AG013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT00219557 
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Results First Posted
: August 24, 2012
Last Update Posted
: August 24, 2012

Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
 Study Details
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Study Type:  Interventional 

Study Design:  Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment 
Condition: 
Pancreatic Neoplasms 
Interventions: 
Drug: Gemcitabine Drug: AG013736 
Participant Flow
Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations 

No text entered. 
PreAssignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment 

No text entered. 
Reporting Groups
Description  

Axitinib + Gemcitabine (Phase 1 LeadIn)  Axitinib (AG013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. 
Axitinib + Gemcitabine  Axitinib (AG013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. 
Gemcitabine  Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. 
Participant Flow for 2 periods
Period 1: Phase 1
Axitinib + Gemcitabine (Phase 1 LeadIn)  Axitinib + Gemcitabine  Gemcitabine  

STARTED  8  0  0 
COMPLETED  1  0  0 
NOT COMPLETED  7  0  0 
Lack of Efficacy  3  0  0 
Adverse Event  2  0  0 
Withdrawal by Subject  1  0  0 
Started chemotherapy at other institute  1  0  0 
Period 2: Phase 2
Axitinib + Gemcitabine (Phase 1 LeadIn)  Axitinib + Gemcitabine  Gemcitabine  

STARTED  0  69  34 
Treated  0  68  31 
COMPLETED  0  0  1 
NOT COMPLETED  0  69  33 
Lack of Efficacy  0  21  15 
Adverse Event  0  22  2 
Death  0  8  2 
Other  0  8  6 
Withdrawal by Subject  0  9  5 
Treatment not received  0  1  3 
Baseline Characteristics
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

No text entered. 
Reporting Groups
Description  

Axitinib + Gemcitabine (Phase 1 LeadIn)  Axitinib (AG013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. 
Axitinib + Gemcitabine  Axitinib (AG013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. 
Gemcitabine  Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. 
Total  Total of all reporting groups 
Baseline Measures
Axitinib + Gemcitabine (Phase 1 LeadIn)  Axitinib + Gemcitabine  Gemcitabine  Total  

Overall Participants Analyzed [Units: Participants] 
8  69  34  111  
Age, Customized [Units: Participants] 

18 years to 44 years  0  2  4  6  
45 years to 64 years  5  31  20  56  
Greater than or equal to 65 years  3  36  10  49  
Gender [Units: Participants] 

Female  1  34  18  53  
Male  7  35  16  58  
Outcome Measures
1. Primary:  Overall Survival (OS) [ Time Frame: Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant ] 
2. Secondary:  Dose Confirmation of Axitinib (AG013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Phase 1 baseline up to Week 4 ] 
3. Secondary:  Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Phase 1 Baseline up to Week 4 ] 
4. Secondary:  Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG013736) [ Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) postdose on Day 15 of Phase 1 Cycle 1 ] 
5. Secondary:  Area Under the Curve From Time Zero to 24 Hours [AUC (024)] of Axitinib (AG013736) [ Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr postdose on Day 15 of Pase 1 Cycle 1 ] 
6. Secondary:  Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG013736) [ Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr postdose on Day 15 of Phase 1 Cycle 1 ] 
7. Secondary:  Plasma Decay Halflife (t1/2) of Axitinib (AG013736) [ Time Frame: 0 (predose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr postdose on Day 15 of Phase 1 Cycle 1 ] 
8. Secondary:  Maximum Observed Plasma Concentration (Cmax) of Gemcitabine [ Time Frame: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1 ] 
9. Secondary:  Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0  ∞)] of Gemcitabine [ Time Frame: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1 ] 
10. Secondary:  Plasma Decay Halflife (t1/2) of Gemcitabine [ Time Frame: 0 (predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1 ] 
11. Secondary:  Percentage of Participants With Overall Response (OR) [ Time Frame: Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks ] 
12. Secondary:  Duration of Response (DR) [ Time Frame: Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks ] 
13. Secondary:  Progressionfree Survival (PFS) [ Time Frame: Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks ] 
14. Secondary:  One Year Survival Probability [ Time Frame: Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant ] 
15. Secondary:  Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study [ Time Frame: Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS). ] 
Hide Outcome Measure 15
Population Description
Reporting Groups
Measured Values
Statistical Analysis 1 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 2 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 3 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 4 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 5 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 6 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 7 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 8 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 9 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 10 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 11 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 12 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 13 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 14 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 15 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 16 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 17 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 18 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 19 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 20 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 21 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 22 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 23 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 24 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 25 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 26 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 27 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 28 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 29 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 30 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 31 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 32 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 33 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 34 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 35 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 36 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 37 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 38 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 39 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 40 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 41 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 42 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 43 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 44 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 45 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 46 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 47 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 48 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 49 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 50 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 51 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 52 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 53 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 54 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 55 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 56 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 57 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 58 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 59 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 60 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 61 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 62 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 63 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 64 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 65 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 66 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 67 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 68 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 69 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 70 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 71 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 72 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 73 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 74 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 75 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 76 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 77 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 78 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 79 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 80 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 81 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 82 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 83 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 84 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 85 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 86 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 87 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 88 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 89 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 90 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 91 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 92 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 93 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 94 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 95 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 96 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 97 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 98 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 99 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 100 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 101 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 102 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 103 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 104 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 105 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 106 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 107 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 108 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 109 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 110 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 111 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 112 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 113 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 114 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 115 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 116 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 117 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 118 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 119 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 120 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 121 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 122 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 123 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 124 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 125 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 126 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 127 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 128 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 129 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 130 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 131 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 132 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 133 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 134 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 135 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 136 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 137 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Statistical Analysis 138 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Measure Type  Secondary 

