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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01774786
Recruitment Status : Active, not recruiting
First Posted : January 24, 2013
Results First Posted : February 14, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Gastric Cancer
Interventions Drug: 5-Fluorouracil
Drug: Capecitabine
Drug: Cisplatin
Drug: Pertuzumab
Drug: Placebo
Drug: Trastuzumab
Enrollment 780
Recruitment Details  
Pre-assignment Details The analysis included data up to a clinical data cut-off date of 9 December 2016.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason. Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Period Title: Overall Study
Started [1] 388 392
Did Not Receive Study Drug 4 3
Received at Least One Dose of Pertuzumab 384 1 [2]
Received at Least One Dose of Placebo 0 388
Completed 0 0
Not Completed 388 392
Reason Not Completed
On Treatment             55             47
Between Treatment and Follow-up             6             2
In Follow-up             65             62
Death             242             262
Lost to Follow-up             3             4
Withdrawal by Subject             15             12
Physician Decision             1             0
Ineligible for Study             1             3
[1]
Intent-to-Treat (ITT) population
[2]
One participant randomized to placebo arm received 1 dose of pertuzumab by error.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy Total
Hide Arm/Group Description Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason. Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason. Total of all reporting groups
Overall Number of Baseline Participants 388 392 780
Hide Baseline Analysis Population Description
ITT population included all randomized participants regardless of treatment received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 388 participants 392 participants 780 participants
60.9  (11.3) 60.1  (10.7) 60.5  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 388 participants 392 participants 780 participants
Female
94
  24.2%
69
  17.6%
163
  20.9%
Male
294
  75.8%
323
  82.4%
617
  79.1%
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was defined as the time from randomization to death from any cause.
Time Frame Baseline up to death (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all randomized participants, regardless of whether study medication was received.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 388 392
Median (95% Confidence Interval)
Unit of Measure: Months
17.5
(16.2 to 19.3)
14.2
(12.9 to 15.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pertuzumab + Trastuzumab + Chemotherapy, Placebo + Trastuzumab + Chemotherapy
Comments The null hypothesis is that the survival distribution of OS is the same in the two treatment arms.
Type of Statistical Test Superiority
Comments The study was designed to have 80% power to show a significant difference with respect to the primary endpoint.
Statistical Test of Hypothesis P-Value 0.0565
Comments The actual p-value significance threshold required for OS was 0.0452, after alpha spent at the interim analysis was taken into account.
Method Stratified Log-Rank
Comments Patients were stratified according to geographic region, prior gastrectomy, and HER2 status.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.71 to 1.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria
Hide Description Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using RECIST v1.1, or death from any cause. Disease progression: 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.
Time Frame Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all randomized participants, regardless of whether study medication was received.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 388 392
Median (95% Confidence Interval)
Unit of Measure: months
8.5
(8.2 to 9.7)
7.0
(6.4 to 8.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pertuzumab + Trastuzumab + Chemotherapy, Placebo + Trastuzumab + Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.62 to 0.86
Estimation Comments A stratified Cox proportional hazards regression model was used to estimate the HR between treatment arms with a 95% Confidence Interval.
3.Secondary Outcome
Title Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria
Hide Description Overall objective response (partial response [PR] or complete response [CR]) occurring on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator using RECIST v1.1. 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 computed tomography (CT) or magnetic resonance imaging (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.
Time Frame Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 351 352
Measure Type: Number
Unit of Measure: Percentage of participants
56.7 48.3
4.Secondary Outcome
Title Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria
Hide Description 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. Disease progression: 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.
Time Frame Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The participants with measurable disease at baseline who achieved a documented objective response, according to RECIST v1.1 criteria.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 199 170
Median (95% Confidence Interval)
Unit of Measure: months
10.2
(8.4 to 10.7)
8.4
(6.8 to 8.7)
5.Secondary Outcome
Title Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria
Hide Description Clinical benefit rate is defined as best response of CR or PR or stable disease 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. Stable Disease: 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.
Time Frame Baseline up to death or disease progression, whichever occurs first (up to the 09 Dec 2016 data cutoff, approximately 3.5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The subset of participants with measurable disease at baseline, according to RECIST v1.1 criteria.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 351 352
Measure Type: Number
Unit of Measure: percentage of participants
84.6 81.3
6.Secondary Outcome
Title Percentage of Participants With Adverse Events
Hide Description An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Time Frame Baseline up to the 09 Dec 2016 data cutoff, approximately 3.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any amount of any study medication.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 385 388
Measure Type: Number
Unit of Measure: percentage of participants
99.0 99.2
7.Secondary Outcome
Title Percentage of Participants With Left Ventricular Systolic Dysfunction (LVSD, Symptomatic or Asymptomatic)
Hide Description Left ventricular systolic dysfunction may either be asymptomatic or have symptoms of heart failure. It is characterized by dilation of the left ventricle and vasoconstriction.
Time Frame Baseline up to the 09 Dec 2016 data cutoff, approximately 3.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received any amount of any study medication.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 385 388
Measure Type: Number
Unit of Measure: percentage of participants
Symptomatic LVSD 0.5 0.3
Asymptomatic LVSD 4.7 4.4
8.Secondary Outcome
Title Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score
Hide Description 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).
Time Frame 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 388 392
Mean (Standard Deviation)
Unit of Measure: score on a scale
Appetite Loss: Cycle 1 (Baseline) Number Analyzed 371 participants 383 participants
26.68  (28.65) 27.59  (29.96)
Appetite Loss: Change at Cycle 2 Number Analyzed 335 participants 343 participants
6.57  (33.18) 0.97  (35.86)
Appetite Loss: Change at Cycle 3 Number Analyzed 321 participants 315 participants
3.63  (36.19) 3.81  (36.76)
Appetite Loss: Change at Cycle 4 Number Analyzed 299 participants 294 participants
5.24  (34.20) 0.79  (34.33)
Appetite Loss: Change at Cycle 5 Number Analyzed 286 participants 287 participants
4.55  (36.50) 2.90  (35.85)
Appetite Loss: Change at Cycle 6 Number Analyzed 271 participants 257 participants
3.94  (36.07) -0.39  (36.86)
Appetite Loss: Change at Cycle 7 Number Analyzed 242 participants 228 participants
2.07  (38.05) 1.61  (35.98)
Appetite Loss: Change at Cycle 8 Number Analyzed 234 participants 217 participants
-2.42  (33.81) -3.69  (34.20)
Appetite Loss: Change at Cycle 9 Number Analyzed 210 participants 196 participants
-6.67  (31.92) -4.76  (31.67)
Appetite Loss: Change at Cycle 10 Number Analyzed 186 participants 166 participants
-8.06  (32.52) -6.63  (28.48)
Appetite Loss: Change at Cycle 11 Number Analyzed 171 participants 155 participants
-9.36  (33.19) -9.68  (27.38)
Appetite Loss: Change at Cycle 12 Number Analyzed 159 participants 140 participants
-9.22  (33.73) -9.05  (28.51)
Appetite Loss: Change at Cycle 13 Number Analyzed 141 participants 111 participants
-10.17  (31.10) -10.81  (29.18)
Appetite Loss: Change at Cycle 14 Number Analyzed 135 participants 102 participants
-12.10  (31.96) -12.09  (30.32)
Appetite Loss: Change at Cycle 15 Number Analyzed 130 participants 98 participants
-8.21  (32.96) -9.18  (29.81)
Appetite Loss: Change at Cycle 16 Number Analyzed 116 participants 85 participants
-6.03  (33.07) -10.59  (28.74)
Appetite Loss: Change at Cycle 17 Number Analyzed 112 participants 74 participants
-6.55  (29.29) -9.91  (29.05)
Appetite Loss: Change at Cycle 18 Number Analyzed 102 participants 71 participants
-4.90  (31.25) -14.08  (27.98)
Appetite Loss: Change at Cycle 19 Number Analyzed 96 participants 66 participants
-8.33  (31.34) -13.13  (28.57)
Appetite Loss: Change at Cycle 20 Number Analyzed 84 participants 63 participants
-3.97  (31.65) -13.23  (29.66)
Appetite Loss: Change at Cycle 21 Number Analyzed 79 participants 54 participants
-5.91  (31.01) -14.20  (32.76)
Appetite Loss: Change at Cycle 22 Number Analyzed 67 participants 47 participants
-4.98  (34.45) -16.31  (29.38)
Appetite Loss: Change at Cycle 23 Number Analyzed 63 participants 44 participants
-6.35  (36.84) -11.36  (35.90)
Appetite Loss: Change at Cycle 24 Number Analyzed 60 participants 40 participants
-7.78  (33.82) -13.33  (30.00)
Appetite Loss: Change at Cycle 25 Number Analyzed 52 participants 36 participants
-7.05  (35.14) -12.04  (31.02)
Appetite Loss: Change at Cycle 26 Number Analyzed 49 participants 32 participants
-7.48  (34.87) -12.50  (32.52)
Appetite Loss: Change at Cycle 27 Number Analyzed 43 participants 29 participants
-10.08  (33.76) -9.20  (28.03)
Appetite Loss: Change at Cycle 28 Number Analyzed 40 participants 26 participants
-10.00  (32.20) -11.54  (29.73)
Appetite Loss: Change at PT Visit 1 Number Analyzed 178 participants 202 participants
7.30  (36.86) 2.64  (33.14)
Appetite Loss: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
-0.33  (33.83) 4.55  (34.53)
Cognitive Functional Scale: Cycle 1 (Baseline) Number Analyzed 372 participants 382 participants
87.95  (17.32) 88.22  (16.18)
Cognitive Functional Scale: Change at Cycle 2 Number Analyzed 333 participants 341 participants
-1.90  (17.82) -1.81  (16.93)
Cognitive Functional Scale: Change at Cycle 3 Number Analyzed 321 participants 315 participants
-0.83  (17.11) -3.17  (18.30)
Cognitive Functional Scale: Change at Cycle 4 Number Analyzed 302 participants 295 participants
-2.04  (17.78) -2.99  (19.28)
Cognitive Functional Scale: Change at Cycle 5 Number Analyzed 285 participants 287 participants
-3.04  (19.09) -4.59  (19.59)
Cognitive Functional Scale: Change at Cycle 6 Number Analyzed 271 participants 256 participants
-5.10  (19.23) -3.84  (19.00)
