 21	1.85 score on a scale Standard Deviation 16.40	3.80 score on a scale Standard Deviation 23.26
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 22	4.26 score on a scale Standard Deviation 17.88	6.97 score on a scale Standard Deviation 24.98
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 23	8.33 score on a scale Standard Deviation 20.49	6.88 score on a scale Standard Deviation 21.72
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 24	3.33 score on a scale Standard Deviation 16.54	7.22 score on a scale Standard Deviation 22.21
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 25	2.78 score on a scale Standard Deviation 14.64	8.97 score on a scale Standard Deviation 23.91
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 26	5.21 score on a scale Standard Deviation 20.93	5.44 score on a scale Standard Deviation 21.89
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 27	3.45 score on a scale Standard Deviation 16.29	3.88 score on a scale Standard Deviation 22.07
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at Cycle 28	2.56 score on a scale Standard Deviation 16.12	7.50 score on a scale Standard Deviation 27.72
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at PT Visit 1	1.98 score on a scale Standard Deviation 24.35	8.14 score on a scale Standard Deviation 26.00
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Diarrhea Symptom Scale: Change at PT Visit 2	4.24 score on a scale Standard Deviation 29.65	7.26 score on a scale Standard Deviation 25.65
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Cycle 1 (Baseline)	12.65 score on a scale Standard Deviation 20.20	12.07 score on a scale Standard Deviation 17.99
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 2	0.29 score on a scale Standard Deviation 19.72	-0.50 score on a scale Standard Deviation 19.04
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 3	-0.32 score on a scale Standard Deviation 20.38	-0.31 score on a scale Standard Deviation 20.18
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 4	1.81 score on a scale Standard Deviation 21.08	1.23 score on a scale Standard Deviation 20.31
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 5	1.39 score on a scale Standard Deviation 21.18	2.58 score on a scale Standard Deviation 20.62
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 6	0.39 score on a scale Standard Deviation 20.55	3.20 score on a scale Standard Deviation 23.79
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 7	0.59 score on a scale Standard Deviation 20.07	0.00 score on a scale Standard Deviation 21.94
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 8	0.93 score on a scale Standard Deviation 20.56	-0.14 score on a scale Standard Deviation 21.99
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 9	0.17 score on a scale Standard Deviation 18.95	-1.12 score on a scale Standard Deviation 20.51
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 10	1.00 score on a scale Standard Deviation 16.99	-0.54 score on a scale Standard Deviation 21.56
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 11	-1.29 score on a scale Standard Deviation 17.77	-2.16 score on a scale Standard Deviation 19.58
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 12	-0.71 score on a scale Standard Deviation 18.95	-2.53 score on a scale Standard Deviation 19.75
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 13	-1.20 score on a scale Standard Deviation 16.77	-1.43 score on a scale Standard Deviation 20.34
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 14	-2.61 score on a scale Standard Deviation 17.98	-1.98 score on a scale Standard Deviation 19.00
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 15	2.72 score on a scale Standard Deviation 18.95	-2.84 score on a scale Standard Deviation 21.26
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 16	1.18 score on a scale Standard Deviation 18.86	-1.45 score on a scale Standard Deviation 20.42
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 17	0.90 score on a scale Standard Deviation 19.87	-1.82 score on a scale Standard Deviation 20.61
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 18	-2.35 score on a scale Standard Deviation 18.10	-0.98 score on a scale Standard Deviation 20.15
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 19	0.51 score on a scale Standard Deviation 18.15	-1.74 score on a scale Standard Deviation 20.73
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 20	-1.06 score on a scale Standard Deviation 16.90	-1.19 score on a scale Standard Deviation 20.98
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 21	-0.62 score on a scale Standard Deviation 19.95	1.27 score on a scale Standard Deviation 22.29
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 22	0.71 score on a scale Standard Deviation 14.73	-1.99 score on a scale Standard Deviation 22.38
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score Dyspnoea Symptom Scale: Change at Cycle 23	1.52 score on a scale Standard Deviation 14.30	-1.59 score on a scale Standard Deviation 21.94

