Melanoma
Conditions
Brief summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than \[\>\] 1 millimeter \[mm\] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.
Interventions
DRUGVemurafenib
4 tablets of vemurafenib 240 mg each (total 960 mg) were administered orally as per the schedule specified in the respective arm.
DRUGPlacebo
Placebo matching to vemurafenib were administered orally as per the schedule specified in the respective arm.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed melanoma of cutaneous origin * Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according to AJCC Staging Criteria version 7 that has been completely resected * BRAF V600 mutation status of the current primary tumor or involved lymph node determined to be positive using the cobas BRAF V600 mutation test * Surgically rendered free of disease within 90 days of randomization * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy of at least 5 years * Fully recovered from the effects of any major surgery or significant traumatic injury prior to the first dose of study treatment * Adequate hematologic, hepatic, and renal function
Exclusion criteria
* History of any systemic or local therapy (e.g., chemotherapy, biologic or targeted therapy, hormonal therapy, or photodynamic therapy) for the treatment or prevention of melanoma, including interferon alpha-2b and pegylated interferon alpha-2b * History of limb perfusion therapy * History of radiotherapy for the treatment of melanoma * Invasive malignancy other than melanoma at the time of enrollment or within 5 years prior to first dose of study treatment * Family history of inherited colon cancer syndromes * Known personal history of \>3 adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) \>2 centimeters (cm) in size * History of or current clinical, radiographic, or pathologic evidence of in-transit metastases, satellite, or microsatellite lesions * History of or current clinical, radiographic, or pathologic evidence of recurrent lymph node involvement after resection of a primary melanoma with lymph node involvement at any time in the past * History of local and/or regional and/or distant melanoma recurrence * History or current radiographic or pathologic evidence of distant metastases * History of clinically significant cardiac or pulmonary dysfunction * Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study treatment * Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT | 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) | 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. |
| Overall Survival (OS) | From randomization until the date of death from any cause (up until 13-July-2018, approximately 6 years) | OS is defined as the time from randomization until the date of death from any cause. |
| Percentage of Participants With Adverse Events | From randomization up to study completion or discontinuation (up until 13-July-2018, approximately 6 years) | An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. |
| Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | 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) | 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). |
| Plasma Concentration of Vemurafenib | 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) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Croatia, Czechia, Estonia, France, Germany, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russia, Serbia, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Vemurafenib 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 | 157 |
| Cohort 1 Placebo Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks | 157 |
| Cohort 2 Vemurafenib Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks | 93 |
| Cohort 2 Placebo Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks | 91 |
| Total | 498 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 18 | 33 | 25 | 26 |
| Overall Study | Lost to Follow-up | 7 | 6 | 2 | 4 |
| Overall Study | Non-compliance | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Reason Not Specified | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 16 | 8 | 9 | 8 |
Baseline characteristics
| Characteristic | Total | Cohort 2 Placebo | Cohort 2 Vemurafenib | Cohort 1 Placebo | Cohort 1 Vemurafenib |
|---|---|---|---|---|---|
| Age, Continuous | 50.2 years STANDARD_DEVIATION 12.9 | 49.1 years STANDARD_DEVIATION 12.9 | 51.6 years STANDARD_DEVIATION 14.1 | 49.6 years STANDARD_DEVIATION 12.7 | 50.7 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 25 Participants | 3 Participants | 8 Participants | 2 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 445 Participants | 80 Participants | 79 Participants | 148 Participants | 138 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 28 Participants | 8 Participants | 6 Participants | 7 Participants | 7 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 26 Participants | 8 Participants | 7 Participants | 5 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 465 Participants | 81 Participants | 84 Participants | 150 Participants | 150 Participants |
| Sex: Female, Male Female | 215 Participants | 32 Participants | 41 Participants | 69 Participants | 73 Participants |
| Sex: Female, Male Male | 283 Participants | 59 Participants | 52 Participants | 88 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 18 / 154 | 33 / 156 | 25 / 93 | 26 / 91 |
| other Total, other adverse events | 150 / 154 | 117 / 156 | 92 / 93 | 67 / 91 |
| serious Total, serious adverse events | 25 / 154 | 16 / 156 | 15 / 93 | 9 / 91 |
Outcome results
Primary
Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT)
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)
Population: The ITT population included all participants enrolled in the study, whether or not they had received study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 Vemurafenib | Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT) | NA months |
| Cohort 1 Placebo | Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT) | 36.9 months |
| Cohort 2 Vemurafenib | Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT) | 23.1 months |
| Cohort 2 Placebo | Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT) | 15.4 months |
p-value: 0.00195% CI: [0.37, 0.78]Log Rank
p-value: 0.259895% CI: [0.54, 1.18]Log Rank
Secondary
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score
European Organisation for Research and Treatment of Cancer 30-Item Quality of Life Questionnaire assesses 8 symptoms, function, financial difficulties, and a global health status/health-related quality of life (HRQoL). Most questions use a 4-point scale (1 'Not at all' to 4 'Very much';2 questions use a 7-point scale (1 'very poor' to 7 'Excellent'). Scores were averaged and transformed to a 0-100 scale. Higher scores for the function and HRQoL represent higher levels of functioning and HRQoL, higher scores for the symptom represent higher levels of symptoms/problems, higher score for financial difficulty represent higher level of perceived financial burden of treatment. Changes of 5-10 points are considered to represent a minimally important difference to participants. A positive value means an increase, and negative value means a decrease in score at the indicated time-point relative to the score at baseline (Cycle 1 Day 1).
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)
Population: The patient-reported outcome (PRO)-evaluable population included all participants who received at least one dose of vemurafenib and who had both a baseline assessment and at least one post-baseline QLQ-C30 assessment that generated a score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 26 Weeks | 4.8 score on a scale | Standard Deviation 16.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 156 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 91 Weeks | 3.0 score on a scale | Standard Deviation 9.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 52 Weeks | 2.0 score on a scale | Standard Deviation 18 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 9 Day 1 | 2.0 score on a scale | Standard Deviation 24.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 13 Weeks | -0.6 score on a scale | Standard Deviation 17.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 13 Day 1 | 11.6 score on a scale | Standard Deviation 23.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 12 Day 1 | -0.4 score on a scale | Standard Deviation 24.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 13 Weeks | 0.4 score on a scale | Standard Deviation 26.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 4 Day 1 | -7.1 score on a scale | Standard Deviation 21.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 11 Day 1 | 10.0 score on a scale | Standard Deviation 25 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 26 Weeks | -3.0 score on a scale | Standard Deviation 22.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 39 Weeks | -1.7 score on a scale | Standard Deviation 22.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 52 Weeks | -2.2 score on a scale | Standard Deviation 21.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 117 Weeks | -9.1 score on a scale | Standard Deviation 18.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 65 Weeks | 2.6 score on a scale | Standard Deviation 26.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 8 | -2.1 score on a scale | Standard Deviation 12.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 117 Weeks | -6.1 score on a scale | Standard Deviation 22.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 130 Weeks | -7.8 score on a scale | Standard Deviation 27.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 10 Day 1 | 8.9 score on a scale | Standard Deviation 22 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 2 Day 15 | -7.1 score on a scale | Standard Deviation 16.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 78 Weeks | 2.2 score on a scale | Standard Deviation 27.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 3 Day 1 | -6.6 score on a scale | Standard Deviation 14.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 9 Day 1 | 12.8 score on a scale | Standard Deviation 27.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 4 Day 1 | -4.9 score on a scale | Standard Deviation 13.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 5 Day 1 | -6.1 score on a scale | Standard Deviation 14.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 6 Day 1 | 8.8 score on a scale | Standard Deviation 22.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 8 Day 1 | -5.2 score on a scale | Standard Deviation 13.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 2 Day 1 | -2.4 score on a scale | Standard Deviation 14.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 9 Day 1 | -6.7 score on a scale | Standard Deviation 18.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 5 Day 1 | 12.7 score on a scale | Standard Deviation 24.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 10 Day 1 | -4.9 score on a scale | Standard Deviation 14 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 13 Day 1 | -4.5 score on a scale | Standard Deviation 15 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 3 Day 1 | -3.6 score on a scale | Standard Deviation 13.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 4 Day 1 | 9.0 score on a scale | Standard Deviation 22.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at End of Treatment | -2.8 score on a scale | Standard Deviation 13.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 15 | 20.8 score on a scale | Standard Deviation 28.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 13 Weeks | 0.5 score on a scale | Standard Deviation 11.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 52 Weeks | -1.4 score on a scale | Standard Deviation 10 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 182 Weeks | -22.2 score on a scale | Standard Deviation 38.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 8 | 9.7 score on a scale | Standard Deviation 22.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 130 Weeks | -2.0 score on a scale | Standard Deviation 8.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 65 Weeks | -0.9 score on a scale | Standard Deviation 8.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 104 Weeks | -2.6 score on a scale | Standard Deviation 18.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 65 Weeks | -6.3 score on a scale | Standard Deviation 23.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Cycle 1 Day 1 (Baseline) | 11.6 score on a scale | Standard Deviation 17.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 91 Weeks | 0.2 score on a scale | Standard Deviation 7.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 8 | 4.2 score on a scale | Standard Deviation 8.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 5 Day 1 | -6.2 score on a scale | Standard Deviation 17.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 143 Weeks | -2.4 score on a scale | Standard Deviation 6.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 15 | 9.8 score on a scale | Standard Deviation 16.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 117 Weeks | 1.2 score on a scale | Standard Deviation 8.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 5.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 22 | 6.1 score on a scale | Standard Deviation 12.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 2 Day 1 | 5.2 score on a scale | Standard Deviation 12.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 7 Day 1 | -6.3 score on a scale | Standard Deviation 17.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 117 Weeks | -1.5 score on a scale | Standard Deviation 4.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 2 Day 15 | 6.3 score on a scale | Standard Deviation 14.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 104 Weeks | 1.9 score on a scale | Standard Deviation 10.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 3 Day 1 | 5.7 score on a scale | Standard Deviation 13.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 52 Weeks | 0.9 score on a scale | Standard Deviation 6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 39 Weeks | 0.2 score on a scale | Standard Deviation 5.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 22 | -17.8 score on a scale | Standard Deviation 27 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 2 Day 1 | -9.8 score on a scale | Standard Deviation 19.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 10 Day 1 | -9.0 score on a scale | Standard Deviation 20.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 26 Weeks | 2.2 score on a scale | Standard Deviation 8.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 5 Day 1 | -12.0 score on a scale | Standard Deviation 20.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at End of Treatment | 0.9 score on a scale | Standard Deviation 6.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 6 Day 1 | 5.3 score on a scale | Standard Deviation 13.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 3 Day 1 | -8.1 score on a scale | Standard Deviation 21.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 13 Day 1 | 2.8 score on a scale | Standard Deviation 11.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 7 Day 1 | 4.7 score on a scale | Standard Deviation 11.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 39 Weeks | -5.9 score on a scale | Standard Deviation 23.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 9 Day 1 | 5.5 score on a scale | Standard Deviation 15.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 11 Day 1 | -10.6 score on a scale | Standard Deviation 20.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 10 Day 1 | 5.2 score on a scale | Standard Deviation 13.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 182 Weeks | 16.7 score on a scale | Standard Deviation 16.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 26 Weeks | -2.6 score on a scale | Standard Deviation 21.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 13 Day 1 | -7.7 score on a scale | Standard Deviation 20.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 26 Weeks | -2.8 score on a scale | Standard Deviation 16.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 4 Day 1 | 5.6 score on a scale | Standard Deviation 13.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 13 Weeks | -4.4 score on a scale | Standard Deviation 21.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 39 Weeks | -2.1 score on a scale | Standard Deviation 13.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 65 Weeks | -4.4 score on a scale | Standard Deviation 17.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 5 Day 1 | 7.3 score on a scale | Standard Deviation 16.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 78 Weeks | -2.5 score on a scale | Standard Deviation 17.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 11 Day 1 | 3.4 score on a scale | Standard Deviation 10.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at End Of Treatment | -3.0 score on a scale | Standard Deviation 25.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 91 Weeks | -2.5 score on a scale | Standard Deviation 16.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 12 Day 1 | 4.3 score on a scale | Standard Deviation 12.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 117 Weeks | 1.5 score on a scale | Standard Deviation 12.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 182 Weeks | 11.1 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT/Discontin. | -2.1 score on a scale | Standard Deviation 16.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 13 Day 1 | 4.1 score on a scale | Standard Deviation 26.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Cycle 1 Day 1 (Baseline) | 3.1 score on a scale | Standard Deviation 10.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 8 | -2.9 score on a scale | Standard Deviation 13.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 22 | 15.9 score on a scale | Standard Deviation 28.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 12 Day 1 | 0.7 score on a scale | Standard Deviation 24.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 15 | 2.1 score on a scale | Standard Deviation 17 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 2 Day 1 | -8.0 score on a scale | Standard Deviation 22.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 22 | -1.6 score on a scale | Standard Deviation 19.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 11 Day 1 | 0.7 score on a scale | Standard Deviation 25 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 2 Day 1 | 1.1 score on a scale | Standard Deviation 12.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 2 Day 15 | 1.4 score on a scale | Standard Deviation 14.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 10 Day 1 | 1.7 score on a scale | Standard Deviation 22.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 8 Day 1 | 1.9 score on a scale | Standard Deviation 14.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 9 Day 1 | 1.4 score on a scale | Standard Deviation 11.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 8 | 1.4 score on a scale | Standard Deviation 18.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 9 Day 1 | 3.3 score on a scale | Standard Deviation 27.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 10 Day 1 | 1.4 score on a scale | Standard Deviation 10.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 39 Weeks | 3.4 score on a scale | Standard Deviation 16.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 13 Weeks | 0.4 score on a scale | Standard Deviation 17.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Cycle 1 Day 1 (Baseline) | 3.6 score on a scale | Standard Deviation 11.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 8 Day 1 | 4.2 score on a scale | Standard Deviation 28.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 26 Weeks | -0.4 score on a scale | Standard Deviation 13.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 39 Weeks | 0.4 score on a scale | Standard Deviation 14.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 7 Day 1 | 13.1 score on a scale | Standard Deviation 21 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 7 Day 1 | 4.7 score on a scale | Standard Deviation 26.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 52 Weeks | 0.0 score on a scale | Standard Deviation 13.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 65 Weeks | 3.8 score on a scale | Standard Deviation 14.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 8 | 2.8 score on a scale | Standard Deviation 9.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 117 Weeks | -6.7 score on a scale | Standard Deviation 13.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 2 Day 15 | 5.9 score on a scale | Standard Deviation 27.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 130 Weeks | -8.3 score on a scale | Standard Deviation 14.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 182 Weeks | -11.1 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT/Discontinuation | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Cycle 1 Day 1 (Baseline) | 89.6 score on a scale | Standard Deviation 16.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 2 Day 1 | 0.8 score on a scale | Standard Deviation 23.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Cycle 1 Day 1 (Baseline) | 4.1 score on a scale | Standard Deviation 13 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 15 | 16.7 score on a scale | Standard Deviation 26.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 8 | 4.2 score on a scale | Standard Deviation 11.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 22 | 9.1 score on a scale | Standard Deviation 27.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 3 Day 1 | 3.4 score on a scale | Standard Deviation 21.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 65 Weeks | 1.3 score on a scale | Standard Deviation 16.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 4 Day 1 | 3.9 score on a scale | Standard Deviation 23 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 156 Weeks | 27.8 score on a scale | Standard Deviation 9.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 5 Day 1 | 7.6 score on a scale | Standard Deviation 23.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 22 | 7.6 score on a scale | Standard Deviation 14.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 6 Day 1 | 7.2 score on a scale | Standard Deviation 25.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 143 Weeks | 7.1 score on a scale | Standard Deviation 18.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 7 Day 1 | 9.4 score on a scale | Standard Deviation 24.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 8 Day 1 | 5.1 score on a scale | Standard Deviation 19.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT/Discontin. | -8.3 score on a scale | Standard Deviation 23.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 12 Day 1 | 7.4 score on a scale | Standard Deviation 25.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at End Of Treatment | -4.7 score on a scale | Standard Deviation 25 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 65 Weeks | 0.0 score on a scale | Standard Deviation 19.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 182 Weeks | -14.8 score on a scale | Standard Deviation 6.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 78 Weeks | -0.7 score on a scale | Standard Deviation 20.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 182 Weeks | 27.8 score on a scale | Standard Deviation 25.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 9 Day 1 | -11.2 score on a scale | Standard Deviation 28.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 91 Weeks | 4.0 score on a scale | Standard Deviation 16.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 4 Day 1 | 9.5 score on a scale | Standard Deviation 20.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 8 Day 1 | -9.2 score on a scale | Standard Deviation 26.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 156 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 7 Day 1 | -9.9 score on a scale | Standard Deviation 27.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 169 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 15 | 6.3 score on a scale | Standard Deviation 18.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 5 Day 1 | 13.3 score on a scale | Standard Deviation 23.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 6 Day 1 | -5.8 score on a scale | Standard Deviation 24.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 22 | 4.8 score on a scale | Standard Deviation 12 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 2 Day 1 | 1.9 score on a scale | Standard Deviation 13.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 9 Day 1 | -11.0 score on a scale | Standard Deviation 26.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 5 Day 1 | -11.1 score on a scale | Standard Deviation 26 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 2 Day 15 | 2.8 score on a scale | Standard Deviation 16 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 8 Day 1 | 10.2 score on a scale | Standard Deviation 22.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 3 Day 1 | 3.4 score on a scale | Standard Deviation 17 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 39 Weeks | -4.1 score on a scale | Standard Deviation 21.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 6 Day 1 | 3.8 score on a scale | Standard Deviation 16.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 130 Weeks | 6.9 score on a scale | Standard Deviation 21.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 9 Day 1 | 5.7 score on a scale | Standard Deviation 17.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 9 Day 1 | 9.7 score on a scale | Standard Deviation 25.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 26 Weeks | -2.2 score on a scale | Standard Deviation 16.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 10 Day 1 | 5.2 score on a scale | Standard Deviation 20.