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Trial record 54 of 508 for:    melanoma phase III

A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma (BRIM8)

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: NCT01667419
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : October 17, 2018
Last Update Posted : May 14, 2019
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 Melanoma
Interventions Drug: Vemurafenib
Drug: Placebo
Enrollment 498
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1 Vemurafenib Cohort 1 Placebo Cohort 2 Vemurafenib Cohort 2 Placebo
Hide Arm/Group Description Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 milligrams (mg) twice daily, in 28-day cycles, for up to 52 weeks Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Period Title: Overall Study
Started 157 157 93 91
Completed 0 0 0 0
Not Completed 157 157 93 91
Reason Not Completed
Reason Not Specified             2             0             0             0
Withdrawal by Subject             15             8             9             8
Non-compliance             0             0             0             1
Protocol Violation             1             0             0             0
Lost to Follow-up             2             5             0             2
Death             16             28             19             20
Continued in ongoing study             121             116             65             60
Arm/Group Title Cohort 1 Vemurafenib Cohort 1 Placebo Cohort 2 Vemurafenib Cohort 2 Placebo Total
Hide Arm/Group Description Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks Total of all reporting groups
Overall Number of Baseline Participants 157 157 93 91 498
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 157 participants 157 participants 93 participants 91 participants 498 participants
50.7  (12.4) 49.6  (12.7) 51.6  (14.1) 49.1  (12.9) 50.2  (12.9)
[1]
Measure Analysis Population Description: The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 157 participants 93 participants 91 participants 498 participants
Female
73
  46.5%
69
  43.9%
41
  44.1%
32
  35.2%
215
  43.2%
Male
84
  53.5%
88
  56.1%
52
  55.9%
59
  64.8%
283
  56.8%
[1]
Measure Analysis Population Description: The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 157 participants 93 participants 91 participants 498 participants
Hispanic or Latino
12
   7.6%
2
   1.3%
8
   8.6%
3
   3.3%
25
   5.0%
Not Hispanic or Latino
138
  87.9%
148
  94.3%
79
  84.9%
80
  87.9%
445
  89.4%
Unknown or Not Reported
7
   4.5%
7
   4.5%
6
   6.5%
8
   8.8%
28
   5.6%
[1]
Measure Analysis Population Description: The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 157 participants 157 participants 93 participants 91 participants 498 participants
White
150
  95.5%
150
  95.5%
84
  90.3%
81
  89.0%
465
  93.4%
Other
1
   0.6%
2
   1.3%
1
   1.1%
2
   2.2%
6
   1.2%
Multiple
0
   0.0%
0
   0.0%
1
   1.1%
0
   0.0%
1
   0.2%
Unknown
6
   3.8%
5
   3.2%
7
   7.5%
8
   8.8%
26
   5.2%
[1]
Measure Analysis Population Description: The intent-to-treat (ITT) population included all participants enrolled in the study, whether or not they had received study medication.
1.Primary Outcome
Title Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT)
Hide Description DFS was defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause.
Time Frame From randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants enrolled in the study, whether or not they had received study medication.
Arm/Group Title Cohort 1 Vemurafenib Cohort 1 Placebo Cohort 2 Vemurafenib Cohort 2 Placebo
Hide Arm/Group Description:
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Overall Number of Participants Analyzed 157 157 93 91
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
36.9 [1] 
(21.4 to NA)
23.1
(18.6 to 26.5)
15.4
(11.1 to 35.9)
[1]
Not estimable due to low number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1 Vemurafenib, Cohort 1 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.37 to 0.78
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2 Vemurafenib, Cohort 2 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2598
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.54 to 1.18
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT
Hide Description DMFS was defined as the time from randomization until the date of diagnosis of distant (i.e. non-locoregional) metastases or death from any cause.
Time Frame From randomization until the date of diagnosis of distant (i.e., non-locoregional) metastases or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants enrolled in the study, whether or not they had received study medication.
Arm/Group Title Cohort 1 Vemurafenib Cohort 1 Placebo Cohort 2 Vemurafenib Cohort 2 Placebo
Hide Arm/Group Description:
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Overall Number of Participants Analyzed 157 157 93 91
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(36.9 to NA)
37.2 [1] 
(22.1 to NA)
30.7 [1] 
(24.5 to NA)
[1]
Not estimable due to low number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1 Vemurafenib, Cohort 1 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0133
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.37 to 0.90
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2 Vemurafenib, Cohort 2 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6815
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.57 to 1.44
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time from randomization until the date of death from any cause.
Time Frame From randomization until the date of death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants enrolled in the study, whether or not they had received study medication.
Arm/Group Title Cohort 1 Vemurafenib Cohort 1 Placebo Cohort 2 Vemurafenib Cohort 2 Placebo
Hide Arm/Group Description:
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Overall Number of Participants Analyzed 157 157 93 91
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(45.6 to NA)
NA [1] 
(NA to NA)
NA [1] 
(41.1 to NA)
[1]
Not estimable due to low number of events.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort 1 Vemurafenib, Cohort 1 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0969
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.32 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cohort 2 Vemurafenib, Cohort 2 Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8633
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.50 to 1.79
Estimation Comments [Not Specified]
4.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 From randomization up to the April 17, 2017 data cut-off, approximately 4.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who received at least one dose of study medication.
Arm/Group Title Cohort 1 Vemurafenib Cohort 1 Placebo Cohort 2 Vemurafenib Cohort 2 Placebo
Hide Arm/Group Description:
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Overall Number of Participants Analyzed 154 156 93 91
Measure Type: Number
Unit of Measure: percentage of participants
99.4 88.5 100.0 89.0
5.Secondary Outcome
Title Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score
Hide Description European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire assesses 8 symptoms, function, financial difficulties, and a global health status/health-related quality of life (HRQoL). Most questions use a 4-point scale (1 'Not at all' to 4 'Very much';2 questions use a 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. Higher scores for the function and HRQoL represent higher levels of functioning and HRQoL, higher scores for the symptom represent higher levels of symptoms/problems, higher score for financial difficulty represent higher level of perceived financial burden of treatment. Changes of 5-10 points are considered to represent a minimally important difference to participants. A positive value means an increase, and negative value means a decrease in score at the indicated time-point relative to the score at baseline (Cycle 1 Day 1).
Time Frame Day 1, Day 8, Day 15, Day 22 of Cycle 1;Day 1, Day 15 of Cycle 2;Day 1 Cycles 3-13;end of treatment(up to 13 months);every 13 weeks thereafter until recurrence or occurrence of a new primary melanoma (up to 17-Apr-17 data cut-off,approximately 4.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The patient-reported outcome (PRO)-evaluable population included all participants who received at least one dose of vemurafenib and who had both a baseline assessment and at least one post-baseline QLQ-C30 assessment that generated a score.
Arm/Group Title Cohort 1 Vemurafenib Cohort 1 Placebo Cohort 2 Vemurafenib Cohort 2 Placebo
Hide Arm/Group Description:
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Overall Number of Participants Analyzed 138 147 87 89
Mean (Standard Deviation)
Unit of Measure: score on a scale
Appetite Loss: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 86 participants 89 participants
3.6  (11.2) 3.9  (14.9) 3.5  (10.3) 3.4  (11.3)
Appetite Loss: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
2.8  (9.4) 1.5  (7.1) 10.4  (16.0) 0.0  (11.1)
Appetite Loss: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 79 participants 84 participants
16.7  (26.5) 1.4  (12.0) 12.2  (22.8) 1.2  (17.5)
Appetite Loss: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
7.6  (14.3) 3.2  (10.0) 11.1  (20.6) 3.9  (20.0)
Appetite Loss: Change at Cycle 2 Day 1 Number Analyzed 126 participants 142 participants 82 participants 84 participants
9.5  (21.0) 1.2  (10.1) 12.2  (23.7) 1.6  (15.4)
Appetite Loss: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 79 participants 81 participants
9.5  (22.2) 1.0  (12.2) 6.8  (16.3) 0.8  (14.9)
Appetite Loss: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 80 participants 77 participants
10.4  (20.7) 1.6  (10.1) 8.3  (18.0) 0.4  (14.8)
Appetite Loss: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
9.5  (20.9) 1.3  (12.1) 10.3  (20.3) 2.6  (15.2)
Appetite Loss: Change at Cycle 5 Day 1 Number Analyzed 110 participants 117 participants 72 participants 64 participants
13.3  (23.5) 1.4  (12.7) 7.4  (15.0) -0.5  (12.6)
Appetite Loss: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
9.7  (21.1) 2.4  (12.4) 13.0  (21.6) 1.1  (17.9)
Appetite Loss: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
10.7  (22.8) 1.5  (14.0) 7.4  (16.1) 4.0  (18.7)
Appetite Loss: Change at Cycle 8 Day 1 Number Analyzed 105 participants 105 participants 65 participants 53 participants
10.2  (22.7) 1.9  (13.7) 10.8  (18.7) -0.6  (12.2)
Appetite Loss: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
9.7  (25.2) 2.3  (13.5) 7.9  (17.7) 3.8  (15.7)
Appetite Loss: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
7.3  (18.9) 1.7  (15.5) 4.8  (15.7) 0.0  (12.0)
Appetite Loss: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
5.4  (19.2) 1.8  (14.2) 4.7  (13.3) 0.7  (12.8)
Appetite Loss: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 48 participants
8.5  (20.9) 1.5  (14.0) 7.3  (15.3) 0.0  (11.9)