SECONDARY outcome

The EORTC QLQ-STO22 is a gastric cancer quality of life questionnaire. There are 22 questions concerning disease, treatment related symptoms, side effects, dysphagia, nutritional aspects, and questions about the emotional problems of gastric cancer (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, body image, and hair loss). The questions are grouped into five scales and 4 single items which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. A positive value means an increase, while a negative values 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	Placebo + Trastuzumab + Chemotherapy n=392 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=388 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 3	3.88 score on a scale Standard Deviation 28.03	1.48 score on a scale Standard Deviation 29.06
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 28	-4.00 score on a scale Standard Deviation 24.19	-4.27 score on a scale Standard Deviation 26.69
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 2	3.00 score on a scale Standard Deviation 25.43	7.72 score on a scale Standard Deviation 28.70
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Cycle 1 (Baseline)	14.15 score on a scale Standard Deviation 18.93	16.29 score on a scale Standard Deviation 21.46
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 27	-7.14 score on a scale Standard Deviation 21.00	0.78 score on a scale Standard Deviation 24.65
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Cycle 1 (Baseline)	40.48 score on a scale Standard Deviation 25.32	40.10 score on a scale Standard Deviation 25.85
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 2	-4.11 score on a scale Standard Deviation 21.19	-2.58 score on a scale Standard Deviation 21.72
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 3	-3.87 score on a scale Standard Deviation 23.19	-4.14 score on a scale Standard Deviation 22.45
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 4	-7.25 score on a scale Standard Deviation 23.16	-4.52 score on a scale Standard Deviation 23.01
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 5	-7.39 score on a scale Standard Deviation 24.36	-4.10 score on a scale Standard Deviation 22.94
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 6	-8.42 score on a scale Standard Deviation 25.21	-4.54 score on a scale Standard Deviation 23.97
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 7	-10.40 score on a scale Standard Deviation 24.37	-6.40 score on a scale Standard Deviation 24.00
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 8	-11.92 score on a scale Standard Deviation 24.50	-9.00 score on a scale Standard Deviation 23.17
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 9	-11.43 score on a scale Standard Deviation 23.24	-10.09 score on a scale Standard Deviation 23.30
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 10	-12.64 score on a scale Standard Deviation 22.09	-11.17 score on a scale Standard Deviation 25.05
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 11	-12.09 score on a scale Standard Deviation 21.84	-10.78 score on a scale Standard Deviation 23.47
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 12	-13.16 score on a scale Standard Deviation 23.11	-12.62 score on a scale Standard Deviation 26.24
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 13	-13.33 score on a scale Standard Deviation 22.47	-13.32 score on a scale Standard Deviation 25.93
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 14	-12.43 score on a scale Standard Deviation 23.59	-14.32 score on a scale Standard Deviation 26.49
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 15	-10.65 score on a scale Standard Deviation 25.74	-13.42 score on a scale Standard Deviation 26.64
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 16	-12.57 score on a scale Standard Deviation 23.89	-12.75 score on a scale Standard Deviation 26.87
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 17	-12.79 score on a scale Standard Deviation 21.01	-13.41 score on a scale Standard Deviation 27.30
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 18	-12.38 score on a scale Standard Deviation 22.90	-13.53 score on a scale Standard Deviation 28.05
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 19	-12.48 score on a scale Standard Deviation 20.08	-14.50 score on a scale Standard Deviation 27.41
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 20	-12.37 score on a scale Standard Deviation 23.73	-15.34 score on a scale Standard Deviation 29.21
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 21	-14.47 score on a scale Standard Deviation 25.00	-16.03 score on a scale Standard Deviation 28.84
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 22	-15.46 score on a scale Standard Deviation 23.83	-13.30 score on a scale Standard Deviation 30.77
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 23	-14.47 score on a scale Standard Deviation 29.55	-17.28 score on a scale Standard Deviation 30.64
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 24	-17.09 score on a scale Standard Deviation 23.76	-16.11 score on a scale Standard Deviation 30.65
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 25	-17.78 score on a scale Standard Deviation 23.68	-16.03 score on a scale Standard Deviation 29.47
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 26	-13.26 score on a scale Standard Deviation 22.11	-19.73 score on a scale Standard Deviation 30.28
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 27	-12.70 score on a scale Standard Deviation 20.67	-21.71 score on a scale Standard Deviation 29.89
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at Cycle 28	-12.89 score on a scale Standard Deviation 22.38	-22.51 score on a scale Standard Deviation 29.34
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at PT Visit 1	-4.73 score on a scale Standard Deviation 27.21	-0.73 score on a scale Standard Deviation 25.18
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Anxiety: Change at PT Visit 2	-3.98 score on a scale Standard Deviation 25.02	-4.04 score on a scale Standard Deviation 28.24
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Cycle 1 (Baseline)	23.68 score on a scale Standard Deviation 27.47	23.53 score on a scale Standard Deviation 28.40
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 2	1.20 score on a scale Standard Deviation 26.44	1.33 score on a scale Standard Deviation 28.19
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 4	1.15 score on a scale Standard Deviation 27.19	4.20 score on a scale Standard Deviation 28.51
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 5	1.06 score on a scale Standard Deviation 25.74	2.86 score on a scale Standard Deviation 30.91
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 6	2.78 score on a scale Standard Deviation 28.48	0.75 score on a scale Standard Deviation 30.11
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 7	0.29 score on a scale Standard Deviation 25.53	-0.56 score on a scale Standard Deviation 28.94