Measure Title  Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study 
Measure Description  EORTC QLQC30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score. 
Time Frame  Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS). 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Phase 2 ITT population was the primary analysis population. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. n signifies the number of participants evaluable for the respective scale at the respective time point. 
Reporting Groups
Description  

Axitinib + Gemcitabine  Axitinib (AG013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. 
Gemcitabine  Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. 
Measured Values
Axitinib + Gemcitabine  Gemcitabine  

Participants Analyzed [Units: Participants] 
65  27 
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study [Units: Units on a scale] Mean (Standard Deviation) 

Global QoL: Baseline(n=65,27)  55.60 (27.18)  54.32 (21.10) 
Physical Functioning: Baseline(n=65,27)  76.90 (24.73)  82.22 (14.44) 
Role Functioning: Baseline(n=65,26)  62.56 (33.21)  60.26 (35.30) 
Emotional Functioning: Baseline(n=65,27)  67.22 (26.17)  66.98 (23.96) 
Cognitive Functioning: Baseline(n=65,27)  82.82 (23.93)  82.10 (19.57) 
Social Functioning: Baseline(n=65,26)  67.44 (33.00)  70.51 (29.56) 
Fatigue: Baseline(n=65,27)  43.50 (29.78)  42.80 (25.73) 
Nausea and Vomiting: Baseline(n=65,27)  19.74 (28.24)  13.58 (20.17) 
Pain: Baseline(n=65,27)  40.00 (33.31)  37.04 (31.80) 
Dyspnea: Baseline(n=64,27)  12.50 (21.82)  16.05 (26.75) 
Insomnia: Baseline(n=65,27)  31.28 (31.66)  39.51 (39.26) 
Appetite loss: Baseline(n=65,27)  41.03 (40.30)  33.33 (34.59) 
Constipation: Baseline(n=65,27)  34.87 (37.93)  38.27 (38.90) 
Diarrhea: Baseline(n=65,27)  20.00 (27.51)  16.05 (28.30) 
Financial Difficulties: Baseline(n=64,27)  10.42 (19.59)  28.40 (41.04) 
Global QoL: Change at C2 D1(n=49,20 )  5.10 (21.17)  3.33 (16.97) 
Physical Functioning: Change at C2 D1(n=51,21)  5.07 (18.85)  0.95 (16.23) 
Role Functioning: Change at C2 D1(n=51,19))  0.33 (25.93)  9.65 (29.56) 
Emotional Functioning: Change at C2 D1(n=52,21)  3.21 (21.34)  7.94 (17.77) 
Cognitive Functioning: Change at C2 D1(n=52,21)  3.53 (21.48)  1.59 (18.93) 
Social Functioning: Change at C2 D1(n=52,20)  4.17 (29.50)  0.83 (28.85) 
Fatigue: Change at C2 D1(n=51,21)  1.42 (21.74)  8.99 (26.67) 
Nausea and Vomiting: Change at C2 D1(n=51,21)  5.88 (26.84)  1.59 (12.81) 
Pain: Change at C2 D1(n=52,21)  9.29 (27.89)  16.67 (31.62) 
Dyspnea: Change at C2 D1(n=50,21)  9.33 (26.97)  3.17 (25.61) 