Appetite Loss: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
5.7  (17.2) 1.9  (13.6) 6.2  (14.6) 0.7  (11.2)
Appetite Loss: Change at End of Treatment Number Analyzed 123 participants 125 participants 66 participants 75 participants
2.7  (16.3) 0.8  (20.1) 5.1  (18.7) 2.7  (18.8)
Appetite Loss: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 55 participants 38 participants
0.0  (13.2) 1.8  (16.5) -1.2  (6.3) 1.8  (10.8)
Appetite Loss: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
0.7  (16.6) -1.4  (15.3) 3.5  (17.4) 1.0  (12.7)
Appetite Loss: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 42 participants 33 participants
-0.4  (12.5) -0.5  (7.0) -0.8  (9.0) 2.0  (14.3)
Appetite Loss: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 26 participants 25 participants
0.4  (17.6) 0.0  (12.1) -1.3  (6.5) 2.7  (9.2)
Appetite Loss: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
-1.9  (12.1) 0.9  (14.5) 0.0  (0.0) 5.6  (17.1)
Appetite Loss: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
-0.7  (11.1) 2.0  (14.3) 0.0  (0.0) 3.7  (11.1)
Appetite Loss: Change at PT 91 Weeks Number Analyzed 32 participants 29 participants 15 participants 12 participants
2.1  (16.8) 2.3  (12.4) 0.0  (0.0) 2.8  (9.6)
Appetite Loss: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
-1.2  (11.3) -1.3  (6.7) 0.0  (0.0) -3.7  (11.1)
Appetite Loss: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 9 participants 5 participants
-1.5  (12.5) 2.0  (14.3) 0.0  (0.0) 0.0  (0.0)
Appetite Loss: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
0.0  (0.0) 2.8  (17.2) 0.0  (0.0) 0.0  (0.0)
Appetite Loss: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
-4.8  (12.6) 0.0  (0.0) 0.0  (0.0) 0.0  (0.0)
Appetite Loss: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
0.0  (0.0) 0.0 [1]   (NA) 16.7  (23.6)
Appetite Loss: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
0.0  (0.0) 0.0 [1]   (NA)
Appetite Loss: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
0.0  (0.0)
Appetite Loss: Change at PT/Discontinuation Number Analyzed 8 participants 1 participants 6 participants 1 participants
0.0  (0.0) 0.0 [1]   (NA) 0.0  (0.0) 0.0 [1]   (NA)
Cognitive Functioning: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
93.0  (14.1) 92.0  (16.2) 91.4  (17.2) 94.9  (11.6)
Cognitive Functioning: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
-2.1  (12.3) 1.5  (14.5) 0.0  (10.5) 2.6  (6.2)
Cognitive Functioning: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 78 participants 84 participants
-4.3  (13.1) 0.8  (12.6) -3.8  (13.4) -0.8  (11.5)
Cognitive Functioning: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
-0.8  (17.4) 1.6  (11.7) -3.3  (9.3) -4.9  (14.1)
Cognitive Functioning: Change at Cycle 2 Day 1 Number Analyzed 127 participants 142 participants 82 participants 84 participants
-2.4  (14.2) -2.5  (14.3) -2.2  (12.2) 0.0  (13.9)
Cognitive Functioning: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 80 participants 80 participants
-3.8  (15.1) -1.1  (14.6) -3.1  (11.9) -0.4  (15.2)
Cognitive Functioning: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
-3.6  (13.4) -0.6  (12.0) -2.5  (12.4) -2.1  (13.3)
Cognitive Functioning: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
-3.8  (14.6) -1.3  (15.1) -4.9  (13.5) -2.9  (13.7)
Cognitive Functioning: Change at Cycle 5 Day 1 Number Analyzed 110 participants 116 participants 72 participants 64 participants
-6.2  (17.3) -2.0  (14.9) -3.9  (12.7) -3.6  (15.3)
Cognitive Functioning: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
-5.7  (15.8) -2.1  (12.5) -4.1  (16.0) -3.4  (18.2)
Cognitive Functioning: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
-6.3  (17.3) -3.1  (13.3) -3.9  (15.5) -5.6  (15.0)
Cognitive Functioning: Change at Cycle 8 Day 1 Number Analyzed 104 participants 106 participants 65 participants 53 participants
-7.4  (16.1) -3.6  (16.9) -5.1  (16.6) -4.7  (13.2)
Cognitive Functioning: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
-8.2  (18.1) -4.6  (17.3) -5.8  (17.7) -5.4  (12.2)
Cognitive Functioning: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
-9.0  (20.1) -3.6  (17.4) -4.5  (17.5) -8.2  (19.3)
Cognitive Functioning: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
-10.6  (20.1) -2.9  (15.9) -5.0  (15.1) -3.8  (12.5)
Cognitive Functioning: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 48 participants
-8.7  (21.5) -4.0  (14.6) -3.9  (13.6) -4.5  (14.5)
Cognitive Functioning: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
-7.7  (20.7) -3.9  (16.1) -6.5  (15.7) -5.2  (12.7)
Cognitive Functioning: Change at End of Treatment Number Analyzed 123 participants 125 participants 67 participants 75 participants
-4.9  (17.3) -3.5  (19.5) -4.0  (17.2) -6.9  (14.3)
Cognitive Functioning: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
-4.4  (14.9) -1.6  (14.1) -1.5  (14.0) -3.5  (14.1)
Cognitive Functioning: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
-2.8  (16.2) -2.5  (14.2) -2.1  (15.4) -3.8  (13.5)
Cognitive Functioning: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 41 participants 33 participants
-2.1  (13.2) -1.0  (14.6) -2.0  (11.9) -3.0  (11.4)
Cognitive Functioning: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 27 participants 25 participants
-3.5  (17.3) -1.9  (9.1) 1.2  (13.0) -7.3  (12.8)
Cognitive Functioning: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
-4.4  (17.3) -3.9  (15.2) -1.0  (12.5) -4.6  (11.2)
Cognitive Functioning: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
-2.5  (17.2) -3.5  (19.4) -1.1  (14.7) -7.4  (12.1)
Cognitive Functioning: Change at PT 91 Weeks Number Analyzed 33 participants 29 participants 15 participants 12 participants
-2.5  (16.2) -2.3  (15.9) 3.3  (11.3) -5.6  (13.0)
Cognitive Functioning: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
1.2  (14.6) -4.0  (16.9) 3.3  (13.1) -5.6  (11.8)
Cognitive Functioning: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 8 participants 5 participants
1.5  (12.5) 0.0  (10.2) -2.1  (5.9) -6.7  (14.9)
Cognitive Functioning: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
-3.9  (15.1) -1.4  (15.0) 0.0  (0.0) -6.7  (14.9)
Cognitive Functioning: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
4.8  (18.5) 0.0  (0.0) 0.0  (0.0) -8.3  (11.8)
Cognitive Functioning: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
11.1  (19.2) 0.0 [1]   (NA) -16.7  (23.6)
Cognitive Functioning: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
16.7  (23.6) 0.0 [1]   (NA)
Cognitive Functioning: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
11.1  (19.2)
Cognitive Functioning: Change at PT/Discontin. Number Analyzed 8 participants 1 participants 6 participants 1 participants
-2.1  (16.5) 0.0 [1]   (NA) -5.6  (8.6) 0.0 [1]   (NA)
Constipation: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 146 participants 87 participants 88 participants
3.1  (10.6) 5.7  (16.3) 4.6  (12.6) 5.7  (15.3)
Constipation: Change at Cycle 1 Day 8 Number Analyzed 23 participants 22 participants 16 participants 19 participants
-2.9  (13.9) 0.0  (0.0) -2.1  (8.3) -5.3  (12.5)
Constipation: Change at Cycle 1 Day 15 Number Analyzed 130 participants 138 participants 80 participants 83 participants
2.1  (17.0) 0.7  (13.0) 1.7  (13.9) -0.4  (16.9)
Constipation: Change at Cycle 1 Day 22 Number Analyzed 21 participants 21 participants 15 participants 17 participants
-1.6  (19.7) 1.6  (7.3) 0.0  (12.6) -3.9  (16.2)
Constipation: Change at Cycle 2 Day 1 Number Analyzed 124 participants 141 participants 82 participants 83 participants
1.1  (12.7) 1.4  (10.4) 1.6  (13.8) -0.4  (16.9)
Constipation: Change at Cycle 2 Day 15 Number Analyzed 117 participants 133 participants 79 participants 79 participants
1.4  (14.8) 0.0  (13.0) 0.0  (11.9) -1.3  (15.5)
Constipation: Change at Cycle 3 Day 1 Number Analyzed 115 participants 127 participants 79 participants 77 participants
-1.2  (12.4) 1.0  (13.9) 0.4  (12.5) -1.7  (18.7)
Constipation: Change at Cycle 4 Day 1 Number Analyzed 118 participants 127 participants 78 participants 75 participants
0.6  (11.5) 0.5  (16.8) 0.0  (10.7) -2.2  (14.8)
Constipation: Change at Cycle 5 Day 1 Number Analyzed 107 participants 116 participants 71 participants 64 participants
-0.6  (9.1) 0.3  (16.7) 3.8  (14.4) -3.1  (17.5)
Constipation: Change at Cycle 6 Day 1 Number Analyzed 104 participants 112 participants 68 participants 63 participants
0.6  (13.1) 1.8  (16.6) 5.4  (16.9) -3.7  (20.0)
Constipation: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 67 participants 59 participants
3.1  (18.1) 1.5  (19.0) 3.0  (12.6) -4.0  (15.3)
Constipation: Change at Cycle 8 Day 1 Number Analyzed 103 participants 106 participants 64 participants 53 participants
1.9  (14.6) 1.6  (16.2) 4.2  (15.1) -1.9  (17.8)
Constipation: Change at Cycle 9 Day 1 Number Analyzed 97 participants 101 participants 62 participants 52 participants
1.4  (11.7) -2.3  (13.5) 3.2  (14.4) -0.6  (20.3)
Constipation: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 62 participants 47 participants
1.4  (10.7) -1.4  (12.7) 1.6  (11.2) -4.3  (17.9)
Constipation: Change at Cycle 11 Day 1 Number Analyzed 92 participants 93 participants 56 participants 48 participants
2.2  (14.7) 0.0  (16.3) 2.4  (14.0) -4.9  (15.4)
Constipation: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 54 participants 48 participants
4.8  (19.1) -1.8  (14.4) 3.1  (13.4) -3.5  (14.2)
Constipation: Change at Cycle 13 Day 1 Number Analyzed 81 participants 89 participants 54 participants 45 participants
4.1  (18.5) 0.0  (18.8) 0.0  (11.2) -3.7  (19.1)
Constipation: Change at End of Treatment Number Analyzed 122 participants 124 participants 67 participants 74 participants
3.3  (15.1) 2.4  (19.1) 4.5  (17.3) -1.4  (17.8)
Constipation: Change at PT 13 Weeks Number Analyzed 88 participants 74 participants 56 participants 38 participants
0.4  (17.1) -0.5  (17.0) 6.0  (16.9) 0.9  (21.2)
Constipation: Change at PT 26 Weeks Number Analyzed 89 participants 71 participants 47 participants 35 participants
-0.4  (13.8) -0.9  (13.8) 2.8  (9.4) -1.0  (18.9)
Constipation: Change at PT 39 Weeks Number Analyzed 77 participants 67 participants 41 participants 33 participants
0.4  (14.8) -0.5  (13.6) 2.4  (13.7) -4.0  (16.2)
Constipation: Change at PT 52 Weeks Number Analyzed 75 participants 62 participants 27 participants 25 participants
0.0  (13.4) 0.0  (14.8) 0.0  (9.2) 0.0  (13.6)
Constipation: Change at PT 65 Weeks Number Analyzed 53 participants 37 participants 17 participants 18 participants
3.8  (14.1) 3.6  (21.9) 2.0  (14.3) 0.0  (11.4)
Constipation: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
-1.4  (9.8) 6.1  (25.6) 0.0  (0.0) 0.0  (0.0)
Constipation: Change at PT 91 Weeks Number Analyzed 31 participants 28 participants 15 participants 12 participants
-4.3  (11.4) 6.0  (18.3) 2.2  (8.6) 0.0  (14.2)
Constipation: Change at PT 104 Weeks Number Analyzed 26 participants 25 participants 10 participants 9 participants
1.3  (14.8) 4.0  (14.7) -3.3  (10.5) 0.0  (16.7)