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 8	0.00 score on a scale Standard Deviation 26.30	-1.74 score on a scale Standard Deviation 29.83
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 9	-0.69 score on a scale Standard Deviation 24.52	-3.58 score on a scale Standard Deviation 28.74
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 10	-3.25 score on a scale Standard Deviation 24.55	-5.07 score on a scale Standard Deviation 30.15
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 11	-1.53 score on a scale Standard Deviation 25.46	-4.62 score on a scale Standard Deviation 30.24
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 12	-2.66 score on a scale Standard Deviation 27.04	-5.31 score on a scale Standard Deviation 31.92
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 13	-2.73 score on a scale Standard Deviation 25.99	-4.73 score on a scale Standard Deviation 30.23
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 14	-4.62 score on a scale Standard Deviation 24.05	-5.43 score on a scale Standard Deviation 29.70
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 15	-2.43 score on a scale Standard Deviation 27.03	-3.08 score on a scale Standard Deviation 30.63
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 16	-1.19 score on a scale Standard Deviation 26.10	-1.74 score on a scale Standard Deviation 32.99
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 17	-2.28 score on a scale Standard Deviation 21.75	-2.70 score on a scale Standard Deviation 32.76
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 18	-5.71 score on a scale Standard Deviation 23.38	-2.64 score on a scale Standard Deviation 30.44
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 19	-5.21 score on a scale Standard Deviation 20.76	-2.81 score on a scale Standard Deviation 33.57
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 20	-5.38 score on a scale Standard Deviation 22.74	-3.97 score on a scale Standard Deviation 30.79
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 21	-8.18 score on a scale Standard Deviation 26.07	1.69 score on a scale Standard Deviation 30.15
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 22	-10.87 score on a scale Standard Deviation 22.28	-1.49 score on a scale Standard Deviation 32.01
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 23	-8.53 score on a scale Standard Deviation 29.18	-5.82 score on a scale Standard Deviation 24.35
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 24	-11.11 score on a scale Standard Deviation 23.36	-0.56 score on a scale Standard Deviation 31.25
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 25	-11.43 score on a scale Standard Deviation 24.18	-3.21 score on a scale Standard Deviation 28.97
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at Cycle 26	-6.45 score on a scale Standard Deviation 18.09	-4.76 score on a scale Standard Deviation 29.66
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at PT Visit 1	3.42 score on a scale Standard Deviation 29.31	2.48 score on a scale Standard Deviation 31.57
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Body Image: Change at PT Visit 2	6.35 score on a scale Standard Deviation 27.38	2.36 score on a scale Standard Deviation 35.40
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Cycle 1 (Baseline)	23.32 score on a scale Standard Deviation 26.79	21.80 score on a scale Standard Deviation 25.07
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 3	4.87 score on a scale Standard Deviation 27.33	6.10 score on a scale Standard Deviation 28.65
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 4	2.66 score on a scale Standard Deviation 31.06	4.76 score on a scale Standard Deviation 29.40
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 5	2.57 score on a scale Standard Deviation 28.68	2.47 score on a scale Standard Deviation 29.67
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 6	1.19 score on a scale Standard Deviation 27.65	2.96 score on a scale Standard Deviation 30.14
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 7	0.44 score on a scale Standard Deviation 28.54	-1.96 score on a scale Standard Deviation 28.82
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 8	-2.66 score on a scale Standard Deviation 26.27	-2.43 score on a scale Standard Deviation 28.68
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 9	-4.32 score on a scale Standard Deviation 24.74	-3.70 score on a scale Standard Deviation 25.70
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 10	-3.46 score on a scale Standard Deviation 23.53	-6.27 score on a scale Standard Deviation 25.04
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 11	-1.96 score on a scale Standard Deviation 26.56	-7.69 score on a scale Standard Deviation 25.46
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 12	-4.35 score on a scale Standard Deviation 26.36	-8.18 score on a scale Standard Deviation 24.22
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 13	-8.48 score on a scale Standard Deviation 26.50	-9.69 score on a scale Standard Deviation 24.08
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 14	-3.63 score on a scale Standard Deviation 29.78	-8.33 score on a scale Standard Deviation 24.60
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 15	-7.29 score on a scale Standard Deviation 26.58	-7.89 score on a scale Standard Deviation 22.20
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 16	-8.33 score on a scale Standard Deviation 27.80	-6.32 score on a scale Standard Deviation 24.44
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 17	-3.20 score on a scale Standard Deviation 24.32	-7.44 score on a scale Standard Deviation 23.12
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 18	-8.10 score on a scale Standard Deviation 28.62	-5.56 score on a scale Standard Deviation 24.86
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 19	-7.69 score on a scale Standard Deviation 25.53	-5.90 score on a scale Standard Deviation 24.18
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 20	-9.68 score on a scale Standard Deviation 27.25	-6.35 score on a scale Standard Deviation 26.62
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 21	-9.43 score on a scale Standard Deviation 20.02	-7.17 score on a scale Standard Deviation 24.27
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 22	-8.70 score on a scale Standard Deviation 23.76	-3.98 score on a scale Standard Deviation 26.29
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 23	-3.88 score on a scale Standard Deviation 25.42	-7.94 score on a scale Standard Deviation 23.73
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 24	-9.40 score on a scale Standard Deviation 28.56	-6.67 score on a scale Standard Deviation 25.15
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 25	-9.52 score on a scale Standard Deviation 28.66	-8.33 score on a scale Standard Deviation 22.75
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 26	-7.53 score on a scale Standard Deviation 26.82	-2.72 score on a scale Standard Deviation 23.41