Cognitive Functional Scale: Change at Cycle 7 Number Analyzed 242 participants 228 participants
-4.34  (19.52) -4.31  (19.09)
Cognitive Functional Scale: Change at Cycle 8 Number Analyzed 233 participants 217 participants
-3.15  (17.90) -3.30  (17.59)
Cognitive Functional Scale: Change at Cycle 9 Number Analyzed 210 participants 196 participants
-2.22  (18.53) -4.59  (18.53)
Cognitive Functional Scale: Change at Cycle 10 Number Analyzed 186 participants 166 participants
-3.32  (19.44) -3.11  (18.50)
Cognitive Functional Scale: Change at Cycle 11 Number Analyzed 171 participants 155 participants
-2.83  (18.44) -3.44  (17.06)
Cognitive Functional Scale: Change at Cycle 12 Number Analyzed 159 participants 139 participants
-3.35  (20.00) -2.52  (18.16)
Cognitive Functional Scale: Change at Cycle 13 Number Analyzed 140 participants 111 participants
-1.79  (19.04) -3.60  (17.89)
Cognitive Functional Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
-1.98  (19.00) -2.29  (17.56)
Cognitive Functional Scale: Change at Cycle 15 Number Analyzed 130 participants 98 participants
-1.15  (18.47) -2.38  (16.05)
Cognitive Functional Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
-2.73  (17.16) -2.55  (17.16)
Cognitive Functional Scale: Change at Cycle 17 Number Analyzed 112 participants 74 participants
-2.53  (17.21) -1.13  (15.44)
Cognitive Functional Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
-2.78  (18.18) 0.47  (16.42)
Cognitive Functional Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
-1.04  (18.07) 0.00  (14.62)
Cognitive Functional Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
-2.18  (19.67) 0.79  (15.68)
Cognitive Functional Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
-2.11  (20.56) 0.62  (16.50)
Cognitive Functional Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
-4.73  (18.98) -0.71  (18.04)
Cognitive Functional Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
-2.38  (19.60) 1.14  (17.75)
Cognitive Functional Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
-2.78  (19.69) 1.25  (16.18)
Cognitive Functional Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
-5.45  (16.41) -0.93  (18.66)
Cognitive Functional Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
-2.38  (16.32) -1.56  (18.63)
Cognitive Functional Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
-3.88  (18.84) -1.15  (18.33)
Cognitive Functional Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
-3.75  (15.78) 0.00  (20.00)
Cognitive Functional Scale: Change at PT Visit 1 Number Analyzed 177 participants 202 participants
-9.13  (21.90) -9.16  (20.02)
Cognitive Functional Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
-8.42  (20.22) -11.21  (22.48)
Constipation Symptom Scale: Cycle 1 (Baseline) Number Analyzed 372 participants 382 participants
20.43  (28.45) 18.41  (27.13)
Constipation Symptom Scale: Change at Cycle 2 Number Analyzed 334 participants 341 participants
-5.39  (27.05) 0.29  (27.23)
Constipation Symptom Scale: Change at Cycle 3 Number Analyzed 321 participants 316 participants
-7.48  (28.98) -2.11  (27.65)
Constipation Symptom Scale: Change at Cycle 4 Number Analyzed 301 participants 295 participants
-5.32  (29.21) -3.73  (28.26)
Constipation Symptom Scale: Change at Cycle 5 Number Analyzed 286 participants 287 participants
-5.94  (29.15) -1.28  (27.64)
Constipation Symptom Scale: Change at Cycle 6 Number Analyzed 271 participants 257 participants
-7.13  (29.65) -2.33  (30.24)
Constipation Symptom Scale: Change at Cycle 7 Number Analyzed 242 participants 228 participants
-8.13  (30.11) -4.09  (29.06)
Constipation Symptom Scale: Change at Cycle 8 Number Analyzed 232 participants 217 participants
-8.05  (30.90) -4.45  (27.32)
Constipation Symptom Scale: Change at Cycle 9 Number Analyzed 210 participants 196 participants
-10.00  (27.10) -5.61  (26.74)
Constipation Symptom Scale: Change at Cycle 10 Number Analyzed 186 participants 166 participants
-9.32  (29.56) -7.43  (26.81)
Constipation Symptom Scale: Change at Cycle 11 Number Analyzed 171 participants 155 participants
-9.16  (29.60) -6.88  (27.84)
Constipation Symptom Scale: Change at Cycle 12 Number Analyzed 159 participants 138 participants
-10.27  (29.04) -7.25  (25.39)
Constipation Symptom Scale: Change at Cycle 13 Number Analyzed 140 participants 110 participants
-11.19  (29.55) -5.76  (26.27)
Constipation Symptom Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
-11.60  (27.11) -6.21  (26.00)
Constipation Symptom Scale: Change at Cycle 15 Number Analyzed 130 participants 98 participants
-10.51  (26.59) -7.14  (24.52)
Constipation Symptom Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
-8.62  (24.91) -7.45  (25.39)
Constipation Symptom Scale: Change at Cycle 17 Number Analyzed 112 participants 74 participants
-8.33  (24.30) -5.86  (18.59)
Constipation Symptom Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
-7.52  (22.93) -6.57  (26.20)
Constipation Symptom Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
-3.47  (25.81) -3.03  (25.97)
Constipation Symptom Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
-3.97  (26.08) -4.76  (26.68)
Constipation Symptom Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
-3.80  (29.23) -9.26  (25.42)
Constipation Symptom Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
-4.98  (28.58) -8.51  (27.34)
Constipation Symptom Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
-6.35  (28.62) -8.33  (26.04)
Constipation Symptom Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
-7.78  (27.01) -10.00  (26.37)
Constipation Symptom Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
-7.05  (29.77) -9.26  (28.30)
Constipation Symptom Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
-6.12  (30.94) -6.25  (23.09)
Constipation Symptom Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
-7.75  (28.95) -10.34  (26.88)
Constipation Symptom Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
-6.67  (26.37) -6.41  (21.12)
Constipation Symptom Scale: Change at PT Visit 1 Number Analyzed 177 participants 202 participants
-6.78  (31.45) -4.62  (26.19)
Constipation Symptom Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
-6.93  (28.41) -0.91  (31.11)
Diarrhea Symptom Scale: Cycle 1 (Baseline) Number Analyzed 372 participants 382 participants
8.87  (17.70) 9.16  (18.87)
Diarrhea Symptom Scale: Change at Cycle 2 Number Analyzed 333 participants 340 participants
15.12  (30.42) 5.20  (23.79)
Diarrhea Symptom Scale: Change at Cycle 3 Number Analyzed 321 participants 314 participants
14.64  (27.71) 4.99  (26.10)
Diarrhea Symptom Scale: Change at Cycle 4 Number Analyzed 302 participants 295 participants
14.13  (27.15) 4.63  (24.07)
Diarrhea Symptom Scale: Change at Cycle 5 Number Analyzed 286 participants 287 participants
13.17  (25.47) 4.99  (23.70)
Diarrhea Symptom Scale: Change at Cycle 6 Number Analyzed 270 participants 256 participants
14.81  (27.01) 2.47  (23.76)
Diarrhea Symptom Scale: Change at Cycle 7 Number Analyzed 242 participants 228 participants
12.26  (23.74) 2.92  (23.44)
Diarrhea Symptom Scale: Change at Cycle 8 Number Analyzed 232 participants 217 participants
8.91  (23.56) 2.61  (23.53)
Diarrhea Symptom Scale: Change at Cycle 9 Number Analyzed 210 participants 196 participants
6.83  (23.76) 2.04  (21.25)
Diarrhea Symptom Scale: Change at Cycle 10 Number Analyzed 186 participants 166 participants
6.63  (23.97) 0.60  (20.91)
Diarrhea Symptom Scale: Change at Cycle 11 Number Analyzed 171 participants 154 participants
5.26  (21.80) 2.60  (20.36)
Diarrhea Symptom Scale: Change at Cycle 12 Number Analyzed 159 participants 139 participants
3.98  (22.30) 1.92  (19.97)
Diarrhea Symptom Scale: Change at Cycle 13 Number Analyzed 140 participants 111 participants
4.29  (24.27) 1.50  (19.27)
Diarrhea Symptom Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
3.95  (24.45) 0.98  (20.15)
Diarrhea Symptom Scale: Change at Cycle 15 Number Analyzed 130 participants 98 participants
3.33  (23.79) 1.02  (19.42)
Diarrhea Symptom Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
5.46  (21.06) 3.14  (15.10)
Diarrhea Symptom Scale: Change at Cycle 17 Number Analyzed 112 participants 74 participants
2.68  (21.05) 2.25  (14.94)
Diarrhea Symptom Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
3.59  (21.95) 3.29  (17.95)
Diarrhea Symptom Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
3.82  (19.86) 2.02  (16.41)
Diarrhea Symptom Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
5.95  (19.47) 3.70  (17.05)
Diarrhea Symptom Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
3.80  (23.26) 1.85  (16.40)
Diarrhea Symptom Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
6.97  (24.98) 4.26  (17.88)
Diarrhea Symptom Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
6.88  (21.72) 8.33  (20.49)
Diarrhea Symptom Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
7.22  (22.21) 3.33  (16.54)
Diarrhea Symptom Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
8.97  (23.91) 2.78  (14.64)
Diarrhea Symptom Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
5.44  (21.89) 5.21  (20.93)
Diarrhea Symptom Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
3.88  (22.07) 3.45  (16.29)
Diarrhea Symptom Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
7.50  (27.72) 2.56  (16.12)
Diarrhea Symptom Scale: Change at PT Visit 1 Number Analyzed 176 participants 202 participants
8.14  (26.00) 1.98  (24.35)
Diarrhea Symptom Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
7.26  (25.65) 4.24  (29.65)
Dyspnoea Symptom Scale: Cycle 1 (Baseline) Number Analyzed 370 participants 382 participants
12.07  (17.99) 12.65  (20.20)
Dyspnoea Symptom Scale: Change at Cycle 2 Number Analyzed 335 participants 341 participants
-0.50  (19.04) 0.29  (19.72)
Dyspnoea Symptom Scale: Change at Cycle 3 Number Analyzed 320 participants 314 participants
-0.31  (20.18) -0.32  (20.38)
Dyspnoea Symptom Scale: Change at Cycle 4 Number Analyzed 299 participants 294 participants
1.23  (20.31) 1.81  (21.08)
Dyspnoea Symptom Scale: Change at Cycle 5 Number Analyzed 284 participants 287 participants
2.58  (20.62) 1.39  (21.18)
Dyspnoea Symptom Scale: Change at Cycle 6 Number Analyzed 271 participants 256 participants
3.20  (23.79) 0.39  (20.55)
Dyspnoea Symptom Scale: Change at Cycle 7 Number Analyzed 241 participants 227 participants
0.00  (21.94) 0.59  (20.07)
Dyspnoea Symptom Scale: Change at Cycle 8 Number Analyzed 233 participants 216 participants
-0.14  (21.99) 0.93  (20.56)
Dyspnoea Symptom Scale: Change at Cycle 9 Number Analyzed 209 participants 196 participants
-1.12  (20.51) 0.17  (18.95)
Dyspnoea Symptom Scale: Change at Cycle 10 Number Analyzed 185 participants 166 participants
-0.54  (21.56) 1.00  (16.99)
Dyspnoea Symptom Scale: Change at Cycle 11 Number Analyzed 170 participants 155 participants
-2.16  (19.58) -1.29  (17.77)
Dyspnoea Symptom Scale: Change at Cycle 12 Number Analyzed 158 participants 140 participants
-2.53  (19.75) -0.71  (18.95)
Dyspnoea Symptom Scale: Change at Cycle 13 Number Analyzed 140 participants 111 participants
-1.43  (20.34) -1.20  (16.77)
Dyspnoea Symptom Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
-1.98  (19.00) -2.61  (17.98)
Dyspnoea Symptom Scale: Change at Cycle 15 Number Analyzed 129 participants 98 participants
-2.84  (21.26) 2.72  (18.95)
Dyspnoea Symptom Scale: Change at Cycle 16 Number Analyzed 115 participants 85 participants
-1.45  (20.42) 1.18  (18.86)
Dyspnoea Symptom Scale: Change at Cycle 17 Number Analyzed 110 participants 74 participants
-1.82  (20.61) 0.90  (19.87)
Dyspnoea Symptom Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
-0.98  (20.15) -2.35  (18.10)
Dyspnoea Symptom Scale: Change at Cycle 19 Number Analyzed 96 participants 65 participants