Constipation: Change at PT 117 Weeks Number Analyzed 20 participants 17 participants 9 participants 5 participants
-6.7  (13.7) 9.8  (19.6) 0.0  (0.0) -6.7  (14.9)
Constipation: Change at PT 130 Weeks Number Analyzed 16 participants 12 participants 5 participants 5 participants
-8.3  (14.9) 5.6  (13.0) 0.0  (23.6) -6.7  (14.9)
Constipation: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
-9.5  (16.3) 0.0  (0.0) 0.0  (0.0) 0.0  (0.0)
Constipation: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
0.0  (0.0) 0.0 [1]   (NA) -16.7  (23.6)
Constipation: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
0.0  (0.0) 0.0 [1]   (NA)
Constipation: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
-11.1  (19.2)
Constipation: Change at PT/Discontinuation Number Analyzed 8 participants 1 participants 6 participants 1 participants
0.0  (0.0) 0.0 [1]   (NA) 0.0  (0.0) 0.0 [1]   (NA)
Diarrhoea: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
4.1  (13.0) 5.4  (17.5) 3.8  (13.9) 4.1  (16.5)
Diarrhoea: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
4.2  (11.3) 0.0  (10.3) -4.2  (20.6) -8.8  (24.4)
Diarrhoea: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 77 participants 84 participants
2.5  (21.3) -0.7  (14.7) 1.7  (19.4) -1.6  (17.1)
Diarrhoea: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
3.0  (9.8) -1.6  (16.6) -2.2  (23.5) -9.8  (25.7)
Diarrhoea: Change at Cycle 2 Day 1 Number Analyzed 127 participants 142 participants 82 participants 84 participants
1.3  (19.9) -0.9  (16.3) 4.9  (21.7) 0.0  (20.0)
Diarrhoea: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 80 participants 80 participants
1.7  (21.2) -1.5  (19.1) 0.4  (17.2) 0.0  (16.8)
Diarrhoea: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
3.4  (21.9) -0.3  (18.4) 3.3  (19.4) -0.9  (15.2)
Diarrhoea: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
3.9  (23.0) 0.3  (19.8) 5.6  (18.2) -2.6  (18.7)
Diarrhoea: Change at Cycle 5 Day 1 Number Analyzed 110 participants 116 participants 72 participants 64 participants
7.6  (23.7) -1.4  (20.3) 2.8  (20.0) -3.6  (18.9)
Diarrhoea: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
7.2  (25.2) -0.6  (20.0) 7.2  (24.8) -2.6  (19.2)
Diarrhoea: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
9.4  (24.2) -1.5  (21.6) 4.9  (22.5) -4.5  (18.0)
Diarrhoea: Change at Cycle 8 Day 1 Number Analyzed 104 participants 106 participants 65 participants 52 participants
5.1  (19.6) -0.9  (21.3) 5.6  (20.9) -3.2  (16.5)
Diarrhoea: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 62 participants 52 participants
7.7  (25.0) 0.7  (24.5) 4.3  (19.5) -1.9  (23.3)
Diarrhoea: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 62 participants 47 participants
6.9  (21.6) -0.3  (22.3) 5.9  (23.8) -2.1  (18.9)
Diarrhoea: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
6.1  (19.6) 1.1  (23.3) 4.7  (23.1) -0.7  (20.0)
Diarrhoea: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 47 participants
7.4  (25.4) -0.7  (23.3) 7.9  (24.8) -0.7  (19.0)
Diarrhoea: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
8.5  (24.5) 0.4  (25.4) 8.0  (28.9) -1.5  (20.0)
Diarrhoea: Change at End of Treatment Number Analyzed 123 participants 125 participants 67 participants 75 participants
0.8  (21.5) 0.0  (20.7) -1.0  (16.4) -1.8  (18.9)
Diarrhoea: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
-0.4  (15.4) -1.8  (24.0) 0.0  (18.0) 0.0  (15.5)
Diarrhoea: Change at PT 26 Weeks Number Analyzed 89 participants 72 participants 47 participants 35 participants
-2.2  (16.5) -3.2  (24.5) 0.7  (8.5) -1.9  (19.7)
Diarrhoea: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 41 participants 33 participants
-1.7  (15.9) -4.9  (23.2) 1.6  (14.8) 0.0  (18.6)
Diarrhoea: Change at PT 52 Weeks Number Analyzed 75 participants 62 participants 27 participants 25 participants
-1.8  (17.2) -3.8  (23.5) -1.2  (21.6) 0.0  (19.2)
Diarrhoea: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
0.0  (19.6) -6.1  (29.9) 2.0  (8.1) -7.4  (24.4)
Diarrhoea: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
-0.7  (20.5) -7.1  (29.8) 0.0  (0.0) -3.7  (11.1)
Diarrhoea: Change at PT 91 Weeks Number Analyzed 33 participants 29 participants 15 participants 12 participants
4.0  (16.2) -9.2  (25.0) 0.0  (0.0) -8.3  (28.9)
Diarrhoea: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
0.0  (9.2) -5.3  (28.3) 3.3  (10.5) -11.1  (33.3)
Diarrhoea: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 8 participants 5 participants
0.0  (10.3) -11.8  (31.0) 0.0  (0.0) 0.0  (0.0)
Diarrhoea: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
-2.0  (8.1) -2.8  (43.7) 6.7  (14.9) 13.3  (18.3)
Diarrhoea: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
0.0  (0.0) 0.0  (0.0) 0.0  (0.0) 0.0  (0.0)
Diarrhoea: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
0.0  (0.0) 0.0 [1]   (NA) 0.0  (0.0)
Diarrhoea: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
0.0  (0.0) 0.0 [1]   (NA)
Diarrhoea: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
0.0  (0.0)
Diarrhoea: Change at PT/Discontinuation Number Analyzed 8 participants 1 participants 6 participants 1 participants
0.0  (17.8) -33.3 [1]   (NA) 0.0  (0.0) 0.0 [1]   (NA)
Dyspnoea: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
3.6  (10.4) 4.8  (12.9) 5.0  (12.0) 3.0  (10.8)
Dyspnoea: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
4.2  (11.3) -1.5  (7.1) 4.2  (16.7) -1.8  (7.6)
Dyspnoea: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 80 participants 84 participants
6.3  (18.9) 0.2  (8.5) 2.9  (15.2) 1.2  (12.1)
Dyspnoea: Change at Cycle 1 Day 22 Number Analyzed 21 participants 21 participants 15 participants 17 participants
4.8  (12.0) -1.6  (7.3) 0.0  (17.8) 0.0  (0.0)
Dyspnoea: Change at Cycle 2 Day 1 Number Analyzed 126 participants 142 participants 83 participants 84 participants
1.9  (13.5) 0.2  (11.6) 4.8  (20.9) 3.2  (14.3)
Dyspnoea: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 80 participants 81 participants
2.8  (16.0) 1.0  (13.5) 4.6  (18.9) 4.1  (17.0)
Dyspnoea: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
3.4  (17.0) 1.8  (13.4) 3.7  (18.3) 3.8  (12.0)
Dyspnoea: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
3.1  (15.6) 3.1  (14.7) 3.0  (18.8) 1.8  (14.3)
Dyspnoea: Change at Cycle 5 Day 1 Number Analyzed 110 participants 116 participants 72 participants 64 participants
5.2  (14.4) 4.0  (14.7) 3.7  (19.0) 3.1  (15.4)
Dyspnoea: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
3.8  (16.8) 2.4  (13.9) 3.9  (19.4) 2.1  (15.7)
Dyspnoea: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
5.3  (16.7) 3.7  (17.3) 3.9  (17.8) 2.8  (12.8)
Dyspnoea: Change at Cycle 8 Day 1 Number Analyzed 104 participants 106 participants 65 participants 53 participants
4.2  (16.5) 4.1  (17.6) 2.6  (14.8) 3.1  (13.5)
Dyspnoea: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
5.7  (17.1) 5.3  (16.8) 2.1  (16.8) 4.5  (18.7)
Dyspnoea: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
5.2  (20.1) 4.5  (16.4) 6.3  (18.8) 3.5  (12.5)
Dyspnoea: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
5.7  (19.4) 5.0  (19.0) 7.0  (20.6) 3.5  (14.2)
Dyspnoea: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 48 participants
6.7  (24.1) 5.5  (18.1) 3.6  (18.9) 5.6  (15.9)
Dyspnoea: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
6.5  (19.2) 4.9  (15.5) 4.9  (19.9) 5.9  (14.7)
Dyspnoea: Change at End of Treatment Number Analyzed 123 participants 125 participants 67 participants 75 participants
4.1  (14.5) 2.4  (19.9) 3.0  (18.1) 6.2  (16.2)
Dyspnoea: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 55 participants 38 participants
3.0  (17.1) 3.2  (16.7) 3.0  (16.1) 2.6  (12.0)
Dyspnoea: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
4.8  (16.2) 1.4  (16.3) 3.5  (19.9) -1.0  (5.6)
Dyspnoea: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 42 participants 33 participants
1.7  (14.0) 2.5  (13.3) 4.8  (18.9) 3.0  (12.8)
Dyspnoea: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 27 participants 25 participants
1.8  (15.3) 3.8  (16.1) 2.5  (15.8) 5.3  (15.8)
Dyspnoea: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
3.8  (14.1) 6.1  (15.2) -3.9  (11.1) 1.9  (7.9)
Dyspnoea: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
4.3  (13.3) 7.1  (18.2) 0.0  (21.8) 0.0  (16.7)
Dyspnoea: Change at PT 91 Weeks Number Analyzed 33 participants 29 participants 15 participants 12 participants
3.0  (9.7) 5.7  (12.8) -2.2  (15.3) 0.0  (14.2)
Dyspnoea: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 8 participants
0.0  (16.0) 6.7  (16.7) 0.0  (22.2) 8.3  (15.4)
Dyspnoea: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 9 participants 5 participants
0.0  (14.5) 5.9  (13.1) -3.7  (20.0) 6.7  (14.9)
Dyspnoea: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
-2.0  (8.1) 0.0  (0.0) 0.0  (23.6) 13.3  (18.3)
Dyspnoea: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
9.5  (25.2) 0.0  (0.0) -11.1  (19.2) 0.0  (0.0)
Dyspnoea: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
0.0  (0.0) 0.0 [1]   (NA) 16.7  (23.6)
Dyspnoea: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
0.0  (0.0) 0.0 [1]   (NA)
Dyspnoea: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
0.0  (0.0)
Dyspnoea: Change at PT/Discontinuation Number Analyzed 8 participants 1 participants 6 participants 1 participants
0.0  (0.0) 0.0 [1]   (NA) 0.0  (0.0) 0.0 [2]   (NA)
Emotional functioning: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
83.8  (15.1) 86.1  (16.4) 81.6  (21.5) 84.5  (17.4)
Emotional functioning: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
-4.5  (15.5) 1.9  (12.0) 3.6  (11.4) 1.8  (14.0)
Emotional functioning: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 78 participants 84 participants
-5.2  (18.0) 1.9  (12.3) -1.0  (16.6) 3.8  (12.0)
Emotional functioning: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
-6.4  (20.6) 2.4  (9.9) -0.6  (12.8) -0.5  (17.3)
Emotional functioning: Change at Cycle 2 Day 1 Number Analyzed 127 participants 142 participants 82 participants 84 participants
-1.2  (16.0) 2.5  (13.2) -1.0  (17.5) 4.0  (12.7)
Emotional functioning: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 80 participants 80 participants
0.2  (18.7) 2.0  (15.4) -0.5  (11.7) 3.8  (13.6)
Emotional functioning: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
-0.1  (17.3) 2.3  (13.2) -0.8  (16.8) 3.5  (13.9)
Emotional functioning: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
-2.7  (18.9) 1.8  (15.1) -1.2  (15.9) 2.4  (14.9)
Emotional functioning: Change at Cycle 5 Day 1 Number Analyzed 110 participants 116 participants 72 participants 64 participants
-3.5  (19.8) -0.2  (18.4) -0.8  (15.4) 3.0  (14.4)
Emotional functioning: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
-2.8  (17.5) -0.7  (16.7) -2.6  (16.0) 1.4  (18.7)
Emotional functioning: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
-3.0  (18.5) 0.5  (16.4) -2.3  (16.1) -0.5  (14.4)
Emotional functioning: Change at Cycle 8 Day 1 Number Analyzed 104 participants 106 participants 65 participants 53 participants
-3.5  (20.0) -0.9  (15.5) -1.9  (15.9) 0.2  (13.1)