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 27	-7.14 score on a scale Standard Deviation 27.75	-6.98 score on a scale Standard Deviation 21.28
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at Cycle 28	-8.00 score on a scale Standard Deviation 22.11	-8.55 score on a scale Standard Deviation 21.24
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at PT Visit 1	2.38 score on a scale Standard Deviation 31.58	0.19 score on a scale Standard Deviation 28.70
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dry Mouth: Change at PT Visit 2	1.89 score on a scale Standard Deviation 25.95	-1.35 score on a scale Standard Deviation 30.09
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 2	-0.53 score on a scale Standard Deviation 19.32	-2.27 score on a scale Standard Deviation 17.64
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 3	-2.15 score on a scale Standard Deviation 19.67	-3.39 score on a scale Standard Deviation 18.57
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 4	-1.08 score on a scale Standard Deviation 18.79	-2.94 score on a scale Standard Deviation 18.93
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 5	-1.83 score on a scale Standard Deviation 18.99	-3.22 score on a scale Standard Deviation 19.92
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 6	-2.25 score on a scale Standard Deviation 18.70	-4.20 score on a scale Standard Deviation 18.99
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 7	-1.97 score on a scale Standard Deviation 19.94	-4.83 score on a scale Standard Deviation 20.56
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 8	-3.29 score on a scale Standard Deviation 18.48	-5.96 score on a scale Standard Deviation 18.80
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 9	-3.86 score on a scale Standard Deviation 18.49	-6.17 score on a scale Standard Deviation 18.21
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 10	-4.61 score on a scale Standard Deviation 16.87	-6.03 score on a scale Standard Deviation 17.37
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 11	-2.83 score on a scale Standard Deviation 17.03	-6.25 score on a scale Standard Deviation 17.09
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 12	-4.19 score on a scale Standard Deviation 15.84	-7.06 score on a scale Standard Deviation 17.65
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 13	-3.54 score on a scale Standard Deviation 17.61	-6.93 score on a scale Standard Deviation 18.71
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 14	-4.95 score on a scale Standard Deviation 18.22	-8.01 score on a scale Standard Deviation 18.53
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 15	-2.14 score on a scale Standard Deviation 18.69	-6.45 score on a scale Standard Deviation 17.38
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 16	-3.70 score on a scale Standard Deviation 21.08	-4.41 score on a scale Standard Deviation 18.29
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 17	-3.20 score on a scale Standard Deviation 14.99	-5.36 score on a scale Standard Deviation 16.87
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 18	-3.33 score on a scale Standard Deviation 19.78	-4.90 score on a scale Standard Deviation 16.44
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 19	-3.59 score on a scale Standard Deviation 14.31	-4.40 score on a scale Standard Deviation 17.10
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 20	-3.76 score on a scale Standard Deviation 15.83	-2.51 score on a scale Standard Deviation 16.21
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 21	-2.10 score on a scale Standard Deviation 17.84	-3.80 score on a scale Standard Deviation 19.24
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 22	-4.83 score on a scale Standard Deviation 15.65	-3.65 score on a scale Standard Deviation 20.41
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 23	-3.88 score on a scale Standard Deviation 17.63	-4.23 score on a scale Standard Deviation 18.87
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 24	-3.70 score on a scale Standard Deviation 13.08	-5.00 score on a scale Standard Deviation 18.35
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 25	-2.22 score on a scale Standard Deviation 16.79	-5.98 score on a scale Standard Deviation 19.61
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 26	-2.87 score on a scale Standard Deviation 16.22	-5.67 score on a scale Standard Deviation 20.43
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 27	-4.37 score on a scale Standard Deviation 12.22	-5.68 score on a scale Standard Deviation 20.91
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at Cycle 28	-3.56 score on a scale Standard Deviation 11.44	-8.26 score on a scale Standard Deviation 19.86
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at PT Visit 1	2.83 score on a scale Standard Deviation 22.63	0.44 score on a scale Standard Deviation 24.15
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Dysphagia: Change at PT Visit 2	3.25 score on a scale Standard Deviation 19.81	-2.81 score on a scale Standard Deviation 24.40
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Cycle 1 (Baseline)	22.33 score on a scale Standard Deviation 20.22	23.26 score on a scale Standard Deviation 21.78
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 3	-2.20 score on a scale Standard Deviation 20.94	-1.04 score on a scale Standard Deviation 21.09
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 2	-1.54 score on a scale Standard Deviation 19.62	-1.41 score on a scale Standard Deviation 19.36
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 4	-1.39 score on a scale Standard Deviation 23.36	-2.24 score on a scale Standard Deviation 20.81
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 5	-0.09 score on a scale Standard Deviation 23.31	-1.39 score on a scale Standard Deviation 22.10
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 6	-3.32 score on a scale Standard Deviation 23.14	-1.35 score on a scale Standard Deviation 22.77
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 7	-2.67 score on a scale Standard Deviation 21.66	-2.45 score on a scale Standard Deviation 22.68
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 8	-5.56 score on a scale Standard Deviation 19.87	-4.29 score on a scale Standard Deviation 22.70
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 9	-6.48 score on a scale Standard Deviation 19.69	-6.99 score on a scale Standard Deviation 21.16
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 10	-5.89 score on a scale Standard Deviation 19.30	-7.06 score on a scale Standard Deviation 21.32
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 11	-5.05 score on a scale Standard Deviation 19.98	-8.22 score on a scale Standard Deviation 21.25
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 12	-6.34 score on a scale Standard Deviation 19.87	-7.74 score on a scale Standard Deviation 21.16
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 13	-8.41 score on a scale Standard Deviation 19.57	-8.55 score on a scale Standard Deviation 20.41