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 12 Day 1 | 6.7 score on a scale | Standard Deviation 24.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 13 Day 1 | 6.5 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 104 Weeks | 2.5 score on a scale | Standard Deviation 18.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at End of Treatment | 4.1 score on a scale | Standard Deviation 14.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 10 Day 1 | 7.3 score on a scale | Standard Deviation 18.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 13 Weeks | 3.0 score on a scale | Standard Deviation 17.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 78 Weeks | 0.7 score on a scale | Standard Deviation 20.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 3 Day 1 | 0.3 score on a scale | Standard Deviation 21.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 6 Day 1 | -7.2 score on a scale | Standard Deviation 22.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 39 Weeks | 1.7 score on a scale | Standard Deviation 14 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 117 Weeks | 7.6 score on a scale | Standard Deviation 26.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 11 Day 1 | 5.4 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 65 Weeks | 2.8 score on a scale | Standard Deviation 18.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at End of Treatment | 1.5 score on a scale | Standard Deviation 18.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 7 Day 1 | 1.9 score on a scale | Standard Deviation 26.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 52 Weeks | -0.7 score on a scale | Standard Deviation 18.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 13 Weeks | 3.2 score on a scale | Standard Deviation 17.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 26 Weeks | 4.9 score on a scale | Standard Deviation 18.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 13 Day 1 | 5.7 score on a scale | Standard Deviation 17.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 13 Day 1 | -8.3 score on a scale | Standard Deviation 24.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 39 Weeks | 2.5 score on a scale | Standard Deviation 15.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 52 Weeks | 2.4 score on a scale | Standard Deviation 17.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 11 Day 1 | 5.7 score on a scale | Standard Deviation 19.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 12 Day 1 | -10.6 score on a scale | Standard Deviation 24.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 65 Weeks | 1.1 score on a scale | Standard Deviation 17.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 78 Weeks | 2.9 score on a scale | Standard Deviation 14.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at End of Treatment | 2.7 score on a scale | Standard Deviation 16.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 11 Day 1 | -8.6 score on a scale | Standard Deviation 24.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 91 Weeks | 1.8 score on a scale | Standard Deviation 16.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 10 Day 1 | 1.0 score on a scale | Standard Deviation 23.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 10 Day 1 | -8.7 score on a scale | Standard Deviation 24.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 52 Weeks | 2.4 score on a scale | Standard Deviation 23.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 130 Weeks | 8.7 score on a scale | Standard Deviation 12.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 26 Weeks | 0.7 score on a scale | Standard Deviation 16.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 7 Day 1 | -3.0 score on a scale | Standard Deviation 18.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Cycle 1 Day 1 (Baseline) | 13.2 score on a scale | Standard Deviation 14.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 104 Weeks | 6.5 score on a scale | Standard Deviation 14.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 8 | 7.9 score on a scale | Standard Deviation 19 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 13 Weeks | 2.0 score on a scale | Standard Deviation 21.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 15 | 22.6 score on a scale | Standard Deviation 26.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 78 Weeks | -0.7 score on a scale | Standard Deviation 11.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 22 | 15.2 score on a scale | Standard Deviation 21.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 3 Day 1 | 14.1 score on a scale | Standard Deviation 22.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 8 | -4.4 score on a scale | Standard Deviation 8.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 4 Day 1 | 12.6 score on a scale | Standard Deviation 21.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 117 Weeks | 7.2 score on a scale | Standard Deviation 12.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 5 Day 1 | 14.2 score on a scale | Standard Deviation 23.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT/Discont. | 0.0 score on a scale | Standard Deviation 17.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 3 Day 1 | -0.1 score on a scale | Standard Deviation 17.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 91 Weeks | 2.1 score on a scale | Standard Deviation 16.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 11 Day 1 | 11.5 score on a scale | Standard Deviation 22.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 2 Day 15 | 0.2 score on a scale | Standard Deviation 18.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 12 Day 1 | 10.3 score on a scale | Standard Deviation 23.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 13 Day 1 | 11.1 score on a scale | Standard Deviation 23.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 182 Weeks | -11.1 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 15 | -5.2 score on a scale | Standard Deviation 18 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at End of Treatment | 6.5 score on a scale | Standard Deviation 21.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 39 Weeks | -1.0 score on a scale | Standard Deviation 16.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 104 Weeks | -1.2 score on a scale | Standard Deviation 11.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 52 Weeks | 1.6 score on a scale | Standard Deviation 16.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 78 Weeks | 2.4 score on a scale | Standard Deviation 16.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT/Discontinuation | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 182 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 169 Weeks | -16.7 score on a scale | Standard Deviation 7.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT/Discontinuation | 6.9 score on a scale | Standard Deviation 16.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 5 Day 1 | -9.4 score on a scale | Standard Deviation 21.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 117 Weeks | -4.5 score on a scale | Standard Deviation 18 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Cycle 1 Day 1 (Baseline) | 12.4 score on a scale | Standard Deviation 25.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 8 | -9.7 score on a scale | Standard Deviation 25 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 15 | 1.5 score on a scale | Standard Deviation 17.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 143 Weeks | -4.8 score on a scale | Standard Deviation 12.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 22 | -1.5 score on a scale | Standard Deviation 26.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 4 Day 1 | -0.8 score on a scale | Standard Deviation 23.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 6 Day 1 | -0.6 score on a scale | Standard Deviation 22.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 143 Weeks | -14.3 score on a scale | Standard Deviation 17.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 65 Weeks | -0.3 score on a scale | Standard Deviation 19.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 78 Weeks | 4.3 score on a scale | Standard Deviation 13.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 8.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 156 Weeks | 2.2 score on a scale | Standard Deviation 3.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 12 Day 1 | -8.7 score on a scale | Standard Deviation 21.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 12 Day 1 | -2.3 score on a scale | Standard Deviation 20 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 15 | -19.1 score on a scale | Standard Deviation 24.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 156 Weeks | -11.1 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 3 Day 1 | -10.6 score on a scale | Standard Deviation 19 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at End of Treatment | -4.9 score on a scale | Standard Deviation 17.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 11 Day 1 | 0.0 score on a scale | Standard Deviation 19.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 4 Day 1 | -10.2 score on a scale | Standard Deviation 19.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 143 Weeks | 9.5 score on a scale | Standard Deviation 25.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 22 | -9.1 score on a scale | Standard Deviation 28 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 10 Day 1 | -1.0 score on a scale | Standard Deviation 20.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 156 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 8 Day 1 | 4.6 score on a scale | Standard Deviation 11.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 9 Day 1 | -1.6 score on a scale | Standard Deviation 22.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 169 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 7 Day 1 | -10.7 score on a scale | Standard Deviation 19.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 13 Weeks | -4.4 score on a scale | Standard Deviation 14.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 8 Day 1 | -3.5 score on a scale | Standard Deviation 20 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 22 | -10.3 score on a scale | Standard Deviation 16.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 13 Weeks | 0.2 score on a scale | Standard Deviation 6.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 104 Weeks | 6.2 score on a scale | Standard Deviation 22.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 10 Day 1 | -7.6 score on a scale | Standard Deviation 19.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 65 Weeks | 0.0 score on a scale | Standard Deviation 5.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 78 Weeks | 0.4 score on a scale | Standard Deviation 5.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 52 Weeks | -3.5 score on a scale | Standard Deviation 17.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 15 | -9.7 score on a scale | Standard Deviation 17.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 91 Weeks | 1.6 score on a scale | Standard Deviation 6.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 156 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Cycle 1 Day 1 (Baseline) | 92.7 score on a scale | Standard Deviation 11 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 8 | 11.1 score on a scale | Standard Deviation 18.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 182 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT/Discont. | 4.2 score on a scale | Standard Deviation 11.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 130 Weeks | -7.8 score on a scale | Standard Deviation 22.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 2 Day 1 | 12.9 score on a scale | Standard Deviation 26.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT/Discontinuation | -4.2 score on a scale | Standard Deviation 21.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 2 Day 15 | 14.3 score on a scale | Standard Deviation 27.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 104 Weeks | -4.9 score on a scale | Standard Deviation 17.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT/Discontin. | 12.5 score on a scale | Standard Deviation 14.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 3 Day 1 | 11.8 score on a scale | Standard Deviation 20.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 7 Day 1 | 8.2 score on a scale | Standard Deviation 21.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 104 Weeks | 1.2 score on a scale | Standard Deviation 14.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 8 Day 1 | -10.3 score on a scale | Standard Deviation 18.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 8 Day 1 | 11.0 score on a scale | Standard Deviation 24.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 182 Weeks | -22.2 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 12 Day 1 | 12.2 score on a scale | Standard Deviation 24.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 130 Weeks | -3.9 score on a scale | Standard Deviation 15.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 169 Weeks | -8.3 score on a scale | Standard Deviation 11.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at End of Treatment | 4.9 score on a scale | Standard Deviation 23.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 26 Weeks | 1.1 score on a scale | Standard Deviation 21.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 2 Day 1 | 9.5 score on a scale | Standard Deviation 21 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 39 Weeks | 0.6 score on a scale | Standard Deviation 19.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 91 Weeks | -4.0 score on a scale | Standard Deviation 16.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 156 Weeks | -22.2 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 78 Weeks | 0.7 score on a scale | Standard Deviation 20.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 91 Weeks | -2.5 score on a scale | Standard Deviation 18.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 143 Weeks | 4.8 score on a scale | Standard Deviation 18.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 130 Weeks | 2.9 score on a scale | Standard Deviation 19.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 143 Weeks | -2.4 score on a scale | Standard Deviation 20.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Cycle 1 Day 1 (Baseline) | 83.8 score on a scale | Standard Deviation 15.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 8 | -4.5 score on a scale | Standard Deviation 15.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 6 Day 1 | -2.8 score on a scale | Standard Deviation 17.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 22 | -6.4 score on a scale | Standard Deviation 20.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 2 Day 1 | -1.2 score on a scale | Standard Deviation 16 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 156 Weeks | 11.1 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 5 Day 1 | -3.5 score on a scale | Standard Deviation 19.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 4 Day 1 | -2.7 score on a scale | Standard Deviation 18.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 78 Weeks | -2.2 score on a scale | Standard Deviation 28.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 169 Weeks | 16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 104 Weeks | -1.2 score on a scale | Standard Deviation 17.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 52 Weeks | -3.9 score on a scale | Standard Deviation 24.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 3 Day 1 | -1.2 score on a scale | Standard Deviation 12.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 15 | -15.0 score on a scale | Standard Deviation 26.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 4 Day 1 | 0.6 score on a scale | Standard Deviation 11.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 2 Day 15 | 9.5 score on a scale | Standard Deviation 22.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 5 Day 1 | -0.6 score on a scale | Standard Deviation 9.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 6 Day 1 | 3.1 score on a scale | Standard Deviation 28.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 6 Day 1 | 0.6 score on a scale | Standard Deviation 13.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 169 Weeks | 3.3 score on a scale | Standard Deviation 4.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 7 Day 1 | 3.1 score on a scale | Standard Deviation 18.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 5 Day 1 | 2.4 score on a scale | Standard Deviation 27.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 11 Day 1 | 2.2 score on a scale | Standard Deviation 14.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 3 Day 1 | 10.4 score on a scale | Standard Deviation 20.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 4 Day 1 | 2.2 score on a scale | Standard Deviation 25.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 12 Day 1 | 4.8 score on a scale | Standard Deviation 19.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 169 Weeks | 16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 13 Day 1 | 4.1 score on a scale | Standard Deviation 18.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 6 Day 1 | 9.7 score on a scale | Standard Deviation 21.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 3 Day 1 | 0.6 score on a scale | Standard Deviation 25.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at End of Treatment | 3.3 score on a scale | Standard Deviation 15.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 78 Weeks | -1.4 score on a scale | Standard Deviation 9.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 2 Day 15 | -11.5 score on a scale | Standard Deviation 21 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 15 | 6.8 score on a scale | Standard Deviation 29.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 91 Weeks | -4.3 score on a scale | Standard Deviation 11.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Cycle 1 Day 1 (Baseline) | 18.4 score on a scale | Standard Deviation 23.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 104 Weeks | 1.3 score on a scale | Standard Deviation 14.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 143 Weeks | -9.5 score on a scale | Standard Deviation 16.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 7 Day 1 | 10.7 score on a scale | Standard Deviation 22.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 156 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 182 Weeks | 27.8 score on a scale | Standard Deviation 9.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 169 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 15 | 2.5 score on a scale | Standard Deviation 21.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 22 | 3.0 score on a scale | Standard Deviation 9.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 169 Weeks | 25.0 score on a scale | Standard Deviation 11.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 2 Day 1 | 1.3 score on a scale | Standard Deviation 19.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 156 Weeks | 27.8 score on a scale | Standard Deviation 25.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 13 Day 1 | -8.1 score on a scale | Standard Deviation 24.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 2 Day 15 | 1.7 score on a scale | Standard Deviation 21.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 130 Weeks | 9.8 score on a scale | Standard Deviation 15.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 9 Day 1 | 7.7 score on a scale | Standard Deviation 25 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 10 Day 1 | 6.9 score on a scale | Standard Deviation 21.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 12 Day 1 | 8.5 score on a scale | Standard Deviation 20.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 12 Day 1 | -8.7 score on a scale | Standard Deviation 26.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 11 Day 1 | 6.1 score on a scale | Standard Deviation 19.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 13 Day 1 | 8.5 score on a scale | Standard Deviation 24.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 11 Day 1 | -6.6 score on a scale | Standard Deviation 24.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at End of Treatment | 0.8 score on a scale | Standard Deviation 21.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 10 Day 1 | -8.5 score on a scale | Standard Deviation 25.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 13 Weeks | -0.4 score on a scale | Standard Deviation 15.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 143 Weeks | 7.1 score on a scale | Standard Deviation 18.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 26 Weeks | -2.2 score on a scale | Standard Deviation 16.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 13 Weeks | 0.0 score on a scale | Standard Deviation 13.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 4 Day 1 | -8.4 score on a scale | Standard Deviation 23.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 39 Weeks | -1.7 score on a scale | Standard Deviation 15.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 52 Weeks | -1.8 score on a scale | Standard Deviation 17.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 104 Weeks | 0.0 score on a scale | Standard Deviation 9.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 39 Weeks | -0.4 score on a scale | Standard Deviation 12.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 3 Day 1 | -9.7 score on a scale | Standard Deviation 25.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 10.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 130 Weeks | -2.0 score on a scale | Standard Deviation 8.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 182 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT/Discontinuation | 0.0 score on a scale | Standard Deviation 17.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 2 Day 15 | -11.1 score on a scale | Standard Deviation 25.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Cycle 1 Day 1 (Baseline) | 3.6 score on a scale | Standard Deviation 10.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 8 | 4.2 score on a scale | Standard Deviation 11.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 4 Day 1 | 3.1 score on a scale | Standard Deviation 15.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 5 Day 1 | 5.2 score on a scale | Standard Deviation 14.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 52 Weeks | 0.4 score on a scale | Standard Deviation 17.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 2 Day 1 | -13.0 score on a scale | Standard Deviation 26.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 7 Day 1 | 5.3 score on a scale | Standard Deviation 16.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 6 Day 1 | -8.9 score on a scale | Standard Deviation 18.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 8 Day 1 | 4.2 score on a scale | Standard Deviation 16.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 22 | -10.6 score on a scale | Standard Deviation 28.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 52 Weeks | 1.8 score on a scale | Standard Deviation 15.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 91 Weeks | 3.5 score on a scale | Standard Deviation 27.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 65 Weeks | 3.8 score on a scale | Standard Deviation 14.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 15 | -19.4 score on a scale | Standard Deviation 29.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 18 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 65 Weeks | -1.9 score on a scale | Standard Deviation 12.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 8 | -2.8 score on a scale | Standard Deviation 15.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 156 Weeks | 22.2 score on a scale | Standard Deviation 9.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 169 Weeks | 25.0 score on a scale | Standard Deviation 11.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT/Discont. | -5.2 score on a scale | Standard Deviation 28.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Cycle 1 Day 1 (Baseline) | 86.7 score on a scale | Standard Deviation 21.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 2 Day 1 | 13.2 score on a scale | Standard Deviation 22 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 2 Day 15 | 15.2 score on a scale | Standard Deviation 23.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 6 Day 1 | 11.9 score on a scale | Standard Deviation 21.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 117 Weeks | -1.5 score on a scale | Standard Deviation 12.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT/Discontin. | -4.2 score on a scale | Standard Deviation 19.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 8 Day 1 | 14.1 score on a scale | Standard Deviation 23.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 182 Weeks | 19.4 score on a scale | Standard Deviation 12.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 9 Day 1 | 16.3 score on a scale | Standard Deviation 25.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 9 Day 1 | -11.3 score on a scale | Standard Deviation 21.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 10 Day 1 | 11.3 score on a scale | Standard Deviation 22.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 78 Weeks | -1.4 score on a scale | Standard Deviation 25.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 169 Weeks | 8.3 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 13 Weeks | 1.6 score on a scale | Standard Deviation 18.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 26 Weeks | 2.5 score on a scale | Standard Deviation 18.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 156 Weeks | 11.1 score on a scale | Standard Deviation 4.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 91 Weeks | -0.8 score on a scale | Standard Deviation 16.