Emotional functioning: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
-1.6  (22.1) -0.9  (17.0) 0.1  (15.8) -0.2  (16.1)
Emotional functioning: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
-1.0  (20.5) -1.1  (14.3) -0.1  (16.5) 0.0  (14.6)
Emotional functioning: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
0.0  (19.6) 0.5  (14.1) 1.2  (15.7) 0.7  (14.3)
Emotional functioning: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 48 participants
-2.3  (20.0) -2.2  (16.4) 1.1  (14.6) -1.6  (14.1)
Emotional functioning: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
-2.0  (20.4) -2.5  (18.6) 0.2  (16.5) 0.2  (13.5)
Emotional functioning: Change at End of Treatment Number Analyzed 123 participants 125 participants 67 participants 75 participants
1.5  (18.8) -2.0  (19.6) 2.2  (22.2) -4.4  (19.9)
Emotional functioning: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
3.2  (17.4) -1.0  (19.5) 6.4  (16.7) 3.5  (13.8)
Emotional functioning: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
4.9  (18.3) -1.4  (14.1) 3.0  (18.2) 1.2  (16.2)
Emotional functioning: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 41 participants 33 participants
2.5  (15.5) -0.2  (14.9) 4.1  (19.0) 2.3  (12.9)
Emotional functioning: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 27 participants 25 participants
2.4  (17.8) -0.7  (16.3) 9.0  (16.8) 1.7  (14.2)
Emotional functioning: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
1.1  (17.9) -2.0  (17.5) 10.3  (17.1) 3.7  (16.0)
Emotional functioning: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
2.9  (14.6) -1.8  (22.1) 8.9  (16.2) 1.9  (10.8)
Emotional functioning: Change at PT 91 Weeks Number Analyzed 33 participants 29 participants 15 participants 12 participants
1.8  (16.8) 0.0  (17.3) 13.3  (16.6) -0.7  (20.6)
Emotional functioning: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
6.5  (14.3) -7.0  (21.9) 4.2  (13.2) 1.9  (20.7)
Emotional functioning: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 8 participants 5 participants
7.2  (12.7) -2.9  (14.7) 0.0  (16.7) 3.3  (29.8)
Emotional functioning: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
8.7  (12.8) -4.9  (15.3) 3.3  (20.1) 1.7  (32.5)
Emotional functioning: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
0.0  (18.0) -4.2  (5.9) 0.0  (25.0) -16.7  (23.6)
Emotional functioning: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
22.2  (9.6) 0.0 [2]   (NA) 4.2  (53.0)
Emotional functioning: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
25.0  (11.8) 0.0 [1]   (NA)
Emotional functioning: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
16.7  (16.7)
Emotional functioning: Change at PT/Discont. Number Analyzed 8 participants 1 participants 6 participants 1 participants
-5.2  (28.1) 0.0 [1]   (NA) 1.4  (11.1) 8.3 [1]   (NA)
Fatigue: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
13.2  (14.7) 16.1  (19.4) 15.5  (18.2) 14.7  (18.6)
Fatigue: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
7.9  (19.0) -0.3  (9.8) 7.6  (13.3) 5.3  (10.1)
Fatigue: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 80 participants 84 participants
22.6  (26.1) 2.3  (14.2) 18.2  (27.0) 3.4  (13.1)
Fatigue: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
15.2  (21.3) -1.9  (14.4) 17.0  (21.4) 9.2  (15.8)
Fatigue: Change at Cycle 2 Day 1 Number Analyzed 127 participants 142 participants 83 participants 84 participants
13.2  (22.0) 2.5  (15.2) 13.7  (24.2) 2.5  (14.5)
Fatigue: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 80 participants 81 participants
15.2  (23.5) 1.5  (18.2) 10.7  (19.9) 2.1  (16.5)
Fatigue: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
14.1  (22.5) 1.5  (16.4) 12.6  (23.1) 4.7  (15.9)
Fatigue: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
12.6  (21.7) 2.0  (18.4) 13.3  (23.1) 3.2  (18.1)
Fatigue: Change at Cycle 5 Day 1 Number Analyzed 110 participants 117 participants 72 participants 64 participants
14.2  (23.7) 1.9  (16.1) 13.6  (18.9) 4.7  (17.2)
Fatigue: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
11.9  (21.6) 1.5  (17.4) 13.8  (22.2) 3.0  (18.7)
Fatigue: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
13.1  (21.0) 0.2  (18.3) 13.2  (23.2) 6.0  (17.7)
Fatigue: Change at Cycle 8 Day 1 Number Analyzed 105 participants 106 participants 65 participants 53 participants
14.1  (23.9) 3.9  (21.9) 12.7  (22.7) 5.0  (15.5)
Fatigue: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
16.3  (25.3) 2.7  (20.5) 13.7  (24.1) 6.0  (21.3)
Fatigue: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
11.3  (22.6) 3.4  (18.7) 11.3  (25.0) 3.3  (16.2)
Fatigue: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
11.5  (22.7) 2.7  (18.2) 10.7  (20.9) 7.6  (18.4)
Fatigue: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 48 participants
10.3  (23.8) 2.1  (16.2) 10.7  (22.5) 3.2  (17.0)
Fatigue: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
11.1  (23.1) 4.0  (19.0) 13.4  (26.6) 4.7  (15.6)
Fatigue: Change at End of Treatment Number Analyzed 123 participants 125 participants 67 participants 75 participants
6.5  (21.3) 2.2  (24.2) 3.3  (21.9) 6.4  (20.9)
Fatigue: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
1.6  (18.4) 0.7  (19.8) -1.2  (19.0) 1.5  (14.9)
Fatigue: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
2.5  (18.4) 1.0  (15.5) 0.5  (21.6) -1.3  (18.8)
Fatigue: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 42 participants 33 participants
-1.0  (16.9) 0.7  (17.2) -0.5  (18.2) -0.3  (12.6)
Fatigue: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 27 participants 25 participants
1.6  (16.7) 1.7  (17.6) -1.2  (14.6) 1.3  (20.6)
Fatigue: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
1.3  (16.5) 4.4  (18.5) -4.6  (11.8) -1.2  (17.8)
Fatigue: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
2.4  (16.2) 4.7  (20.8) -4.4  (10.1) -4.9  (18.5)
Fatigue: Change at PT 91 Weeks Number Analyzed 33 participants 29 participants 15 participants 12 participants
-0.8  (16.3) 3.8  (18.8) -3.7  (15.5) -2.8  (26.0)
Fatigue: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
-1.2  (14.6) 8.9  (18.7) -1.1  (17.7) -1.2  (29.1)
Fatigue: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 9 participants 5 participants
-3.0  (13.4) 4.2  (19.2) -7.4  (15.7) 0.0  (28.3)
Fatigue: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
-0.7  (15.5) 6.5  (19.2) -4.4  (16.9) 0.0  (33.3)
Fatigue: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
-1.6  (14.9) 5.6  (7.9) -3.7  (17.0) 16.7  (23.6)
Fatigue: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
-11.1  (11.1) 0.0 [1]   (NA) 33.3  (15.7)
Fatigue: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
-16.7  (7.9) 0.0 [1]   (NA)
Fatigue: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
-14.8  (6.4)
Fatigue: Change at PT/Discontinuation Number Analyzed 8 participants 1 participants 6 participants 1 participants
6.9  (16.7) -22.2 [1]   (NA) -11.1  (25.3) 0.0 [1]   (NA)
Financial difficulties: Cycle 1 Day 1 (Baseline) Number Analyzed 137 participants 147 participants 87 participants 88 participants
12.4  (25.2) 20.9  (30.0) 16.5  (30.4) 15.9  (26.3)
Financial difficulties: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
-9.7  (25.0) -3.0  (14.2) 2.1  (8.3) -7.0  (17.8)
Financial difficulties: Change at Cycle 1 Day 15 Number Analyzed 131 participants 139 participants 78 participants 84 participants
1.5  (17.5) -1.9  (20.0) 0.0  (15.2) -4.4  (21.2)
Financial difficulties: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
-1.5  (26.2) -3.2  (14.5) 0.0  (0.0) 0.0  (20.4)
Financial difficulties: Change at Cycle 2 Day 1 Number Analyzed 126 participants 141 participants 82 participants 83 participants
0.0  (17.9) -3.1  (21.0) 0.8  (16.5) -4.4  (19.3)
Financial difficulties: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 80 participants 79 participants
1.1  (20.8) -2.2  (20.1) -0.4  (17.2) -7.2  (20.4)
Financial difficulties: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 80 participants 77 participants
0.3  (21.5) -5.2  (24.1) 1.3  (20.2) -5.6  (19.8)
Financial difficulties: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 75 participants
-0.8  (23.6) -2.8  (24.3) -0.4  (19.7) -5.8  (18.5)
Financial difficulties: Change at Cycle 5 Day 1 Number Analyzed 110 participants 116 participants 72 participants 64 participants
1.2  (23.0) -5.5  (26.7) 2.3  (18.0) -7.8  (23.6)
Financial difficulties: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
-0.6  (22.5) -7.4  (26.4) 2.9  (20.4) -5.8  (22.0)
Financial difficulties: Change at Cycle 7 Day 1 Number Analyzed 106 participants 107 participants 68 participants 59 participants
1.9  (26.8) -5.6  (26.1) 4.9  (27.2) -5.6  (21.6)
Financial difficulties: Change at Cycle 8 Day 1 Number Analyzed 104 participants 106 participants 65 participants 53 participants
-0.6  (23.2) -4.7  (27.0) 4.1  (26.7) -3.1  (20.9)
Financial difficulties: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
2.0  (24.1) -8.9  (23.0) 4.2  (23.6) -5.8  (20.6)
Financial difficulties: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
1.0  (23.4) -8.6  (25.1) 2.6  (22.6) -6.4  (20.4)
Financial difficulties: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
1.4  (21.4) -7.5  (21.5) 0.6  (20.4) -8.3  (22.3)
Financial difficulties: Change at Cycle 12 Day 1 Number Analyzed 89 participants 90 participants 55 participants 48 participants
-0.4  (24.4) -6.3  (23.9) 0.0  (26.4) -6.3  (23.5)
Financial difficulties: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
1.2  (23.7) -6.0  (22.2) -1.9  (27.8) -8.1  (24.8)
Financial difficulties: Change at End of Treatment Number Analyzed 122 participants 125 participants 67 participants 75 participants
2.5  (23.1) -3.7  (26.5) -2.5  (23.4) -0.9  (23.9)
Financial difficulties: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
0.4  (26.2) -5.9  (24.3) -10.1  (27.6) -8.8  (25.3)
Financial difficulties: Change at PT 26 Weeks Number Analyzed 89 participants 72 participants 47 participants 35 participants
-3.0  (22.3) -6.0  (18.8) -5.7  (26.3) -7.6  (25.7)
Financial difficulties: Change at PT 39 Weeks Number Analyzed 78 participants 68 participants 41 participants 33 participants
-1.7  (22.1) -7.8  (25.8) -2.4  (28.3) -8.1  (26.4)
Financial difficulties: Change at PT 52 Weeks Number Analyzed 75 participants 62 participants 27 participants 25 participants
-2.2  (21.5) -5.4  (21.1) -11.1  (24.5) -1.3  (32.6)
Financial difficulties: Change at PT 65 Weeks Number Analyzed 52 participants 38 participants 17 participants 18 participants
2.6  (26.3) -6.1  (30.9) -9.8  (19.6) -7.4  (31.4)
Financial difficulties: Change at PT 78 Weeks Number Analyzed 45 participants 33 participants 15 participants 9 participants
2.2  (27.9) -8.1  (31.2) -11.1  (20.6) 0.0  (16.7)
Financial difficulties: Change at PT 91 Weeks Number Analyzed 31 participants 29 participants 15 participants 12 participants
0.0  (27.2) -10.3  (29.7) -11.1  (20.6) -11.1  (32.8)
Financial difficulties: Change at PT 104 Weeks Number Analyzed 26 participants 25 participants 10 participants 9 participants