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 14	-8.58 score on a scale Standard Deviation 21.16	-8.62 score on a scale Standard Deviation 19.16
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 15	-5.56 score on a scale Standard Deviation 21.21	-6.85 score on a scale Standard Deviation 20.92
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 16	-6.94 score on a scale Standard Deviation 20.36	-5.77 score on a scale Standard Deviation 22.01
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 17	-7.42 score on a scale Standard Deviation 17.76	-5.56 score on a scale Standard Deviation 21.95
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 18	-6.90 score on a scale Standard Deviation 21.14	-7.27 score on a scale Standard Deviation 20.40
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 19	-5.38 score on a scale Standard Deviation 18.07	-7.03 score on a scale Standard Deviation 21.78
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 20	-4.44 score on a scale Standard Deviation 16.72	-4.56 score on a scale Standard Deviation 21.03
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 21	-5.03 score on a scale Standard Deviation 19.97	-5.80 score on a scale Standard Deviation 22.58
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 22	-6.16 score on a scale Standard Deviation 16.80	-3.65 score on a scale Standard Deviation 21.79
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 23	-5.23 score on a scale Standard Deviation 20.25	-3.70 score on a scale Standard Deviation 22.74
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 24	-7.91 score on a scale Standard Deviation 15.76	-5.00 score on a scale Standard Deviation 20.77
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 25	-5.95 score on a scale Standard Deviation 16.61	-5.77 score on a scale Standard Deviation 21.10
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 26	-2.42 score on a scale Standard Deviation 22.89	-6.80 score on a scale Standard Deviation 21.22
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 27	-3.87 score on a scale Standard Deviation 10.26	-5.62 score on a scale Standard Deviation 23.48
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at Cycle 28	-5.00 score on a scale Standard Deviation 11.02	-7.91 score on a scale Standard Deviation 21.79
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at PT Visit 1	0.94 score on a scale Standard Deviation 24.70	1.52 score on a scale Standard Deviation 24.48
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Eating Restrictions: Change at PT Visit 2	0.94 score on a scale Standard Deviation 21.46	-2.10 score on a scale Standard Deviation 25.32
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Cycle 1 (Baseline)	4.04 score on a scale Standard Deviation 13.20	4.73 score on a scale Standard Deviation 13.28
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 2	1.27 score on a scale Standard Deviation 16.59	0.20 score on a scale Standard Deviation 14.85
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 3	4.52 score on a scale Standard Deviation 18.71	4.34 score on a scale Standard Deviation 17.51
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 4	6.53 score on a scale Standard Deviation 20.99	5.40 score on a scale Standard Deviation 18.46
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 5	7.18 score on a scale Standard Deviation 19.49	6.12 score on a scale Standard Deviation 19.38
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 6	10.07 score on a scale Standard Deviation 22.94	6.93 score on a scale Standard Deviation 18.87
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 7	9.26 score on a scale Standard Deviation 22.92	5.72 score on a scale Standard Deviation 19.91
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 8	7.38 score on a scale Standard Deviation 23.05	5.00 score on a scale Standard Deviation 18.96
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 9	6.46 score on a scale Standard Deviation 21.06	2.38 score on a scale Standard Deviation 17.43
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 10	4.22 score on a scale Standard Deviation 19.51	0.64 score on a scale Standard Deviation 16.88
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 11	2.54 score on a scale Standard Deviation 17.51	-0.10 score on a scale Standard Deviation 17.02
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 12	1.96 score on a scale Standard Deviation 15.72	0.21 score on a scale Standard Deviation 19.70
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 13	2.29 score on a scale Standard Deviation 15.46	0.36 score on a scale Standard Deviation 18.91
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 14	1.83 score on a scale Standard Deviation 15.15	-1.37 score on a scale Standard Deviation 17.59
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 15	1.58 score on a scale Standard Deviation 12.65	-0.39 score on a scale Standard Deviation 15.65
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 16	1.42 score on a scale Standard Deviation 13.91	-1.47 score on a scale Standard Deviation 17.47
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 17	0.23 score on a scale Standard Deviation 12.57	-1.07 score on a scale Standard Deviation 17.75
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 18	-0.71 score on a scale Standard Deviation 13.14	-1.68 score on a scale Standard Deviation 17.58
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 19	0.51 score on a scale Standard Deviation 14.12	-0.90 score on a scale Standard Deviation 18.12
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 20	-1.61 score on a scale Standard Deviation 12.70	-0.20 score on a scale Standard Deviation 19.21
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 21	-1.57 score on a scale Standard Deviation 8.81	-1.07 score on a scale Standard Deviation 19.43
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 22	-3.26 score on a scale Standard Deviation 11.98	-0.50 score on a scale Standard Deviation 16.66
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 23	-1.19 score on a scale Standard Deviation 11.28	-0.54 score on a scale Standard Deviation 16.79
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 24	1.71 score on a scale Standard Deviation 16.13	-1.39 score on a scale Standard Deviation 17.44
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 25	-0.95 score on a scale Standard Deviation 9.85	-1.96 score on a scale Standard Deviation 18.75
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 26	-0.54 score on a scale Standard Deviation 10.08	-1.02 score on a scale Standard Deviation 19.37
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 27	-0.60 score on a scale Standard Deviation 10.62	-3.10 score on a scale Standard Deviation 15.96
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at Cycle 28	-1.33 score on a scale Standard Deviation 10.67	-4.70 score on a scale Standard Deviation 20.57
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at PT Visit 1	4.51 score on a scale Standard Deviation 20.39	4.98 score on a scale Standard Deviation 19.73