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 104 Weeks | -1.2 score on a scale | Standard Deviation 14.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 169 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 143 Weeks | -1.2 score on a scale | Standard Deviation 18.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 117 Weeks | -3.0 score on a scale | Standard Deviation 13.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 130 Weeks | -0.7 score on a scale | Standard Deviation 15.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 182 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 130 Weeks | 2.1 score on a scale | Standard Deviation 7.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 143 Weeks | -1.6 score on a scale | Standard Deviation 14.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT/Discontinuation | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 156 Weeks | -11.1 score on a scale | Standard Deviation 11.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 117 Weeks | 0.4 score on a scale | Standard Deviation 20.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 2 Day 1 | 0.0 score on a scale | Standard Deviation 17.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 7 Day 1 | -8.0 score on a scale | Standard Deviation 22.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 2 Day 15 | 1.1 score on a scale | Standard Deviation 20.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 65 Weeks | 5.3 score on a scale | Standard Deviation 19.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 117 Weeks | 9.1 score on a scale | Standard Deviation 15.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Cycle 1 Day 1 (Baseline) | 93.0 score on a scale | Standard Deviation 14.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 5 Day 1 | 1.2 score on a scale | Standard Deviation 23 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 104 Weeks | 1.2 score on a scale | Standard Deviation 14.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 104 Weeks | 0.0 score on a scale | Standard Deviation 16 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 15 | -4.3 score on a scale | Standard Deviation 13.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 91 Weeks | 0.3 score on a scale | Standard Deviation 17.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 14.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 8 Day 1 | -0.6 score on a scale | Standard Deviation 23.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 2 Day 1 | -6.2 score on a scale | Standard Deviation 14.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 78 Weeks | -0.9 score on a scale | Standard Deviation 15.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 11 Day 1 | 1.4 score on a scale | Standard Deviation 21.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 13 Day 1 | 1.2 score on a scale | Standard Deviation 23.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at End of Treatment | 2.5 score on a scale | Standard Deviation 23.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 22 | -0.8 score on a scale | Standard Deviation 17.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 65 Weeks | -0.9 score on a scale | Standard Deviation 17.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 91 Weeks | 0.0 score on a scale | Standard Deviation 27.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 52 Weeks | -2.3 score on a scale | Standard Deviation 15.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 143 Weeks | 4.8 score on a scale | Standard Deviation 40.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 39 Weeks | 2.7 score on a scale | Standard Deviation 24.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 156 Weeks | -22.2 score on a scale | Standard Deviation 38.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 91 Weeks | 2.6 score on a scale | Standard Deviation 21.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 169 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 2 Day 15 | -3.8 score on a scale | Standard Deviation 15.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 6 Day 1 | -4.7 score on a scale | Standard Deviation 14.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 8 Day 1 | -8.3 score on a scale | Standard Deviation 23.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 26 Weeks | -2.6 score on a scale | Standard Deviation 20.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 7 Day 1 | -4.7 score on a scale | Standard Deviation 13.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 4 Day 1 | -3.8 score on a scale | Standard Deviation 14.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 11 Day 1 | -4.2 score on a scale | Standard Deviation 14.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 13 Weeks | -1.7 score on a scale | Standard Deviation 18.9 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 12 Day 1 | -5.4 score on a scale | Standard Deviation 15.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 2 Day 15 | -8.3 score on a scale | Standard Deviation 21.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 26 Weeks | 0.9 score on a scale | Standard Deviation 24.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 26 Weeks | -1.9 score on a scale | Standard Deviation 12.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 6 Day 1 | -5.7 score on a scale | Standard Deviation 15.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 13 Weeks | 0.1 score on a scale | Standard Deviation 16 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at End of Treatment | -6.1 score on a scale | Standard Deviation 21.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 39 Weeks | 0.4 score on a scale | Standard Deviation 10.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 8 Day 1 | -7.4 score on a scale | Standard Deviation 16.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at EOT | -5.2 score on a scale | Standard Deviation 19 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 78 Weeks | -0.5 score on a scale | Standard Deviation 8.6 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT/Discontin. | 0.0 score on a scale | Standard Deviation 17.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 13 Day 1 | -7.5 score on a scale | Standard Deviation 17.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Cycle 1 Day 1 (Baseline) | 1.4 score on a scale | Standard Deviation 5.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 104 Weeks | 2.5 score on a scale | Standard Deviation 8.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 9 Day 1 | -8.2 score on a scale | Standard Deviation 18.1 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 130 Weeks | -1.2 score on a scale | Standard Deviation 4.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 12 Day 1 | -9.3 score on a scale | Standard Deviation 20.2 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 11 Day 1 | -7.8 score on a scale | Standard Deviation 19.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 13 Day 1 | -2.0 score on a scale | Standard Deviation 20.4 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 182 Weeks | 2.2 score on a scale | Standard Deviation 3.8 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT/Discontin. | -0.8 score on a scale | Standard Deviation 8.3 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 169 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Cycle 1 Day 1 (Baseline) | 79.0 score on a scale | Standard Deviation 16.7 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 8 | -9.4 score on a scale | Standard Deviation 20.5 |
| Cohort 1 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 169 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 91 Weeks | -3.4 score on a scale | Standard Deviation 12.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 13 Day 1 | 0.4 score on a scale | Standard Deviation 25.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at End of Treatment | 0.8 score on a scale | Standard Deviation 20.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT/Discontin. | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 15 | 1.8 score on a scale | Standard Deviation 6.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 12 Day 1 | -2.2 score on a scale | Standard Deviation 16.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 13 Weeks | 1.8 score on a scale | Standard Deviation 17.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Cycle 1 Day 1 (Baseline) | 77.9 score on a scale | Standard Deviation 18.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at End of Treatment | 0.0 score on a scale | Standard Deviation 20.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 8 | 0.4 score on a scale | Standard Deviation 7.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 5 Day 1 | 2.6 score on a scale | Standard Deviation 9.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at End of Treatment | 4.1 score on a scale | Standard Deviation 23.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 143 Weeks | 5.6 score on a scale | Standard Deviation 7.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 5 Day 1 | -1.0 score on a scale | Standard Deviation 11.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 13 Weeks | -1.8 score on a scale | Standard Deviation 24 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 15 | -0.4 score on a scale | Standard Deviation 11.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 10 Day 1 | -1.7 score on a scale | Standard Deviation 19.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 117 Weeks | 2.5 score on a scale | Standard Deviation 15 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 11 Day 1 | 0.5 score on a scale | Standard Deviation 14.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 9 Day 1 | 0.0 score on a scale | Standard Deviation 20.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 3 Day 1 | -1.0 score on a scale | Standard Deviation 14.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 2 Day 15 | -1.1 score on a scale | Standard Deviation 14.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 26 Weeks | -3.2 score on a scale | Standard Deviation 24.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT/Discontinuation | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 4 Day 1 | -1.0 score on a scale | Standard Deviation 14.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at End of Treatment | -3.5 score on a scale | Standard Deviation 19.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 10 Day 1 | -1.1 score on a scale | Standard Deviation 14.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 39 Weeks | 2.7 score on a scale | Standard Deviation 15.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 39 Weeks | -4.9 score on a scale | Standard Deviation 23.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 13 Weeks | 1.8 score on a scale | Standard Deviation 16.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 143 Weeks | -16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 9 Day 1 | -0.9 score on a scale | Standard Deviation 17 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 3 Day 1 | 0.4 score on a scale | Standard Deviation 19 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 2 Day 1 | -3.1 score on a scale | Standard Deviation 21 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 52 Weeks | -3.8 score on a scale | Standard Deviation 23.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 8 Day 1 | 1.1 score on a scale | Standard Deviation 9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 6 Day 1 | -0.8 score on a scale | Standard Deviation 12.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 7 Day 1 | -1.6 score on a scale | Standard Deviation 16.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 8 Day 1 | -0.9 score on a scale | Standard Deviation 15.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 11 Day 1 | 2.0 score on a scale | Standard Deviation 8.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 104 Weeks | -5.3 score on a scale | Standard Deviation 28.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 117 Weeks | 2.0 score on a scale | Standard Deviation 21.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 12 Day 1 | 1.3 score on a scale | Standard Deviation 7.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 13 Weeks | -1.6 score on a scale | Standard Deviation 14.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at End of Treatment | 0.3 score on a scale | Standard Deviation 12.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 39 Weeks | -1.0 score on a scale | Standard Deviation 14.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 13 Weeks | -0.1 score on a scale | Standard Deviation 15.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 2 Day 15 | -2.2 score on a scale | Standard Deviation 20.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 13 Weeks | 1.8 score on a scale | Standard Deviation 8.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 52 Weeks | 0.3 score on a scale | Standard Deviation 4.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 117 Weeks | -11.8 score on a scale | Standard Deviation 31 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 39 Weeks | -0.5 score on a scale | Standard Deviation 7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 2 Day 15 | -0.6 score on a scale | Standard Deviation 18.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 65 Weeks | 3.5 score on a scale | Standard Deviation 12.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 130 Weeks | -8.3 score on a scale | Standard Deviation 20.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 15 | -0.2 score on a scale | Standard Deviation 8.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT/Discont. | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 78 Weeks | 2.0 score on a scale | Standard Deviation 11.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 130 Weeks | -2.8 score on a scale | Standard Deviation 43.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at EOT | -3.6 score on a scale | Standard Deviation 19 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 7 Day 1 | 0.4 score on a scale | Standard Deviation 11.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 91 Weeks | 2.3 score on a scale | Standard Deviation 8.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 52 Weeks | -1.9 score on a scale | Standard Deviation 9.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 52 Weeks | 1.6 score on a scale | Standard Deviation 14.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Cycle 1 Day 1 (Baseline) | 92.3 score on a scale | Standard Deviation 11.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT/Discontinuation | -33.3 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 2 Day 15 | 2.7 score on a scale | Standard Deviation 16.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 104 Weeks | -4.7 score on a scale | Standard Deviation 19.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 26 Weeks | 3.0 score on a scale | Standard Deviation 17.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Cycle 1 Day 1 (Baseline) | 4.8 score on a scale | Standard Deviation 12.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT/Discont. | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 91 Weeks | -1.7 score on a scale | Standard Deviation 17.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 22 | -3.2 score on a scale | Standard Deviation 13.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 91 Weeks | -2.3 score on a scale | Standard Deviation 15.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 8 Day 1 | -1.6 score on a scale | Standard Deviation 17.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 2 Day 1 | 0.2 score on a scale | Standard Deviation 16.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 2 Day 1 | 0.5 score on a scale | Standard Deviation 15.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 5 Day 1 | -5.5 score on a scale | Standard Deviation 26.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT/Discontin. | -33.3 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 8 | -1.5 score on a scale | Standard Deviation 7.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 2 Day 15 | 2.4 score on a scale | Standard Deviation 17.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Cycle 1 Day 1 (Baseline) | 92.0 score on a scale | Standard Deviation 16.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 10 Day 1 | -1.6 score on a scale | Standard Deviation 11.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 5 Day 1 | 4.0 score on a scale | Standard Deviation 14.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 3 Day 1 | 1.2 score on a scale | Standard Deviation 16.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 52 Weeks | 0.8 score on a scale | Standard Deviation 20.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 7 Day 1 | 0.9 score on a scale | Standard Deviation 16.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 6 Day 1 | 2.4 score on a scale | Standard Deviation 13.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 52 Weeks | 0.0 score on a scale | Standard Deviation 12.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 91 Weeks | -2.6 score on a scale | Standard Deviation 17.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 8 Day 1 | 3.6 score on a scale | Standard Deviation 20.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 15 | 0.8 score on a scale | Standard Deviation 13.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 12 Day 1 | -0.8 score on a scale | Standard Deviation 16 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 11 Day 1 | 2.7 score on a scale | Standard Deviation 21.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 91 Weeks | -1.1 score on a scale | Standard Deviation 25.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 7 Day 1 | 3.7 score on a scale | Standard Deviation 17.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 13 Day 1 | 3.4 score on a scale | Standard Deviation 21.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 104 Weeks | 6.7 score on a scale | Standard Deviation 16.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 22 | 1.6 score on a scale | Standard Deviation 9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 13 Weeks | 2.7 score on a scale | Standard Deviation 15.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 130 Weeks | -1.4 score on a scale | Standard Deviation 15 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 8 Day 1 | 4.1 score on a scale | Standard Deviation 17.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 26 Weeks | -1.2 score on a scale | Standard Deviation 16.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 130 Weeks | -5.0 score on a scale | Standard Deviation 11.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 11 Day 1 | -1.3 score on a scale | Standard Deviation 10.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 39 Weeks | 2.2 score on a scale | Standard Deviation 22.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 52 Weeks | 3.8 score on a scale | Standard Deviation 16.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 7 Day 1 | -5.6 score on a scale | Standard Deviation 26.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 143 Weeks | 8.3 score on a scale | Standard Deviation 11.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 15 | 0.2 score on a scale | Standard Deviation 16.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 15 | 0.8 score on a scale | Standard Deviation 12.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 91 Weeks | 4.6 score on a scale | Standard Deviation 25.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 117 Weeks | 8.8 score on a scale | Standard Deviation 22.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 78 Weeks | -1.5 score on a scale | Standard Deviation 15.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 8 | -0.8 score on a scale | Standard Deviation 10.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 130 Weeks | 6.9 score on a scale | Standard Deviation 31.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 4 Day 1 | -1.3 score on a scale | Standard Deviation 15.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 143 Weeks | -4.2 score on a scale | Standard Deviation 5.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Cycle 1 Day 1 (Baseline) | 86.1 score on a scale | Standard Deviation 16.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 6 Day 1 | -0.7 score on a scale | Standard Deviation 16.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 104 Weeks | -4.9 score on a scale | Standard Deviation 10.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 2 Day 1 | 1.2 score on a scale | Standard Deviation 10.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 2 Day 1 | -0.3 score on a scale | Standard Deviation 9.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 10 Day 1 | -8.6 score on a scale | Standard Deviation 25.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 22 | 2.4 score on a scale | Standard Deviation 9.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 78 Weeks | 1.0 score on a scale | Standard Deviation 30.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 5 Day 1 | -0.2 score on a scale | Standard Deviation 18.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 2 Day 1 | 2.5 score on a scale | Standard Deviation 13.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Cycle 1 Day 1 (Baseline) | 87.2 score on a scale | Standard Deviation 22.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 11 Day 1 | -0.8 score on a scale | Standard Deviation 15.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT/Discontin. | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 4 Day 1 | 1.8 score on a scale | Standard Deviation 15.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 65 Weeks | 0.9 score on a scale | Standard Deviation 14.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 12 Day 1 | -1.6 score on a scale | Standard Deviation 11.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 2 Day 15 | 0.0 score on a scale | Standard Deviation 13 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 11 Day 1 | -7.5 score on a scale | Standard Deviation 21.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 2 Day 1 | 2.5 score on a scale | Standard Deviation 15.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 7 Day 1 | 4.5 score on a scale | Standard Deviation 17 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 3 Day 1 | 1.0 score on a scale | Standard Deviation 13.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT/Discontin. | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 26 Weeks | 0.5 score on a scale | Standard Deviation 28.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 8 Day 1 | -3.6 score on a scale | Standard Deviation 16.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 4 Day 1 | 0.5 score on a scale | Standard Deviation 16.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 2 Day 15 | 1.5 score on a scale | Standard Deviation 18.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 6 Day 1 | 1.8 score on a scale | Standard Deviation 25.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 78 Weeks | -4.0 score on a scale | Standard Deviation 20 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 5 Day 1 | 0.3 score on a scale | Standard Deviation 16.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 2 Day 15 | 1.0 score on a scale | Standard Deviation 12.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 13 Day 1 | -6.0 score on a scale | Standard Deviation 22.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 6 Day 1 | 1.5 score on a scale | Standard Deviation 17.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 6 Day 1 | 1.8 score on a scale | Standard Deviation 16.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 7 Day 1 | 0.2 score on a scale | Standard Deviation 18.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 5 Day 1 | 0.3 score on a scale | Standard Deviation 23.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 39 Weeks | 0.2 score on a scale | Standard Deviation 21.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 7 Day 1 | 1.5 score on a scale | Standard Deviation 19 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 65 Weeks | -2.0 score on a scale | Standard Deviation 15.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 13 Weeks | 0.1 score on a scale | Standard Deviation 9.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 11 Day 1 | 0.0 score on a scale | Standard Deviation 16.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 8 Day 1 | 3.9 score on a scale | Standard Deviation 21.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 117 Weeks | 2.0 score on a scale | Standard Deviation 14.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at End of Treatment | -3.7 score on a scale | Standard Deviation 26.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 12 Day 1 | -1.8 score on a scale | Standard Deviation 14.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 13 Day 1 | -2.5 score on a scale | Standard Deviation 18.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 3 Day 1 | -1.3 score on a scale | Standard Deviation 23 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 9 Day 1 | 2.7 score on a scale | Standard Deviation 20.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 13 Day 1 | 0.0 score on a scale | Standard Deviation 18.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at End of Treatment | 1.2 score on a scale | Standard Deviation 25.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 22 | 1.6 score on a scale | Standard Deviation 11.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 6 Day 1 | 2.4 score on a scale | Standard Deviation 12.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 15 | 1.0 score on a scale | Standard Deviation 19.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at End of Treatment | 2.2 score on a scale | Standard Deviation 24.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 78 Weeks | 6.1 score on a scale | Standard Deviation 25.