Insomnia: Change at C2 D1(n=51,21)  9.15 (28.35)  19.05 (34.27) 
Appetite loss: Change at C2 D1(n=51,21)  0.65 (35.58)  14.29 (35.86) 
Constipation: Change at C2 D1(n=52,21)  9.62 (32.56)  14.29 (29.00) 
Diarrhea: Change at C2 D1(n=52,21)  1.28 (29.49)  0.00 (18.26) 
Financial Difficulties: Change at C2 D1(n=50,21)  0.67 (19.62)  4.76 (19.11) 
Global QoL: Change at C3 D1(n=40,15)  9.17 (30.36)  6.67 (15.17) 
Physical Functioning: Change at C3 D1(n=42,15)  8.13 (21.46)  3.44 (18.73) 
Role Functioning: Change at C3 D1(n=42,14)  5.56 (27.71)  13.10 (25.47) 
Emotional Functioning: Change at C3 D1(n=41,15)  1.69 (26.80)  12.22 (19.89) 
Cognitive Functioning: Change at C3 D1(n=41,15)  4.88 (24.79)  2.22 (16.51) 
Social Functioning: Change at C3 D1(n=41,15)  4.07 (32.66)  5.56 (24.93) 
Fatigue: Change at C3 D1(n=42,14)  7.41 (28.61)  8.73 (26.57) 
Nausea and Vomiting: Change at C3 D1(n=42,13)  4.37 (29.00)  2.56 (16.45) 
Pain: Change at C3 D1(n=42,15)  6.75 (33.75)  23.33 (30.08) 
Dyspnea: Change at C3 D1(n=41,14)  3.25 (27.69)  7.14 (19.30) 
Insomnia: Change at C3 D1(n=42,14)  10.32 (34.13)  11.90 (38.36) 
Appetite loss: Change at C3 D1(n=42,13)  11.11 (39.42)  5.13 (29.96) 
Constipation: Change at C3 D1(n=41,15)  10.57 (32.86)  13.33 (35.19) 
Diarrhea: Change at C3 D1(n=41,15)  7.32 (32.07)  4.44 (30.52) 
Financial Difficulties: Change at C3 D1(n=40,15)  3.33 (24.81)  2.22 (26.63) 
Global QoL: Change at C3 D1(n=30,12)  6.67 (21.04)  1.03 (15.27) 
Physical Functioning: Change at C3 D1(n=32,13)  6.67 (23.15)  1.03 (15.36) 
Role Functioning: Change at C4 D1(n=32,12)  7.81 (29.63)  9.72 (36.56) 
Emotional Functioning: Change at C4 D1(n=31,12)  3.23 (22.64)  9.03 (36.56) 
Cognitive Functioning: Change at C4 D1(n=31,12)  6.99 (25.74)  0.00 (15.89) 
Social Functioning: Change at C4 D1(n=31,11)  8.60 (35.45)  1.52 (24.10) 
Fatigue: Change at C4 D1(n=32,13)  7.47 (25.19)  3.42 (25.41) 
Nausea and Vomiting: Change at C4 D1(n=32,13)  4.69 (19.96)  6.41 (18.68) 
Pain: Change at C4 D1(n=32,13)  16.67 (29.02)  11.54 (28.37) 
Dyspnea: Change at C4 D1(n=31,13)  0.00 (28.54)  5.13 (29.96) 
Insomnia: Change at C4 D1(n=32,13)  11.46 (28.85)  5.13 (32.90) 
Appetite loss: Change at C4 D1(n=32,12)  6.25 (36.35)  2.78 (33.21) 
Constipation: Change at C4 D1(n=30,12)  24.44 (37.07)  25.00 (40.51) 
Diarrhea: Change at C4 D1(n=31, 12)  7.53 (39.17)  5.56 (34.33) 
Financial Difficulties: Change at C4 D1(n=29,12)  1.15 (22.68)  8.33 (20.72) 
Global QoL: Change at C5 D1(n=26,7)  9.29 (27.82)  10.71 (21.36) 
Physical Functioning: Change at C5 D1(n=28,8)  8.57 (23.08)  0.00 (22.25) 