-1.74  (20.73) 0.51  (18.15)
Dyspnoea Symptom Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
-1.19  (20.98) -1.06  (16.90)
Dyspnoea Symptom Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
1.27  (22.29) -0.62  (19.95)
Dyspnoea Symptom Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
-1.99  (22.38) 0.71  (14.73)
Dyspnoea Symptom Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
-1.59  (21.94) 1.52  (14.30)
Dyspnoea Symptom Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
1.11  (22.10) -1.67  (12.96)
Dyspnoea Symptom Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
0.64  (21.38) -3.70  (15.49)
Dyspnoea Symptom Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
0.00  (22.57) 1.04  (23.16)
Dyspnoea Symptom Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
0.78  (21.19) 3.45  (22.44)
Dyspnoea Symptom Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
1.67  (21.28) 3.85  (17.20)
Dyspnoea Symptom Scale: Change at PT Visit 1 Number Analyzed 177 participants 202 participants
6.97  (26.98) 6.77  (23.82)
Dyspnoea Symptom Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
3.30  (23.81) 9.39  (26.76)
Emotional Functional Scale: Cycle 1 (Baseline) Number Analyzed 372 participants 382 participants
76.90  (20.21) 76.56  (19.84)
Emotional Functional Scale: Change at Cycle 2 Number Analyzed 333 participants 341 participants
3.53  (16.84) 3.05  (18.49)
Emotional Functional Scale: Change at Cycle 3 Number Analyzed 321 participants 315 participants
2.65  (18.63) 3.96  (19.95)
Emotional Functional Scale: Change at Cycle 4 Number Analyzed 302 participants 295 participants
3.10  (21.11) 3.67  (20.44)
Emotional Functional Scale: Change at Cycle 5 Number Analyzed 286 participants 287 participants
2.62  (19.97) 2.74  (21.72)
Emotional Functional Scale: Change at Cycle 6 Number Analyzed 271 participants 256 participants
1.01  (19.64) 4.93  (21.00)
Emotional Functional Scale: Change at Cycle 7 Number Analyzed 242 participants 228 participants
1.72  (21.09) 4.41  (20.18)
Emotional Functional Scale: Change at Cycle 8 Number Analyzed 233 participants 217 participants
3.43  (20.66) 5.66  (19.63)
Emotional Functional Scale: Change at Cycle 9 Number Analyzed 210 participants 196 participants
4.72  (20.10) 4.78  (19.45)
Emotional Functional Scale: Change at Cycle 10 Number Analyzed 186 participants 166 participants
3.72  (21.76) 6.74  (18.13)
Emotional Functional Scale: Change at Cycle 11 Number Analyzed 171 participants 155 participants
5.85  (19.64) 4.96  (19.21)
Emotional Functional Scale: Change at Cycle 12 Number Analyzed 159 participants 139 participants
4.93  (21.38) 5.24  (19.14)
Emotional Functional Scale: Change at Cycle 13 Number Analyzed 140 participants 111 participants
5.00  (23.07) 5.18  (17.95)
Emotional Functional Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
5.93  (22.90) 6.29  (19.03)
Emotional Functional Scale: Change at Cycle 15 Number Analyzed 130 participants 98 participants
6.03  (22.13) 5.19  (19.61)
Emotional Functional Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
5.17  (23.20) 5.29  (20.81)
Emotional Functional Scale: Change at Cycle 17 Number Analyzed 111 participants 74 participants
6.01  (23.55) 6.31  (18.70)
Emotional Functional Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
3.68  (24.11) 5.87  (19.39)
Emotional Functional Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
4.69  (26.01) 5.56  (18.68)
Emotional Functional Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
3.47  (26.92) 5.42  (17.91)
Emotional Functional Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
4.54  (26.55) 6.48  (22.00)
Emotional Functional Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
5.35  (28.67) 6.91  (18.66)
Emotional Functional Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
5.82  (28.42) 6.63  (21.00)
Emotional Functional Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
5.28  (26.22) 8.54  (19.57)
Emotional Functional Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
5.93  (25.48) 8.80  (20.89)
Emotional Functional Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
5.44  (27.77) 5.99  (16.15)
Emotional Functional Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
7.56  (28.34) 5.75  (18.51)
Emotional Functional Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
7.08  (25.43) 7.05  (18.96)
Emotional Functional Scale: Change at PT Visit 1 Number Analyzed 177 participants 202 participants
-5.48  (23.16) -3.92  (23.28)
Emotional Functional Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
-2.64  (23.33) -4.47  (23.34)
Fatigue Symptom Scale: Cycle 1 (Baseline) Number Analyzed 372 participants 383 participants
31.96  (23.46) 32.27  (21.92)
Fatigue Symptom Scale: Change at Cycle 2 Number Analyzed 336 participants 343 participants
3.13  (19.80) 2.32  (21.57)
Fatigue Symptom Scale: Change at Cycle 3 Number Analyzed 322 participants 315 participants
1.41  (22.65) 3.19  (22.97)
Fatigue Symptom Scale: Change at Cycle 4 Number Analyzed 301 participants 295 participants
2.77  (23.14) 1.58  (24.04)
Fatigue Symptom Scale: Change at Cycle 5 Number Analyzed 286 participants 288 participants
3.87  (25.75) 3.05  (24.29)
Fatigue Symptom Scale: Change at Cycle 6 Number Analyzed 272 participants 257 participants
4.37  (25.64) 2.62  (23.68)
Fatigue Symptom Scale: Change at Cycle 7 Number Analyzed 242 participants 228 participants
2.36  (26.79) 0.97  (23.44)
Fatigue Symptom Scale: Change at Cycle 8 Number Analyzed 234 participants 217 participants
-0.19  (25.00) -1.18  (22.74)
Fatigue Symptom Scale: Change at Cycle 9 Number Analyzed 210 participants 196 participants
-2.38  (22.69) -2.01  (22.84)
Fatigue Symptom Scale: Change at Cycle 10 Number Analyzed 186 participants 166 participants
-3.41  (24.69) -3.08  (22.41)
Fatigue Symptom Scale: Change at Cycle 11 Number Analyzed 171 participants 155 participants
-4.35  (22.66) -3.44  (21.21)
Fatigue Symptom Scale: Change at Cycle 12 Number Analyzed 159 participants 140 participants
-3.14  (24.56) -4.60  (24.39)
Fatigue Symptom Scale: Change at Cycle 13 Number Analyzed 141 participants 111 participants
-4.57  (23.31) -4.50  (21.47)
Fatigue Symptom Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
-6.75  (24.32) -6.54  (22.89)
Fatigue Symptom Scale: Change at Cycle 15 Number Analyzed 130 participants 98 participants
-5.47  (24.68) -4.99  (22.40)
Fatigue Symptom Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
-3.54  (24.81) -6.93  (21.89)
Fatigue Symptom Scale: Change at Cycle 17 Number Analyzed 112 participants 74 participants
-4.27  (25.50) -3.45  (21.91)
Fatigue Symptom Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
-4.14  (24.42) -8.92  (20.54)
Fatigue Symptom Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
-5.32  (27.83) -9.01  (20.71)
Fatigue Symptom Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
-5.56  (26.64) -6.53  (21.83)
Fatigue Symptom Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
-3.94  (25.97) -7.41  (23.45)
Fatigue Symptom Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
-1.49  (25.58) -10.64  (22.22)
Fatigue Symptom Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
-5.82  (25.23) -9.60  (28.01)
Fatigue Symptom Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
-1.67  (27.05) -12.50  (24.29)
Fatigue Symptom Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
-4.70  (26.16) -12.35  (22.03)
Fatigue Symptom Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
-4.99  (24.85) -11.46  (22.84)
Fatigue Symptom Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
-6.98  (23.76) -5.36  (23.87)
Fatigue Symptom Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
-6.39  (18.98) -4.70  (26.14)
Fatigue Symptom Scale: Change at PT Visit 1 Number Analyzed 178 participants 202 participants
10.02  (28.48) 5.25  (24.00)
Fatigue Symptom Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
7.70  (27.65) 9.70  (25.01)
Financial Difficulties Scale: Cycle 1 (Baseline) Number Analyzed 370 participants 379 participants
26.67  (30.32) 26.21  (29.78)
Financial Difficulties Scale: Change at Cycle 2 Number Analyzed 332 participants 339 participants
-0.90  (26.85) -2.46  (25.46)
Financial Difficulties Scale: Change at Cycle 3 Number Analyzed 320 participants 312 participants
0.31  (27.62) 0.00  (26.33)
Financial Difficulties Scale: Change at Cycle 4 Number Analyzed 301 participants 292 participants
0.89  (25.95) 0.11  (25.10)
Financial Difficulties Scale: Change at Cycle 5 Number Analyzed 285 participants 284 participants
1.75  (27.71) 2.58  (26.46)
Financial Difficulties Scale: Change at Cycle 6 Number Analyzed 270 participants 255 participants
1.11  (27.62) 0.92  (26.36)
Financial Difficulties Scale: Change at Cycle 7 Number Analyzed 240 participants 224 participants
1.11  (31.08) 0.30  (26.41)
Financial Difficulties Scale: Change at Cycle 8 Number Analyzed 232 participants 215 participants
1.15  (30.21) 0.47  (25.27)
Financial Difficulties Scale: Change at Cycle 9 Number Analyzed 210 participants 195 participants
1.11  (29.78) -0.51  (24.75)
Financial Difficulties Scale: Change at Cycle 10 Number Analyzed 186 participants 165 participants
0.90  (30.10) -2.42  (24.30)
Financial Difficulties Scale: Change at Cycle 11 Number Analyzed 171 participants 154 participants
0.39  (29.37) -0.22  (24.84)
Financial Difficulties Scale: Change at Cycle 12 Number Analyzed 159 participants 138 participants
-1.05  (28.91) -0.97  (26.39)
Financial Difficulties Scale: Change at Cycle 13 Number Analyzed 140 participants 111 participants
-0.95  (28.82) 0.30  (24.82)
Financial Difficulties Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
-1.73  (29.74) -0.98  (25.02)
Financial Difficulties Scale: Change at Cycle 15 Number Analyzed 129 participants 98 participants
-1.81  (28.96) 1.36  (26.18)
Financial Difficulties Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
-3.16  (30.13) 0.39  (25.97)
Financial Difficulties Scale: Change at Cycle 17 Number Analyzed 112 participants 74 participants
-3.87  (29.59) 1.35  (27.28)
Financial Difficulties Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
-2.29  (27.46) 2.35  (26.02)
Financial Difficulties Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
-0.35  (28.41) -0.51  (27.73)
Financial Difficulties Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
1.19  (29.47) 1.59  (27.71)
Financial Difficulties Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
1.27  (28.96) -4.94  (27.78)
Financial Difficulties Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
2.49  (26.79) -4.26  (23.69)
Financial Difficulties Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
-0.53  (26.43) -2.27  (29.11)
Financial Difficulties Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
1.11  (24.52) -5.83  (26.03)
Financial Difficulties Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
3.21  (27.42) -4.63  (25.39)
Financial Difficulties Scale: Change at Cycle 26 Number Analyzed 49 participants 30 participants
2.72  (28.74) -2.22  (26.16)
Financial Difficulties Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
-3.10  (23.92) 1.15  (24.37)
Financial Difficulties Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
-1.67  (23.81) -1.28  (24.00)
Financial Difficulties Scale: Change at PT Visit 1 Number Analyzed 176 participants 201 participants
1.70  (29.66) 1.33  (26.21)
Financial Difficulties Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
1.98  (26.17) 4.24  (31.32)
Nausea and Vomiting Scale: Cycle 1 (Baseline) Number Analyzed 371 participants 383 participants
11.14  (19.11) 11.92  (18.76)
Nausea And Vomiting Scale: Change at Cycle 2 Number Analyzed 336 participants 343 participants
5.85  (22.65) 4.08  (22.25)