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Hair Loss: Change at PT Visit 2	22.22 score on a scale Standard Deviation 30.81	15.82 score on a scale Standard Deviation 25.35
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Cycle 1 (Baseline)	26.47 score on a scale Standard Deviation 20.70	26.48 score on a scale Standard Deviation 21.34
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 2	-5.86 score on a scale Standard Deviation 19.15	-4.63 score on a scale Standard Deviation 20.30
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 3	-5.86 score on a scale Standard Deviation 20.68	-6.96 score on a scale Standard Deviation 20.37
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 4	-7.48 score on a scale Standard Deviation 21.23	-6.45 score on a scale Standard Deviation 21.47
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 5	-6.89 score on a scale Standard Deviation 22.10	-7.28 score on a scale Standard Deviation 20.95
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 6	-7.22 score on a scale Standard Deviation 21.62	-7.24 score on a scale Standard Deviation 20.84
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 7	-6.62 score on a scale Standard Deviation 21.63	-9.52 score on a scale Standard Deviation 21.18
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 8	-8.16 score on a scale Standard Deviation 20.11	-10.53 score on a scale Standard Deviation 21.62
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 9	-8.98 score on a scale Standard Deviation 20.29	-10.08 score on a scale Standard Deviation 19.60
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 10	-8.59 score on a scale Standard Deviation 20.38	-10.63 score on a scale Standard Deviation 19.23
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 11	-8.01 score on a scale Standard Deviation 18.97	-11.65 score on a scale Standard Deviation 19.35
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 12	-7.19 score on a scale Standard Deviation 19.11	-11.76 score on a scale Standard Deviation 19.87
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 13	-9.24 score on a scale Standard Deviation 19.79	-11.92 score on a scale Standard Deviation 18.93
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 14	-9.82 score on a scale Standard Deviation 19.91	-11.66 score on a scale Standard Deviation 19.51
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 15	-8.51 score on a scale Standard Deviation 20.94	-11.15 score on a scale Standard Deviation 18.16
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 16	-10.52 score on a scale Standard Deviation 21.30	-8.72 score on a scale Standard Deviation 18.02
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 17	-9.93 score on a scale Standard Deviation 17.27	-8.88 score on a scale Standard Deviation 18.17
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 18	-11.19 score on a scale Standard Deviation 18.16	-8.31 score on a scale Standard Deviation 18.33
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 19	-10.38 score on a scale Standard Deviation 14.51	-6.63 score on a scale Standard Deviation 17.25
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 20	-10.35 score on a scale Standard Deviation 16.65	-5.72 score on a scale Standard Deviation 19.98
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 21	-7.55 score on a scale Standard Deviation 16.77	-8.19 score on a scale Standard Deviation 18.27
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 22	-9.42 score on a scale Standard Deviation 16.72	-9.08 score on a scale Standard Deviation 18.10
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 23	-8.53 score on a scale Standard Deviation 19.96	-9.66 score on a scale Standard Deviation 20.75
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 24	-8.76 score on a scale Standard Deviation 15.53	-9.86 score on a scale Standard Deviation 21.56
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 25	-8.10 score on a scale Standard Deviation 18.69	-10.58 score on a scale Standard Deviation 19.88
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 26	-9.41 score on a scale Standard Deviation 17.58	-9.01 score on a scale Standard Deviation 17.99
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 27	-9.23 score on a scale Standard Deviation 14.58	-12.02 score on a scale Standard Deviation 17.28
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at Cycle 28	-7.33 score on a scale Standard Deviation 13.46	-11.54 score on a scale Standard Deviation 18.20
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at PT Visit 1	-2.99 score on a scale Standard Deviation 23.86	-1.70 score on a scale Standard Deviation 23.07
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Pain: Change at PT Visit 2	-0.03 score on a scale Standard Deviation 22.04	-7.49 score on a scale Standard Deviation 24.09
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Cycle 1 (Baseline)	17.34 score on a scale Standard Deviation 18.31	16.68 score on a scale Standard Deviation 19.03
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 2	-1.99 score on a scale Standard Deviation 18.03	-0.13 score on a scale Standard Deviation 16.33
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 3	-2.28 score on a scale Standard Deviation 19.53	-0.52 score on a scale Standard Deviation 18.95
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 4	-1.90 score on a scale Standard Deviation 19.93	-0.98 score on a scale Standard Deviation 19.18
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 5	-1.72 score on a scale Standard Deviation 20.10	-1.92 score on a scale Standard Deviation 18.98
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 6	-3.59 score on a scale Standard Deviation 19.04	-2.90 score on a scale Standard Deviation 20.42
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 7	-3.20 score on a scale Standard Deviation 20.21	-4.18 score on a scale Standard Deviation 18.36
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 8	-5.74 score on a scale Standard Deviation 19.53	-4.96 score on a scale Standard Deviation 19.39
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 9	-5.18 score on a scale Standard Deviation 19.81	-5.02 score on a scale Standard Deviation 18.97
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 10	-6.48 score on a scale Standard Deviation 18.55	-6.12 score on a scale Standard Deviation 17.81
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 11	-6.03 score on a scale Standard Deviation 18.07	-6.44 score on a scale Standard Deviation 18.74
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 12	-7.49 score on a scale Standard Deviation 16.99	-4.82 score on a scale Standard Deviation 18.00
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 13	-6.77 score on a scale Standard Deviation 18.19	-6.42 score on a scale Standard Deviation 17.09
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 14	-7.37 score on a scale Standard Deviation 17.45	-5.39 score on a scale Standard Deviation 18.24