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 52 Weeks | -0.7 score on a scale | Standard Deviation 15.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 78 Weeks | -1.0 score on a scale | Standard Deviation 10.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 91 Weeks | -10.3 score on a scale | Standard Deviation 29.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 91 Weeks | 6.0 score on a scale | Standard Deviation 18.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 13 Weeks | 0.7 score on a scale | Standard Deviation 19.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 2 Day 1 | -2.5 score on a scale | Standard Deviation 14.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 26 Weeks | 1.0 score on a scale | Standard Deviation 15.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT/Discontinuation | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 13 Day 1 | -3.4 score on a scale | Standard Deviation 19.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 117 Weeks | 5.9 score on a scale | Standard Deviation 13.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 26 Weeks | 0.0 score on a scale | Standard Deviation 8.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 91 Weeks | 3.8 score on a scale | Standard Deviation 18.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 15 | -0.7 score on a scale | Standard Deviation 14.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 7 Day 1 | 1.5 score on a scale | Standard Deviation 14 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 130 Weeks | 2.8 score on a scale | Standard Deviation 17.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 22 | -1.6 score on a scale | Standard Deviation 16.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 2 Day 15 | 0.2 score on a scale | Standard Deviation 13.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 143 Weeks | -4.2 score on a scale | Standard Deviation 5.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 143 Weeks | 16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 2 Day 1 | -0.9 score on a scale | Standard Deviation 16.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 104 Weeks | 8.9 score on a scale | Standard Deviation 18.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 11 Day 1 | -2.9 score on a scale | Standard Deviation 15.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 91 Weeks | 1.7 score on a scale | Standard Deviation 20.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 2 Day 15 | -1.5 score on a scale | Standard Deviation 19.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 11 Day 1 | 1.8 score on a scale | Standard Deviation 14.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 8 Day 1 | -0.9 score on a scale | Standard Deviation 21.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 5 Day 1 | -0.1 score on a scale | Standard Deviation 15.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 22 | 5.6 score on a scale | Standard Deviation 13.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 117 Weeks | 4.2 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 9 Day 1 | 0.7 score on a scale | Standard Deviation 24.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 12 Day 1 | -0.4 score on a scale | Standard Deviation 17.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 10 Day 1 | -0.3 score on a scale | Standard Deviation 22.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 130 Weeks | -3.5 score on a scale | Standard Deviation 16.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 130 Weeks | 6.5 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 12 Day 1 | -0.7 score on a scale | Standard Deviation 23.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 12 Day 1 | 1.5 score on a scale | Standard Deviation 14 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 11 Day 1 | -1.3 score on a scale | Standard Deviation 19.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 3 Day 1 | -5.2 score on a scale | Standard Deviation 24.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 65 Weeks | 0.9 score on a scale | Standard Deviation 21.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Cycle 1 Day 1 (Baseline) | 20.9 score on a scale | Standard Deviation 30 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 4 Day 1 | -2.8 score on a scale | Standard Deviation 24.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 2 Day 15 | 0.5 score on a scale | Standard Deviation 25.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 6 Day 1 | -7.4 score on a scale | Standard Deviation 26.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 4 Day 1 | 1.7 score on a scale | Standard Deviation 18.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 65 Weeks | 6.1 score on a scale | Standard Deviation 15.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 117 Weeks | 9.8 score on a scale | Standard Deviation 19.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 8 | 1.5 score on a scale | Standard Deviation 7.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 78 Weeks | 7.1 score on a scale | Standard Deviation 18.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 26 Weeks | 1.4 score on a scale | Standard Deviation 16.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 52 Weeks | 0.0 score on a scale | Standard Deviation 16.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 9 Day 1 | -0.5 score on a scale | Standard Deviation 16.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 91 Weeks | 5.7 score on a scale | Standard Deviation 12.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 8 Day 1 | -4.7 score on a scale | Standard Deviation 27 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 130 Weeks | 5.6 score on a scale | Standard Deviation 13 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 9 Day 1 | 1.7 score on a scale | Standard Deviation 19.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 13 Weeks | -0.2 score on a scale | Standard Deviation 18.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 9 Day 1 | -8.9 score on a scale | Standard Deviation 23 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 2 Day 1 | -1.2 score on a scale | Standard Deviation 22.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 65 Weeks | 0.9 score on a scale | Standard Deviation 16 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 39 Weeks | 0.7 score on a scale | Standard Deviation 17.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 12 Day 1 | -6.3 score on a scale | Standard Deviation 23.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 117 Weeks | -7.8 score on a scale | Standard Deviation 30.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 12 Day 1 | 1.3 score on a scale | Standard Deviation 19.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT/Discontinuation | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 13 Weeks | -5.9 score on a scale | Standard Deviation 24.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 39 Weeks | 2.5 score on a scale | Standard Deviation 13.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 22 | -1.9 score on a scale | Standard Deviation 14.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 8 | 0.3 score on a scale | Standard Deviation 4.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 26 Weeks | -6.0 score on a scale | Standard Deviation 18.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Cycle 1 Day 1 (Baseline) | 5.4 score on a scale | Standard Deviation 17.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 39 Weeks | -7.8 score on a scale | Standard Deviation 25.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 52 Weeks | -5.4 score on a scale | Standard Deviation 21.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 22 | -3.2 score on a scale | Standard Deviation 23.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 3 Day 1 | 1.5 score on a scale | Standard Deviation 16.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 65 Weeks | -6.1 score on a scale | Standard Deviation 30.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 8 | 0.0 score on a scale | Standard Deviation 10.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 15 | 1.4 score on a scale | Standard Deviation 12 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 117 Weeks | -5.9 score on a scale | Standard Deviation 24.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at End of Treatment | -2.0 score on a scale | Standard Deviation 19.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 130 Weeks | -5.6 score on a scale | Standard Deviation 31.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 8 | 1.5 score on a scale | Standard Deviation 14.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 10 Day 1 | 1.9 score on a scale | Standard Deviation 17.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Cycle 1 Day 1 (Baseline) | 17.0 score on a scale | Standard Deviation 25.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 78 Weeks | 2.0 score on a scale | Standard Deviation 14.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 2 Day 15 | -0.7 score on a scale | Standard Deviation 10.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 3 Day 1 | -0.3 score on a scale | Standard Deviation 18.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 9 Day 1 | 3.6 score on a scale | Standard Deviation 21.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 8 | 1.9 score on a scale | Standard Deviation 12 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 3 Day 1 | -0.7 score on a scale | Standard Deviation 11 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 78 Weeks | -8.1 score on a scale | Standard Deviation 31.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT/Discontinuation | -22.2 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 4 Day 1 | -0.2 score on a scale | Standard Deviation 10.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 104 Weeks | 4.0 score on a scale | Standard Deviation 27.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 6 Day 1 | 2.2 score on a scale | Standard Deviation 18.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 4 Day 1 | 0.3 score on a scale | Standard Deviation 19.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT/Discontin. | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 13 Weeks | -1.0 score on a scale | Standard Deviation 19.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 8 Day 1 | -0.8 score on a scale | Standard Deviation 13.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 104 Weeks | -7.3 score on a scale | Standard Deviation 20.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 5 Day 1 | 1.9 score on a scale | Standard Deviation 17.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 5 Day 1 | -1.4 score on a scale | Standard Deviation 20.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 9 Day 1 | -0.5 score on a scale | Standard Deviation 12.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 65 Weeks | 1.8 score on a scale | Standard Deviation 21.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 13 Day 1 | -1.9 score on a scale | Standard Deviation 21.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 4 Day 1 | 4.0 score on a scale | Standard Deviation 19.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 4 Day 1 | 2.0 score on a scale | Standard Deviation 18.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 13 Day 1 | -3.0 score on a scale | Standard Deviation 14.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 6 Day 1 | -0.6 score on a scale | Standard Deviation 20 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 22 | 3.2 score on a scale | Standard Deviation 10 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 26 Weeks | -1.4 score on a scale | Standard Deviation 14.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at End of Treatment | -2.9 score on a scale | Standard Deviation 16 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 3 Day 1 | -0.6 score on a scale | Standard Deviation 12 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 52 Weeks | 1.7 score on a scale | Standard Deviation 17.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 7 Day 1 | -1.5 score on a scale | Standard Deviation 21.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 39 Weeks | -1.7 score on a scale | Standard Deviation 13.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 3 Day 1 | 2.3 score on a scale | Standard Deviation 17.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 8 | -1.5 score on a scale | Standard Deviation 15.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 65 Weeks | 4.4 score on a scale | Standard Deviation 18.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 130 Weeks | 6.9 score on a scale | Standard Deviation 16.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 3 Day 1 | 2.3 score on a scale | Standard Deviation 13.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 11 Day 1 | 1.1 score on a scale | Standard Deviation 23.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 52 Weeks | -0.5 score on a scale | Standard Deviation 11.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 104 Weeks | -1.3 score on a scale | Standard Deviation 6.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 65 Weeks | -2.6 score on a scale | Standard Deviation 13.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at End Of Treatment | -1.3 score on a scale | Standard Deviation 23.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Cycle 1 Day 1 (Baseline) | 1.8 score on a scale | Standard Deviation 9.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 39 Weeks | -0.2 score on a scale | Standard Deviation 14.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Cycle 1 Day 1 (Baseline) | 12.8 score on a scale | Standard Deviation 21.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 3 Day 1 | 1.6 score on a scale | Standard Deviation 10.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 13 Day 1 | 1.9 score on a scale | Standard Deviation 13.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 12 Day 1 | -0.4 score on a scale | Standard Deviation 15.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 8 | 0.8 score on a scale | Standard Deviation 6.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 65 Weeks | -6.1 score on a scale | Standard Deviation 29.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 5 Day 1 | 1.9 score on a scale | Standard Deviation 16.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 13 Day 1 | -4.5 score on a scale | Standard Deviation 22.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 130 Weeks | 4.2 score on a scale | Standard Deviation 10.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 52 Weeks | -0.7 score on a scale | Standard Deviation 16.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 117 Weeks | -7.1 score on a scale | Standard Deviation 14.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 5 Day 1 | -2.0 score on a scale | Standard Deviation 14.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 78 Weeks | -7.1 score on a scale | Standard Deviation 29.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT/Discontinuation | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 22 | 0.8 score on a scale | Standard Deviation 6.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 6 Day 1 | -2.1 score on a scale | Standard Deviation 12.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 117 Weeks | 4.9 score on a scale | Standard Deviation 9.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 104 Weeks | -8.0 score on a scale | Standard Deviation 30.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 117 Weeks | -2.9 score on a scale | Standard Deviation 14.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 2 Day 1 | 0.9 score on a scale | Standard Deviation 5.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 52 Weeks | 0.5 score on a scale | Standard Deviation 26.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 10 Day 1 | 3.4 score on a scale | Standard Deviation 18.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 91 Weeks | -9.2 score on a scale | Standard Deviation 25 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 104 Weeks | 0.0 score on a scale | Standard Deviation 4.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 65 Weeks | -2.0 score on a scale | Standard Deviation 17.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 2 Day 15 | 1.1 score on a scale | Standard Deviation 8.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 7 Day 1 | -3.1 score on a scale | Standard Deviation 13.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 8 Day 1 | -1.9 score on a scale | Standard Deviation 23 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 4 Day 1 | 1.3 score on a scale | Standard Deviation 12.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 3 Day 1 | 1.6 score on a scale | Standard Deviation 7.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 9 Day 1 | -4.6 score on a scale | Standard Deviation 17.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 65 Weeks | -1.3 score on a scale | Standard Deviation 16.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 4 Day 1 | 1.9 score on a scale | Standard Deviation 11.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 39 Weeks | 0.2 score on a scale | Standard Deviation 6.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 11 Day 1 | 1.4 score on a scale | Standard Deviation 15.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 22 | 1.2 score on a scale | Standard Deviation 10.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 39 Weeks | -0.5 score on a scale | Standard Deviation 29.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 26 Weeks | 0.7 score on a scale | Standard Deviation 15.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 8 | -3.0 score on a scale | Standard Deviation 14.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 2 Day 1 | -1.2 score on a scale | Standard Deviation 14.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 7 Day 1 | 0.9 score on a scale | Standard Deviation 21.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 8 | -3.0 score on a scale | Standard Deviation 14.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 6 Day 1 | -2.2 score on a scale | Standard Deviation 16.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 10 Day 1 | -3.6 score on a scale | Standard Deviation 17.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 78 Weeks | -1.8 score on a scale | Standard Deviation 22.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 13 Day 1 | 1.7 score on a scale | Standard Deviation 7.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 2 Day 15 | 2.0 score on a scale | Standard Deviation 15.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 6 Day 1 | 2.4 score on a scale | Standard Deviation 9.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 130 Weeks | -5.6 score on a scale | Standard Deviation 14.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 6 Day 1 | -0.5 score on a scale | Standard Deviation 18.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 7 Day 1 | 2.0 score on a scale | Standard Deviation 7.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 104 Weeks | 11.3 score on a scale | Standard Deviation 22.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 10 Day 1 | 0.9 score on a scale | Standard Deviation 10.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 15 | 0.2 score on a scale | Standard Deviation 8.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 9 Day 1 | 2.5 score on a scale | Standard Deviation 10.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 11 Day 1 | 2.7 score on a scale | Standard Deviation 18.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 91 Weeks | 0.0 score on a scale | Standard Deviation 17.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 12 Day 1 | -4.0 score on a scale | Standard Deviation 14.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 10 Day 1 | 0.0 score on a scale | Standard Deviation 16.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 22 | -1.6 score on a scale | Standard Deviation 7.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 5 Day 1 | 1.4 score on a scale | Standard Deviation 12.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 13 Day 1 | -3.9 score on a scale | Standard Deviation 16.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 15 | 2.3 score on a scale | Standard Deviation 14.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 13 Weeks | -1.8 score on a scale | Standard Deviation 25.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 5 Day 1 | 0.6 score on a scale | Standard Deviation 20.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 26 Weeks | -2.5 score on a scale | Standard Deviation 14.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 104 Weeks | -7.0 score on a scale | Standard Deviation 21.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 2 Day 1 | 0.2 score on a scale | Standard Deviation 11.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 91 Weeks | 2.3 score on a scale | Standard Deviation 12.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 78 Weeks | 4.7 score on a scale | Standard Deviation 20.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 65 Weeks | -3.9 score on a scale | Standard Deviation 15.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 169 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at End Of Treatment | 1.3 score on a scale | Standard Deviation 28.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 2 Day 15 | 1.0 score on a scale | Standard Deviation 13.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 78 Weeks | -3.5 score on a scale | Standard Deviation 19.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 7 Day 1 | 0.5 score on a scale | Standard Deviation 16.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 4 Day 1 | 0.3 score on a scale | Standard Deviation 21.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 12 Day 1 | 2.1 score on a scale | Standard Deviation 16.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 104 Weeks | -4.0 score on a scale | Standard Deviation 16.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 3 Day 1 | 1.8 score on a scale | Standard Deviation 13.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 13 Day 1 | 3.8 score on a scale | Standard Deviation 31.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 8 Day 1 | 1.9 score on a scale | Standard Deviation 13.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 10.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 39 Weeks | -0.9 score on a scale | Standard Deviation 15.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 4 Day 1 | 3.1 score on a scale | Standard Deviation 14.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT/Discontin. | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 2 Day 1 | 2.2 score on a scale | Standard Deviation 16.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 6 Day 1 | 1.9 score on a scale | Standard Deviation 17.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 130 Weeks | -4.9 score on a scale | Standard Deviation 15.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Cycle 1 Day 1 (Baseline) | 5.7 score on a scale | Standard Deviation 16.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 15 | 0.5 score on a scale | Standard Deviation 12.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 12 Day 1 | 0.0 score on a scale | Standard Deviation 27.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 26 Weeks | 0.5 score on a scale | Standard Deviation 14.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 8 | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 5 Day 1 | 3.3 score on a scale | Standard Deviation 17.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT/Discont. | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 26 Weeks | -1.4 score on a scale | Standard Deviation 15.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 15 | 0.7 score on a scale | Standard Deviation 13 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 9 Day 1 | 5.3 score on a scale | Standard Deviation 16.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 11 Day 1 | -0.7 score on a scale | Standard Deviation 25.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 15 | 1.9 score on a scale | Standard Deviation 12.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 22 | 1.6 score on a scale | Standard Deviation 7.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 11 Day 1 | 5.0 score on a scale | Standard Deviation 19 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 22 | -3.2 score on a scale | Standard Deviation 14.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Cycle 1 Day 1 (Baseline) | 16.1 score on a scale | Standard Deviation 19.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 2 Day 1 | 1.4 score on a scale | Standard Deviation 10.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 8 | 0.8 score on a scale | Standard Deviation 12 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 10 Day 1 | 0.7 score on a scale | Standard Deviation 22 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 10 Day 1 | 4.5 score on a scale | Standard Deviation 16.4 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 26 Weeks | 4.2 score on a scale | Standard Deviation 15 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 9 Day 1 | 2.3 score on a scale | Standard Deviation 13.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 13 Day 1 | 4.0 score on a scale | Standard Deviation 19 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 8 Day 1 | 1.6 score on a scale | Standard Deviation 16.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 8 Day 1 | 2.2 score on a scale | Standard Deviation 17.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 9 Day 1 | 0.7 score on a scale | Standard Deviation 27.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 12 Day 1 | 5.5 score on a scale | Standard Deviation 18.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 9 Day 1 | -2.3 score on a scale | Standard Deviation 13.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 15 | -1.9 score on a scale | Standard Deviation 20 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 104 Weeks | 0.0 score on a scale | Standard Deviation 19.2 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 10 Day 1 | -0.7 score on a scale | Standard Deviation 15.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 10 Day 1 | -1.4 score on a scale | Standard Deviation 12.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at End of Treatment | 2.4 score on a scale | Standard Deviation 19.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 13 Day 1 | 4.9 score on a scale | Standard Deviation 15.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 8 Day 1 | 0.6 score on a scale | Standard Deviation 29.1 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 117 Weeks | -2.0 score on a scale | Standard Deviation 10 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 13 Weeks | -0.5 score on a scale | Standard Deviation 17 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 156 Weeks | 0.0 score on a scale | — |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 8 | -0.3 score on a scale | Standard Deviation 9.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at End of Treatment | 2.4 score on a scale | Standard Deviation 19.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 26 Weeks | -0.9 score on a scale | Standard Deviation 13.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Cycle 1 Day 1 (Baseline) | 3.9 score on a scale | Standard Deviation 14.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 7 Day 1 | -0.3 score on a scale | Standard Deviation 25.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 78 Weeks | 2.5 score on a scale | Standard Deviation 19.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 39 Weeks | -0.5 score on a scale | Standard Deviation 13.6 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 78 Weeks | 6.1 score on a scale | Standard Deviation 14.3 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 22 | -0.6 score on a scale | Standard Deviation 7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 13 Weeks | 3.2 score on a scale | Standard Deviation 16.7 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 52 Weeks | 0.0 score on a scale | Standard Deviation 14.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Cycle 1 Day 1 (Baseline) | 88.2 score on a scale | Standard Deviation 20.8 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 4 Day 1 | -1.0 score on a scale | Standard Deviation 25 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 10 Day 1 | 1.7 score on a scale | Standard Deviation 15.5 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 65 Weeks | 3.6 score on a scale | Standard Deviation 21.9 |