Role Functioning: Change at C5 D1(n=28,7)  8.93 (29.22)  7.14 (28.64) 
Emotional Functioning: Change at C5 D1(n=28,7)  3.87 (22.96)  20.24 (14.32) 
Cognitive Functioning: Change at C5 D1(n=28,7)  2.38 (24.73)  7.14 (16.27) 
Social Functioning: Change at C5 D1(n=28,7)  15.48 (33.92)  4.76 (23.00) 
Fatigue: Change at C5 D1(n=28,8)  9.72 (28.59)  15.28 (17.76) 
Nausea and Vomiting: Change at C5 D1(n=28,8)  0.00 (26.06)  6.25 (15.27) 
Pain: Change at C5 D1(n=28,8)  5.36 (34.26)  25.00 (26.73) 
Dyspnea: Change at C5 D1(n=28,8)  9.52 (27.00)  12.50 (24.80) 
Insomnia: Change at C5 D1(n=28,8)  19.05 (35.63)  29.17 (33.03) 
Appetite loss: Change at C5 D1(n=28,8)  0.00 (42.55)  20.83 (43.42) 
Constipation: Change at C5 D1(n=28,7)  21.43 (35.39)  33.33 (38.49) 
Diarrhea: Change at C5 D1(n=28,7)  7.14 (33.16)  4.76 (29.99) 
Financial Difficulties: Change at C5 D1(n=27,6)  0.00 (22.65)  0.00 (36.51) 
Global QoL: Change at C6 D1(n=17,3)  14.22 (20.36)  5.56 (12.73) 
Physical Functioning: Change at C6 D1(n=19,2)  6.32 (25.38)  6.67 (18.86) 
Role Functioning: Change at C6 D1(n=19,2)  9.65 (27.95)  16.67 (47.14) 
Emotional Functioning: Change at C6 D1(n=19,3)  2.19 (15.92)  8.33 (14.43) 
Cognitive Functioning: Change at C6 D1(n=19,3)  0.88 (18.82)  11.11 (9.62) 
Social Functioning: Change at C6 D1(n=19,3)  2.63 (27.92)  16.67 (16.67) 
Fatigue: Change at C6 D1(n=19,2)  6.73 (24.19)  16.67 (39.28) 
Nausea and Vomiting: Change at C6 D1(n=19,2)  4.39 (22.80)  8.33 (11.79) 
Pain: Change at C6 D1(n=19,3)  8.77 (30.11)  33.33 (16.67) 
Dyspnea: Change at C6 D1(n=18,2)  1.85 (21.30)  0.00 (47.14) 
Insomnia: Change at C6 D1(n=19,2)  7.02 (30.59)  16.67 (23.57) 
Appetite loss: Change at C6 D1(n=19,2)  3.51 (53.16)  16.67 (70.71) 
Constipation: Change at C6 D1(n=19,3)  10.53 (35.23)  33.33 (33.33) 
Diarrhea: Change at C6 D1(n=19,3)  1.75 (28.27)  0.00 (33.33) 
Financial Difficulties: Change at C6 D1(n=19,3)  1.75 (13.49)  22.22 (38.49) 
Global QoL: Change at C7 D1(n=9,3)  4.63 (37.76)  16.67 (14.43) 
Role Functioning: Change at C7 D1(n=10,2)  3.33 (24.80)  22.22 (36.72) 
Role Functioning: Change at C7 D1(n=10,2)  15.00 (30.88)  33.33 (70.71) 
Emotional Functioning: Change at C7 D1(n=10,3)  8.33 (13.03)  7.41 (21.58) 
Cognitive Functioning: Change at C7 D1(n=10,3)  1.67 (24.15)  5.56 (9.62) 
Social Functioning: Change at C7 D1(n=10,2)  15.00 (41.16)  25.00 (11.79) 
Fatigue: Change at C7 D1(n=10,3)  2.22 (25.01)  14.81 (42.07) 
Nausea and Vomiting: Change at C7D1(n=10,3)  1.67 (21.44)  16.67 (0.00) 
Pain: Change at C7 D1(n=10,3)  3.33 (32.20)  11.11 (41.94) 