Nausea And Vomiting Scale: Change at Cycle 3 Number Analyzed 322 participants 316 participants
5.12  (23.62) 5.06  (21.14)
Nausea And Vomiting Scale: Change at Cycle 4 Number Analyzed 301 participants 295 participants
4.10  (21.85) 3.56  (23.76)
Nausea And Vomiting Scale: Change at Cycle 5 Number Analyzed 286 participants 288 participants
5.13  (22.58) 5.15  (23.81)
Nausea And Vomiting Scale: Change at Cycle 6 Number Analyzed 272 participants 257 participants
4.11  (23.36) 2.59  (21.24)
Nausea And Vomiting Scale: Change at Cycle 7 Number Analyzed 242 participants 228 participants
2.07  (23.58) 2.49  (22.31)
Nausea And Vomiting Scale: Change at Cycle 8 Number Analyzed 233 participants 217 participants
-0.86  (20.80) -0.77  (20.21)
Nausea And Vomiting Scale: Change at Cycle 9 Number Analyzed 210 participants 196 participants
-2.54  (20.85) -2.98  (19.78)
Nausea And Vomiting Scale: Change at Cycle 10 Number Analyzed 186 participants 166 participants
-4.30  (18.81) -2.81  (20.57)
Nausea And Vomiting Scale: Change at Cycle 11 Number Analyzed 171 participants 155 participants
-3.51  (18.01) -3.66  (20.04)
Nausea And Vomiting Scale: Change at Cycle 12 Number Analyzed 159 participants 140 participants
-3.04  (18.07) -3.45  (20.34)
Nausea And Vomiting Scale: Change at Cycle 13 Number Analyzed 141 participants 111 participants
-4.02  (16.29) -3.60  (19.25)
Nausea And Vomiting Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
-3.46  (19.54) -5.72  (18.54)
Nausea And Vomiting Scale: Change at Cycle 15 Number Analyzed 130 participants 98 participants
-3.59  (16.34) -3.91  (16.55)
Nausea And Vomiting Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
-0.43  (20.32) -2.55  (20.00)
Nausea And Vomiting Scale: Change at Cycle 17 Number Analyzed 112 participants 74 participants
-0.60  (17.46) -3.15  (16.48)
Nausea And Vomiting Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
-0.65  (16.90) -3.52  (18.24)
Nausea And Vomiting Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
-0.87  (18.32) -4.04  (19.62)
Nausea And Vomiting Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
-1.79  (18.48) -3.97  (17.89)
Nausea And Vomiting Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
-1.05  (20.03) -6.48  (19.80)
Nausea And Vomiting Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
-3.48  (19.14) -8.16  (18.99)
Nausea And Vomiting Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
-4.23  (17.70) -6.44  (24.70)
Nausea And Vomiting Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
-4.72  (16.26) -7.92  (17.70)
Nausea And Vomiting Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
-4.17  (20.84) -7.41  (19.29)
Nausea And Vomiting Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
-3.40  (24.29) -9.38  (19.37)
Nausea And Vomiting Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
-5.04  (22.58) -7.47  (20.70)
Nausea And Vomiting Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
-1.25  (20.11) -6.41  (17.69)
Nausea and Vomiting Scale: Change at PT Visit 1 Number Analyzed 178 participants 202 participants
4.68  (22.20) 4.13  (23.91)
Nausea and Vomiting Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
4.29  (23.05) 2.73  (21.60)
Pain Symptom Scale: Cycle 1 (Baseline) Number Analyzed 372 participants 383 participants
23.92  (25.92) 23.72  (24.82)
Pain Symptom Scale: Change at Cycle 2 Number Analyzed 336 participants 342 participants
-6.80  (24.69) -6.38  (23.58)
Pain Symptom Scale: Change at Cycle 3 Number Analyzed 322 participants 316 participants
-9.89  (25.16) -7.23  (25.78)
Pain Symptom Scale: Change at Cycle 4 Number Analyzed 302 participants 295 participants
-10.26  (24.78) -7.46  (26.06)
Pain Symptom Scale: Change at Cycle 5 Number Analyzed 286 participants 288 participants
-8.86  (25.88) -6.25  (25.42)
Pain Symptom Scale: Change at Cycle 6 Number Analyzed 272 participants 257 participants
-8.95  (25.73) -7.33  (24.85)
Pain Symptom Scale: Change at Cycle 7 Number Analyzed 242 participants 228 participants
-10.95  (26.13) -7.46  (24.79)
Pain Symptom Scale: Change at Cycle 8 Number Analyzed 234 participants 217 participants
-9.97  (25.80) -8.53  (22.86)
Pain Symptom Scale: Change at Cycle 9 Number Analyzed 210 participants 196 participants
-9.29  (24.83) -7.82  (22.98)
Pain Symptom Scale: Change at Cycle 10 Number Analyzed 186 participants 166 participants
-9.41  (26.10) -8.13  (22.75)
Pain Symptom Scale: Change at Cycle 11 Number Analyzed 171 participants 155 participants
-10.33  (25.77) -6.34  (22.97)
Pain Symptom Scale: Change at Cycle 12 Number Analyzed 159 participants 140 participants
-10.27  (23.10) -5.24  (25.29)
Pain Symptom Scale: Change at Cycle 13 Number Analyzed 141 participants 111 participants
-10.28  (25.79) -4.80  (20.27)
Pain Symptom Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
-10.49  (25.49) -5.56  (23.37)
Pain Symptom Scale: Change at Cycle 15 Number Analyzed 130 participants 98 participants
-11.15  (22.86) -3.74  (22.77)
Pain Symptom Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
-9.91  (22.94) -4.71  (23.66)
Pain Symptom Scale: Change at Cycle 17 Number Analyzed 112 participants 74 participants
-7.59  (25.00) -5.63  (22.63)
Pain Symptom Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
-8.82  (23.42) -8.22  (20.68)
Pain Symptom Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
-8.16  (25.13) -5.05  (21.48)
Pain Symptom Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
-6.94  (25.90) -6.08  (19.24)
Pain Symptom Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
-9.92  (27.15) -6.48  (23.44)
Pain Symptom Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
-7.71  (26.96) -8.51  (19.62)
Pain Symptom Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
-10.85  (22.03) -7.95  (26.29)
Pain Symptom Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
-10.00  (24.39) -10.00  (17.21)
Pain Symptom Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
-9.94  (24.09) -12.96  (19.96)
Pain Symptom Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
-10.54  (22.49) -8.33  (18.45)
Pain Symptom Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
-11.24  (22.34) -5.75  (21.95)
Pain Symptom Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
-10.42  (27.91) -9.62  (19.54)
Pain Symptom Scale: Change at PT Visit 1 Number Analyzed 177 participants 202 participants
1.13  (27.27) 2.06  (28.70)
Pain Symptom Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
-1.49  (28.39) 5.45  (29.96)
Physical Functional Scale: Cycle 1 (Baseline) Number Analyzed 372 participants 383 participants
80.86  (19.53) 82.05  (18.32)
Physical Functional Scale: Change at Cycle 2 Number Analyzed 336 participants 343 participants
-3.58  (14.56) -3.01  (15.34)
Physical Functional Scale: Change at Cycle 3 Number Analyzed 322 participants 316 participants
-2.99  (17.19) -3.92  (17.03)
Physical Functional Scale: Change at Cycle 4 Number Analyzed 301 participants 294 participants
-3.28  (18.87) -3.50  (17.99)
Physical Functional Scale: Change at Cycle 5 Number Analyzed 286 participants 288 participants
-3.10  (19.35) -4.62  (17.62)
Physical Functional Scale: Change at Cycle 6 Number Analyzed 272 participants 257 participants
-5.00  (20.30) -3.84  (18.65)
Physical Functional Scale: Change at Cycle 7 Number Analyzed 242 participants 228 participants
-3.66  (20.75) -3.79  (19.82)
Physical Functional Scale: Change at Cycle 8 Number Analyzed 234 participants 217 participants
-2.24  (21.14) -1.56  (18.55)
Physical Functional Scale: Change at Cycle 9 Number Analyzed 210 participants 196 participants
-1.59  (20.21) -0.75  (18.44)
Physical Functional Scale: Change at Cycle 10 Number Analyzed 186 participants 166 participants
0.11  (19.93) -0.27  (17.16)
Physical Functional Scale: Change at Cycle 11 Number Analyzed 171 participants 155 participants
0.35  (19.43) 0.27  (17.09)
Physical Functional Scale: Change at Cycle 12 Number Analyzed 159 participants 140 participants
-1.05  (20.06) 0.89  (16.35)
Physical Functional Scale: Change at Cycle 13 Number Analyzed 141 participants 111 participants
-0.80  (20.65) 0.27  (17.41)
Physical Functional Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
-0.02  (20.14) 1.70  (18.09)
Physical Functional Scale: Change at Cycle 15 Number Analyzed 130 participants 98 participants
0.41  (18.91) -0.95  (17.99)
Physical Functional Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
-1.08  (19.85) -0.08  (18.18)
Physical Functional Scale: Change at Cycle 17 Number Analyzed 112 participants 74 participants
-0.46  (19.43) -0.81  (17.55)
Physical Functional Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
0.13  (19.74) 0.75  (16.85)
Physical Functional Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
1.39  (19.82) 1.31  (14.38)
Physical Functional Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
0.71  (21.08) 0.85  (16.74)
Physical Functional Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
0.42  (22.20) 0.25  (18.18)
Physical Functional Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
-2.79  (21.90) 1.42  (16.79)
Physical Functional Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
-1.48  (21.47) 0.61  (19.60)
Physical Functional Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
-2.67  (22.27) 3.00  (16.47)
Physical Functional Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
-2.18  (20.61) 4.81  (15.91)
Physical Functional Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
-1.90  (20.09) -1.88  (20.69)
Physical Functional Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
0.16  (18.66) -3.68  (19.40)
Physical Functional Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
-1.17  (17.79) -2.82  (18.97)
Physical Functional Scale: Change at PT Visit 1 Number Analyzed 178 participants 202 participants
-11.37  (23.67) -7.51  (20.53)
Physical Functional Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
-11.49  (24.31) -11.82  (20.27)
Global Health Status Scale: Cycle 1 (Baseline) Number Analyzed 370 participants 382 participants
59.77  (22.88) 59.90  (22.11)
Global Health Status Scale: Change at Cycle 2 Number Analyzed 331 participants 340 participants
1.81  (23.35) 4.29  (23.42)
Global Health Status Scale: Change at Cycle 3 Number Analyzed 320 participants 315 participants
1.56  (25.05) 2.86  (25.03)
Global Health Status Scale: Change at Cycle 4 Number Analyzed 300 participants 295 participants
1.39  (25.26) 4.15  (23.79)
Global Health Status Scale: Change at Cycle 5 Number Analyzed 284 participants 287 participants
1.17  (25.70) 3.92  (23.05)
Global Health Status Scale: Change at Cycle 6 Number Analyzed 268 participants 256 participants
0.68  (27.89) 3.61  (23.13)
Global Health Status Scale: Change at Cycle 7 Number Analyzed 241 participants 228 participants
1.83  (27.81) 3.33  (22.77)
Global Health Status Scale: Change at Cycle 8 Number Analyzed 234 participants 217 participants
3.06  (27.09) 5.18  (23.18)
Global Health Status Scale: Change at Cycle 9 Number Analyzed 209 participants 196 participants
4.39  (26.25) 4.68  (22.99)
Global Health Status Scale: Change at Cycle 10 Number Analyzed 184 participants 166 participants
4.80  (25.35) 5.07  (22.77)
Global Health Status Scale: Change at Cycle 11 Number Analyzed 170 participants 155 participants
5.78  (26.62) 3.82  (23.75)
Global Health Status Scale: Change at Cycle 12 Number Analyzed 158 participants 139 participants
3.11  (24.89) 5.34  (24.47)
Global Health Status Scale: Change at Cycle 13 Number Analyzed 140 participants 111 participants
3.51  (23.82) 3.83  (23.78)
Global Health Status Scale: Change at Cycle 14 Number Analyzed 134 participants 102 participants
5.97  (23.09) 4.82  (24.86)
Global Health Status Scale: Change at Cycle 15 Number Analyzed 129 participants 98 participants