| Cohort 1 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 104 Weeks | 4.0 score on a scale | Standard Deviation 14.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 9 Day 1 | -8.2 score on a scale | Standard Deviation 22.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 11 Day 1 | 7.0 score on a scale | Standard Deviation 20.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 91 Weeks | 13.3 score on a scale | Standard Deviation 16.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 6 Day 1 | 13.8 score on a scale | Standard Deviation 22.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 13 Weeks | -1.2 score on a scale | Standard Deviation 19 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 8 | 2.1 score on a scale | Standard Deviation 8.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 9 Day 1 | 4.2 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 11 Day 1 | 0.6 score on a scale | Standard Deviation 20.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 26 Weeks | -5.7 score on a scale | Standard Deviation 26.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 39 Weeks | -2.4 score on a scale | Standard Deviation 28.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 117 Weeks | -4.2 score on a scale | Standard Deviation 11.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Cycle 1 Day 1 (Baseline) | 17.2 score on a scale | Standard Deviation 23.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 15 | 8.8 score on a scale | Standard Deviation 17 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 78 Weeks | 4.4 score on a scale | Standard Deviation 11.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 26 Weeks | 0.0 score on a scale | Standard Deviation 13.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Cycle 1 Day 1 (Baseline) | 3.5 score on a scale | Standard Deviation 10.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 8 | 10.4 score on a scale | Standard Deviation 16 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 15 | 12.2 score on a scale | Standard Deviation 22.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 22 | 11.1 score on a scale | Standard Deviation 20.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 3 Day 1 | 8.3 score on a scale | Standard Deviation 18 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 4 Day 1 | 10.3 score on a scale | Standard Deviation 20.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 5 Day 1 | 7.4 score on a scale | Standard Deviation 15 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 8 Day 1 | 10.8 score on a scale | Standard Deviation 18.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 9 Day 1 | 7.9 score on a scale | Standard Deviation 17.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 10 Day 1 | 4.8 score on a scale | Standard Deviation 15.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 12 Day 1 | 7.3 score on a scale | Standard Deviation 15.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 13 Day 1 | 6.2 score on a scale | Standard Deviation 14.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 13 Weeks | -1.2 score on a scale | Standard Deviation 6.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 26 Weeks | 3.5 score on a scale | Standard Deviation 17.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 78 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 91 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 104 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Cycle 1 Day 1 (Baseline) | 91.4 score on a scale | Standard Deviation 17.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 8 | 0.0 score on a scale | Standard Deviation 10.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 22 | -3.3 score on a scale | Standard Deviation 9.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 3 Day 1 | -2.5 score on a scale | Standard Deviation 12.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 4 Day 1 | -4.9 score on a scale | Standard Deviation 13.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 6 Day 1 | -4.1 score on a scale | Standard Deviation 16 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 9 Day 1 | -5.8 score on a scale | Standard Deviation 17.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 10 Day 1 | -4.5 score on a scale | Standard Deviation 17.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 12 Day 1 | -3.9 score on a scale | Standard Deviation 13.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 13 Weeks | -1.5 score on a scale | Standard Deviation 14 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 26 Weeks | -2.1 score on a scale | Standard Deviation 15.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 65 Weeks | -1.0 score on a scale | Standard Deviation 12.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 78 Weeks | -1.1 score on a scale | Standard Deviation 14.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 104 Weeks | 3.3 score on a scale | Standard Deviation 13.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT/Discontin. | -5.6 score on a scale | Standard Deviation 8.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Cycle 1 Day 1 (Baseline) | 4.6 score on a scale | Standard Deviation 12.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 8 | -2.1 score on a scale | Standard Deviation 8.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 15 | 1.7 score on a scale | Standard Deviation 13.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 22 | 0.0 score on a scale | Standard Deviation 12.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 2 Day 1 | 1.6 score on a scale | Standard Deviation 13.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 7 Day 1 | 3.0 score on a scale | Standard Deviation 12.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 8 Day 1 | 4.2 score on a scale | Standard Deviation 15.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 9 Day 1 | 3.2 score on a scale | Standard Deviation 14.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at End of Treatment | 4.5 score on a scale | Standard Deviation 17.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 13 Weeks | 6.0 score on a scale | Standard Deviation 16.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 26 Weeks | 2.8 score on a scale | Standard Deviation 9.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 39 Weeks | 2.4 score on a scale | Standard Deviation 13.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 52 Weeks | 0.0 score on a scale | Standard Deviation 9.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 104 Weeks | -3.3 score on a scale | Standard Deviation 10.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT/Discontinuation | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Cycle 1 Day 1 (Baseline) | 3.8 score on a scale | Standard Deviation 13.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 8 | -4.2 score on a scale | Standard Deviation 20.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 3 Day 1 | 3.3 score on a scale | Standard Deviation 19.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 4 Day 1 | 5.6 score on a scale | Standard Deviation 18.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 5 Day 1 | 2.8 score on a scale | Standard Deviation 20 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 6 Day 1 | 7.2 score on a scale | Standard Deviation 24.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 7 Day 1 | 4.9 score on a scale | Standard Deviation 22.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 11 Day 1 | 4.7 score on a scale | Standard Deviation 23.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 52 Weeks | -1.2 score on a scale | Standard Deviation 21.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 65 Weeks | 2.0 score on a scale | Standard Deviation 8.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 78 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 91 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 130 Weeks | 6.7 score on a scale | Standard Deviation 14.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 8 | 4.2 score on a scale | Standard Deviation 16.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 15 | 2.9 score on a scale | Standard Deviation 15.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 22 | 0.0 score on a scale | Standard Deviation 17.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 2 Day 1 | 4.8 score on a scale | Standard Deviation 20.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 2 Day 15 | 4.6 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 3 Day 1 | 3.7 score on a scale | Standard Deviation 18.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 4 Day 1 | 3.0 score on a scale | Standard Deviation 18.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 8 Day 1 | 2.6 score on a scale | Standard Deviation 14.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 9 Day 1 | 2.1 score on a scale | Standard Deviation 16.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 10 Day 1 | 6.3 score on a scale | Standard Deviation 18.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 12 Day 1 | 3.6 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 13 Day 1 | 4.9 score on a scale | Standard Deviation 19.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at End of Treatment | 3.0 score on a scale | Standard Deviation 18.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 13 Weeks | 3.0 score on a scale | Standard Deviation 16.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 26 Weeks | 3.5 score on a scale | Standard Deviation 19.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 39 Weeks | 4.8 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 13 Day 1 | 0.2 score on a scale | Standard Deviation 16.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at End of Treatment | 2.2 score on a scale | Standard Deviation 22.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 13 Weeks | 6.4 score on a scale | Standard Deviation 16.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 26 Weeks | 3.0 score on a scale | Standard Deviation 18.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 39 Weeks | 4.1 score on a scale | Standard Deviation 19 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 52 Weeks | 9.0 score on a scale | Standard Deviation 16.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 65 Weeks | 10.3 score on a scale | Standard Deviation 17.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 78 Weeks | 8.9 score on a scale | Standard Deviation 16.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 104 Weeks | 4.2 score on a scale | Standard Deviation 13.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 16.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 130 Weeks | 3.3 score on a scale | Standard Deviation 20.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT/Discont. | 1.4 score on a scale | Standard Deviation 11.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Cycle 1 Day 1 (Baseline) | 15.5 score on a scale | Standard Deviation 18.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 8 | 7.6 score on a scale | Standard Deviation 13.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 15 | 18.2 score on a scale | Standard Deviation 27 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 3 Day 1 | 12.6 score on a scale | Standard Deviation 23.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 4 Day 1 | 13.3 score on a scale | Standard Deviation 23.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 5 Day 1 | 13.6 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 10 Day 1 | 11.3 score on a scale | Standard Deviation 25 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 11 Day 1 | 10.7 score on a scale | Standard Deviation 20.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 12 Day 1 | 10.7 score on a scale | Standard Deviation 22.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 13 Day 1 | 13.4 score on a scale | Standard Deviation 26.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 39 Weeks | -0.5 score on a scale | Standard Deviation 18.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 52 Weeks | -1.2 score on a scale | Standard Deviation 14.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 65 Weeks | -4.6 score on a scale | Standard Deviation 11.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 78 Weeks | -4.4 score on a scale | Standard Deviation 10.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT/Discontinuation | -11.1 score on a scale | Standard Deviation 25.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Cycle 1 Day 1 (Baseline) | 16.5 score on a scale | Standard Deviation 30.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 15 | 0.0 score on a scale | Standard Deviation 15.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 3 Day 1 | 1.3 score on a scale | Standard Deviation 20.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 6 Day 1 | 2.9 score on a scale | Standard Deviation 20.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 65 Weeks | -3.9 score on a scale | Standard Deviation 11.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 78 Weeks | 0.0 score on a scale | Standard Deviation 21.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 8 Day 1 | 4.1 score on a scale | Standard Deviation 26.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 12 Day 1 | 0.0 score on a scale | Standard Deviation 26.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 13 Weeks | -10.1 score on a scale | Standard Deviation 27.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 52 Weeks | -11.1 score on a scale | Standard Deviation 24.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 65 Weeks | -9.8 score on a scale | Standard Deviation 19.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 2 Day 15 | -7.6 score on a scale | Standard Deviation 13.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 3 Day 1 | -7.3 score on a scale | Standard Deviation 15 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 4 Day 1 | -7.4 score on a scale | Standard Deviation 13.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 8 Day 1 | -6.7 score on a scale | Standard Deviation 12.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 9 Day 1 | -5.5 score on a scale | Standard Deviation 10.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 13 Day 1 | -5.6 score on a scale | Standard Deviation 12.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at End of Treatment | -5.8 score on a scale | Standard Deviation 13.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 39 Weeks | -3.3 score on a scale | Standard Deviation 13.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 65 Weeks | 2.7 score on a scale | Standard Deviation 9.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Cycle 1 Day 1 (Baseline) | 1.9 score on a scale | Standard Deviation 7.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 8 | 5.2 score on a scale | Standard Deviation 8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 117 Weeks | 0.7 score on a scale | Standard Deviation 13.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 22 | 5.6 score on a scale | Standard Deviation 10.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 143 Weeks | -4.4 score on a scale | Standard Deviation 20.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 2 Day 1 | 4.6 score on a scale | Standard Deviation 11.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Cycle 1 Day 1 (Baseline) | 76.5 score on a scale | Standard Deviation 20.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 2 Day 15 | 2.9 score on a scale | Standard Deviation 9.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 3 Day 1 | 4.5 score on a scale | Standard Deviation 9.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 4 Day 1 | 6.6 score on a scale | Standard Deviation 14.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 22 | -16.7 score on a scale | Standard Deviation 19.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 2 Day 1 | -10.9 score on a scale | Standard Deviation 17.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 6 Day 1 | -12.4 score on a scale | Standard Deviation 19.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 6 Day 1 | 6.3 score on a scale | Standard Deviation 12.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 8 Day 1 | 5.9 score on a scale | Standard Deviation 15.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 9 Day 1 | 4.0 score on a scale | Standard Deviation 10.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 10 Day 1 | 4.8 score on a scale | Standard Deviation 10.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 13 Day 1 | 3.4 score on a scale | Standard Deviation 9.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 13 Weeks | 0.6 score on a scale | Standard Deviation 6.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 26 Weeks | 0.7 score on a scale | Standard Deviation 10.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 39 Weeks | 1.6 score on a scale | Standard Deviation 8.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 104 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 117 Weeks | -1.9 score on a scale | Standard Deviation 5.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 130 Weeks | -3.3 score on a scale | Standard Deviation 7.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Cycle 1 Day 1 (Baseline) | 10.9 score on a scale | Standard Deviation 19 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 8 | 10.4 score on a scale | Standard Deviation 14.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 15 | 16.3 score on a scale | Standard Deviation 28.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 3 Day 1 | 13.2 score on a scale | Standard Deviation 25.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 4 Day 1 | 12.0 score on a scale | Standard Deviation 25.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 5 Day 1 | 14.6 score on a scale | Standard Deviation 21.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 6 Day 1 | 14.5 score on a scale | Standard Deviation 22.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 9 Day 1 | 10.3 score on a scale | Standard Deviation 23.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 10 Day 1 | 11.6 score on a scale | Standard Deviation 24.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 12 Day 1 | 12.7 score on a scale | Standard Deviation 19.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 13 Weeks | 4.2 score on a scale | Standard Deviation 19.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 65 Weeks | 6.9 score on a scale | Standard Deviation 15.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 78 Weeks | 1.1 score on a scale | Standard Deviation 14.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 91 Weeks | 4.4 score on a scale | Standard Deviation 14.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 130 Weeks | 6.7 score on a scale | Standard Deviation 27.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT/Discontinuation | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 8 | 3.6 score on a scale | Standard Deviation 11.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 2 Day 15 | -0.5 score on a scale | Standard Deviation 11.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 3 Day 1 | -0.8 score on a scale | Standard Deviation 16.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Cycle 1 Day 1 (Baseline) | 91.3 score on a scale | Standard Deviation 13.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 9 Day 1 | -8.3 score on a scale | Standard Deviation 19.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 6 Day 1 | -2.6 score on a scale | Standard Deviation 16 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 7 Day 1 | -2.3 score on a scale | Standard Deviation 16.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 10 Day 1 | -8.7 score on a scale | Standard Deviation 23.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 11 Day 1 | -9.9 score on a scale | Standard Deviation 23.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 12 Day 1 | -9.1 score on a scale | Standard Deviation 22.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 13 Weeks | -1.0 score on a scale | Standard Deviation 18.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 13 Day 1 | -10.2 score on a scale | Standard Deviation 25.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 39 Weeks | 0.0 score on a scale | Standard Deviation 18.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 52 Weeks | 2.5 score on a scale | Standard Deviation 13.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 65 Weeks | 4.9 score on a scale | Standard Deviation 11.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 26 Weeks | 0.4 score on a scale | Standard Deviation 19.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 39 Weeks | -0.4 score on a scale | Standard Deviation 16.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 4 Day 1 | -9.0 score on a scale | Standard Deviation 19.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 5 Day 1 | -10.4 score on a scale | Standard Deviation 22.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 6 Day 1 | -11.6 score on a scale | Standard Deviation 22.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 7 Day 1 | -8.8 score on a scale | Standard Deviation 24 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 8 Day 1 | -9.5 score on a scale | Standard Deviation 24.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 13 Day 1 | -8.3 score on a scale | Standard Deviation 25.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at End Of Treatment | -4.2 score on a scale | Standard Deviation 25 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 15 | 9.6 score on a scale | Standard Deviation 26.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 22 | 6.7 score on a scale | Standard Deviation 18.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 2 Day 1 | 2.4 score on a scale | Standard Deviation 24.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 2 Day 15 | 2.1 score on a scale | Standard Deviation 28.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 6 Day 1 | 3.4 score on a scale | Standard Deviation 26.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 7 Day 1 | 3.4 score on a scale | Standard Deviation 23.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 8 Day 1 | 7.7 score on a scale | Standard Deviation 29.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 9 Day 1 | 6.3 score on a scale | Standard Deviation 28.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 10 Day 1 | 4.2 score on a scale | Standard Deviation 27.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 11 Day 1 | 5.3 score on a scale | Standard Deviation 32 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 12 Day 1 | 3.6 score on a scale | Standard Deviation 29.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 13 Day 1 | 6.2 score on a scale | Standard Deviation 29 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at End Of Treatment | 3.5 score on a scale | Standard Deviation 32.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 13 Weeks | -2.4 score on a scale | Standard Deviation 24.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 65 Weeks | -3.9 score on a scale | Standard Deviation 33.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 91 Weeks | -4.4 score on a scale | Standard Deviation 21.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 104 Weeks | 0.0 score on a scale | Standard Deviation 22.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 16.