-2.6  (18.7) -8.0  (30.9) -13.3  (23.3) -18.5  (37.7)
Financial difficulties: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 8 participants 5 participants
-6.1  (22.1) -5.9  (24.3) -4.2  (11.8) -13.3  (18.3)
Financial difficulties: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
-7.8  (27.7) -5.6  (31.2) 0.0  (0.0) -20.0  (29.8)
Financial difficulties: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
4.8  (40.5) 16.7  (23.6) 0.0  (0.0) 0.0  (0.0)
Financial difficulties: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
-22.2  (38.5) 0.0 [1]   (NA) -16.7  (23.6)
Financial difficulties: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
0.0  (0.0) 0.0 [1]   (NA)
Financial difficulties: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
-22.2  (38.5)
Financial difficulties: Change at PT/Discontin. Number Analyzed 8 participants 1 participants 6 participants 1 participants
0.0  (17.8) 0.0 [1]   (NA) 0.0  (0.0) 0.0 [1]   (NA)
Nausea and vomiting: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
1.4  (5.1) 1.8  (9.6) 1.9  (7.4) 1.3  (5.2)
Nausea and vomiting: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
4.2  (8.9) 0.8  (6.3) 5.2  (8.0) 3.5  (8.9)
Nausea and vomiting: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 80 participants 84 participants
9.8  (16.9) 1.8  (6.9) 8.8  (17.0) 1.2  (7.7)
Nausea and vomiting: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
6.1  (12.1) 0.8  (6.4) 5.6  (10.3) 2.9  (8.8)
Nausea and vomiting: Change at Cycle 2 Day 1 Number Analyzed 127 participants 142 participants 83 participants 84 participants
5.2  (12.9) 0.9  (5.9) 4.6  (11.1) 1.4  (7.9)
Nausea and vomiting: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 80 participants 81 participants
6.3  (14.1) 1.1  (8.5) 2.9  (9.1) 1.6  (10.4)
Nausea and vomiting: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
5.7  (13.1) 1.6  (7.3) 4.5  (9.9) 1.3  (8.4)
Nausea and vomiting: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
5.6  (13.6) 1.9  (11.7) 6.6  (14.3) 1.3  (10.8)
Nausea and vomiting: Change at Cycle 5 Day 1 Number Analyzed 110 participants 117 participants 72 participants 64 participants
7.3  (16.4) 2.6  (9.2) 5.1  (10.7) -0.5  (7.8)
Nausea and vomiting: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
5.3  (13.1) 2.4  (9.7) 6.3  (12.2) -0.5  (7.9)
Nausea and vomiting: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
4.7  (11.7) 2.0  (7.8) 4.2  (11.3) 0.6  (6.9)
Nausea and vomiting: Change at Cycle 8 Day 1 Number Analyzed 105 participants 106 participants 65 participants 53 participants
4.6  (11.9) 1.1  (9.0) 5.9  (15.7) 2.5  (12.4)
Nausea and vomiting: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
5.5  (15.7) 2.5  (10.4) 4.0  (10.2) 0.3  (7.0)
Nausea and vomiting: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
5.2  (13.1) 0.9  (10.3) 4.8  (10.6) 0.4  (6.5)
Nausea and vomiting: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
3.4  (10.9) 2.0  (8.5) 3.2  (8.6) -0.3  (5.4)
Nausea and vomiting: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 48 participants
4.3  (12.6) 1.3  (7.9) 4.8  (10.5) 3.5  (13.7)
Nausea and vomiting: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
2.8  (11.7) 1.7  (7.1) 3.4  (9.9) 2.2  (9.8)
Nausea and vomiting: Change at End of Treatment Number Analyzed 123 participants 125 participants 67 participants 75 participants
0.9  (6.5) 0.3  (12.5) 1.5  (11.9) 3.8  (13.9)
Nausea and vomiting: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
0.2  (6.4) 1.8  (8.5) 0.6  (6.3) 0.9  (6.7)
Nausea and vomiting: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
2.2  (8.7) 0.7  (15.7) 0.7  (10.4) -1.0  (3.9)
Nausea and vomiting: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 42 participants 33 participants
0.2  (5.7) 0.2  (6.1) 1.6  (8.1) 1.5  (6.4)
Nausea and vomiting: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 27 participants 25 participants
0.9  (6.0) 0.3  (4.8) 0.0  (4.6) 0.7  (3.3)
Nausea and vomiting: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
0.0  (5.7) 3.5  (12.9) -1.0  (4.0) 2.8  (8.6)
Nausea and vomiting: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
0.4  (5.5) 2.0  (11.6) -1.1  (4.3) 1.9  (5.6)
Nausea and vomiting: Change at PT 91 Weeks Number Analyzed 32 participants 29 participants 15 participants 12 participants
1.6  (6.5) 2.3  (8.6) -1.1  (4.3) 1.4  (4.8)
Nausea and vomiting: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
1.9  (10.7) 0.0  (4.8) 0.0  (0.0) 0.0  (0.0)
Nausea and vomiting: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 9 participants 5 participants
-1.5  (4.9) 4.9  (9.8) -1.9  (5.6) 0.0  (0.0)
Nausea and vomiting: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
0.0  (5.9) 4.2  (10.4) -3.3  (7.5) 0.0  (0.0)
Nausea and vomiting: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
-2.4  (6.3) 0.0  (0.0) 0.0  (0.0) 0.0  (0.0)
Nausea and vomiting: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
0.0  (0.0) 0.0 [1]   (NA) 8.3  (11.8)
Nausea and vomiting: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
0.0  (0.0) 0.0 [1]   (NA)
Nausea and vomiting: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
0.0  (0.0)
Nausea and vomiting: Change at PT/Discont. Number Analyzed 8 participants 1 participants 6 participants 1 participants
4.2  (11.8) 0.0 [1]   (NA) 8.3  (13.9) 0.0 [1]   (NA)
Pain: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
11.6  (17.5) 12.8  (21.6) 10.9  (19.0) 14.6  (23.9)
Pain: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
9.7  (22.5) -1.5  (15.4) 10.4  (14.8) -3.5  (8.9)
Pain: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 80 participants 84 participants
20.8  (28.5) 0.5  (12.4) 16.3  (28.1) -1.4  (14.7)
Pain: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
15.9  (28.9) -3.2  (13.6) 22.2  (18.5) 9.8  (21.3)
Pain: Change at Cycle 2 Day 1 Number Analyzed 127 participants 142 participants 83 participants 84 participants
12.9  (26.5) 0.5  (15.1) 15.1  (28.9) -3.8  (18.0)
Pain: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 80 participants 81 participants
14.3  (27.5) 2.4  (17.2) 12.7  (23.3) -3.5  (18.0)
Pain: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
11.8  (20.2) 1.2  (16.3) 13.2  (25.6) -0.6  (17.1)
Pain: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
9.0  (22.1) 4.0  (19.7) 12.0  (25.9) -2.4  (19.6)
Pain: Change at Cycle 5 Day 1 Number Analyzed 110 participants 117 participants 72 participants 64 participants
12.7  (24.3) 1.9  (17.6) 14.6  (21.1) -4.9  (20.5)
Pain: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
8.8  (22.7) 2.2  (18.9) 14.5  (22.9) -3.7  (20.0)
Pain: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
8.2  (21.4) 0.9  (16.6) 8.3  (20.5) -2.0  (19.1)
Pain: Change at Cycle 8 Day 1 Number Analyzed 105 participants 106 participants 65 participants 53 participants
11.0  (24.9) 3.6  (20.1) 12.1  (23.7) -1.6  (18.3)
Pain: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
12.8  (27.5) 3.6  (21.2) 10.3  (23.5) -0.3  (23.9)
Pain: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
8.9  (22.0) 1.9  (17.5) 11.6  (24.6) -3.2  (16.9)
Pain: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
10.0  (25.0) 2.7  (21.3) 13.5  (26.1) -0.7  (24.3)
Pain: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 48 participants
12.2  (24.6) 1.3  (19.8) 12.7  (19.5) -2.1  (20.2)
Pain: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
11.6  (23.5) 3.4  (21.2) 16.4  (27.4) -1.9  (22.0)
Pain: Change at End of Treatment Number Analyzed 123 participants 125 participants 67 participants 75 participants
4.9  (23.4) 4.1  (23.3) 6.7  (21.1) 1.6  (21.4)
Pain: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
-0.6  (17.6) -0.2  (18.2) 4.2  (19.7) -4.8  (23.5)
Pain: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
1.1  (21.8) -1.2  (16.6) 7.1  (24.0) -4.3  (19.5)
Pain: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 42 participants 33 participants
0.6  (19.9) 2.2  (22.1) 7.5  (23.0) -7.6  (23.2)
Pain: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 27 participants 25 participants
2.0  (18.0) 0.0  (16.3) 9.3  (21.8) -1.3  (20.4)
Pain: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
-0.3  (19.7) 0.9  (21.2) 6.9  (15.7) -4.6  (12.5)
Pain: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
0.7  (20.2) 2.5  (19.6) 1.1  (14.7) -5.6  (8.3)
Pain: Change at PT 91 Weeks Number Analyzed 33 participants 29 participants 15 participants 12 participants
-2.5  (18.7) 4.6  (25.9) 4.4  (14.7) -9.7  (21.9)
Pain: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
-1.2  (17.9) 11.3  (22.4) 3.3  (13.1) -13.0  (21.7)
Pain: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 9 participants 5 participants
-4.5  (18.0) 8.8  (22.9) 1.9  (13.0) -10.0  (25.3)
Pain: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
2.9  (19.8) 6.9  (31.3) 6.7  (27.9) -13.3  (32.1)
Pain: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
-2.4  (20.2) 8.3  (11.8) 5.6  (25.5) 0.0  (0.0)
Pain: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
-22.2  (19.2) 0.0 [1]   (NA) 8.3  (11.8)
Pain: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
-8.3  (11.8) 0.0 [1]   (NA)
Pain: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
-22.2  (19.2)
Pain: Change at PT/Discontin. Number Analyzed 8 participants 1 participants 6 participants 1 participants
12.5  (14.8) -33.3 [1]   (NA) -2.8  (19.5) 0.0 [1]   (NA)
Physical functioning: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
92.7  (11.0) 92.3  (11.6) 91.3  (13.6) 92.7  (13.1)
Physical functioning: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
-4.4  (8.7) 0.3  (4.4) -5.0  (6.7) -2.5  (11.6)
Physical functioning: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 80 participants 84 participants
-9.7  (17.4) -0.2  (8.2) -7.4  (15.0) -1.5  (6.5)
Physical functioning: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
-10.3  (16.6) -0.6  (7.0) -10.2  (15.3) -2.7  (9.7)
Physical functioning: Change at Cycle 2 Day 1 Number Analyzed 127 participants 142 participants 83 participants 84 participants
-6.2  (14.4) -0.3  (9.1) -9.2  (16.9) -1.8  (8.2)
Physical functioning: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 80 participants 81 participants
-7.1  (16.4) -0.7  (10.8) -7.6  (13.9) -1.4  (9.4)
Physical functioning: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
-6.6  (14.8) -0.7  (11.0) -7.3  (15.0) -2.7  (10.4)
Physical functioning: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
-4.9  (13.1) -0.2  (10.8) -7.4  (13.8) -1.0  (10.3)
Physical functioning: Change at Cycle 5 Day 1 Number Analyzed 110 participants 117 participants 72 participants 64 participants
-6.1  (14.7) -1.0  (11.3) -5.6  (13.3) -1.8  (12.7)
Physical functioning: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
-4.7  (14.5) -0.8  (12.1) -7.5  (15.2) -0.6  (10.0)
Physical functioning: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
-4.7  (13.6) 0.4  (11.2) -8.0  (12.7) 0.2  (9.5)
Physical functioning: Change at Cycle 8 Day 1 Number Analyzed 105 participants 106 participants 65 participants 53 participants
-5.2  (13.6) -0.8  (13.1) -6.7  (12.6) -0.3  (11.0)