4.26  (25.98) 1.70  (24.46)
Global Health Status Scale: Change at Cycle 16 Number Analyzed 115 participants 85 participants
3.12  (25.16) 3.04  (23.77)
Global Health Status Scale: Change at Cycle 17 Number Analyzed 111 participants 74 participants
2.93  (24.84) 3.83  (24.84)
Global Health Status Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
3.02  (23.88) 2.58  (27.08)
Global Health Status Scale: Change at Cycle 19 Number Analyzed 95 participants 65 participants
3.25  (26.39) 3.97  (25.43)
Global Health Status Scale: Change at Cycle 20 Number Analyzed 83 participants 63 participants
5.12  (24.20) 4.89  (25.69)
Global Health Status Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
5.38  (23.87) 5.40  (24.72)
Global Health Status Scale: Change at Cycle 22 Number Analyzed 66 participants 47 participants
3.79  (22.56) 3.19  (25.57)
Global Health Status Scale: Change at Cycle 23 Number Analyzed 62 participants 43 participants
4.03  (23.85) 4.07  (27.18)
Global Health Status Scale: Change at Cycle 24 Number Analyzed 59 participants 40 participants
4.24  (22.66) 2.92  (30.58)
Global Health Status Scale: Change at Cycle 25 Number Analyzed 51 participants 36 participants
3.59  (22.38) 8.10  (25.39)
Global Health Status Scale: Change at Cycle 26 Number Analyzed 47 participants 32 participants
7.27  (24.55) 5.47  (26.91)
Global Health Status Scale: Change at Cycle 27 Number Analyzed 42 participants 29 participants
7.54  (23.19) 1.72  (28.38)
Global Health Status Scale: Change at Cycle 28 Number Analyzed 39 participants 26 participants
4.49  (22.69) 4.81  (28.98)
Global Health Status Scale: Change at PT Visit 1 Number Analyzed 176 participants 201 participants
-7.24  (27.24) -6.14  (24.97)
Global Health Status Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
-2.72  (27.46) -5.68  (26.57)
Role Functional Scale: Cycle 1 (Baseline) Number Analyzed 372 participants 383 participants
77.06  (27.02) 79.33  (25.12)
Role Functional Scale: Change at Cycle 2 Number Analyzed 335 participants 343 participants
-3.78  (24.99) -2.82  (24.35)
Role Functional Scale: Change at Cycle 3 Number Analyzed 322 participants 315 participants
-3.62  (25.96) -4.55  (28.00)
Role Functional Scale: Change at Cycle 4 Number Analyzed 302 participants 295 participants
-4.64  (27.69) -5.99  (26.87)
Role Functional Scale: Change at Cycle 5 Number Analyzed 286 participants 288 participants
-4.72  (27.68) -7.41  (27.25)
Role Functional Scale: Change at Cycle 6 Number Analyzed 272 participants 257 participants
-6.13  (28.94) -6.03  (28.51)
Role Functional Scale: Change at Cycle 7 Number Analyzed 242 participants 228 participants
-4.82  (29.75) -5.34  (26.31)
Role Functional Scale: Change at Cycle 8 Number Analyzed 234 participants 217 participants
-1.85  (28.87) -2.38  (26.41)
Role Functional Scale: Change at Cycle 9 Number Analyzed 210 participants 196 participants
-1.19  (28.57) -2.47  (27.29)
Role Functional Scale: Change at Cycle 10 Number Analyzed 186 participants 166 participants
-1.79  (28.10) 0.90  (25.97)
Role Functional Scale: Change at Cycle 11 Number Analyzed 171 participants 155 participants
-0.78  (28.34) -2.69  (24.94)
Role Functional Scale: Change at Cycle 12 Number Analyzed 159 participants 140 participants
-1.05  (27.28) 0.24  (24.07)
Role Functional Scale: Change at Cycle 13 Number Analyzed 141 participants 111 participants
-2.01  (26.61) -2.40  (24.91)
Role Functional Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
-0.86  (27.27) -1.31  (25.66)
Role Functional Scale: Change at Cycle 15 Number Analyzed 130 participants 98 participants
-1.03  (27.51) -3.23  (25.40)
Role Functional Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
-3.16  (28.73) -2.35  (25.48)
Role Functional Scale: Change at Cycle 17 Number Analyzed 112 participants 74 participants
-1.04  (26.69) -3.38  (25.88)
Role Functional Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
-0.16  (27.10) 0.23  (26.05)
Role Functional Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
1.04  (27.55) -0.25  (23.48)
Role Functional Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
-1.19  (30.04) 0.79  (23.46)
Role Functional Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
-0.84  (28.98) 0.00  (27.47)
Role Functional Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
-2.24  (27.96) 1.06  (22.63)
Role Functional Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
-3.44  (30.11) 1.14  (25.01)
Role Functional Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
-4.44  (29.73) 2.08  (24.22)
Role Functional Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
-3.53  (29.21) 4.63  (26.91)
Role Functional Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
-1.36  (28.02) 0.52  (26.60)
Role Functional Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
-1.55  (30.82) -4.02  (29.77)
Role Functional Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
-0.42  (27.86) -3.85  (29.56)
Role Functional Scale: Change at PT Visit 1 Number Analyzed 178 participants 202 participants
-14.61  (30.41) -9.49  (28.64)
Role Functional Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
-10.73  (31.94) -15.45  (31.82)
Social Functional Scale: Cycle 1 (Baseline) Number Analyzed 372 participants 381 participants
77.96  (24.09) 75.90  (24.69)
Social Functional Scale: Change at Cycle 2 Number Analyzed 333 participants 341 participants
-3.45  (24.07) -0.44  (23.09)
Social Functional Scale: Change at Cycle 3 Number Analyzed 321 participants 314 participants
-4.62  (25.25) -2.07  (25.35)
Social Functional Scale: Change at Cycle 4 Number Analyzed 302 participants 294 participants
-2.59  (25.08) -1.70  (26.58)
Social Functional Scale: Change at Cycle 5 Number Analyzed 286 participants 286 participants
-5.54  (27.03) -3.26  (27.24)
Social Functional Scale: Change at Cycle 6 Number Analyzed 271 participants 256 participants
-5.72  (27.87) -1.04  (27.20)
Social Functional Scale: Change at Cycle 7 Number Analyzed 242 participants 227 participants
-2.69  (27.13) -0.15  (26.00)
Social Functional Scale: Change at Cycle 8 Number Analyzed 233 participants 216 participants
-1.72  (26.93) 1.08  (26.49)
Social Functional Scale: Change at Cycle 9 Number Analyzed 210 participants 196 participants
0.56  (27.59) 0.77  (25.11)
Social Functional Scale: Change at Cycle 10 Number Analyzed 186 participants 166 participants
-0.81  (27.31) 2.31  (25.75)
Social Functional Scale: Change at Cycle 11 Number Analyzed 171 participants 155 participants
0.58  (27.35) 1.94  (24.39)
Social Functional Scale: Change at Cycle 12 Number Analyzed 159 participants 139 participants
0.52  (28.59) 2.40  (24.70)
Social Functional Scale: Change at Cycle 13 Number Analyzed 140 participants 111 participants
0.83  (25.31) 2.10  (25.73)
Social Functional Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
1.98  (26.71) 2.12  (24.89)
Social Functional Scale: Change at Cycle 15 Number Analyzed 130 participants 98 participants
1.79  (27.24) 0.00  (27.08)
Social Functional Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
-0.72  (25.76) 0.39  (25.84)
Social Functional Scale: Change at Cycle 17 Number Analyzed 112 participants 74 participants
-0.45  (26.51) 1.58  (24.39)
Social Functional Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
-0.98  (25.99) 2.11  (26.42)
Social Functional Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
2.26  (26.56) 3.28  (21.53)
Social Functional Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
1.59  (27.09) 0.79  (22.88)
Social Functional Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
1.27  (28.09) 5.86  (22.00)
Social Functional Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
1.24  (27.72) 2.84  (24.16)
Social Functional Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
6.08  (27.32) 1.89  (22.51)
Social Functional Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
5.83  (25.64) 4.17  (24.39)
Social Functional Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
1.60  (27.27) 2.78  (23.40)
Social Functional Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
3.74  (26.19) 1.56  (24.45)
Social Functional Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
5.81  (24.37) -1.72  (26.85)
Social Functional Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
6.25  (23.48) -0.64  (24.26)
Social Functional Scale: Change at PT Visit 1 Number Analyzed 177 participants 202 participants
-9.13  (26.47) -3.80  (28.74)
Social Functional Scale: Change at PT Visit 2 Number Analyzed 101 participants 110 participants
-5.45  (28.49) -8.48  (28.98)
Insomnia Symptom Scale: Cycle 1 (Baseline) Number Analyzed 372 participants 383 participants
22.94  (28.00) 25.41  (28.81)
Insomnia Symptom Scale: Change at Cycle 2 Number Analyzed 336 participants 343 participants
-0.69  (26.82) -0.39  (28.27)
Insomnia Symptom Scale: Change at Cycle 3 Number Analyzed 321 participants 316 participants
-3.53  (27.03) -3.48  (30.14)
Insomnia Symptom Scale: Change at Cycle 4 Number Analyzed 301 participants 295 participants
-2.88  (28.14) -3.62  (30.40)
Insomnia Symptom Scale: Change at Cycle 5 Number Analyzed 286 participants 288 participants
-2.21  (29.27) -2.66  (30.17)
Insomnia Symptom Scale: Change at Cycle 6 Number Analyzed 272 participants 257 participants
-2.94  (28.63) -5.58  (32.53)
Insomnia Symptom Scale: Change at Cycle 7 Number Analyzed 241 participants 228 participants
-4.56  (28.42) -4.82  (32.98)
Insomnia Symptom Scale: Change at Cycle 8 Number Analyzed 234 participants 217 participants
-6.13  (27.72) -6.45  (30.75)
Insomnia Symptom Scale: Change at Cycle 9 Number Analyzed 208 participants 196 participants
-8.97  (25.69) -6.12  (30.32)
Insomnia Symptom Scale: Change at Cycle 10 Number Analyzed 186 participants 166 participants
-8.24  (26.69) -4.42  (28.79)
Insomnia Symptom Scale: Change at Cycle 11 Number Analyzed 171 participants 155 participants
-8.97  (28.19) -5.81  (27.69)
Insomnia Symptom Scale: Change at Cycle 12 Number Analyzed 159 participants 140 participants
-8.81  (27.67) -6.43  (26.49)
Insomnia Symptom Scale: Change at Cycle 13 Number Analyzed 141 participants 111 participants
-10.17  (26.71) -5.11  (24.29)
Insomnia Symptom Scale: Change at Cycle 14 Number Analyzed 135 participants 102 participants
-9.14  (26.84) -7.84  (24.45)
Insomnia Symptom Scale: Change at Cycle 15 Number Analyzed 130 participants 98 participants
-9.74  (28.89) -5.10  (21.59)
Insomnia Symptom Scale: Change at Cycle 16 Number Analyzed 116 participants 85 participants
-8.91  (26.14) -4.31  (26.62)
Insomnia Symptom Scale: Change at Cycle 17 Number Analyzed 112 participants 74 participants
-11.01  (26.62) -5.41  (26.48)
Insomnia Symptom Scale: Change at Cycle 18 Number Analyzed 102 participants 71 participants
-8.82  (28.12) -8.45  (20.09)
Insomnia Symptom Scale: Change at Cycle 19 Number Analyzed 96 participants 66 participants
-11.46  (29.35) -7.58  (22.49)
Insomnia Symptom Scale: Change at Cycle 20 Number Analyzed 84 participants 63 participants
-10.32  (27.37) -5.29  (25.55)
Insomnia Symptom Scale: Change at Cycle 21 Number Analyzed 79 participants 54 participants
-11.81  (27.24) -4.94  (27.02)
Insomnia Symptom Scale: Change at Cycle 22 Number Analyzed 67 participants 47 participants
-10.95  (31.46) -7.80  (19.92)
Insomnia Symptom Scale: Change at Cycle 23 Number Analyzed 63 participants 44 participants
-10.58  (34.82) -6.06  (23.04)
Insomnia Symptom Scale: Change at Cycle 24 Number Analyzed 60 participants 40 participants
-9.44  (31.94) -7.50  (21.99)
Insomnia Symptom Scale: Change at Cycle 25 Number Analyzed 52 participants 36 participants
-10.26  (28.42) -8.33  (26.87)
Insomnia Symptom Scale: Change at Cycle 26 Number Analyzed 49 participants 32 participants