Dyspnea: Change at C7 D1(n=10,3)  16.67 (23.57)  33.33 (33.33) 
Insomnia: Change at C7 D1(n=10,3)  10.00 (35.31)  11.11 (38.49) 
Appetite loss: Change at C7 D1(n=10,3)  10.00 (58.90)  22.22 (50.92) 
Constipation: Change at C7 D1(n=10,3)  13.33 (47.66)  66.67 (57.74) 
Diarrhea: Change at C7 D1(n=10,3)  3.33 (29.19)  0.00 (0.00) 
Financial Difficulties: Change at C7 D1(n=10,3)  6.67 (21.08)  0.00 (0.00) 
Global QoL: Change at C8 D1(n=10,1)  12.50 (33.62)  33.33 ^{[1] } 
Physical Functioning Change at C8 D1(n=10,1)  10.67 (22.71)  20.00 ^{[1] } 
Role Functioning: Change at C8 D1(n=10,1)  13.33 (23.31)  33.33 ^{[1] } 
Emotional Functioning: Change at C8 D1(n=10,1)  7.50 (18.61)  0.00 ^{[1] } 
Cognitive Functioning: Change at C8 D1(n=10,1)  0.00 (22.22)  16.67 ^{[1] } 
Social Functioning: Change at C8 D1(n=10,1)  11.67 (34.29)  16.67 ^{[1] } 
Fatigue: Change at C8 D1(n=10,1)  4.44 (25.23)  2.22 ^{[1] } 
Nausea and Vomiting: Change at C8 D1(n=10,1)  0.00 (19.25)  16.67 ^{[1] } 
Pain: Change at C8 D1(n=10,1)  8.33 (37.06)  16.67 ^{[1] } 
Dyspnea: Change at C8 D1(n=9,1)  14.81 (29.40)  33.33 ^{[1] } 
Insomnia: Change at C8 D1(n=10,1)  20.00 (47.66)  0.00 ^{[1] } 
Appetite loss: Change at C8 D1(n=10,1)  3.33 (48.30)  33.33 ^{[1] } 
Constipation: Change at C8 D1(n=10,1)  3.33 (29.19)  0.00 ^{[1] } 
Diarrhea: Change at C8 D1(n=10,1)  6.67 (37.84)  66.67 ^{[1] } 
Financial Difficulties: Change at C8 D1(n=10,1)  3.33 (18.92)  0.00 ^{[1] } 
Global QoL: Change at C9 D1(n=8,1)  17.71 (36.03)  33.33 ^{[1] } 
Physical Functioning: Change at C9 D1(n=8,1)  6.67 (20.16)  40.00 ^{[1] } 
Role Functioning: Change at C9 D1(n=8,1)  29.17 (24.80)  33.33 ^{[1] } 
Emotional Functioning: Change at C9 D1(n=8,1)  3.13 (13.32)  8.33 ^{[1] } 
Cognitive Functioning: Change at C9 D1(n=8,1)  2.08 (28.78)  33.33 ^{[1] } 
Social Functioning: Change at C9 D1(n=8,1)  6.25 (47.09)  33.33 ^{[1] } 
Fatigue: Change at C9 D1(n=8,1)  18.06 (33.56)  33.33 ^{[1] } 
Nausea and Vomiting: Change at C9 D1(n=8,1)  8.33 (17.82)  16.67 ^{[1] } 
Pain: Change at C9 D1(n=8,1 )  0.00 (30.86)  0.00 ^{[1] } 
Dyspnea: Change at C9 D1(n=7,1)  19.05 (26.23)  33.33 ^{[1] } 
Insomnia: Change at C9 D1(n=8,1)  4.17 (33.03)  0.00 ^{[1] } 
Appetite loss: Change at C9 D1(n=8,1)  8.33 (63.62)  33.33 ^{[1] } 
Constipation: Change at C9 D1(n=8,1)  8.33 (38.83)  0.00 ^{[1] } 
Diarrhea: Change at C9 D1(n=8,1)  12.50 (43.42)  66.67 ^{[1] } 
Financial Difficulties: Change at C9 D1(n=8,1)  4.17 (21.36)  0.00 ^{[1] } 
Global QoL: Change at C10 D1(n=7,1)  16.67 (21.52)  33.33 ^{[1] } 