Physical functioning: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
-6.7  (18.2) -0.5  (12.2) -5.5  (10.6) -1.5  (14.7)
Physical functioning: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
-4.9  (14.0) -1.6  (11.8) -6.5  (13.2) -1.7  (9.9)
Physical functioning: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
-4.2  (14.4) -1.3  (10.8) -6.0  (12.8) -3.3  (13.5)
Physical functioning: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 48 participants
-5.4  (15.7) -1.6  (11.5) -4.8  (11.9) -0.6  (10.8)
Physical functioning: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
-4.5  (15.0) -3.0  (14.7) -5.6  (12.4) -1.9  (12.3)
Physical functioning: Change at End of Treatment Number Analyzed 123 participants 125 participants 67 participants 75 participants
-2.8  (13.3) -2.9  (16.0) -5.8  (13.8) -5.1  (14.7)
Physical functioning: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
0.5  (11.3) 0.1  (9.8) -0.8  (10.9) -0.5  (12.6)
Physical functioning: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
-1.9  (12.5) 0.0  (8.5) -4.1  (10.5) 0.6  (12.6)
Physical functioning: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 42 participants 33 participants
0.4  (10.7) -1.7  (13.5) -3.3  (13.4) 0.6  (8.1)
Physical functioning: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 27 participants 25 participants
-1.4  (10.0) -0.5  (11.7) -1.4  (9.6) -1.1  (14.2)
Physical functioning: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
-0.9  (8.6) -2.6  (13.6) 2.7  (9.7) -0.4  (10.3)
Physical functioning: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
-0.5  (8.6) -1.0  (10.8) 2.7  (10.0) -3.7  (11.6)
Physical functioning: Change at PT 91 Weeks Number Analyzed 33 participants 29 participants 15 participants 12 participants
0.2  (7.2) -3.4  (12.9) -0.9  (10.3) 0.0  (17.5)
Physical functioning: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
2.5  (8.3) -4.9  (10.3) 1.3  (11.2) 1.5  (18.2)
Physical functioning: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 9 participants 5 participants
1.2  (8.1) -7.1  (14.2) 0.7  (13.1) 2.7  (19.2)
Physical functioning: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
-1.2  (4.2) -5.0  (11.4) -2.7  (10.1) 5.3  (20.2)
Physical functioning: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
0.0  (8.6) 0.0  (0.0) -4.4  (20.4) -3.3  (4.7)
Physical functioning: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
2.2  (3.8) 0.0 [1]   (NA) -6.7  (9.4)
Physical functioning: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
3.3  (4.7) 0.0 [1]   (NA)
Physical functioning: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
2.2  (3.8)
Physical functioning: Change at PT/Discontin. Number Analyzed 8 participants 1 participants 6 participants 1 participants
-0.8  (8.3) 0.0 [2]   (NA) 10.0  (15.6) 0.0 [1]   (NA)
Global health status/QoL: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
79.0  (16.7) 77.9  (18.4) 76.5  (20.6) 78.8  (17.6)
Global health status/QoL: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
-9.4  (20.5) 0.4  (7.5) -9.9  (15.9) 1.3  (6.4)
Global health status/QoL: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 78 participants 83 participants
-19.1  (24.2) -0.4  (11.4) -14.5  (20.4) -0.3  (11.7)
Global health status/QoL: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
-17.8  (27.0) 1.2  (10.3) -16.7  (19.9) 0.5  (11.2)
Global health status/QoL: Change at Cycle 2 Day 1 Number Analyzed 127 participants 142 participants 82 participants 84 participants
-9.8  (19.7) -1.2  (14.5) -10.9  (17.6) 1.0  (10.8)
Global health status/QoL: Change at Cycle 2 Day 15 Number Analyzed 118 participants 134 participants 80 participants 80 participants
-11.5  (21.0) 0.2  (13.5) -9.5  (18.0) -1.4  (14.4)
Global health status/QoL: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
-10.6  (19.0) -1.0  (14.6) -9.4  (17.0) -0.9  (14.6)
Global health status/QoL: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
-10.2  (19.6) -1.0  (14.9) -8.4  (18.9) -1.8  (15.4)
Global health status/QoL: Change at Cycle 5 Day 1 Number Analyzed 110 participants 116 participants 72 participants 64 participants
-12.0  (20.4) -0.1  (15.1) -8.9  (17.3) 0.4  (16.6)
Global health status/QoL: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
-8.9  (18.9) -2.2  (16.1) -12.4  (19.3) -0.5  (16.5)
Global health status/QoL: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
-10.7  (19.4) -1.6  (16.8) -11.8  (17.9) -2.3  (15.8)
Global health status/QoL: Change at Cycle 8 Day 1 Number Analyzed 104 participants 106 participants 65 participants 53 participants
-10.3  (18.3) -1.6  (17.6) -11.2  (20.5) -3.3  (17.0)
Global health status/QoL: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
-11.3  (21.9) -0.5  (16.9) -8.3  (19.7) -1.6  (16.6)
Global health status/QoL: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
-7.6  (19.1) -0.7  (15.9) -9.8  (18.7) 0.2  (15.0)
Global health status/QoL: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
-7.8  (19.5) -0.8  (15.3) -8.8  (18.9) -3.1  (18.2)
Global health status/QoL: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 48 participants
-9.3  (20.2) -0.8  (16.0) -10.5  (17.4) -3.6  (18.0)
Global health status/QoL: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
-7.5  (17.5) -3.4  (19.4) -9.4  (18.9) -3.9  (15.8)
Global health status/QoL: Change at EOT Number Analyzed 123 participants 125 participants 67 participants 75 participants
-5.2  (19.0) -3.6  (19.0) -3.0  (18.4) -7.4  (21.7)
Global health status/QoL: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
0.1  (16.0) -0.1  (15.7) -1.0  (18.1) 0.2  (20.0)
Global health status/QoL: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
-2.2  (16.2) 0.5  (14.8) 0.4  (19.5) 0.0  (19.7)
Global health status/QoL: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 41 participants 33 participants
-4.1  (21.6) -0.9  (15.2) -0.4  (16.9) -1.3  (19.9)
Global health status/QoL: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 27 participants 25 participants
-2.3  (15.6) -0.7  (15.3) 2.2  (13.2) -2.0  (23.6)
Global health status/QoL: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
-0.9  (17.7) -2.0  (15.1) 1.5  (15.1) -0.5  (17.7)
Global health status/QoL: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
-0.9  (15.6) -1.5  (15.8) 1.7  (14.8) -0.9  (13.5)
Global health status/QoL: Change at PT 91 Weeks Number Analyzed 33 participants 29 participants 15 participants 12 participants
0.3  (17.4) -2.6  (17.6) 6.1  (15.3) -2.1  (24.7)
Global health status/QoL: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
1.2  (14.9) -4.7  (19.4) -3.3  (19.3) 0.0  (29.2)
Global health status/QoL: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 8 participants 5 participants
0.4  (20.5) 2.5  (15.0) -1.0  (13.7) 6.7  (21.6)
Global health status/QoL: Change at PT 130 Weeks Number Analyzed 16 participants 12 participants 5 participants 5 participants
2.1  (7.1) -3.5  (16.8) -3.3  (12.6) 5.0  (24.0)
Global health status/QoL: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
-1.2  (18.9) -4.2  (5.9) -11.1  (9.6) -8.3  (11.8)
Global health status/QoL: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
11.1  (4.8) 0.0 [2]   (NA) 12.5  (5.9)
Global health status/QoL: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
8.3  (0.0) 0.0 [1]   (NA)
Global health status/QoL: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
19.4  (12.7)
Global health status/QoL: Change at PT/Discontin. Number Analyzed 8 participants 1 participants 6 participants 1 participants
-4.2  (19.9) 0.0 [1]   (NA) 0.0  (31.2) 0.0 [1]   (NA)
Role functioning: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
86.7  (21.9) 87.2  (22.5) 86.6  (22.0) 88.6  (23.2)
Role functioning: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
-2.8  (15.3) -0.8  (10.9) -1.0  (16.6) 4.4  (18.3)
Role functioning: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 80 participants 84 participants
-19.4  (29.1) 0.2  (16.3) -15.2  (27.6) -2.4  (19.6)
Role functioning: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
-10.6  (28.4) 1.6  (9.0) -16.7  (20.9) -1.0  (25.3)
Role functioning: Change at Cycle 2 Day 1 Number Analyzed 127 participants 142 participants 83 participants 84 participants
-13.0  (26.6) 0.2  (16.6) -13.3  (27.5) 0.4  (17.5)
Role functioning: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 80 participants 81 participants
-11.1  (25.7) -0.6  (18.4) -9.6  (21.5) -0.4  (17.5)
Role functioning: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
-9.7  (25.4) 0.4  (19.0) -8.2  (21.3) -2.1  (21.2)
Role functioning: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
-8.4  (23.8) 0.3  (21.3) -9.0  (19.7) -1.3  (19.0)
Role functioning: Change at Cycle 5 Day 1 Number Analyzed 110 participants 117 participants 72 participants 64 participants
-11.1  (26.0) 0.6  (20.5) -10.4  (22.3) 0.8  (22.7)
Role functioning: Change at Cycle 6 Day 1 Number Analyzed 106 participants 111 participants 69 participants 63 participants
-5.8  (24.2) -0.5  (18.3) -11.6  (22.9) 0.5  (20.1)
Role functioning: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
-9.9  (27.6) 0.9  (21.5) -8.8  (24.0) 0.3  (21.3)
Role functioning: Change at Cycle 8 Day 1 Number Analyzed 105 participants 105 participants 65 participants 53 participants
-9.2  (26.5) -1.9  (23.0) -9.5  (24.5) -0.3  (21.3)
Role functioning: Change at Cycle 9 Day 1 Number Analyzed 100 participants 100 participants 63 participants 52 participants
-11.2  (28.4) 0.0  (20.7) -7.9  (23.5) -1.9  (25.7)
Role functioning: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
-8.5  (25.5) -1.7  (19.3) -7.7  (23.2) 3.9  (22.3)
Role functioning: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
-6.6  (24.5) -1.3  (19.7) -10.2  (25.0) -3.5  (24.8)
Role functioning: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 48 participants
-8.7  (26.2) -0.4  (17.2) -8.2  (25.2) 0.3  (26.3)
Role functioning: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
-8.1  (24.6) -4.5  (22.2) -8.3  (25.9) -2.2  (24.3)
Role functioning: Change at End Of Treatment Number Analyzed 123 participants 125 participants 67 participants 75 participants
-4.7  (25.0) -1.3  (23.2) -4.2  (25.0) -6.0  (27.6)
Role functioning: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
2.0  (21.8) 1.8  (17.6) 1.2  (19.0) 5.3  (26.9)
Role functioning: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
0.9  (24.7) 3.0  (17.3) 0.4  (20.1) 5.2  (24.5)
Role functioning: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 42 participants 33 participants
2.7  (24.2) 0.2  (21.1) 0.4  (21.3) 7.1  (28.0)
Role functioning: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 27 participants 25 participants
2.4  (23.8) 0.8  (20.3) 0.6  (18.2) 4.0  (29.0)
Role functioning: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
5.3  (19.3) -1.3  (16.6) 3.9  (11.1) 7.4  (29.3)
Role functioning: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
-1.4  (25.5) -4.0  (20.0) 4.4  (11.7) -3.7  (13.9)
Role functioning: Change at PT 91 Weeks Number Analyzed 33 participants 29 participants 15 participants 12 participants