-9.52  (32.63) -4.17  (20.30)
Insomnia Symptom Scale: Change at Cycle 27 Number Analyzed 43 participants 29 participants
-13.18  (30.11) -4.60  (19.36)
Insomnia Symptom Scale: Change at Cycle 28 Number Analyzed 40 participants 26 participants
-11.67  (31.62) -1.28  (22.07)
Insomnia Symptom Scale: Change at PT Visit 1 Number Analyzed 178 participants 202 participants
2.81  (29.19) -1.32  (30.81)
Insomnia Symptom Scale: Change at PT Visit 2 Number Analyzed 100 participants 110 participants
5.67  (29.23) 3.03  (31.13)
9.Secondary Outcome
Title Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score
Hide Description 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).
Time Frame 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 388 392
Mean (Standard Deviation)
Unit of Measure: score on a scale
Anxiety: Cycle 1 (Baseline) Number Analyzed 366 participants 373 participants
40.10  (25.85) 40.48  (25.32)
Anxiety: Change at Cycle 2 Number Analyzed 329 participants 334 participants
-2.58  (21.72) -4.11  (21.19)
Anxiety: Change at Cycle 3 Number Analyzed 317 participants 309 participants
-4.14  (22.45) -3.87  (23.19)
Anxiety: Change at Cycle 4 Number Analyzed 295 participants 289 participants
-4.52  (23.01) -7.25  (23.16)
Anxiety: Change at Cycle 5 Number Analyzed 282 participants 285 participants
-4.10  (22.94) -7.39  (24.36)
Anxiety: Change at Cycle 6 Number Analyzed 269 participants 252 participants
-4.54  (23.97) -8.42  (25.21)
Anxiety: Change at Cycle 7 Number Analyzed 238 participants 226 participants
-6.40  (24.00) -10.40  (24.37)
Anxiety: Change at Cycle 8 Number Analyzed 232 participants 213 participants
-9.00  (23.17) -11.92  (24.50)
Anxiety: Change at Cycle 9 Number Analyzed 206 participants 193 participants
-10.09  (23.30) -11.43  (23.24)
Anxiety: Change at Cycle 10 Number Analyzed 185 participants 164 participants
-11.17  (25.05) -12.64  (22.09)
Anxiety: Change at Cycle 11 Number Analyzed 168 participants 153 participants
-10.78  (23.47) -12.09  (21.84)
Anxiety: Change at Cycle 12 Number Analyzed 158 participants 138 participants
-12.62  (26.24) -13.16  (23.11)
Anxiety: Change at Cycle 13 Number Analyzed 141 participants 110 participants
-13.32  (25.93) -13.33  (22.47)
Anxiety: Change at Cycle 14 Number Analyzed 135 participants 101 participants
-14.32  (26.49) -12.43  (23.59)
Anxiety: Change at Cycle 15 Number Analyzed 130 participants 96 participants
-13.42  (26.64) -10.65  (25.74)
Anxiety: Change at Cycle 16 Number Analyzed 115 participants 84 participants
-12.75  (26.87) -12.57  (23.89)
Anxiety: Change at Cycle 17 Number Analyzed 111 participants 73 participants
-13.41  (27.30) -12.79  (21.01)
Anxiety: Change at Cycle 18 Number Analyzed 101 participants 70 participants
-13.53  (28.05) -12.38  (22.90)
Anxiety: Change at Cycle 19 Number Analyzed 95 participants 65 participants
-14.50  (27.41) -12.48  (20.08)
Anxiety: Change at Cycle 20 Number Analyzed 84 participants 62 participants
-15.34  (29.21) -12.37  (23.73)
Anxiety: Change at Cycle 21 Number Analyzed 79 participants 53 participants
-16.03  (28.84) -14.47  (25.00)
Anxiety: Change at Cycle 22 Number Analyzed 66 participants 46 participants
-13.30  (30.77) -15.46  (23.83)
Anxiety: Change at Cycle 23 Number Analyzed 63 participants 43 participants
-17.28  (30.64) -14.47  (29.55)
Anxiety: Change at Cycle 24 Number Analyzed 60 participants 39 participants
-16.11  (30.65) -17.09  (23.76)
Anxiety: Change at Cycle 25 Number Analyzed 52 participants 35 participants
-16.03  (29.47) -17.78  (23.68)
Anxiety: Change at Cycle 26 Number Analyzed 49 participants 31 participants
-19.73  (30.28) -13.26  (22.11)
Anxiety: Change at Cycle 27 Number Analyzed 43 participants 28 participants
-21.71  (29.89) -12.70  (20.67)
Anxiety: Change at Cycle 28 Number Analyzed 39 participants 25 participants
-22.51  (29.34) -12.89  (22.38)
Anxiety: Change at PT Visit 1 Number Analyzed 175 participants 196 participants
-0.73  (25.18) -4.73  (27.21)
Anxiety: Change at PT Visit 2 Number Analyzed 99 participants 106 participants
-4.04  (28.24) -3.98  (25.02)
Body Image: Cycle 1 (Baseline) Number Analyzed 364 participants 373 participants
23.53  (28.40) 23.68  (27.47)
Body Image: Change at Cycle 2 Number Analyzed 326 participants 334 participants
1.33  (28.19) 1.20  (26.44)
Body Image: Change at Cycle 3 Number Analyzed 316 participants 309 participants
1.48  (29.06) 3.88  (28.03)
Body Image: Change at Cycle 4 Number Analyzed 294 participants 289 participants
4.20  (28.51) 1.15  (27.19)
Body Image: Change at Cycle 5 Number Analyzed 280 participants 284 participants
2.86  (30.91) 1.06  (25.74)
Body Image: Change at Cycle 6 Number Analyzed 268 participants 252 participants
0.75  (30.11) 2.78  (28.48)
Body Image: Change at Cycle 7 Number Analyzed 237 participants 226 participants
-0.56  (28.94) 0.29  (25.53)
Body Image: Change at Cycle 8 Number Analyzed 230 participants 213 participants
-1.74  (29.83) 0.00  (26.30)
Body Image: Change at Cycle 9 Number Analyzed 205 participants 193 participants
-3.58  (28.74) -0.69  (24.52)
Body Image: Change at Cycle 10 Number Analyzed 184 participants 164 participants
-5.07  (30.15) -3.25  (24.55)
Body Image: Change at Cycle 11 Number Analyzed 166 participants 153 participants
-4.62  (30.24) -1.53  (25.46)
Body Image: Change at Cycle 12 Number Analyzed 157 participants 138 participants
-5.31  (31.92) -2.66  (27.04)
Body Image: Change at Cycle 13 Number Analyzed 141 participants 110 participants
-4.73  (30.23) -2.73  (25.99)
Body Image: Change at Cycle 14 Number Analyzed 135 participants 101 participants
-5.43  (29.70) -4.62  (24.05)
Body Image: Change at Cycle 15 Number Analyzed 130 participants 96 participants
-3.08  (30.63) -2.43  (27.03)
Body Image: Change at Cycle 16 Number Analyzed 115 participants 84 participants
-1.74  (32.99) -1.19  (26.10)
Body Image: Change at Cycle 17 Number Analyzed 111 participants 73 participants
-2.70  (32.76) -2.28  (21.75)
Body Image: Change at Cycle 18 Number Analyzed 101 participants 70 participants
-2.64  (30.44) -5.71  (23.38)
Body Image: Change at Cycle 19 Number Analyzed 95 participants 64 participants
-2.81  (33.57) -5.21  (20.76)
Body Image: Change at Cycle 20 Number Analyzed 84 participants 62 participants
-3.97  (30.79) -5.38  (22.74)
Body Image: Change at Cycle 21 Number Analyzed 79 participants 53 participants
1.69  (30.15) -8.18  (26.07)
Body Image: Change at Cycle 22 Number Analyzed 67 participants 46 participants
-1.49  (32.01) -10.87  (22.28)
Body Image: Change at Cycle 23 Number Analyzed 63 participants 43 participants
-5.82  (24.35) -8.53  (29.18)
Body Image: Change at Cycle 24 Number Analyzed 59 participants 39 participants
-0.56  (31.25) -11.11  (23.36)
Body Image: Change at Cycle 25 Number Analyzed 52 participants 35 participants
-3.21  (28.97) -11.43  (24.18)
Body Image: Change at Cycle 26 Number Analyzed 49 participants 31 participants
-4.76  (29.66) -6.45  (18.09)
Body Image: Change at Cycle 27 Number Analyzed 43 participants 28 participants
0.78  (24.65) -7.14  (21.00)
Body Image: Change at Cycle 28 Number Analyzed 39 participants 25 participants
-4.27  (26.69) -4.00  (24.19)
Body Image: Change at PT Visit 1 Number Analyzed 175 participants 195 participants
2.48  (31.57) 3.42  (29.31)
Body Image: Change at PT Visit 2 Number Analyzed 99 participants 105 participants
2.36  (35.40) 6.35  (27.38)
Dry Mouth: Cycle 1 (Baseline) Number Analyzed 367 participants 373 participants
21.80  (25.07) 23.32  (26.79)
Dry Mouth: Change at Cycle 2 Number Analyzed 328 participants 333 participants
7.72  (28.70) 3.00  (25.43)
Dry Mouth: Change at Cycle 3 Number Analyzed 317 participants 308 participants
6.10  (28.65) 4.87  (27.33)
Dry Mouth: Change at Cycle 4 Number Analyzed 294 participants 288 participants
4.76  (29.40) 2.66  (31.06)
Dry Mouth: Change at Cycle 5 Number Analyzed 283 participants 285 participants
2.47  (29.67) 2.57  (28.68)
Dry Mouth: Change at Cycle 6 Number Analyzed 270 participants 252 participants
2.96  (30.14) 1.19  (27.65)
Dry Mouth: Change at Cycle 7 Number Analyzed 238 participants 226 participants
-1.96  (28.82) 0.44  (28.54)
Dry Mouth: Change at Cycle 8 Number Analyzed 233 participants 213 participants
-2.43  (28.68) -2.66  (26.27)
Dry Mouth: Change at Cycle 9 Number Analyzed 207 participants 193 participants
-3.70  (25.70) -4.32  (24.74)
Dry Mouth: Change at Cycle 10 Number Analyzed 186 participants 164 participants
-6.27  (25.04) -3.46  (23.53)
Dry Mouth: Change at Cycle 11 Number Analyzed 169 participants 153 participants
-7.69  (25.46) -1.96  (26.56)
Dry Mouth: Change at Cycle 12 Number Analyzed 159 participants 138 participants
-8.18  (24.22) -4.35  (26.36)
Dry Mouth: Change at Cycle 13 Number Analyzed 141 participants 110 participants
-9.69  (24.08) -8.48  (26.50)
Dry Mouth: Change at Cycle 14 Number Analyzed 136 participants 101 participants
-8.33  (24.60) -3.63  (29.78)
Dry Mouth: Change at Cycle 15 Number Analyzed 131 participants 96 participants
-7.89  (22.20) -7.29  (26.58)
Dry Mouth: Change at Cycle 16 Number Analyzed 116 participants 84 participants
-6.32  (24.44) -8.33  (27.80)
Dry Mouth: Change at Cycle 17 Number Analyzed 112 participants 73 participants
-7.44  (23.12) -3.20  (24.32)
Dry Mouth: Change at Cycle 18 Number Analyzed 102 participants 70 participants
-5.56  (24.86) -8.10  (28.62)
Dry Mouth: Change at Cycle 19 Number Analyzed 96 participants 65 participants
-5.90  (24.18) -7.69  (25.53)
Dry Mouth: Change at Cycle 20 Number Analyzed 84 participants 62 participants
-6.35  (26.62) -9.68  (27.25)
Dry Mouth: Change at Cycle 21 Number Analyzed 79 participants 53 participants
-7.17  (24.27) -9.43  (20.02)
Dry Mouth: Change at Cycle 22 Number Analyzed 67 participants 46 participants
-3.98  (26.29) -8.70  (23.76)
Dry Mouth: Change at Cycle 23 Number Analyzed 63 participants 43 participants
-7.94  (23.73) -3.88  (25.42)
Dry Mouth: Change at Cycle 24 Number Analyzed 60 participants 39 participants
-6.67  (25.15) -9.40  (28.56)
Dry Mouth: Change at Cycle 25 Number Analyzed 52 participants 35 participants
-8.33  (22.75) -9.52  (28.66)
Dry Mouth: Change at Cycle 26 Number Analyzed 49 participants 31 participants
-2.72  (23.41) -7.53  (26.82)
Dry Mouth: Change at Cycle 27 Number Analyzed 43 participants 28 participants
-6.98  (21.28) -7.14  (27.75)
Dry Mouth: Change at Cycle 28 Number Analyzed 39 participants 25 participants
-8.55  (21.24) -8.00  (22.11)
Dry Mouth: Change at PT Visit 1 Number Analyzed 175 participants 196 participants
0.19  (28.70) 2.38  (31.58)
Dry Mouth: Change at PT Visit 2 Number Analyzed 99 participants 106 participants
-1.35  (30.09) 1.89  (25.95)
Dysphagia: Cycle 1 (Baseline) Number Analyzed 367 participants 373 participants
16.29  (21.46) 14.15  (18.93)
Dysphagia: Change at Cycle 2 Number Analyzed 330 participants 334 participants
-2.27  (17.64) -0.53  (19.32)
Dysphagia: Change at Cycle 3 Number Analyzed 318 participants 308 participants
-3.39  (18.57) -2.15  (19.67)
Dysphagia: Change at Cycle 4 Number Analyzed 295 participants 289 participants
-2.94  (18.93) -1.08  (18.79)
Dysphagia: Change at Cycle 5 Number Analyzed 283 participants 285 participants
-3.22  (19.92) -1.83  (18.99)
Dysphagia: Change at Cycle 6 Number Analyzed 270 participants 252 participants
-4.20  (18.99) -2.25  (18.70)
Dysphagia: Change at Cycle 7 Number Analyzed 239 participants 226 participants
-4.83  (20.56) -1.97  (19.94)
Dysphagia: Change at Cycle 8 Number Analyzed 233 participants 213 participants
-5.96  (18.80) -3.29  (18.48)
Dysphagia: Change at Cycle 9 Number Analyzed 207 participants 193 participants
-6.17  (18.21) -3.86  (18.49)
Dysphagia: Change at Cycle 10 Number Analyzed 186 participants 164 participants