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 39 Weeks | 0.4 score on a scale | Standard Deviation 21.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 104 Weeks | 6.7 score on a scale | Standard Deviation 14.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 117 Weeks | 5.6 score on a scale | Standard Deviation 11.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 130 Weeks | 3.3 score on a scale | Standard Deviation 18.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT/Discontin. | 11.1 score on a scale | Standard Deviation 17.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Cycle 1 Day 1 (Baseline) | 87.7 score on a scale | Standard Deviation 21.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 22 | -5.6 score on a scale | Standard Deviation 17.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 2 Day 1 | -10.2 score on a scale | Standard Deviation 23.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 5 Day 1 | -9.5 score on a scale | Standard Deviation 18.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 6 Day 1 | -11.4 score on a scale | Standard Deviation 22.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 8 Day 1 | -7.9 score on a scale | Standard Deviation 23 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 11 Day 1 | -5.0 score on a scale | Standard Deviation 15.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 52 Weeks | 9.3 score on a scale | Standard Deviation 21.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 104 Weeks | 3.3 score on a scale | Standard Deviation 13.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 15 | -7.4 score on a scale | Standard Deviation 15 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 22 | -10.2 score on a scale | Standard Deviation 15.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 5 Day 1 | -8.9 score on a scale | Standard Deviation 17.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 8 Day 1 | -11.2 score on a scale | Standard Deviation 20.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 10 Day 1 | -9.8 score on a scale | Standard Deviation 18.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 13 Day 1 | -9.4 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 2 Day 1 | 12.2 score on a scale | Standard Deviation 23.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 2 Day 15 | 6.8 score on a scale | Standard Deviation 16.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 6 Day 1 | 13.0 score on a scale | Standard Deviation 21.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 7 Day 1 | 7.4 score on a scale | Standard Deviation 16.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 11 Day 1 | 4.7 score on a scale | Standard Deviation 13.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at End of Treatment | 5.1 score on a scale | Standard Deviation 18.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 39 Weeks | -0.8 score on a scale | Standard Deviation 9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 52 Weeks | -1.3 score on a scale | Standard Deviation 6.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 65 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT/Discontinuation | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 15 | -3.8 score on a scale | Standard Deviation 13.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 2 Day 1 | -2.2 score on a scale | Standard Deviation 12.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 2 Day 15 | -3.1 score on a scale | Standard Deviation 11.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 5 Day 1 | -3.9 score on a scale | Standard Deviation 12.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 7 Day 1 | -3.9 score on a scale | Standard Deviation 15.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 8 Day 1 | -5.1 score on a scale | Standard Deviation 16.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 13 Day 1 | -6.5 score on a scale | Standard Deviation 15.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at End of Treatment | -4.0 score on a scale | Standard Deviation 17.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 39 Weeks | -2.0 score on a scale | Standard Deviation 11.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 52 Weeks | 1.2 score on a scale | Standard Deviation 13 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 91 Weeks | 3.3 score on a scale | Standard Deviation 11.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 117 Weeks | -2.1 score on a scale | Standard Deviation 5.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 2 Day 15 | 0.0 score on a scale | Standard Deviation 11.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 3 Day 1 | 0.4 score on a scale | Standard Deviation 12.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 4 Day 1 | 0.0 score on a scale | Standard Deviation 10.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 5 Day 1 | 3.8 score on a scale | Standard Deviation 14.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 6 Day 1 | 5.4 score on a scale | Standard Deviation 16.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 10 Day 1 | 1.6 score on a scale | Standard Deviation 11.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 11 Day 1 | 2.4 score on a scale | Standard Deviation 14 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 12 Day 1 | 3.1 score on a scale | Standard Deviation 13.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 13 Day 1 | 0.0 score on a scale | Standard Deviation 11.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 65 Weeks | 2.0 score on a scale | Standard Deviation 14.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 78 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 91 Weeks | 2.2 score on a scale | Standard Deviation 8.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 15 | 1.7 score on a scale | Standard Deviation 19.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 22 | -2.2 score on a scale | Standard Deviation 23.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 2 Day 1 | 4.9 score on a scale | Standard Deviation 21.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 2 Day 15 | 0.4 score on a scale | Standard Deviation 17.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 8 Day 1 | 5.6 score on a scale | Standard Deviation 20.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 9 Day 1 | 4.3 score on a scale | Standard Deviation 19.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 10 Day 1 | 5.9 score on a scale | Standard Deviation 23.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 12 Day 1 | 7.9 score on a scale | Standard Deviation 24.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 13 Day 1 | 8.0 score on a scale | Standard Deviation 28.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at End of Treatment | -1.0 score on a scale | Standard Deviation 16.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 13 Weeks | 0.0 score on a scale | Standard Deviation 18 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 26 Weeks | 0.7 score on a scale | Standard Deviation 8.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 39 Weeks | 1.6 score on a scale | Standard Deviation 14.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 104 Weeks | 3.3 score on a scale | Standard Deviation 10.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT/Discontinuation | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Cycle 1 Day 1 (Baseline) | 5.0 score on a scale | Standard Deviation 12 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 5 Day 1 | 3.7 score on a scale | Standard Deviation 19 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 6 Day 1 | 3.9 score on a scale | Standard Deviation 19.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 7 Day 1 | 3.9 score on a scale | Standard Deviation 17.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 52 Weeks | 2.5 score on a scale | Standard Deviation 15.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 25 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 22 | 17.0 score on a scale | Standard Deviation 21.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 2 Day 1 | 13.7 score on a scale | Standard Deviation 24.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 2 Day 15 | 10.7 score on a scale | Standard Deviation 19.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 7 Day 1 | 13.2 score on a scale | Standard Deviation 23.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 8 Day 1 | 12.7 score on a scale | Standard Deviation 22.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 9 Day 1 | 13.7 score on a scale | Standard Deviation 24.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at End of Treatment | 3.3 score on a scale | Standard Deviation 21.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 26 Weeks | 0.5 score on a scale | Standard Deviation 21.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 91 Weeks | -3.7 score on a scale | Standard Deviation 15.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 104 Weeks | -1.1 score on a scale | Standard Deviation 17.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 117 Weeks | -7.4 score on a scale | Standard Deviation 15.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 130 Weeks | -4.4 score on a scale | Standard Deviation 16.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 143 Weeks | -3.7 score on a scale | Standard Deviation 17 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 22 | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 2 Day 1 | 0.8 score on a scale | Standard Deviation 16.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 2 Day 15 | -0.4 score on a scale | Standard Deviation 17.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 4 Day 1 | -0.4 score on a scale | Standard Deviation 19.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 5 Day 1 | 2.3 score on a scale | Standard Deviation 18 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 91 Weeks | -2.2 score on a scale | Standard Deviation 15.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 104 Weeks | 0.0 score on a scale | Standard Deviation 22.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 7 Day 1 | 4.9 score on a scale | Standard Deviation 27.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 10 Day 1 | 2.6 score on a scale | Standard Deviation 22.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 13 Day 1 | -1.9 score on a scale | Standard Deviation 27.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at End of Treatment | -2.5 score on a scale | Standard Deviation 23.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 78 Weeks | -11.1 score on a scale | Standard Deviation 20.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 91 Weeks | -11.1 score on a scale | Standard Deviation 20.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 104 Weeks | -13.3 score on a scale | Standard Deviation 23.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 2 Day 1 | -9.2 score on a scale | Standard Deviation 16.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 5 Day 1 | -5.6 score on a scale | Standard Deviation 13.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 6 Day 1 | -7.5 score on a scale | Standard Deviation 15.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 7 Day 1 | -8.0 score on a scale | Standard Deviation 12.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 10 Day 1 | -6.5 score on a scale | Standard Deviation 13.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 11 Day 1 | -6.0 score on a scale | Standard Deviation 12.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 12 Day 1 | -4.8 score on a scale | Standard Deviation 11.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 13 Weeks | -0.8 score on a scale | Standard Deviation 10.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 117 Weeks | -3.7 score on a scale | Standard Deviation 20 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 26 Weeks | -4.1 score on a scale | Standard Deviation 10.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 52 Weeks | -1.4 score on a scale | Standard Deviation 9.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT/Discontin. | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 78 Weeks | 2.7 score on a scale | Standard Deviation 10 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 91 Weeks | -0.9 score on a scale | Standard Deviation 10.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 104 Weeks | 1.3 score on a scale | Standard Deviation 11.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 130 Weeks | -2.7 score on a scale | Standard Deviation 10.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT/Discontin. | 10.0 score on a scale | Standard Deviation 15.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 5 Day 1 | 5.1 score on a scale | Standard Deviation 10.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 8 | -9.9 score on a scale | Standard Deviation 15.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 15 | -14.5 score on a scale | Standard Deviation 20.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 2 Day 15 | -9.5 score on a scale | Standard Deviation 18 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 3 Day 1 | -9.4 score on a scale | Standard Deviation 17 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 4 Day 1 | -8.4 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 143 Weeks | -11.1 score on a scale | Standard Deviation 19.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 7 Day 1 | 4.2 score on a scale | Standard Deviation 11.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 11 Day 1 | 3.2 score on a scale | Standard Deviation 8.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 12 Day 1 | 4.8 score on a scale | Standard Deviation 10.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at End of Treatment | 1.5 score on a scale | Standard Deviation 11.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 52 Weeks | 0.0 score on a scale | Standard Deviation 4.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 65 Weeks | -1.0 score on a scale | Standard Deviation 4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 78 Weeks | -1.1 score on a scale | Standard Deviation 4.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 91 Weeks | -1.1 score on a scale | Standard Deviation 4.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT/Discont. | 8.3 score on a scale | Standard Deviation 13.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 22 | 22.2 score on a scale | Standard Deviation 18.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 2 Day 1 | 15.1 score on a scale | Standard Deviation 28.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 2 Day 15 | 12.7 score on a scale | Standard Deviation 23.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 7 Day 1 | 8.3 score on a scale | Standard Deviation 20.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 8 Day 1 | 12.1 score on a scale | Standard Deviation 23.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 11 Day 1 | 13.5 score on a scale | Standard Deviation 26.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 13 Day 1 | 16.4 score on a scale | Standard Deviation 27.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at End of Treatment | 6.7 score on a scale | Standard Deviation 21.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 26 Weeks | 7.1 score on a scale | Standard Deviation 24 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 39 Weeks | 7.5 score on a scale | Standard Deviation 23 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 117 Weeks | 1.9 score on a scale | Standard Deviation 13 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Cycle 1 Day 1 (Baseline) | 81.6 score on a scale | Standard Deviation 21.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 15 | -1.0 score on a scale | Standard Deviation 16.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 22 | -0.6 score on a scale | Standard Deviation 12.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 2 Day 1 | -1.0 score on a scale | Standard Deviation 17.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 4 Day 1 | -1.2 score on a scale | Standard Deviation 15.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 5 Day 1 | -0.8 score on a scale | Standard Deviation 15.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 143 Weeks | 5.6 score on a scale | Standard Deviation 25.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 7 Day 1 | -11.8 score on a scale | Standard Deviation 17.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT/Discontin. | -2.8 score on a scale | Standard Deviation 19.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 8 | -5.0 score on a scale | Standard Deviation 6.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 8 Day 1 | -1.9 score on a scale | Standard Deviation 15.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 9 Day 1 | 0.1 score on a scale | Standard Deviation 15.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 10 Day 1 | -0.1 score on a scale | Standard Deviation 16.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 11 Day 1 | 1.2 score on a scale | Standard Deviation 15.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 12 Day 1 | 1.1 score on a scale | Standard Deviation 14.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 11 Day 1 | -8.8 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 12 Day 1 | -10.5 score on a scale | Standard Deviation 17.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at EOT | -3.0 score on a scale | Standard Deviation 18.4 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at End of Treatment | -5.5 score on a scale | Standard Deviation 23.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 13 Weeks | 1.2 score on a scale | Standard Deviation 16.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 78 Weeks | 4.4 score on a scale | Standard Deviation 13.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 91 Weeks | 2.2 score on a scale | Standard Deviation 13.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 52 Weeks | 2.2 score on a scale | Standard Deviation 13.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 65 Weeks | 1.5 score on a scale | Standard Deviation 15.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 78 Weeks | 1.7 score on a scale | Standard Deviation 14.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 91 Weeks | 6.1 score on a scale | Standard Deviation 15.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 104 Weeks | -3.3 score on a scale | Standard Deviation 19.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 104 Weeks | 3.3 score on a scale | Standard Deviation 10.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 117 Weeks | -1.0 score on a scale | Standard Deviation 13.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 130 Weeks | -3.3 score on a scale | Standard Deviation 12.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 143 Weeks | -11.1 score on a scale | Standard Deviation 9.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT/Discontin. | 0.0 score on a scale | Standard Deviation 31.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Cycle 1 Day 1 (Baseline) | 86.6 score on a scale | Standard Deviation 22 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 8 | -1.0 score on a scale | Standard Deviation 16.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 15 | -15.2 score on a scale | Standard Deviation 27.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 22 | -16.7 score on a scale | Standard Deviation 20.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 2 Day 1 | -13.3 score on a scale | Standard Deviation 27.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 2 Day 15 | -9.6 score on a scale | Standard Deviation 21.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 3 Day 1 | -8.2 score on a scale | Standard Deviation 21.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 9 Day 1 | -7.9 score on a scale | Standard Deviation 23.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 10 Day 1 | -7.7 score on a scale | Standard Deviation 23.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 11 Day 1 | -10.2 score on a scale | Standard Deviation 25 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 12 Day 1 | -8.2 score on a scale | Standard Deviation 25.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 117 Weeks | -2.1 score on a scale | Standard Deviation 5.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT/Discontinuation | 0.0 score on a scale | Standard Deviation 10.5 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 8 | 2.1 score on a scale | Standard Deviation 22.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 3 Day 1 | -0.4 score on a scale | Standard Deviation 28.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 4 Day 1 | 3.4 score on a scale | Standard Deviation 26.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 5 Day 1 | 3.2 score on a scale | Standard Deviation 26.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 26 Weeks | -1.4 score on a scale | Standard Deviation 23 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 39 Weeks | -2.4 score on a scale | Standard Deviation 27.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 52 Weeks | -2.5 score on a scale | Standard Deviation 26 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 78 Weeks | -4.4 score on a scale | Standard Deviation 27.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 130 Weeks | 6.7 score on a scale | Standard Deviation 27.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 33.3 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT/Discont. | 5.6 score on a scale | Standard Deviation 25.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 13 Weeks | 1.2 score on a scale | Standard Deviation 19 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 26 Weeks | 0.4 score on a scale | Standard Deviation 20.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 52 Weeks | 0.6 score on a scale | Standard Deviation 18.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 65 Weeks | 3.9 score on a scale | Standard Deviation 11.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 91 Weeks | 1.1 score on a scale | Standard Deviation 14.7 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 143 Weeks | 11.1 score on a scale | Standard Deviation 19.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 8 | 2.1 score on a scale | Standard Deviation 14.8 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 15 | -7.5 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 2 Day 15 | -7.7 score on a scale | Standard Deviation 18.2 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 3 Day 1 | -7.4 score on a scale | Standard Deviation 21.1 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 4 Day 1 | -7.5 score on a scale | Standard Deviation 20.6 |