Physical Functioning: Change at C10 D1(n=7,1)  19.05 (13.01)  46.67 ^{[1] } 
Role Functioning: Change at C10 D1(n=7,1)  23.81 (21.21)  50.00 ^{[1] } 
Emotional Functioning: Change at C10 D1(n=7,1)  20.24 (23.00)  16.67 ^{[1] } 
Cognitive Functioning: Change at C10 D1(n=7,1)  9.52 (21.21)  33.33 ^{[1] } 
Social Functioning: Change at C10 D1(n=7,1)  21.43 (31.50)  50.00 ^{[1] } 
Fatigue: Change at C10 D1(n=7,1)  25.40 (24.61)  55.56 ^{[1] } 
Nausea and Vomiting: Change at C10 D1(n=7,1)  0.00 (25.46)  16.67 ^{[1] } 
Pain: Change at C10 D1(n=7,1)  11.90 (35.63)  16.67 ^{[1] } 
Dyspnea: Change at C10 D1(n=6,1)  22.22 (27.22)  33.33 ^{[1] } 
Insomnia: Change at C10 D1(n=7,1)  4.76 (23.00)  0.00 ^{[1] } 
Appetite loss: Change at C10 D1(n=7,1)  23.81 (46.00)  33.33 ^{[1] } 
Constipation: Change at C10 D1(n=7,1)  19.05 (37.80)  0.00 ^{[1] } 
Diarrhea: Change at C10 D1(n=7,1)  9.52 (31.71)  66.67 ^{[1] } 
Financial Difficulties: Change at C10 D1(n=7,1)  4.76 (23.00)  0.00 ^{[1] } 
Global QoL: Change at C11 D1(n=3,1)  38.89 (53.58)  33.33 ^{[1] } 
Physical Functioning: Change at C11 D1(n=3,1)  24.44 (36.72)  40.00 ^{[1] } 
Role Functioning: Change at C11 D1(n=3,1)  38.89 (53.58)  66.67 ^{[1] } 
Emotional Functioning: Change at C11 D1(n=3,1)  25.00 (52.04)  8.33 ^{[1] } 
Cognitive Functioning: Change at C11 D1(n=3,1)  27.78 (63.10)  33.33 ^{[1] } 
Social Functioning: Change at C11 D1(n=3,1)  38.89 (53.58)  66.67 ^{[1] } 
Fatigue: Change at C11 D1(n=3,1)  37.04 (46.26)  22.22 ^{[1] } 
Nausea and Vomiting: Change at C11 D1(n=3,1)  27.78 (63.10)  16.67 ^{[1] } 
Pain: Change at C11 D1(n=3,1)  22.22 (69.39)  16.67 ^{[1] } 
Dyspnea: Change at C11 D1(n=3,1)  22.22 (69.39)  33.33 ^{[1] } 
Insomnia: Change at C11 D1(n=3,1)  22.22 (69.39)  0.00 ^{[1] } 
Appetite loss: Change at C11 D1(n=3,1)  44.44 (50.92)  0.00 ^{[1] } 
Constipation: Change at C11 D1(n=3,1)  0.00 (33.33)  0.00 ^{[1] } 
Diarrhea: Change at C11 D1(n=3,1)  11.11 (19.25)  66.67 ^{[1] } 
Financial Difficulties: Change at C11 D1(n=3,1)  11.11 (19.25)  0.00 ^{[1] } 
Global QoL: Change at C12 D1(n=3,0)  11.11 (17.35)  NA ^{[2] } 
Physical Functioning: Change at C12 D1(n=3,0)  6.67 (6.67)  NA ^{[2] } 
Role Functioning: Change at C12 D1(n=3,0)  11.11 (19.25)  NA ^{[2] } 
Emotional Functioning: Change at C12 D1(n=3,0)  2.78 (20.97)  NA ^{[2] } 
Cognitive Functioning: Change at C12 D1(n=3,0)  0.00 (16.67)  NA ^{[2] } 
Social Functioning: Change at C12 D1(n=3,0)  5.56 (9.62)  NA ^{[2] } 
Fatigue: Change at C12 D1(n=3,0)  7.41 (12.83)  NA ^{[2] } 
Nausea and Vomiting: Change at C12 D1(n=3,0)  16.67 (60.09)  NA ^{[2] } 