-6.03  (17.37) -4.61  (16.87)
Dysphagia: Change at Cycle 11 Number Analyzed 169 participants 153 participants
-6.25  (17.09) -2.83  (17.03)
Dysphagia: Change at Cycle 12 Number Analyzed 159 participants 138 participants
-7.06  (17.65) -4.19  (15.84)
Dysphagia: Change at Cycle 13 Number Analyzed 141 participants 110 participants
-6.93  (18.71) -3.54  (17.61)
Dysphagia: Change at Cycle 14 Number Analyzed 136 participants 101 participants
-8.01  (18.53) -4.95  (18.22)
Dysphagia: Change at Cycle 15 Number Analyzed 131 participants 96 participants
-6.45  (17.38) -2.14  (18.69)
Dysphagia: Change at Cycle 16 Number Analyzed 116 participants 84 participants
-4.41  (18.29) -3.70  (21.08)
Dysphagia: Change at Cycle 17 Number Analyzed 112 participants 73 participants
-5.36  (16.87) -3.20  (14.99)
Dysphagia: Change at Cycle 18 Number Analyzed 102 participants 70 participants
-4.90  (16.44) -3.33  (19.78)
Dysphagia: Change at Cycle 19 Number Analyzed 96 participants 65 participants
-4.40  (17.10) -3.59  (14.31)
Dysphagia: Change at Cycle 20 Number Analyzed 84 participants 62 participants
-2.51  (16.21) -3.76  (15.83)
Dysphagia: Change at Cycle 21 Number Analyzed 79 participants 53 participants
-3.80  (19.24) -2.10  (17.84)
Dysphagia: Change at Cycle 22 Number Analyzed 67 participants 46 participants
-3.65  (20.41) -4.83  (15.65)
Dysphagia: Change at Cycle 23 Number Analyzed 63 participants 43 participants
-4.23  (18.87) -3.88  (17.63)
Dysphagia: Change at Cycle 24 Number Analyzed 60 participants 39 participants
-5.00  (18.35) -3.70  (13.08)
Dysphagia: Change at Cycle 25 Number Analyzed 52 participants 35 participants
-5.98  (19.61) -2.22  (16.79)
Dysphagia: Change at Cycle 26 Number Analyzed 49 participants 31 participants
-5.67  (20.43) -2.87  (16.22)
Dysphagia: Change at Cycle 27 Number Analyzed 43 participants 28 participants
-5.68  (20.91) -4.37  (12.22)
Dysphagia: Change at Cycle 28 Number Analyzed 39 participants 25 participants
-8.26  (19.86) -3.56  (11.44)
Dysphagia: Change at PT Visit 1 Number Analyzed 176 participants 196 participants
0.44  (24.15) 2.83  (22.63)
Dysphagia: Change at PT Visit 2 Number Analyzed 99 participants 106 participants
-2.81  (24.40) 3.25  (19.81)
Eating Restrictions: Cycle 1 (Baseline) Number Analyzed 366 participants 373 participants
23.26  (21.78) 22.33  (20.22)
Eating Restrictions: Change at Cycle 2 Number Analyzed 328 participants 334 participants
-1.41  (19.36) -1.54  (19.62)
Eating Restrictions: Change at Cycle 3 Number Analyzed 318 participants 308 participants
-1.04  (21.09) -2.20  (20.94)
Eating Restrictions: Change at Cycle 4 Number Analyzed 295 participants 289 participants
-2.24  (20.81) -1.39  (23.36)
Eating Restrictions: Change at Cycle 5 Number Analyzed 283 participants 285 participants
-1.39  (22.10) -0.09  (23.31)
Eating Restrictions: Change at Cycle 6 Number Analyzed 270 participants 252 participants
-1.35  (22.77) -3.32  (23.14)
Eating Restrictions: Change at Cycle 7 Number Analyzed 239 participants 225 participants
-2.45  (22.68) -2.67  (21.66)
Eating Restrictions: Change at Cycle 8 Number Analyzed 233 participants 213 participants
-4.29  (22.70) -5.56  (19.87)
Eating Restrictions: Change at Cycle 9 Number Analyzed 207 participants 193 participants
-6.99  (21.16) -6.48  (19.69)
Eating Restrictions: Change at Cycle 10 Number Analyzed 186 participants 164 participants
-7.06  (21.32) -5.89  (19.30)
Eating Restrictions: Change at Cycle 11 Number Analyzed 169 participants 153 participants
-8.22  (21.25) -5.05  (19.98)
Eating Restrictions: Change at Cycle 12 Number Analyzed 159 participants 138 participants
-7.74  (21.16) -6.34  (19.87)
Eating Restrictions: Change at Cycle 13 Number Analyzed 141 participants 110 participants
-8.55  (20.41) -8.41  (19.57)
Eating Restrictions: Change at Cycle 14 Number Analyzed 136 participants 101 participants
-8.62  (19.16) -8.58  (21.16)
Eating Restrictions: Change at Cycle 15 Number Analyzed 131 participants 96 participants
-6.85  (20.92) -5.56  (21.21)
Eating Restrictions: Change at Cycle 16 Number Analyzed 116 participants 84 participants
-5.77  (22.01) -6.94  (20.36)
Eating Restrictions: Change at Cycle 17 Number Analyzed 112 participants 73 participants
-5.56  (21.95) -7.42  (17.76)
Eating Restrictions: Change at Cycle 18 Number Analyzed 102 participants 70 participants
-7.27  (20.40) -6.90  (21.14)
Eating Restrictions: Change at Cycle 19 Number Analyzed 96 participants 65 participants
-7.03  (21.78) -5.38  (18.07)
Eating Restrictions: Change at Cycle 20 Number Analyzed 84 participants 62 participants
-4.56  (21.03) -4.44  (16.72)
Eating Restrictions: Change at Cycle 21 Number Analyzed 79 participants 53 participants
-5.80  (22.58) -5.03  (19.97)
Eating Restrictions: Change at Cycle 22 Number Analyzed 67 participants 46 participants
-3.65  (21.79) -6.16  (16.80)
Eating Restrictions: Change at Cycle 23 Number Analyzed 63 participants 43 participants
-3.70  (22.74) -5.23  (20.25)
Eating Restrictions: Change at Cycle 24 Number Analyzed 60 participants 39 participants
-5.00  (20.77) -7.91  (15.76)
Eating Restrictions: Change at Cycle 25 Number Analyzed 52 participants 35 participants
-5.77  (21.10) -5.95  (16.61)
Eating Restrictions: Change at Cycle 26 Number Analyzed 49 participants 31 participants
-6.80  (21.22) -2.42  (22.89)
Eating Restrictions: Change at Cycle 27 Number Analyzed 43 participants 28 participants
-5.62  (23.48) -3.87  (10.26)
Eating Restrictions: Change at Cycle 28 Number Analyzed 39 participants 25 participants
-7.91  (21.79) -5.00  (11.02)
Eating Restrictions: Change at PT Visit 1 Number Analyzed 176 participants 196 participants
1.52  (24.48) 0.94  (24.70)
Eating Restrictions: Change at PT Visit 2 Number Analyzed 99 participants 106 participants
-2.10  (25.32) 0.94  (21.46)
Hair Loss: Cycle 1 (Baseline) Number Analyzed 363 participants 371 participants
4.73  (13.28) 4.04  (13.20)
Hair Loss: Change at Cycle 2 Number Analyzed 326 participants 329 participants
0.20  (14.85) 1.27  (16.59)
Hair Loss: Change at Cycle 3 Number Analyzed 315 participants 306 participants
4.34  (17.51) 4.52  (18.71)
Hair Loss: Change at Cycle 4 Number Analyzed 293 participants 286 participants
5.40  (18.46) 6.53  (20.99)
Hair Loss: Change at Cycle 5 Number Analyzed 278 participants 281 participants
6.12  (19.38) 7.18  (19.49)
Hair Loss: Change at Cycle 6 Number Analyzed 267 participants 250 participants
6.93  (18.87) 10.07  (22.94)
Hair Loss: Change at Cycle 7 Number Analyzed 236 participants 225 participants
5.72  (19.91) 9.26  (22.92)
Hair Loss: Change at Cycle 8 Number Analyzed 230 participants 210 participants
5.00  (18.96) 7.38  (23.05)
Hair Loss: Change at Cycle 9 Number Analyzed 203 participants 191 participants
2.38  (17.43) 6.46  (21.06)
Hair Loss: Change at Cycle 10 Number Analyzed 183 participants 162 participants
0.64  (16.88) 4.22  (19.51)
Hair Loss: Change at Cycle 11 Number Analyzed 165 participants 151 participants
-0.10  (17.02) 2.54  (17.51)
Hair Loss: Change at Cycle 12 Number Analyzed 157 participants 136 participants
0.21  (19.70) 1.96  (15.72)
Hair Loss: Change at Cycle 13 Number Analyzed 140 participants 109 participants
0.36  (18.91) 2.29  (15.46)
Hair Loss: Change at Cycle 14 Number Analyzed 134 participants 100 participants
-1.37  (17.59) 1.83  (15.15)
Hair Loss: Change at Cycle 15 Number Analyzed 129 participants 95 participants
-0.39  (15.65) 1.58  (12.65)
Hair Loss: Change at Cycle 16 Number Analyzed 113 participants 82 participants
-1.47  (17.47) 1.42  (13.91)
Hair Loss: Change at Cycle 17 Number Analyzed 109 participants 73 participants
-1.07  (17.75) 0.23  (12.57)
Hair Loss: Change at Cycle 18 Number Analyzed 99 participants 70 participants
-1.68  (17.58) -0.71  (13.14)
Hair Loss: Change at Cycle 19 Number Analyzed 93 participants 65 participants
-0.90  (18.12) 0.51  (14.12)
Hair Loss: Change at Cycle 20 Number Analyzed 83 participants 62 participants
-0.20  (19.21) -1.61  (12.70)
Hair Loss: Change at Cycle 21 Number Analyzed 78 participants 53 participants
-1.07  (19.43) -1.57  (8.81)
Hair Loss: Change at Cycle 22 Number Analyzed 67 participants 46 participants
-0.50  (16.66) -3.26  (11.98)
Hair Loss: Change at Cycle 23 Number Analyzed 62 participants 42 participants
-0.54  (16.79) -1.19  (11.28)
Hair Loss: Change at Cycle 24 Number Analyzed 60 participants 39 participants
-1.39  (17.44) 1.71  (16.13)
Hair Loss: Change at Cycle 25 Number Analyzed 51 participants 35 participants
-1.96  (18.75) -0.95  (9.85)
Hair Loss: Change at Cycle 26 Number Analyzed 49 participants 31 participants
-1.02  (19.37) -0.54  (10.08)
Hair Loss: Change at Cycle 27 Number Analyzed 43 participants 28 participants
-3.10  (15.96) -0.60  (10.62)
Hair Loss: Change at Cycle 28 Number Analyzed 39 participants 25 participants
-4.70  (20.57) -1.33  (10.67)
Hair Loss: Change at PT Visit 1 Number Analyzed 174 participants 192 participants
4.98  (19.73) 4.51  (20.39)
Hair Loss: Change at PT Visit 2 Number Analyzed 99 participants 105 participants
15.82  (25.35) 22.22  (30.81)
Pain: Cycle 1 (Baseline) Number Analyzed 367 participants 373 participants
26.48  (21.34) 26.47  (20.70)
Pain: Change at Cycle 2 Number Analyzed 330 participants 334 participants
-4.63  (20.30) -5.86  (19.15)
Pain: Change at Cycle 3 Number Analyzed 318 participants 308 participants
-6.96  (20.37) -5.86  (20.68)
Pain: Change at Cycle 4 Number Analyzed 296 participants 289 participants
-6.45  (21.47) -7.48  (21.23)
Pain: Change at Cycle 5 Number Analyzed 283 participants 285 participants
-7.28  (20.95) -6.89  (22.10)
Pain: Change at Cycle 6 Number Analyzed 270 participants 252 participants
-7.24  (20.84) -7.22  (21.62)
Pain: Change at Cycle 7 Number Analyzed 239 participants 226 participants
-9.52  (21.18) -6.62  (21.63)
Pain: Change at Cycle 8 Number Analyzed 233 participants 213 participants
-10.53  (21.62) -8.16  (20.11)
Pain: Change at Cycle 9 Number Analyzed 207 participants 193 participants
-10.08  (19.60) -8.98  (20.29)
Pain: Change at Cycle 10 Number Analyzed 186 participants 164 participants
-10.63  (19.23) -8.59  (20.38)
Pain: Change at Cycle 11 Number Analyzed 169 participants 153 participants
-11.65  (19.35) -8.01  (18.97)
Pain: Change at Cycle 12 Number Analyzed 159 participants 138 participants
-11.76  (19.87) -7.19  (19.11)
Pain: Change at Cycle 13 Number Analyzed 141 participants 110 participants
-11.92  (18.93) -9.24  (19.79)
Pain: Change at Cycle 14 Number Analyzed 136 participants 101 participants
-11.66  (19.51) -9.82  (19.91)
Pain: Change at Cycle 15 Number Analyzed 131 participants 96 participants
-11.15  (18.16) -8.51  (20.94)
Pain: Change at Cycle 16 Number Analyzed 116 participants 84 participants
-8.72  (18.02) -10.52  (21.30)
Pain: Change at Cycle 17 Number Analyzed 112 participants 73 participants
-8.88  (18.17) -9.93  (17.27)
Pain: Change at Cycle 18 Number Analyzed 102 participants 70 participants
-8.31  (18.33) -11.19  (18.16)
Pain: Change at Cycle 19 Number Analyzed 96 participants 65 participants
-6.63  (17.25) -10.38  (14.51)
Pain: Change at Cycle 20 Number Analyzed 84 participants 62 participants
-5.72  (19.98) -10.35  (16.65)
Pain: Change at Cycle 21 Number Analyzed 79 participants 53 participants
-8.19  (18.27) -7.55  (16.77)
Pain: Change at Cycle 22 Number Analyzed 67 participants 46 participants
-9.08  (18.10) -9.42  (16.72)
Pain: Change at Cycle 23 Number Analyzed 63 participants 43 participants
-9.66  (20.75) -8.53  (19.96)
Pain: Change at Cycle 24 Number Analyzed 60 participants 39 participants
-9.86  (21.56) -8.76  (15.53)
Pain: Change at Cycle 25 Number Analyzed 52 participants 35 participants
-10.58  (19.88) -8.10  (18.69)
Pain: Change at Cycle 26 Number Analyzed 49 participants 31 participants