| Cohort 2 Vemurafenib | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 7 Day 1 | -9.6 score on a scale | Standard Deviation 22.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 91 Weeks | 0.0 score on a scale | Standard Deviation 17.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT/Discont. | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 12 Day 1 | -3.6 score on a scale | Standard Deviation 18 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT/Discontin. | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 65 Weeks | -0.4 score on a scale | Standard Deviation 10.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 130 Weeks | 13.3 score on a scale | Standard Deviation 18.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 7 Day 1 | -5.6 score on a scale | Standard Deviation 15 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at EOT | -7.4 score on a scale | Standard Deviation 21.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 52 Weeks | -1.1 score on a scale | Standard Deviation 14.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 26 Weeks | 0.6 score on a scale | Standard Deviation 12.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 13 Weeks | -0.5 score on a scale | Standard Deviation 12.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 104 Weeks | -13.0 score on a scale | Standard Deviation 21.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at End of Treatment | -3.3 score on a scale | Standard Deviation 21.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 11 Day 1 | -3.3 score on a scale | Standard Deviation 13.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 10 Day 1 | -1.7 score on a scale | Standard Deviation 9.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 13 Weeks | 5.3 score on a scale | Standard Deviation 26.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 13 Weeks | 1.3 score on a scale | Standard Deviation 19.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 6 Day 1 | -0.6 score on a scale | Standard Deviation 10 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 5 Day 1 | -1.8 score on a scale | Standard Deviation 12.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 5 Day 1 | -3.6 score on a scale | Standard Deviation 15.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 78 Weeks | -1.9 score on a scale | Standard Deviation 13 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 156 Weeks | -16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 3 Day 1 | -2.1 score on a scale | Standard Deviation 13.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 39 Weeks | -1.3 score on a scale | Standard Deviation 19.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 104 Weeks | -18.5 score on a scale | Standard Deviation 37.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 78 Weeks | 0.0 score on a scale | Standard Deviation 16.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 2 Day 15 | 4.0 score on a scale | Standard Deviation 17 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 52 Weeks | -2.0 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at End of Treatment | -0.9 score on a scale | Standard Deviation 23.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 13 Day 1 | -8.1 score on a scale | Standard Deviation 24.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 26 Weeks | 5.2 score on a scale | Standard Deviation 24.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 65 Weeks | -0.5 score on a scale | Standard Deviation 17.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 10 Day 1 | -6.4 score on a scale | Standard Deviation 20.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 7 Day 1 | -5.6 score on a scale | Standard Deviation 21.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 2 Day 1 | 0.0 score on a scale | Standard Deviation 13.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 78 Weeks | -0.9 score on a scale | Standard Deviation 13.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 104 Weeks | 8.3 score on a scale | Standard Deviation 15.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 91 Weeks | 0.0 score on a scale | Standard Deviation 14.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 15 | -0.8 score on a scale | Standard Deviation 11.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 91 Weeks | -2.1 score on a scale | Standard Deviation 24.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 5 Day 1 | -7.8 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 4 Day 1 | -5.8 score on a scale | Standard Deviation 18.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 8 | 2.6 score on a scale | Standard Deviation 6.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 5 Day 1 | -4.9 score on a scale | Standard Deviation 20.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 104 Weeks | 1.9 score on a scale | Standard Deviation 13 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 2 Day 15 | -7.2 score on a scale | Standard Deviation 20.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 2 Day 1 | -4.4 score on a scale | Standard Deviation 19.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 104 Weeks | 0.0 score on a scale | Standard Deviation 29.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 22 | 0.0 score on a scale | Standard Deviation 20.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 143 Weeks | 16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 52 Weeks | 4.0 score on a scale | Standard Deviation 29 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 117 Weeks | 6.7 score on a scale | Standard Deviation 21.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 33.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 28.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT/Discontinuation | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 130 Weeks | 5.0 score on a scale | Standard Deviation 24 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 104 Weeks | -1.2 score on a scale | Standard Deviation 29.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 91 Weeks | -2.8 score on a scale | Standard Deviation 26 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 3 Day 1 | 1.5 score on a scale | Standard Deviation 17.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 143 Weeks | -8.3 score on a scale | Standard Deviation 11.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 26 Weeks | -1.3 score on a scale | Standard Deviation 18.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 13 Weeks | 1.5 score on a scale | Standard Deviation 14.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 156 Weeks | 12.5 score on a scale | Standard Deviation 5.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at End of Treatment | 6.4 score on a scale | Standard Deviation 20.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 9 Day 1 | 6.0 score on a scale | Standard Deviation 21.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 8 Day 1 | 5.0 score on a scale | Standard Deviation 15.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 7 Day 1 | 6.0 score on a scale | Standard Deviation 17.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 2 Day 1 | 2.5 score on a scale | Standard Deviation 14.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 65 Weeks | 7.4 score on a scale | Standard Deviation 29.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT/Discontin. | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 22 | 9.2 score on a scale | Standard Deviation 15.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 156 Weeks | 4.2 score on a scale | Standard Deviation 53 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Cycle 1 Day 1 (Baseline) | 88.6 score on a scale | Standard Deviation 23.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 143 Weeks | -16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 130 Weeks | 1.7 score on a scale | Standard Deviation 32.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 65 Weeks | 5.6 score on a scale | Standard Deviation 17.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 8 | 4.4 score on a scale | Standard Deviation 18.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Cycle 1 Day 1 (Baseline) | 18.7 score on a scale | Standard Deviation 24.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 52 Weeks | 5.3 score on a scale | Standard Deviation 15.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 52 Weeks | 2.7 score on a scale | Standard Deviation 9.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 39 Weeks | 3.0 score on a scale | Standard Deviation 12.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 7 Day 1 | 2.8 score on a scale | Standard Deviation 12.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 39 Weeks | 2.0 score on a scale | Standard Deviation 14.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 22 | -1.0 score on a scale | Standard Deviation 25.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 6 Day 1 | 2.1 score on a scale | Standard Deviation 15.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Cycle 1 Day 1 (Baseline) | 3.0 score on a scale | Standard Deviation 10.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 7 Day 1 | 0.0 score on a scale | Standard Deviation 17.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 2 Day 1 | 0.4 score on a scale | Standard Deviation 17.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT/Discontinuation | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at End of Treatment | 2.7 score on a scale | Standard Deviation 18.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 2 Day 15 | -0.4 score on a scale | Standard Deviation 17.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 104 Weeks | -11.1 score on a scale | Standard Deviation 33.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 39 Weeks | 0.0 score on a scale | Standard Deviation 18.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 11 Day 1 | 0.7 score on a scale | Standard Deviation 12.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 3 Day 1 | -2.1 score on a scale | Standard Deviation 21.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 26 Weeks | -1.9 score on a scale | Standard Deviation 19.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 13 Weeks | 0.0 score on a scale | Standard Deviation 15.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 4 Day 1 | 1.3 score on a scale | Standard Deviation 13.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 9 Day 1 | -1.9 score on a scale | Standard Deviation 25.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at End of Treatment | -1.8 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 143 Weeks | 8.3 score on a scale | Standard Deviation 11.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 10 Day 1 | 3.9 score on a scale | Standard Deviation 22.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 13 Day 1 | -1.5 score on a scale | Standard Deviation 20 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 12 Day 1 | -0.7 score on a scale | Standard Deviation 19 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 7 Day 1 | 4.0 score on a scale | Standard Deviation 18.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 11 Day 1 | -3.5 score on a scale | Standard Deviation 24.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 10 Day 1 | -2.1 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 9 Day 1 | -1.9 score on a scale | Standard Deviation 23.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 6 Day 1 | 1.1 score on a scale | Standard Deviation 17.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 12 Day 1 | 0.3 score on a scale | Standard Deviation 26.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 156 Weeks | 16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 117 Weeks | 3.3 score on a scale | Standard Deviation 18.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 8 Day 1 | -3.2 score on a scale | Standard Deviation 16.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 2 Day 1 | 0.0 score on a scale | Standard Deviation 20 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 156 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 22 | -9.8 score on a scale | Standard Deviation 25.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 15 | -1.6 score on a scale | Standard Deviation 17.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 156 Weeks | -16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 5 Day 1 | -0.5 score on a scale | Standard Deviation 12.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT/Discontinuation | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 91 Weeks | 0.0 score on a scale | Standard Deviation 14.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 2 Day 15 | 0.8 score on a scale | Standard Deviation 14.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 8 | 1.8 score on a scale | Standard Deviation 20.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 78 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 65 Weeks | 0.0 score on a scale | Standard Deviation 11.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 2 Day 15 | -3.7 score on a scale | Standard Deviation 23 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 13 Day 1 | -3.7 score on a scale | Standard Deviation 19.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 12 Day 1 | -3.5 score on a scale | Standard Deviation 14.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 6 Day 1 | 0.0 score on a scale | Standard Deviation 17.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 11 Day 1 | -4.9 score on a scale | Standard Deviation 15.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 8 | 0.9 score on a scale | Standard Deviation 8.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 4 Day 1 | -4.9 score on a scale | Standard Deviation 23.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 10 Day 1 | -4.3 score on a scale | Standard Deviation 17.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 6 Day 1 | -3.7 score on a scale | Standard Deviation 20 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 2 Day 1 | 1.6 score on a scale | Standard Deviation 15.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 5 Day 1 | -5.7 score on a scale | Standard Deviation 22.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 5 Day 1 | -3.1 score on a scale | Standard Deviation 17.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 4 Day 1 | -2.2 score on a scale | Standard Deviation 14.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at End Of Treatment | 0.4 score on a scale | Standard Deviation 26.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 3 Day 1 | -1.7 score on a scale | Standard Deviation 18.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 10 Day 1 | -1.4 score on a scale | Standard Deviation 19.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 117 Weeks | -10.0 score on a scale | Standard Deviation 25.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 2 Day 15 | -1.3 score on a scale | Standard Deviation 15.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 15 | 0.4 score on a scale | Standard Deviation 13.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 52 Weeks | -8.0 score on a scale | Standard Deviation 26 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 156 Weeks | -16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 143 Weeks | -8.3 score on a scale | Standard Deviation 11.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 91 Weeks | 16.7 score on a scale | Standard Deviation 35.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 78 Weeks | -3.7 score on a scale | Standard Deviation 26.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 130 Weeks | -6.7 score on a scale | Standard Deviation 14.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 117 Weeks | -6.7 score on a scale | Standard Deviation 14.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 91 Weeks | -2.8 score on a scale | Standard Deviation 26.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 91 Weeks | -5.6 score on a scale | Standard Deviation 13 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 117 Weeks | -13.3 score on a scale | Standard Deviation 29.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 52 Weeks | -7.3 score on a scale | Standard Deviation 12.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 4 Day 1 | 2.4 score on a scale | Standard Deviation 14.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 3 Day 1 | 3.5 score on a scale | Standard Deviation 13.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 22 | -0.5 score on a scale | Standard Deviation 17.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 39 Weeks | -3.0 score on a scale | Standard Deviation 11.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 5 Day 1 | 3.0 score on a scale | Standard Deviation 14.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 15 | 3.8 score on a scale | Standard Deviation 12 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Cycle 1 Day 1 (Baseline) | 84.5 score on a scale | Standard Deviation 17.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 130 Weeks | -13.3 score on a scale | Standard Deviation 32.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT/Discontinuation | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 65 Weeks | -4.6 score on a scale | Standard Deviation 12.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 1 Day 15 | -2.4 score on a scale | Standard Deviation 19.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 39 Weeks | -7.6 score on a scale | Standard Deviation 23.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 26 Weeks | -4.3 score on a scale | Standard Deviation 19.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 156 Weeks | 8.3 score on a scale | Standard Deviation 11.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 13 Day 1 | -1.9 score on a scale | Standard Deviation 22 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 130 Weeks | -6.7 score on a scale | Standard Deviation 14.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 11 Day 1 | -0.7 score on a scale | Standard Deviation 24.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 8 Day 1 | -1.6 score on a scale | Standard Deviation 18.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 7 Day 1 | -2.3 score on a scale | Standard Deviation 15.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 7 Day 1 | -2.0 score on a scale | Standard Deviation 19.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 2 Day 15 | -3.5 score on a scale | Standard Deviation 18 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 2 Day 1 | -3.8 score on a scale | Standard Deviation 18 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at End of Treatment | -6.9 score on a scale | Standard Deviation 14.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT/Discontin. | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 22 | 9.8 score on a scale | Standard Deviation 21.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 156 Weeks | 8.3 score on a scale | Standard Deviation 11.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 13 Day 1 | -3.9 score on a scale | Standard Deviation 15.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 8 | -2.5 score on a scale | Standard Deviation 11.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 78 Weeks | 1.9 score on a scale | Standard Deviation 5.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 65 Weeks | 2.8 score on a scale | Standard Deviation 8.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 9 Day 1 | -1.6 score on a scale | Standard Deviation 16.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 15 | -1.5 score on a scale | Standard Deviation 6.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 52 Weeks | 0.7 score on a scale | Standard Deviation 3.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at End of Treatment | 3.8 score on a scale | Standard Deviation 13.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 7 Day 1 | -0.5 score on a scale | Standard Deviation 14.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 11 Day 1 | -0.3 score on a scale | Standard Deviation 5.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 10 Day 1 | 0.4 score on a scale | Standard Deviation 6.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 8 Day 1 | 0.2 score on a scale | Standard Deviation 13.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 156 Weeks | 16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 7 Day 1 | 0.6 score on a scale | Standard Deviation 6.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 13 Day 1 | -5.2 score on a scale | Standard Deviation 12.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 4 Day 1 | -1.8 score on a scale | Standard Deviation 15.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 156 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 10 Day 1 | 0.0 score on a scale | Standard Deviation 14.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 3 Day 1 | -0.9 score on a scale | Standard Deviation 14.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 2 Day 15 | -1.4 score on a scale | Standard Deviation 14.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 11 Day 1 | -3.8 score on a scale | Standard Deviation 12.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 11 Day 1 | 0.7 score on a scale | Standard Deviation 14.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 8 | 1.3 score on a scale | Standard Deviation 6.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT/Discontin. | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 8 Day 1 | -4.7 score on a scale | Standard Deviation 13.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 12 Day 1 | -1.6 score on a scale | Standard Deviation 14.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 156 Weeks | -6.7 score on a scale | Standard Deviation 9.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 143 Weeks | -3.3 score on a scale | Standard Deviation 4.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 9 Day 1 | -3.8 score on a scale | Standard Deviation 21.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 130 Weeks | 5.3 score on a scale | Standard Deviation 20.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 5 Day 1 | 0.4 score on a scale | Standard Deviation 16.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 11 Day 1 | -3.1 score on a scale | Standard Deviation 18.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 15 | 1.2 score on a scale | Standard Deviation 7.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 65 Weeks | 1.9 score on a scale | Standard Deviation 7.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 3 Day 1 | -5.6 score on a scale | Standard Deviation 19.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 39 Weeks | -8.1 score on a scale | Standard Deviation 26.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 15 | -4.4 score on a scale | Standard Deviation 21.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 104 Weeks | -3.7 score on a scale | Standard Deviation 11.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 78 Weeks | -5.6 score on a scale | Standard Deviation 8.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Cycle 1 Day 1 (Baseline) | 94.9 score on a scale | Standard Deviation 11.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 91 Weeks | -9.7 score on a scale | Standard Deviation 21.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Cycle 1 Day 1 (Baseline) | 15.9 score on a scale | Standard Deviation 26.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT/Discontinuation | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 156 Weeks | 16.7 score on a scale | Standard Deviation 23.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 156 Weeks | 33.3 score on a scale | Standard Deviation 15.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 78 Weeks | -4.9 score on a scale | Standard Deviation 18.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 65 Weeks | -1.2 score on a scale | Standard Deviation 17.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 52 Weeks | 1.3 score on a scale | Standard Deviation 20.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 26 Weeks | -7.6 score on a scale | Standard Deviation 25.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at PT 39 Weeks | -0.3 score on a scale | Standard Deviation 12.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 1 Day 8 | 1.8 score on a scale | Standard Deviation 14 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 13 Day 1 | 4.7 score on a scale | Standard Deviation 15.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 12 Day 1 | 3.2 score on a scale | Standard Deviation 17 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 2 Day 1 | 4.0 score on a scale | Standard Deviation 12.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 11 Day 1 | 7.6 score on a scale | Standard Deviation 18.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 10 Day 1 | 3.3 score on a scale | Standard Deviation 16.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 2 Day 15 | 3.8 score on a scale | Standard Deviation 13.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 5 Day 1 | 4.7 score on a scale | Standard Deviation 17.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 4 Day 1 | 3.2 score on a scale | Standard Deviation 18.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 104 Weeks | -3.7 score on a scale | Standard Deviation 11.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 91 Weeks | 2.8 score on a scale | Standard Deviation 9.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Cycle 1 Day 1 (Baseline) | 92.7 score on a scale | Standard Deviation 13.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 3 Day 1 | 4.7 score on a scale | Standard Deviation 15.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 2 Day 15 | 2.1 score on a scale | Standard Deviation 16.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 8 Day 1 | -3.3 score on a scale | Standard Deviation 17 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 15 | 3.4 score on a scale | Standard Deviation 13.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 78 Weeks | 3.7 score on a scale | Standard Deviation 11.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 1 Day 8 | 5.3 score on a scale | Standard Deviation 10.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at End Of Treatment | -6.0 score on a scale | Standard Deviation 27.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 6 Day 1 | 1.4 score on a scale | Standard Deviation 18.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Cycle 1 Day 1 (Baseline) | 14.7 score on a scale | Standard Deviation 18.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 10 Day 1 | 0.2 score on a scale | Standard Deviation 15 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT/Discont. | 8.3 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 117 Weeks | 3.3 score on a scale | Standard Deviation 29.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 26 Weeks | 1.0 score on a scale | Standard Deviation 12.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 9 Day 1 | -0.2 score on a scale | Standard Deviation 16.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 104 Weeks | 1.9 score on a scale | Standard Deviation 20.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 91 Weeks | -0.7 score on a scale | Standard Deviation 20.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 11 Day 1 | 3.5 score on a scale | Standard Deviation 14.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 10 Day 1 | -0.7 score on a scale | Standard Deviation 16.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 78 Weeks | 1.9 score on a scale | Standard Deviation 10.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 65 Weeks | 3.7 score on a scale | Standard Deviation 16 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at PT 13 Weeks | 1.8 score on a scale | Standard Deviation 10.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 11 Day 1 | -2.1 score on a scale | Standard Deviation 21.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 52 Weeks | 1.7 score on a scale | Standard Deviation 14.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 39 Weeks | 2.3 score on a scale | Standard Deviation 12.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 13 Day 1 | 0.7 score on a scale | Standard Deviation 11.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 12 Day 1 | 0.0 score on a scale | Standard Deviation 16.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 26 Weeks | 1.2 score on a scale | Standard Deviation 16.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 12 Day 1 | 0.0 score on a scale | Standard Deviation 11.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at PT 13 Weeks | 3.5 score on a scale | Standard Deviation 13.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 5 Day 1 | 2.6 score on a scale | Standard Deviation 18.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 13 Day 1 | 1.5 score on a scale | Standard Deviation 17.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 104 Weeks | 14.8 score on a scale | Standard Deviation 38.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 39 Weeks | 5.1 score on a scale | Standard Deviation 17.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at End of Treatment | -4.4 score on a scale | Standard Deviation 19.