Pain: Change at C12 D1(n=3,0)  5.56 (9.62)  NA ^{[2] } 
Dyspnea: Change at C12 D1(n=2,0)  0.00 (0.00)  NA ^{[2] } 
Insomnia: Change at C12 D1(n=3,0)  11.11 (19.25)  NA ^{[2] } 
Appetite loss: Change at C12 D1(n=3,0)  22.22 (19.25)  NA ^{[2] } 
Constipation: Change at C12 D1(n=3,0)  22.22 (38.49)  NA ^{[2] } 
Diarrhea: Change at C12 D1(n=3,0)  22.22 (19.25)  NA ^{[2] } 
Financial Difficulties: Change at C12 D1(n=3,0)  11.11 (19.25)  NA ^{[2] } 
Global QoL: Change at C13 D1(n=2,0)  50.00 (35.36)  NA ^{[2] } 
Physical Functioning: Change at C13 D1(n=2,0)  23.33 (33.00)  NA ^{[2] } 
Role Functioning: Change at C13 D1(n=2,0)  41.67 (35.36)  NA ^{[2] } 
Emotional Functioning: Change at C13 D1(n=2,0)  8.33 (11.79)  NA ^{[2] } 
Cognitive Functioning: Change at C13 D1(n=2,0)  0.00 (0.00)  NA ^{[2] } 
Social Functioning: Change at C13 D1(n=2,0)  8.33 (35.36)  NA ^{[2] } 
Fatigue: Change at C13 D1(n=2,0)  33.33 (47.14)  NA ^{[2] } 
Nausea and Vomiting: Change at C13 D1(n=2,0)  8.33 (35.36)  NA ^{[2] } 
Pain: Change at C13 D1(n=2,0)  41.67 (58.93)  NA ^{[2] } 
Dyspnea: Change at C13 D1(n=1,0)  0.00 ^{[1] }  NA ^{[2] } 
Insomnia: Change at C13 D1(n=2,0)  0.00 (0.00)  NA ^{[2] } 
Appetite loss: Change at C13 D1(n=2,0)  33.33 (47.14)  NA ^{[2] } 
Constipation: Change at C13 D1(n=2,0)  16.67 (23.57)  NA ^{[2] } 
Diarrhea: Change at C13 D1(n=2,0)  16.67 (23.57)  NA ^{[2] } 
Financial Difficulties: Change at C13 D1(n=2,0)  16.67 (23.57)  NA ^{[2] } 
Global QoL: Change at C14 D1(n=1,0)  16.67 ^{[1] }  NA ^{[2] } 
Physical Functioning: Change at C14 D1(n=1,0)  6.67 ^{[1] }  NA ^{[2] } 
Role Functioning: Change at C14 D1(n=1,0)  33.33 ^{[1] }  NA ^{[2] } 
Emotional Functioning: Change at C14 D1(n=1,0)  8.33 ^{[1] }  NA ^{[2] } 
Cognitive Functioning: Change at C14 D1(n=1,0)  16.67 ^{[1] }  NA ^{[2] } 
Social Functioning: Change at C14 D1(n=1,0)  0.00 ^{[1] }  NA ^{[2] } 
Fatigue: Change at C14 D1(n=1,0)  22.22 ^{[1] }  NA ^{[2] } 
Nausea and Vomiting: Change at C14 D1(n=1,0)  0.00 ^{[1] }  NA ^{[2] } 
Pain: Change at C14 D1(n=1,0)  16.67 ^{[1] }  NA ^{[2] } 
Dyspnea: Change at C14 D1(n=1,0)  33.33 ^{[1] }  NA ^{[2] } 
Insomnia: Change at C14 D1(n=1,0)  33.33 ^{[1] }  NA ^{[2] } 
Appetite loss: Change at C14 D1(n=1,0)  0.00 ^{[1] }  NA ^{[2] } 
Constipation: Change at C14 D1(n=1,0)  0.00 ^{[1] }  NA ^{[2] } 
Diarrhea: Change at C14 D1(n=1,0)  33.33 ^{[1] }  NA ^{[2] } 
Financial Difficulties: Change at C14 D1(n=1,0)  33.33 ^{[1] }  NA ^{[2] } 
Global QoL: Change at EoS(n=2,1)  54.17 (29.46)  0.00 ^{[1] } 
Physical Functioning: Change at EoS(n=2,1)  70.00 (4.71)  0.00 ^{[1] } 