-9.01  (17.99) -9.41  (17.58)
Pain: Change at Cycle 27 Number Analyzed 43 participants 28 participants
-12.02  (17.28) -9.23  (14.58)
Pain: Change at Cycle 28 Number Analyzed 39 participants 25 participants
-11.54  (18.20) -7.33  (13.46)
Pain: Change at PT Visit 1 Number Analyzed 176 participants 196 participants
-1.70  (23.07) -2.99  (23.86)
Pain: Change at PT Visit 2 Number Analyzed 99 participants 106 participants
-7.49  (24.09) -0.03  (22.04)
Reflux Symptoms: Cycle 1 (Baseline) Number Analyzed 367 participants 373 participants
16.68  (19.03) 17.34  (18.31)
Reflux Symptoms: Change at Cycle 2 Number Analyzed 331 participants 333 participants
-0.13  (16.33) -1.99  (18.03)
Reflux Symptoms: Change at Cycle 3 Number Analyzed 318 participants 309 participants
-0.52  (18.95) -2.28  (19.53)
Reflux Symptoms: Change at Cycle 4 Number Analyzed 295 participants 289 participants
-0.98  (19.18) -1.90  (19.93)
Reflux Symptoms: Change at Cycle 5 Number Analyzed 283 participants 285 participants
-1.92  (18.98) -1.72  (20.10)
Reflux Symptoms: Change at Cycle 6 Number Analyzed 270 participants 252 participants
-2.90  (20.42) -3.59  (19.04)
Reflux Symptoms: Change at Cycle 7 Number Analyzed 239 participants 226 participants
-4.18  (18.36) -3.20  (20.21)
Reflux Symptoms: Change at Cycle 8 Number Analyzed 233 participants 213 participants
-4.96  (19.39) -5.74  (19.53)
Reflux Symptoms: Change at Cycle 9 Number Analyzed 207 participants 193 participants
-5.02  (18.97) -5.18  (19.81)
Reflux Symptoms: Change at Cycle 10 Number Analyzed 186 participants 163 participants
-6.12  (17.81) -6.48  (18.55)
Reflux Symptoms: Change at Cycle 11 Number Analyzed 169 participants 153 participants
-6.44  (18.74) -6.03  (18.07)
Reflux Symptoms: Change at Cycle 12 Number Analyzed 158 participants 138 participants
-4.82  (18.00) -7.49  (16.99)
Reflux Symptoms: Change at Cycle 13 Number Analyzed 141 participants 110 participants
-6.42  (17.09) -6.77  (18.19)
Reflux Symptoms: Change at Cycle 14 Number Analyzed 136 participants 101 participants
-5.39  (18.24) -7.37  (17.45)
Reflux Symptoms: Change at Cycle 15 Number Analyzed 131 participants 96 participants
-5.00  (16.66) -4.98  (18.72)
Reflux Symptoms: Change at Cycle 16 Number Analyzed 116 participants 84 participants
-3.07  (18.39) -4.89  (22.31)
Reflux Symptoms: Change at Cycle 17 Number Analyzed 111 participants 73 participants
-3.35  (18.38) -4.57  (20.44)
Reflux Symptoms: Change at Cycle 18 Number Analyzed 102 participants 70 participants
-2.94  (18.36) -6.51  (20.33)
Reflux Symptoms: Change at Cycle 19 Number Analyzed 96 participants 65 participants
-2.43  (16.38) -6.15  (18.43)
Reflux Symptoms: Change at Cycle 20 Number Analyzed 84 participants 62 participants
-1.85  (18.32) -5.38  (18.63)
Reflux Symptoms: Change at Cycle 21 Number Analyzed 79 participants 53 participants
-1.83  (18.44) -4.19  (17.73)
Reflux Symptoms: Change at Cycle 22 Number Analyzed 67 participants 46 participants
-3.81  (19.30) -7.00  (19.65)
Reflux Symptoms: Change at Cycle 23 Number Analyzed 63 participants 43 participants
-5.11  (17.03) -6.98  (19.70)
Reflux Symptoms: Change at Cycle 24 Number Analyzed 60 participants 39 participants
-4.07  (19.30) -7.98  (18.19)
Reflux Symptoms: Change at Cycle 25 Number Analyzed 52 participants 35 participants
-5.56  (18.86) -5.71  (16.69)
Reflux Symptoms: Change at Cycle 26 Number Analyzed 49 participants 31 participants
-4.99  (20.67) -4.30  (21.98)
Reflux Symptoms: Change at Cycle 27 Number Analyzed 43 participants 28 participants
-7.75  (20.51) -6.75  (16.10)
Reflux Symptoms: Change at Cycle 28 Number Analyzed 39 participants 25 participants
-7.12  (18.64) -4.44  (11.56)
Reflux Symptoms: Change at PT Visit 1 Number Analyzed 176 participants 196 participants
0.88  (20.01) -0.45  (22.92)
Reflux Symptoms: Change at PT Visit 2 Number Analyzed 99 participants 106 participants
0.56  (18.67) -1.47  (22.28)
Taste: Cycle 1 (Baseline) Number Analyzed 365 participants 372 participants
13.79  (23.99) 16.22  (25.49)
Taste: Change at Cycle 2 Number Analyzed 328 participants 333 participants
12.09  (28.78) 6.61  (26.94)
Taste: Change at Cycle 3 Number Analyzed 317 participants 307 participants
16.72  (32.11) 9.99  (30.16)
Taste: Change at Cycle 4 Number Analyzed 293 participants 286 participants
18.43  (34.70) 11.07  (31.93)
Taste: Change at Cycle 5 Number Analyzed 282 participants 284 participants
17.61  (32.93) 11.85  (30.25)
Taste: Change at Cycle 6 Number Analyzed 269 participants 251 participants
17.97  (31.20) 11.82  (32.21)
Taste: Change at Cycle 7 Number Analyzed 238 participants 225 participants
16.25  (33.51) 9.19  (31.09)
Taste: Change at Cycle 8 Number Analyzed 232 participants 213 participants
11.64  (29.81) 3.29  (28.13)
Taste: Change at Cycle 9 Number Analyzed 206 participants 193 participants
9.22  (28.25) 1.73  (26.30)
Taste: Change at Cycle 10 Number Analyzed 185 participants 164 participants
7.93  (26.41) 1.63  (28.79)
Taste: Change at Cycle 11 Number Analyzed 168 participants 153 participants
4.96  (26.72) 2.61  (26.91)
Taste: Change at Cycle 12 Number Analyzed 158 participants 138 participants
5.27  (24.82) 0.24  (24.66)
Taste: Change at Cycle 13 Number Analyzed 139 participants 110 participants
4.08  (25.53) -0.91  (25.33)
Taste: Change at Cycle 14 Number Analyzed 136 participants 101 participants
0.49  (25.66) -5.28  (24.37)
Taste: Change at Cycle 15 Number Analyzed 130 participants 96 participants
3.08  (24.36) -1.04  (26.25)
Taste: Change at Cycle 16 Number Analyzed 115 participants 84 participants
5.51  (27.90) -3.57  (20.71)
Taste: Change at Cycle 17 Number Analyzed 111 participants 73 participants
4.80  (24.96) -3.65  (23.28)
Taste: Change at Cycle 18 Number Analyzed 102 participants 70 participants
3.59  (23.87) -4.29  (23.34)
Taste: Change at Cycle 19 Number Analyzed 96 participants 65 participants
3.13  (25.17) -4.62  (15.45)
Taste: Change at Cycle 20 Number Analyzed 84 participants 62 participants
5.56  (27.78) -3.76  (18.21)
Taste: Change at Cycle 21 Number Analyzed 79 participants 53 participants
6.33  (27.26) -5.03  (17.78)
Taste: Change at Cycle 22 Number Analyzed 67 participants 46 participants
9.45  (30.04) -4.35  (16.64)
Taste: Change at Cycle 23 Number Analyzed 63 participants 43 participants
8.99  (30.06) 0.00  (23.00)
Taste: Change at Cycle 24 Number Analyzed 60 participants 39 participants
7.78  (28.37) -5.13  (19.55)
Taste: Change at Cycle 25 Number Analyzed 52 participants 35 participants
3.21  (28.97) -4.76  (18.33)
Taste: Change at Cycle 26 Number Analyzed 49 participants 31 participants
4.08  (34.45) -3.23  (21.70)
Taste: Change at Cycle 27 Number Analyzed 43 participants 28 participants
4.65  (29.62) -3.57  (20.96)
Taste: Change at Cycle 28 Number Analyzed 39 participants 25 participants
3.42  (21.35) -6.67  (25.46)
Taste: Change at PT Visit 1 Number Analyzed 175 participants 195 participants
12.76  (34.59) 9.06  (33.56)
Taste: Change at PT Visit 2 Number Analyzed 99 participants 105 participants
8.42  (31.35) 6.67  (28.64)
10.Secondary Outcome
Title Maximum Serum Concentration (Cmax) of Pertuzumab
Hide Description [Not Specified]
Time Frame Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day (D1) of Cycles 1, 2, 4, and 8 (1 cycle = 21 days; up to approximately 3.5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 374
Mean (Standard Deviation)
Unit of Measure: micrograms per milliliter (μg/mL)
Cycle 1 Number Analyzed 374 participants
258  (90.3)
Cycle 2 Number Analyzed 346 participants
288  (83.7)
Cycle 4 Number Analyzed 302 participants
341  (111)
Cycle 8 Number Analyzed 106 participants
371  (127)
11.Secondary Outcome
Title Cmax of Trastuzumab
Hide Description [Not Specified]
Time Frame Post-dose (0.5 hour after end of 30-60 minutes infusion) on D1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days; up to approximately 3.5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 372 375
Mean (Standard Deviation)
Unit of Measure: μg/mL
Cycle 1 Number Analyzed 372 participants 375 participants
142  (86.8) 139  (58.6)
Cycle 2 Number Analyzed 346 participants 354 participants
120  (46.6) 120  (44.3)
Cycle 4 Number Analyzed 304 participants 299 participants
127  (50.9) 129  (58.1)
Cycle 8 Number Analyzed 115 participants 90 participants
130  (50.8) 147  (90.2)
12.Secondary Outcome
Title Minimum Serum Concentration (Cmin) of Pertuzumab
Hide Description [Not Specified]
Time Frame Pre-dose (0-6 hours before infusion) on D1 of Cycles 1, 2, 3, 4, 6, and 8; at 28 & 60-90 days (Post-Treatment [PT] Monitoring Visits 1 and 2, respectively) after D1 of last cycle (1 cycle = 21 days; up to approximately 3.5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 376
Mean (Standard Deviation)
Unit of Measure: μg/mL
Cycle 1 Number Analyzed 376 participants
NA [1]   (NA)
Cycle 2 Number Analyzed 349 participants
42.4  (24.8)
Cycle 3 Number Analyzed 327 participants
74.0  (40.9)
Cycle 4 Number Analyzed 305 participants
90.4  (42.4)
Cycle 6 Number Analyzed 274 participants
114  (51.8)
Cycle 8 Number Analyzed 114 participants
142  (67.9)
PT Monitoring Visit 1 Number Analyzed 191 participants
101  (64.7)
PT Monitoring Visit 2 Number Analyzed 131 participants
24.1  (27.5)
[1]
The Cmin of pertuzumab at Cycle 1 (before first dose) is non-reportable (i.e., lower than quantifiable).
13.Secondary Outcome
Title Cmin of Trastuzumab
Hide Description [Not Specified]
Time Frame Pre-dose (0-6 hours before infusion) on D1 of Cycles 1, 2, 3, 4, 6, and 8; at 28 & 60-90 days (Post-Treatment [PT] Monitoring Visits 1 and 2, respectively) after D1 of last cycle (1 cycle = 21 days; up to approximately 3.5 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic analysis included all participants who were treated with study medication and who had at least one measurable concentration of pertuzumab or trastuzumab. Data are reported for evaluable participants.
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description:
Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Overall Number of Participants Analyzed 379 381
Mean (Standard Deviation)
Unit of Measure: μg/mL
Cycle 1 Number Analyzed 379 participants 381 participants
NA [1]   (NA) NA [1]   (NA)
Cycle 2 Number Analyzed 345 participants 354 participants
15.4  (11.3) 17.2  (15.4)
Cycle 3 Number Analyzed 328 participants 326 participants
19.9  (13.4) 20.7  (15.2)
Cycle 4 Number Analyzed 305 participants 300 participants
22.9  (12.7) 24.1  (19.0)
Cycle 6 Number Analyzed 274 participants 254 participants
26.3  (14.8) 29.8  (21.9)
Cycle 8 Number Analyzed 114 participants 92 participants
32.7  (15.0) 37.4  (20.3)
PT Monitoring Visit 1 Number Analyzed 196 participants 212 participants
22.6  (18.2) 23.9  (19.3)
PT Monitoring Visit 2 Number Analyzed 132 participants 127 participants
5.84  (12.8) 9.62  (17.7)
[1]
The Cmin of trastuzumab at Cycle 1 (before first dose) is non-reportable (i.e., lower than quantifiable).
Time Frame Baseline up to the 09 Dec 2016 data cutoff, approximately 3.5 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Hide Arm/Group Description Participants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason. Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
All-Cause Mortality
Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   240/385 (62.34%)   262/388 (67.53%) 
Show Serious Adverse Events Hide Serious Adverse Events
Pertuzumab + Trastuzumab + Chemotherapy Placebo + Trastuzumab + Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   175/385 (45.45%)   152/388 (39.18%) 
Blood and lymphatic system disorders     
Anaemia * 1  8/385 (2.08%)  16/388 (4.12%) 
Disseminated intravascular coagulation * 1  0/385 (0.00%)  1/388 (0.26%) 
Febrile neutropenia * 1