3.5  (27.2) -1.7  (17.4) 1.1  (14.7) 16.7  (35.5)
Role functioning: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
6.2  (22.2) -7.3  (20.5) 6.7  (14.1) 14.8  (38.6)
Role functioning: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 9 participants 5 participants
7.6  (26.6) -2.0  (10.0) 5.6  (11.8) 26.7  (41.8)
Role functioning: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
6.9  (21.3) -5.6  (14.8) 3.3  (18.3) 23.3  (43.5)
Role functioning: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
7.1  (18.9) 0.0  (0.0) 11.1  (19.2) 8.3  (11.8)
Role functioning: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
27.8  (25.5) 0.0 [1]   (NA) 16.7  (23.6)
Role functioning: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
16.7  (23.6) 0.0 [1]   (NA)
Role functioning: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
27.8  (25.5)
Role functioning: Change at PT/Discontin. Number Analyzed 8 participants 1 participants 6 participants 1 participants
-8.3  (23.6) 0.0 [1]   (NA) 11.1  (17.2) 0.0 [1]   (NA)
Social functioning: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
89.6  (16.6) 88.2  (20.8) 87.7  (21.2) 90.4  (19.9)
Social functioning: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
1.4  (18.3) 0.8  (12.0) 2.1  (14.8) 0.9  (8.7)
Social functioning: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 78 participants 84 participants
-15.0  (26.9) 0.8  (13.8) -7.5  (18.9) 0.4  (13.4)
Social functioning: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
-9.1  (28.0) 5.6  (13.3) -5.6  (17.4) -2.0  (20.3)
Social functioning: Change at Cycle 2 Day 1 Number Analyzed 127 participants 142 participants 82 participants 84 participants
-8.0  (22.9) 2.2  (16.6) -10.2  (23.8) 3.0  (13.7)
Social functioning: Change at Cycle 2 Day 15 Number Analyzed 118 participants 134 participants 80 participants 80 participants
-8.3  (21.5) 2.7  (16.9) -7.7  (18.2) 4.0  (17.0)
Social functioning: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
-8.1  (21.5) 2.3  (17.8) -7.4  (21.1) 1.5  (17.9)
Social functioning: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 76 participants
-7.1  (21.5) 1.7  (18.1) -7.5  (20.6) 1.3  (13.5)
Social functioning: Change at Cycle 5 Day 1 Number Analyzed 110 participants 116 participants 72 participants 64 participants
-9.4  (21.7) 3.3  (17.6) -9.5  (18.5) 2.6  (18.6)
Social functioning: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 69 participants 63 participants
-7.2  (22.2) 1.9  (17.6) -11.4  (22.4) 0.0  (17.2)
Social functioning: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
-8.0  (22.7) 4.5  (17.0) -9.6  (22.9) 0.0  (17.2)
Social functioning: Change at Cycle 8 Day 1 Number Analyzed 104 participants 106 participants 65 participants 53 participants
-8.3  (23.6) 2.2  (17.7) -7.9  (23.0) 0.6  (16.0)
Social functioning: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
-11.0  (26.2) 1.7  (19.7) -8.2  (22.8) -3.8  (21.5)
Social functioning: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
-8.7  (24.9) 0.0  (16.1) -8.7  (23.4) -0.7  (16.3)
Social functioning: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
-8.6  (24.4) 1.4  (15.1) -9.9  (23.1) -2.1  (21.6)
Social functioning: Change at Cycle 12 Day 1 Number Analyzed 90 participants 91 participants 55 participants 48 participants
-10.6  (24.2) -0.4  (15.7) -9.1  (22.2) 0.0  (16.5)
Social functioning: Change at Cycle 13 Day 1 Number Analyzed 82 participants 89 participants 54 participants 45 participants
-8.3  (24.2) -1.9  (21.1) -10.2  (25.2) 1.5  (17.7)
Social functioning: Change at End of Treatment Number Analyzed 123 participants 125 participants 67 participants 75 participants
-6.1  (21.8) 1.2  (25.8) -5.5  (23.3) -3.3  (21.2)
Social functioning: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
-1.7  (18.9) 2.7  (15.4) 1.2  (16.2) 1.3  (19.5)
Social functioning: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
-2.6  (20.3) 4.2  (15.0) 0.0  (13.9) 2.4  (14.1)
Social functioning: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 41 participants 33 participants
3.4  (16.5) 2.7  (15.4) 0.0  (18.3) 5.1  (17.4)
Social functioning: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 27 participants 25 participants
-0.7  (18.9) 1.6  (14.7) 2.5  (13.6) -1.3  (18.0)
Social functioning: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
2.8  (18.7) 0.9  (16.0) 4.9  (11.4) 0.9  (10.7)
Social functioning: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
0.7  (20.8) 6.1  (14.3) 4.4  (13.3) -1.9  (13.0)
Social functioning: Change at PT 91 Weeks Number Analyzed 32 participants 29 participants 15 participants 12 participants
2.6  (21.6) 1.7  (20.1) 2.2  (13.9) 2.8  (12.0)
Social functioning: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
2.5  (18.3) 0.0  (19.2) 3.3  (10.5) 1.9  (13.0)
Social functioning: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 8 participants 5 participants
9.1  (15.2) 2.0  (21.1) -2.1  (5.9) 3.3  (18.3)
Social functioning: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
9.8  (15.7) 6.9  (16.6) 0.0  (0.0) 10.0  (32.5)
Social functioning: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
7.1  (18.9) 0.0  (0.0) 0.0  (0.0) -8.3  (11.8)
Social functioning: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
27.8  (9.6) 0.0 [1]   (NA) 0.0  (0.0)
Social functioning: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
25.0  (11.8) 0.0 [1]   (NA)
Social functioning: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
27.8  (9.6)
Social functioning: Change at PT/Discontinuation Number Analyzed 8 participants 1 participants 6 participants 1 participants
-4.2  (21.4) 0.0 [1]   (NA) 0.0  (10.5) 0.0 [1]   (NA)
Insomnia: Cycle 1 Day 1 (Baseline) Number Analyzed 138 participants 147 participants 87 participants 89 participants
18.4  (23.2) 17.0  (25.4) 17.2  (23.2) 18.7  (24.6)
Insomnia: Change at Cycle 1 Day 8 Number Analyzed 24 participants 22 participants 16 participants 19 participants
11.1  (18.8) -3.0  (14.2) 2.1  (22.7) 1.8  (20.7)
Insomnia: Change at Cycle 1 Day 15 Number Analyzed 132 participants 139 participants 80 participants 84 participants
6.8  (29.6) 1.0  (19.6) 9.6  (26.1) -4.4  (21.2)
Insomnia: Change at Cycle 1 Day 22 Number Analyzed 22 participants 21 participants 15 participants 17 participants
9.1  (27.6) -3.2  (23.3) 6.7  (18.7) -7.8  (22.1)
Insomnia: Change at Cycle 2 Day 1 Number Analyzed 127 participants 142 participants 83 participants 84 participants
0.8  (23.9) -1.2  (22.6) 2.4  (24.8) -5.6  (19.9)
Insomnia: Change at Cycle 2 Day 15 Number Analyzed 119 participants 134 participants 80 participants 81 participants
5.9  (27.7) 0.5  (25.2) 2.1  (28.7) -3.7  (23.0)
Insomnia: Change at Cycle 3 Day 1 Number Analyzed 119 participants 129 participants 81 participants 78 participants
0.6  (25.7) -1.3  (23.0) -0.4  (28.1) -2.6  (22.0)
Insomnia: Change at Cycle 4 Day 1 Number Analyzed 119 participants 129 participants 78 participants 75 participants
2.2  (25.6) -1.0  (25.0) 3.4  (26.1) -4.9  (23.1)
Insomnia: Change at Cycle 5 Day 1 Number Analyzed 110 participants 117 participants 72 participants 64 participants
2.4  (27.4) 0.3  (23.8) 3.2  (26.9) -5.7  (22.7)
Insomnia: Change at Cycle 6 Day 1 Number Analyzed 106 participants 112 participants 68 participants 63 participants
3.1  (28.6) 1.8  (25.6) 3.4  (26.5) -4.2  (24.3)
Insomnia: Change at Cycle 7 Day 1 Number Analyzed 106 participants 108 participants 68 participants 59 participants
4.7  (26.6) -0.3  (25.6) 3.4  (23.8) -2.3  (17.4)
Insomnia: Change at Cycle 8 Day 1 Number Analyzed 104 participants 106 participants 65 participants 53 participants
4.2  (28.5) 0.6  (29.1) 7.7  (29.9) -6.3  (18.6)
Insomnia: Change at Cycle 9 Day 1 Number Analyzed 100 participants 101 participants 63 participants 52 participants
3.3  (27.8) 0.7  (27.1) 6.3  (28.6) 0.0  (21.9)
Insomnia: Change at Cycle 10 Day 1 Number Analyzed 96 participants 97 participants 63 participants 47 participants
1.7  (22.9) 0.7  (22.0) 4.2  (27.1) -1.4  (19.6)
Insomnia: Change at Cycle 11 Day 1 Number Analyzed 93 participants 93 participants 57 participants 48 participants
0.7  (25.0) -0.7  (25.5) 5.3  (32.0) 1.4  (18.1)
Insomnia: Change at Cycle 12 Day 1 Number Analyzed 89 participants 91 participants 55 participants 48 participants
0.7  (24.6) 0.0  (27.7) 3.6  (29.2) 0.0  (23.8)
Insomnia: Change at Cycle 13 Day 1 Number Analyzed 82 participants 88 participants 54 participants 45 participants
4.1  (26.4) 3.8  (31.7) 6.2  (29.0) -1.5  (22.4)
Insomnia: Change at End Of Treatment Number Analyzed 123 participants 125 participants 67 participants 75 participants
-3.0  (25.3) 1.3  (28.8) 3.5  (32.4) 0.4  (26.6)
Insomnia: Change at PT 13 Weeks Number Analyzed 90 participants 74 participants 56 participants 38 participants
-4.4  (21.9) -1.8  (25.2) -2.4  (24.5) -0.9  (22.6)
Insomnia: Change at PT 26 Weeks Number Analyzed 90 participants 72 participants 47 participants 35 participants
-2.6  (21.9) 0.5  (28.2) -1.4  (23.0) -3.8  (22.5)
Insomnia: Change at PT 39 Weeks Number Analyzed 79 participants 68 participants 42 participants 33 participants
-5.9  (23.7) -0.5  (29.6) -2.4  (27.9) -5.1  (23.7)
Insomnia: Change at PT 52 Weeks Number Analyzed 76 participants 62 participants 27 participants 25 participants
-3.9  (24.3) 0.5  (26.6) -2.5  (26.0) -8.0  (26.0)
Insomnia: Change at PT 65 Weeks Number Analyzed 53 participants 38 participants 17 participants 18 participants
-6.3  (23.6) 1.8  (21.8) -3.9  (33.1) -3.7  (22.5)
Insomnia: Change at PT 78 Weeks Number Analyzed 46 participants 33 participants 15 participants 9 participants
-2.2  (28.5) 1.0  (30.6) -4.4  (27.8) -3.7  (26.1)
Insomnia: Change at PT 91 Weeks Number Analyzed 33 participants 29 participants 15 participants 12 participants
-4.0  (16.2) -1.1  (25.9) -4.4  (21.3) -2.8  (26.4)
Insomnia: Change at PT 104 Weeks Number Analyzed 27 participants 25 participants 10 participants 9 participants
-4.9  (17.8) 4.0  (27.8) 0.0  (22.2) -3.7  (11.1)
Insomnia: Change at PT 117 Weeks Number Analyzed 22 participants 17 participants 9 participants 5 participants
-9.1  (18.3) -7.8  (30.1) 0.0  (16.7) -13.3  (29.8)
Insomnia: Change at PT 130 Weeks Number Analyzed 17 participants 12 participants 5 participants 5 participants
-7.8  (22.1) -8.3  (20.7) 6.7  (27.9) -6.7  (14.9)
Insomnia: Change at PT 143 Weeks Number Analyzed 7 participants 2 participants 3 participants 2 participants
-14.3  (17.8) -16.7  (23.6) 0.0  (33.3) 0.0  (0.0)
Insomnia: Change at PT 156 Weeks Number Analyzed 3 participants 1 participants 0 participants 2 participants
-11.1  (19.2) 0.0 [1]   (NA) 0.0  (0.0)
Insomnia: Change at PT 169 Weeks Number Analyzed 2 participants 1 participants 0 participants 0 participants
0.0  (0.0) 0.0 [1]   (NA)
Insomnia: Change at PT 182 Weeks Number Analyzed 3 participants 0 participants 0 participants 0 participants
-11.1  (19.2)
Insomnia: Change at PT/Discont. Number Analyzed 8 participants 1 participants 6 participants 1 participants
0.0  (17.8) 0.0 [1]   (NA) 5.6  (25.1) 0.0 [1]   (NA)
[1]
1 participant was analyzed, so standard deviation is not applicable.