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 13 Weeks | 0.2 score on a scale | Standard Deviation 20 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 10 Day 1 | 0.0 score on a scale | Standard Deviation 12 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 52 Weeks | -1.3 score on a scale | Standard Deviation 18 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Emotional functioning: Change at Cycle 13 Day 1 | 0.2 score on a scale | Standard Deviation 13.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 26 Weeks | -1.0 score on a scale | Standard Deviation 5.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 9 Day 1 | 3.8 score on a scale | Standard Deviation 15.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 65 Weeks | 0.9 score on a scale | Standard Deviation 10.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 13 Weeks | 2.6 score on a scale | Standard Deviation 12 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at End of Treatment | 6.2 score on a scale | Standard Deviation 16.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 91 Weeks | 2.8 score on a scale | Standard Deviation 12 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 13 Day 1 | 5.9 score on a scale | Standard Deviation 14.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 12 Day 1 | 5.6 score on a scale | Standard Deviation 15.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 9 Day 1 | 4.5 score on a scale | Standard Deviation 18.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 5 Day 1 | 3.1 score on a scale | Standard Deviation 15.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 6 Day 1 | -5.8 score on a scale | Standard Deviation 22 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at PT 26 Weeks | 0.0 score on a scale | Standard Deviation 19.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 4 Day 1 | 1.8 score on a scale | Standard Deviation 14.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 3 Day 1 | 3.8 score on a scale | Standard Deviation 12 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 117 Weeks | 26.7 score on a scale | Standard Deviation 41.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 2 Day 15 | 4.1 score on a scale | Standard Deviation 17 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 8 Day 1 | -0.6 score on a scale | Standard Deviation 12.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 4 Day 1 | -1.3 score on a scale | Standard Deviation 19 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 2 Day 1 | 3.2 score on a scale | Standard Deviation 14.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 22 | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 4 Day 1 | 2.6 score on a scale | Standard Deviation 15.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 5 Day 1 | 0.8 score on a scale | Standard Deviation 22.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 15 | 1.2 score on a scale | Standard Deviation 12.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 1 Day 8 | -1.8 score on a scale | Standard Deviation 7.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 1 Day 8 | -7.0 score on a scale | Standard Deviation 17.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 6 Day 1 | 0.5 score on a scale | Standard Deviation 20.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 156 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 143 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 130 Weeks | 23.3 score on a scale | Standard Deviation 43.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 7 Day 1 | 0.3 score on a scale | Standard Deviation 21.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 130 Weeks | 13.3 score on a scale | Standard Deviation 18.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 91 Weeks | -8.3 score on a scale | Standard Deviation 28.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 3 Day 1 | 0.4 score on a scale | Standard Deviation 14.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 8 Day 1 | -0.3 score on a scale | Standard Deviation 21.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 78 Weeks | -3.7 score on a scale | Standard Deviation 11.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 65 Weeks | -7.4 score on a scale | Standard Deviation 24.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 22 | 3.9 score on a scale | Standard Deviation 20 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at Cycle 13 Day 1 | -2.2 score on a scale | Standard Deviation 24.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at PT 52 Weeks | 0.0 score on a scale | Standard Deviation 19.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 11 Day 1 | -0.7 score on a scale | Standard Deviation 20 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 15 | 1.2 score on a scale | Standard Deviation 17.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 7 Day 1 | -4.5 score on a scale | Standard Deviation 18 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 10 Day 1 | 3.5 score on a scale | Standard Deviation 12.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 130 Weeks | 10.0 score on a scale | Standard Deviation 32.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 6 Day 1 | -2.6 score on a scale | Standard Deviation 19.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 5 Day 1 | -3.6 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT/Discontin. | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 143 Weeks | -8.3 score on a scale | Standard Deviation 11.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 4 Day 1 | -2.6 score on a scale | Standard Deviation 18.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 3 Day 1 | -0.9 score on a scale | Standard Deviation 15.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 2 Day 15 | 0.0 score on a scale | Standard Deviation 16.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Change at Cycle 1 Day 8 | 0.0 score on a scale | Standard Deviation 11.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 15 | -4.4 score on a scale | Standard Deviation 21.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Change at Cycle 1 Day 8 | -8.8 score on a scale | Standard Deviation 24.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Diarrhoea: Cycle 1 Day 1 (Baseline) | 4.1 score on a scale | Standard Deviation 16.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Appetite Loss: Cycle 1 Day 1 (Baseline) | 3.4 score on a scale | Standard Deviation 11.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 1 Day 22 | -7.8 score on a scale | Standard Deviation 22.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT/Discontinuation | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 130 Weeks | -6.7 score on a scale | Standard Deviation 14.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Fatigue: Change at Cycle 6 Day 1 | 3.0 score on a scale | Standard Deviation 18.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 2 Day 1 | -5.6 score on a scale | Standard Deviation 19.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 117 Weeks | -6.7 score on a scale | Standard Deviation 14.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 104 Weeks | 0.0 score on a scale | Standard Deviation 16.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Cycle 1 Day 1 (Baseline) | 90.4 score on a scale | Standard Deviation 19.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 3 Day 1 | -2.6 score on a scale | Standard Deviation 22 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 52 Weeks | 0.0 score on a scale | Standard Deviation 13.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at PT 26 Weeks | 2.4 score on a scale | Standard Deviation 14.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 6 Day 1 | -4.2 score on a scale | Standard Deviation 24.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 39 Weeks | -4.0 score on a scale | Standard Deviation 16.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 26 Weeks | -1.0 score on a scale | Standard Deviation 18.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 78 Weeks | -3.7 score on a scale | Standard Deviation 13.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 7 Day 1 | -2.3 score on a scale | Standard Deviation 17.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at PT 13 Weeks | 0.9 score on a scale | Standard Deviation 21.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at End of Treatment | -1.4 score on a scale | Standard Deviation 17.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at Cycle 8 Day 1 | 3.1 score on a scale | Standard Deviation 13.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 8 Day 1 | -6.3 score on a scale | Standard Deviation 18.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 9 Day 1 | -0.6 score on a scale | Standard Deviation 20.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 8 Day 1 | -1.9 score on a scale | Standard Deviation 17.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 1 Day 22 | -2.0 score on a scale | Standard Deviation 20.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 9 Day 1 | 0.0 score on a scale | Standard Deviation 21.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 7 Day 1 | -4.0 score on a scale | Standard Deviation 15.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 2 Day 1 | -0.4 score on a scale | Standard Deviation 16.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Role functioning: Change at PT 39 Weeks | 7.1 score on a scale | Standard Deviation 28 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 22 | -3.9 score on a scale | Standard Deviation 16.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 15 | -0.4 score on a scale | Standard Deviation 16.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 39 Weeks | 1.5 score on a scale | Standard Deviation 6.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 11 Day 1 | 1.4 score on a scale | Standard Deviation 18.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Change at Cycle 1 Day 8 | -5.3 score on a scale | Standard Deviation 12.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Constipation: Cycle 1 Day 1 (Baseline) | 5.7 score on a scale | Standard Deviation 15.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 8 Day 1 | 0.6 score on a scale | Standard Deviation 16 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 12 Day 1 | 0.0 score on a scale | Standard Deviation 23.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT/Discontin. | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 104 Weeks | -5.6 score on a scale | Standard Deviation 11.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Social functioning: Change at Cycle 2 Day 1 | 3.0 score on a scale | Standard Deviation 13.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at Cycle 13 Day 1 | -1.5 score on a scale | Standard Deviation 22.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 9 Day 1 | 0.3 score on a scale | Standard Deviation 7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 8 Day 1 | 2.5 score on a scale | Standard Deviation 12.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 78 Weeks | -7.4 score on a scale | Standard Deviation 12.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 12 Day 1 | 3.5 score on a scale | Standard Deviation 13.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 6 Day 1 | -0.5 score on a scale | Standard Deviation 7.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 5 Day 1 | -0.5 score on a scale | Standard Deviation 7.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 65 Weeks | -4.6 score on a scale | Standard Deviation 11.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 13 Day 1 | 2.2 score on a scale | Standard Deviation 9.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 6 Day 1 | -0.5 score on a scale | Standard Deviation 16.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 117 Weeks | -13.3 score on a scale | Standard Deviation 18.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 13 Weeks | 0.9 score on a scale | Standard Deviation 6.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 2 Day 1 | 1.0 score on a scale | Standard Deviation 10.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 22 | 0.5 score on a scale | Standard Deviation 11.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 26 Weeks | -3.8 score on a scale | Standard Deviation 13.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 26 Weeks | -1.0 score on a scale | Standard Deviation 3.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Change at Cycle 1 Day 15 | -0.3 score on a scale | Standard Deviation 11.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 4 Day 1 | 1.3 score on a scale | Standard Deviation 10.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at PT 13 Weeks | -3.5 score on a scale | Standard Deviation 14.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 3 Day 1 | 1.3 score on a scale | Standard Deviation 8.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 91 Weeks | 1.4 score on a scale | Standard Deviation 4.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 2 Day 15 | 1.6 score on a scale | Standard Deviation 10.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 2 Day 1 | 1.4 score on a scale | Standard Deviation 7.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 91 Weeks | -11.1 score on a scale | Standard Deviation 32.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 104 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Global health status/QoL: Cycle 1 Day 1 (Baseline) | 78.8 score on a scale | Standard Deviation 17.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 22 | 2.9 score on a scale | Standard Deviation 8.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 13 Weeks | -0.9 score on a scale | Standard Deviation 22.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 117 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 117 Weeks | 2.7 score on a scale | Standard Deviation 19.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 104 Weeks | 1.5 score on a scale | Standard Deviation 18.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 12 Day 1 | -4.5 score on a scale | Standard Deviation 14.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT 130 Weeks | 0.0 score on a scale | Standard Deviation 0 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at Cycle 1 Day 8 | 3.5 score on a scale | Standard Deviation 8.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Change at PT/Discont. | 0.0 score on a scale | — |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 78 Weeks | -3.7 score on a scale | Standard Deviation 11.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Nausea and vomiting: Cycle 1 Day 1 (Baseline) | 1.3 score on a scale | Standard Deviation 5.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 26 Weeks | -3.8 score on a scale | Standard Deviation 22.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Cycle 1 Day 1 (Baseline) | 14.6 score on a scale | Standard Deviation 23.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 117 Weeks | 6.7 score on a scale | Standard Deviation 14.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at PT 39 Weeks | 0.6 score on a scale | Standard Deviation 8.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 10 Day 1 | -8.2 score on a scale | Standard Deviation 19.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 8 | -3.5 score on a scale | Standard Deviation 8.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at End of Treatment | -5.1 score on a scale | Standard Deviation 14.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 9 Day 1 | -5.4 score on a scale | Standard Deviation 12.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 1 Day 15 | -1.4 score on a scale | Standard Deviation 14.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 39 Weeks | -5.1 score on a scale | Standard Deviation 23.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 3 Day 1 | -0.6 score on a scale | Standard Deviation 17.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 13 Day 1 | -1.9 score on a scale | Standard Deviation 12.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 12 Day 1 | -0.6 score on a scale | Standard Deviation 10.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 6 Day 1 | -3.4 score on a scale | Standard Deviation 18.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 4 Day 1 | -2.4 score on a scale | Standard Deviation 19.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 9 Day 1 | -1.5 score on a scale | Standard Deviation 14.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 8 Day 1 | -0.3 score on a scale | Standard Deviation 11 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 4 Day 1 | -2.9 score on a scale | Standard Deviation 13.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 7 Day 1 | 0.2 score on a scale | Standard Deviation 9.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 4 Day 1 | -1.0 score on a scale | Standard Deviation 10.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 2 Day 15 | -0.4 score on a scale | Standard Deviation 15.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 6 Day 1 | -3.7 score on a scale | Standard Deviation 20 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 3 Day 1 | -2.7 score on a scale | Standard Deviation 10.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 2 Day 15 | -1.4 score on a scale | Standard Deviation 9.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 65 Weeks | -7.4 score on a scale | Standard Deviation 31.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 9 Day 1 | -0.3 score on a scale | Standard Deviation 23.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 2 Day 1 | -1.8 score on a scale | Standard Deviation 8.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 130 Weeks | -20.0 score on a scale | Standard Deviation 29.8 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Insomnia: Change at PT 65 Weeks | -3.7 score on a scale | Standard Deviation 22.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 10 Day 1 | -3.2 score on a scale | Standard Deviation 16.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 13 Weeks | -8.8 score on a scale | Standard Deviation 25.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 12 Day 1 | -6.3 score on a scale | Standard Deviation 23.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at PT 52 Weeks | -1.3 score on a scale | Standard Deviation 32.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at Cycle 12 Day 1 | -2.1 score on a scale | Standard Deviation 20.2 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 11 Day 1 | -8.3 score on a scale | Standard Deviation 22.3 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at End of Treatment | 1.6 score on a scale | Standard Deviation 21.4 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 9 Day 1 | -5.8 score on a scale | Standard Deviation 20.6 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Physical functioning: Change at Cycle 1 Day 22 | -2.7 score on a scale | Standard Deviation 9.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Cognitive Functioning: Change at Cycle 1 Day 22 | -4.9 score on a scale | Standard Deviation 14.1 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 13 Weeks | -4.8 score on a scale | Standard Deviation 23.5 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Financial difficulties: Change at Cycle 8 Day 1 | -3.1 score on a scale | Standard Deviation 20.9 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Dyspnoea: Change at PT 78 Weeks | 0.0 score on a scale | Standard Deviation 16.7 |
| Cohort 2 Placebo | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score | Pain: Change at PT 52 Weeks | -1.3 score on a scale | Standard Deviation 20.4 |
Secondary
Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT
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)
Population: The ITT population included all participants enrolled in the study, whether or not they had received study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 Vemurafenib | Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT | NA months |
| Cohort 1 Placebo | Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT | NA months |
| Cohort 2 Vemurafenib | Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT | 37.2 months |
| Cohort 2 Placebo | Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT | 30.7 months |
p-value: 0.013395% CI: [0.37, 0.9]Log Rank
p-value: 0.681595% CI: [0.57, 1.44]Log Rank
Secondary
Overall Survival (OS)
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 until 13-July-2018, approximately 6 years)
Population: The ITT population included all participants enrolled in the study, whether or not they had received study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 Vemurafenib | Overall Survival (OS) | NA months |
| Cohort 1 Placebo | Overall Survival (OS) | NA months |
| Cohort 2 Vemurafenib | Overall Survival (OS) | 59.9 months |
| Cohort 2 Placebo | Overall Survival (OS) | NA months |
p-value: 0.027495% CI: [0.3, 0.94]Log Rank
p-value: 0.859795% CI: [0.55, 1.66]Log Rank
Secondary
Percentage of Participants With Adverse Events
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 study completion or discontinuation (up until 13-July-2018, approximately 6 years)
Population: The safety population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 Vemurafenib | Percentage of Participants With Adverse Events | 99.4 percentage of participants |
| Cohort 1 Placebo | Percentage of Participants With Adverse Events | 88.5 percentage of participants |
| Cohort 2 Vemurafenib | Percentage of Participants With Adverse Events | 100.0 percentage of participants |
| Cohort 2 Placebo | Percentage of Participants With Adverse Events | 89.0 percentage of participants |
Secondary
Plasma Concentration of Vemurafenib
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)
Population: The pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of vemurafenib and had provided valid PK assessments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 2 Day 1 | 40200 nanograms per milliliter (ng/mL) | Standard Deviation 24100 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 6 Day 1 | 46000 nanograms per milliliter (ng/mL) | Standard Deviation 18900 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 1 Day 8 | 49900 nanograms per milliliter (ng/mL) | Standard Deviation 19800 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 7 Day 1 | 42800 nanograms per milliliter (ng/mL) | Standard Deviation 20500 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 2 Day 15 | 42400 nanograms per milliliter (ng/mL) | Standard Deviation 21700 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 8 Day 1 | 43600 nanograms per milliliter (ng/mL) | Standard Deviation 19900 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 1 Day 1 (nominal Day 1) | 2880 nanograms per milliliter (ng/mL) | Standard Deviation 2770 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 9 Day 1 | 42900 nanograms per milliliter (ng/mL) | Standard Deviation 18400 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 1 Day 22 | 44000 nanograms per milliliter (ng/mL) | Standard Deviation 22400 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 10 Day 1 | 41000 nanograms per milliliter (ng/mL) | Standard Deviation 19000 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 4 Day 1 | 44800 nanograms per milliliter (ng/mL) | Standard Deviation 19300 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 11 Day 1 | 45900 nanograms per milliliter (ng/mL) | Standard Deviation 15300 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 1 Day 15 | 45300 nanograms per milliliter (ng/mL) | Standard Deviation 23000 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 12 Day 1 | 43700 nanograms per milliliter (ng/mL) | Standard Deviation 15200 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 5 Day 1 | 43100 nanograms per milliliter (ng/mL) | Standard Deviation 18800 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 13 Day 1 | 44000 nanograms per milliliter (ng/mL) | Standard Deviation 17200 |
| Cohort 1 Vemurafenib | Plasma Concentration of Vemurafenib | Cycle 3 Day 1 | 46700 nanograms per milliliter (ng/mL) | Standard Deviation 21500 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 13 Day 1 | 42600 nanograms per milliliter (ng/mL) | Standard Deviation 19900 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 1 Day 8 | 43400 nanograms per milliliter (ng/mL) | Standard Deviation 13600 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 1 Day 1 (nominal Day 1) | 3050 nanograms per milliliter (ng/mL) | Standard Deviation 3010 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 1 Day 15 | 50200 nanograms per milliliter (ng/mL) | Standard Deviation 20500 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 1 Day 22 | 48800 nanograms per milliliter (ng/mL) | Standard Deviation 23700 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 2 Day 1 | 43800 nanograms per milliliter (ng/mL) | Standard Deviation 19400 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 2 Day 15 | 44200 nanograms per milliliter (ng/mL) | Standard Deviation 21200 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 3 Day 1 | 43700 nanograms per milliliter (ng/mL) | Standard Deviation 22000 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 4 Day 1 | 47400 nanograms per milliliter (ng/mL) | Standard Deviation 20100 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 5 Day 1 | 43700 nanograms per milliliter (ng/mL) | Standard Deviation 19400 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 6 Day 1 | 42000 nanograms per milliliter (ng/mL) | Standard Deviation 22000 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 7 Day 1 | 45200 nanograms per milliliter (ng/mL) | Standard Deviation 20500 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 8 Day 1 | 42600 nanograms per milliliter (ng/mL) | Standard Deviation 18900 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 9 Day 1 | 43000 nanograms per milliliter (ng/mL) | Standard Deviation 17700 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 10 Day 1 | 43900 nanograms per milliliter (ng/mL) | Standard Deviation 18500 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 11 Day 1 | 39700 nanograms per milliliter (ng/mL) | Standard Deviation 17600 |
| Cohort 1 Placebo | Plasma Concentration of Vemurafenib | Cycle 12 Day 1 | 46600 nanograms per milliliter (ng/mL) | Standard Deviation 19800 |