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 15	-4.98 score on a scale Standard Deviation 18.72	-5.00 score on a scale Standard Deviation 16.66
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 16	-4.89 score on a scale Standard Deviation 22.31	-3.07 score on a scale Standard Deviation 18.39
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 17	-4.57 score on a scale Standard Deviation 20.44	-3.35 score on a scale Standard Deviation 18.38
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 18	-6.51 score on a scale Standard Deviation 20.33	-2.94 score on a scale Standard Deviation 18.36
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 19	-6.15 score on a scale Standard Deviation 18.43	-2.43 score on a scale Standard Deviation 16.38
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 20	-5.38 score on a scale Standard Deviation 18.63	-1.85 score on a scale Standard Deviation 18.32
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 21	-4.19 score on a scale Standard Deviation 17.73	-1.83 score on a scale Standard Deviation 18.44
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 22	-7.00 score on a scale Standard Deviation 19.65	-3.81 score on a scale Standard Deviation 19.30
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 23	-6.98 score on a scale Standard Deviation 19.70	-5.11 score on a scale Standard Deviation 17.03
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 24	-7.98 score on a scale Standard Deviation 18.19	-4.07 score on a scale Standard Deviation 19.30
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 25	-5.71 score on a scale Standard Deviation 16.69	-5.56 score on a scale Standard Deviation 18.86
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 26	-4.30 score on a scale Standard Deviation 21.98	-4.99 score on a scale Standard Deviation 20.67
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 27	-6.75 score on a scale Standard Deviation 16.10	-7.75 score on a scale Standard Deviation 20.51
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at Cycle 28	-4.44 score on a scale Standard Deviation 11.56	-7.12 score on a scale Standard Deviation 18.64
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at PT Visit 1	-0.45 score on a scale Standard Deviation 22.92	0.88 score on a scale Standard Deviation 20.01
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Reflux Symptoms: Change at PT Visit 2	-1.47 score on a scale Standard Deviation 22.28	0.56 score on a scale Standard Deviation 18.67
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Cycle 1 (Baseline)	16.22 score on a scale Standard Deviation 25.49	13.79 score on a scale Standard Deviation 23.99
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 2	6.61 score on a scale Standard Deviation 26.94	12.09 score on a scale Standard Deviation 28.78
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 3	9.99 score on a scale Standard Deviation 30.16	16.72 score on a scale Standard Deviation 32.11
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 4	11.07 score on a scale Standard Deviation 31.93	18.43 score on a scale Standard Deviation 34.70
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 5	11.85 score on a scale Standard Deviation 30.25	17.61 score on a scale Standard Deviation 32.93
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 6	11.82 score on a scale Standard Deviation 32.21	17.97 score on a scale Standard Deviation 31.20
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 7	9.19 score on a scale Standard Deviation 31.09	16.25 score on a scale Standard Deviation 33.51
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 8	3.29 score on a scale Standard Deviation 28.13	11.64 score on a scale Standard Deviation 29.81
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 9	1.73 score on a scale Standard Deviation 26.30	9.22 score on a scale Standard Deviation 28.25
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 10	1.63 score on a scale Standard Deviation 28.79	7.93 score on a scale Standard Deviation 26.41
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 11	2.61 score on a scale Standard Deviation 26.91	4.96 score on a scale Standard Deviation 26.72
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 12	0.24 score on a scale Standard Deviation 24.66	5.27 score on a scale Standard Deviation 24.82
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 13	-0.91 score on a scale Standard Deviation 25.33	4.08 score on a scale Standard Deviation 25.53
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 14	-5.28 score on a scale Standard Deviation 24.37	0.49 score on a scale Standard Deviation 25.66
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 15	-1.04 score on a scale Standard Deviation 26.25	3.08 score on a scale Standard Deviation 24.36
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 16	-3.57 score on a scale Standard Deviation 20.71	5.51 score on a scale Standard Deviation 27.90
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 17	-3.65 score on a scale Standard Deviation 23.28	4.80 score on a scale Standard Deviation 24.96
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 18	-4.29 score on a scale Standard Deviation 23.34	3.59 score on a scale Standard Deviation 23.87
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 19	-4.62 score on a scale Standard Deviation 15.45	3.13 score on a scale Standard Deviation 25.17
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 20	-3.76 score on a scale Standard Deviation 18.21	5.56 score on a scale Standard Deviation 27.78
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 21	-5.03 score on a scale Standard Deviation 17.78	6.33 score on a scale Standard Deviation 27.26
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 22	-4.35 score on a scale Standard Deviation 16.64	9.45 score on a scale Standard Deviation 30.04
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 23	0.00 score on a scale Standard Deviation 23.00	8.99 score on a scale Standard Deviation 30.06
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 24	-5.13 score on a scale Standard Deviation 19.55	7.78 score on a scale Standard Deviation 28.37
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 25	-4.76 score on a scale Standard Deviation 18.33	3.21 score on a scale Standard Deviation 28.97
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 26	-3.23 score on a scale Standard Deviation 21.70	4.08 score on a scale Standard Deviation 34.45
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 27	-3.57 score on a scale Standard Deviation 20.96	4.65 score on a scale Standard Deviation 29.62
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at Cycle 28	-6.67 score on a scale Standard Deviation 25.46	3.42 score on a scale Standard Deviation 21.35
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at PT Visit 1	9.06 score on a scale Standard Deviation 33.56	12.76 score on a scale Standard Deviation 34.59
Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score Taste: Change at PT Visit 2	6.67 score on a scale Standard Deviation 28.64	8.42 score on a scale Standard Deviation 31.35