[2]
1 participant was analyzed, so standard deviation is not applicable
6.Secondary Outcome
Title Plasma Concentration of Vemurafenib
Hide Description [Not Specified]
Time Frame Pre-morning dose (0 hour [hr]) and 1 to 4 hrs post-dose on Days 1, 8, 15, and 22 of Cycle 1; pre-morning dose (0 hr) on Days 1 and 15 of Cycle 2; pre-morning dose (0 hr) on Day 1 of Cycles 3-13; at end of treatment (up to 13 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of vemurafenib and had provided valid PK assessments.
Arm/Group Title Cohort 1 Vemurafenib Cohort 2 Vemurafenib
Hide Arm/Group Description:
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Overall Number of Participants Analyzed 149 92
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter (ng/mL)
Cycle 1 Day 1 (nominal Day 1) Number Analyzed 122 participants 77 participants
2880  (2770) 3050  (3010)
Cycle 1 Day 8 Number Analyzed 79 participants 52 participants
49900  (19800) 43400  (13600)
Cycle 1 Day 15 Number Analyzed 55 participants 43 participants
45300  (23000) 50200  (20500)
Cycle 1 Day 22 Number Analyzed 49 participants 45 participants
44000  (22400) 48800  (23700)
Cycle 2 Day 1 Number Analyzed 107 participants 69 participants
40200  (24100) 43800  (19400)
Cycle 2 Day 15 Number Analyzed 102 participants 68 participants
42400  (21700) 44200  (21200)
Cycle 3 Day 1 Number Analyzed 100 participants 69 participants
46700  (21500) 43700  (22000)
Cycle 4 Day 1 Number Analyzed 98 participants 68 participants
44800  (19300) 47400  (20100)
Cycle 5 Day 1 Number Analyzed 92 participants 61 participants
43100  (18800) 43700  (19400)
Cycle 6 Day 1 Number Analyzed 82 participants 62 participants
46000  (18900) 42000  (22000)
Cycle 7 Day 1 Number Analyzed 86 participants 57 participants
42800  (20500) 45200  (20500)
Cycle 8 Day 1 Number Analyzed 81 participants 55 participants
43600  (19900) 42600  (18900)
Cycle 9 Day 1 Number Analyzed 77 participants 51 participants
42900  (18400) 43000  (17700)
Cycle 10 Day 1 Number Analyzed 38 participants 29 participants
41000  (19000) 43900  (18500)
Cycle 11 Day 1 Number Analyzed 35 participants 35 participants
45900  (15300) 39700  (17600)
Cycle 12 Day 1 Number Analyzed 34 participants 26 participants
43700  (15200) 46600  (19800)
Cycle 13 Day 1 Number Analyzed 36 participants 26 participants
44000  (17200) 42600  (19900)
Time Frame Up to the data cutoff of April 17, 2017 (approximately 4.5 years).
Adverse Event Reporting Description The safety population included all participants who received at least one dose of study medication.
 
Arm/Group Title Cohort 1 Vemurafenib Cohort 1 Placebo Cohort 2 Vemurafenib Cohort 2 Placebo
Hide Arm/Group Description Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
All-Cause Mortality
Cohort 1 Vemurafenib Cohort 1 Placebo Cohort 2 Vemurafenib Cohort 2 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   15/154 (9.74%)   28/156 (17.95%)   19/93 (20.43%)   20/91 (21.98%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 Vemurafenib Cohort 1 Placebo Cohort 2 Vemurafenib Cohort 2 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/154 (16.23%)   16/156 (10.26%)   15/93 (16.13%)   9/91 (9.89%) 
Cardiac disorders         
Pericarditis * 1  1/154 (0.65%)  0/156 (0.00%)  1/93 (1.08%)  0/91 (0.00%) 
Atrial fibrillation * 1  0/154 (0.00%)  0/156 (0.00%)  2/93 (2.15%)  0/91 (0.00%) 
Coronary artery occlusion * 1  0/154 (0.00%)  0/156 (0.00%)  0/93 (0.00%)  1/91 (1.10%) 
Myocardial infarction * 1  0/154 (0.00%)  0/156 (0.00%)  0/93 (0.00%)  1/91 (1.10%) 
Ear and labyrinth disorders         
Vertigo positional * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Eye disorders         
Iridocyclitis * 1  0/154 (0.00%)  0/156 (0.00%)  1/93 (1.08%)  0/91 (0.00%) 
Gastrointestinal disorders         
Leukoplakia oral * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Pancreatitis * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Pancreatitis acute * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Inguinal hernia * 1  0/154 (0.00%)  0/156 (0.00%)  0/93 (0.00%)  1/91 (1.10%) 
General disorders         
Chest pain * 1  0/154 (0.00%)  1/156 (0.64%)  1/93 (1.08%)  0/91 (0.00%) 
Hepatobiliary disorders         
Bile duct stone * 1  0/154 (0.00%)  1/156 (0.64%)  0/93 (0.00%)  0/91 (0.00%) 
Hepatic function abnormal * 1  0/154 (0.00%)  0/156 (0.00%)  1/93 (1.08%)  0/91 (0.00%) 
Infections and infestations         
Appendicitis * 1  0/154 (0.00%)  1/156 (0.64%)  0/93 (0.00%)  0/91 (0.00%) 
Bronchitis * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Cellulitis * 1  0/154 (0.00%)  2/156 (1.28%)  0/93 (0.00%)  1/91 (1.10%) 
Groin infection * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Hepatitis B * 1  0/154 (0.00%)  1/156 (0.64%)  0/93 (0.00%)  0/91 (0.00%) 
Infection * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Soft tissue infection * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Erysipelas * 1  0/154 (0.00%)  0/156 (0.00%)  1/93 (1.08%)  0/91 (0.00%) 
Infected skin ulcer * 1  0/154 (0.00%)  0/156 (0.00%)  1/93 (1.08%)  0/91 (0.00%) 
Investigations         
Electrocardiogram QT prolonged * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Lipase increased * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Metabolism and nutrition disorders         
Hyperlipasaemia * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Hypokalaemia * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Hypophosphataemia * 1  0/154 (0.00%)  1/156 (0.64%)  0/93 (0.00%)  0/91 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  2/154 (1.30%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Dupuytren’s contracture * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Acute promyelocytic leukaemia * 1  0/154 (0.00%)  1/156 (0.64%)  0/93 (0.00%)  0/91 (0.00%) 
Atypical fibroxanthoma * 1  0/154 (0.00%)  1/156 (0.64%)  0/93 (0.00%)  0/91 (0.00%) 
Basal cell carcinoma * 1  5/154 (3.25%)  7/156 (4.49%)  3/93 (3.23%)  1/91 (1.10%) 
Malignant melanoma * 1  1/154 (0.65%)  0/156 (0.00%)  1/93 (1.08%)  0/91 (0.00%) 
Prostate cancer * 1  0/154 (0.00%)  1/156 (0.64%)  0/93 (0.00%)  2/91 (2.20%) 
Squamous cell carcinoma of skin * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Thyroid cancer * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Gastrointestinal stromal tumour * 1  0/154 (0.00%)  0/156 (0.00%)  0/93 (0.00%)  1/91 (1.10%) 
Neuroendocrine carcinoma * 1  0/154 (0.00%)  0/156 (0.00%)  1/93 (1.08%)  1/91 (1.10%) 
Nervous system disorders         
Carotid artery stenosis * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Facial paralysis * 1  1/154 (0.65%)  0/156 (0.00%)  1/93 (1.08%)  0/91 (0.00%) 
Psychiatric disorders         
Suicidal ideation * 1  0/154 (0.00%)  0/156 (0.00%)  1/93 (1.08%)  0/91 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pleuritic pain * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)  0/91 (0.00%) 
Pneumothorax * 1  0/154 (0.00%)  0/156 (0.00%)  1/93 (1.08%)  0/91 (0.00%) 
Skin and subcutaneous tissue disorders         
Actinic keratosis * 1  1/154 (0.65%)  0/156 (0.00%)  0/93 (0.00%)