SECONDARY outcome

Timeframe: Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day 1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days)

Population: The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. In this analysis, results are reported only for evaluable participants who received pertuzumab.

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=374 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Maximum Serum Concentration (Cmax) of Pertuzumab Cycle 1	—	258 micrograms per milliliter (μg/mL) Standard Deviation 90.3
Maximum Serum Concentration (Cmax) of Pertuzumab Cycle 2	—	288 micrograms per milliliter (μg/mL) Standard Deviation 83.7
Maximum Serum Concentration (Cmax) of Pertuzumab Cycle 4	—	341 micrograms per milliliter (μg/mL) Standard Deviation 111
Maximum Serum Concentration (Cmax) of Pertuzumab Cycle 8	—	371 micrograms per milliliter (μg/mL) Standard Deviation 127

SECONDARY outcome

Timeframe: Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day 1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days)

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy n=375 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=372 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Cmax of Trastuzumab Cycle 1	139 μg/mL Standard Deviation 58.6	142 μg/mL Standard Deviation 86.8
Cmax of Trastuzumab Cycle 2	120 μg/mL Standard Deviation 44.3	120 μg/mL Standard Deviation 46.6
Cmax of Trastuzumab Cycle 4	129 μg/mL Standard Deviation 58.1	127 μg/mL Standard Deviation 50.9
Cmax of Trastuzumab Cycle 8	147 μg/mL Standard Deviation 90.2	130 μg/mL Standard Deviation 50.8

SECONDARY outcome

Timeframe: Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days)

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=376 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Minimum Serum Concentration (Cmin) of Pertuzumab Cycle 3	—	74.0 μg/mL Standard Deviation 40.9
Minimum Serum Concentration (Cmin) of Pertuzumab Cycle 1	—	NA μg/mL Standard Deviation NA The Cmin of pertuzumab at Cycle 1 (before first dose) is non-reportable (i.e., lower than quantifiable).
Minimum Serum Concentration (Cmin) of Pertuzumab Cycle 2	—	42.4 μg/mL Standard Deviation 24.8
Minimum Serum Concentration (Cmin) of Pertuzumab Cycle 4	—	90.4 μg/mL Standard Deviation 42.4
Minimum Serum Concentration (Cmin) of Pertuzumab Cycle 6	—	114 μg/mL Standard Deviation 51.8
Minimum Serum Concentration (Cmin) of Pertuzumab Cycle 8	—	142 μg/mL Standard Deviation 67.9

SECONDARY outcome

Timeframe: Pre-dose (0-6 hours before infusion) on Day 1 of Cycles 1, 2, 3, 4, 6, and 8 (1 cycle = 21 days)

Outcome measures

Outcome measures
Measure	Placebo + Trastuzumab + Chemotherapy n=381 Participants Participants received placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive placebo and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.	Pertuzumab + Trastuzumab + Chemotherapy n=379 Participants Participants received pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine \[capecitabine or 5-fluorouracil\]) for the first 6 treatment cycles (cycle length = 21 days). Thereafter, participants continued to receive pertuzumab and trastuzumab until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
Cmin of Trastuzumab Cycle 2	17.2 μg/mL Standard Deviation 15.4	15.4 μg/mL Standard Deviation 11.3
Cmin of Trastuzumab Cycle 1	NA μg/mL Standard Deviation NA The Cmin of trastuzumab at Cycle 1 (before first dose) is non-reportable (i.e., lower than quantifiable).	NA μg/mL Standard Deviation NA The Cmin of trastuzumab at Cycle 1 (before first dose) is non-reportable (i.e., lower than quantifiable).
Cmin of Trastuzumab Cycle 3	20.7 μg/mL Standard Deviation 15.2	19.9 μg/mL Standard Deviation 13.4
Cmin of Trastuzumab Cycle 4	24.1 μg/mL Standard Deviation 19.0	22.9 μg/mL Standard Deviation 12.7
Cmin of Trastuzumab Cycle 6	29.8 μg/mL Standard Deviation 21.9	26.3 μg/mL Standard Deviation 14.8
Cmin of Trastuzumab Cycle 8	37.4 μg/mL Standard Deviation 20.3	32.7 μg/mL Standard Deviation 15.0

Adverse Events

Pertuzumab + Trastuzumab + Chemotherapy

Serious events: 178 serious events

Other events: 373 other events

Deaths: 299 deaths

Placebo + Trastuzumab + Chemotherapy

Serious events: 156 serious events

Other events: 376 other events

Deaths: 318 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 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