Role Functioning: Change at EoS(n=2,1)  33.33 (23.57)  0.00 ^{[1] } 
Emotional Functioning: Change at EoS(n=2,1)  66.67 (35.36)  25.00 ^{[1] } 
Cognitive Functioning: Change at EoS(n=2,1)  66.67 (0.00)  0.00 ^{[1] } 
Social Functioning: Change at EoS(n=2,1)  83.33 (23.57)  0.00 ^{[1] } 
Fatigue: Change at EoS(n=2,1)  55.56 (15.71)  11.11 ^{[1] } 
Nausea and Vomiting: Change at EoS(n=2,1)  33.33 (23.57)  0.00 ^{[1] } 
Pain: Change at EoS(n=2,1)  41.67 (82.50)  16.67 ^{[1] } 
Dyspnea: Change at EoS(n=2,1)  83.33 (23.57)  0.00 ^{[1] } 
Insomnia: Change at EoS(n=2,1)  66.67 (47.14)  33.33 ^{[1] } 
Appetite loss: Change at EoS(n=2,1)  50.00 (70.71)  0.00 ^{[1] } 
Constipation: Change at EoS(n=2,1)  16.67 (117.85)  0.00 ^{[1] } 
Diarrhea: Change at EoS(n=2,1)  33.33 (47.14)  0.00 ^{[1] } 
Financial Difficulties: Change at EoS(n=2,1)  16.67 (23.57)  0.00 ^{[1] } 
[1]  Standard deviation was not calculated because only one participant was evaluable. 

[2]  Mean was not calculated because no participant was evaluable. 
Statistical Analysis 1 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  8.44 
95% Confidence Interval  19.06 to 2.19 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in global QoL at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  6.02 
95% Confidence Interval  15.4 to 3.36 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in physical functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 3 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  9.32 
95% Confidence Interval  23.77 to 5.12 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in role functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 4 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  4.73 
95% Confidence Interval  15.25 to 5.79 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in emotional functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 5 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  5.11 
95% Confidence Interval  15.83 to 5.61 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in cognitive functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 6 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  3.33 
95% Confidence Interval  18.72 to 12.06 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in social functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 7 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  10.41 
95% Confidence Interval  1.62 to 22.44 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in fatigue at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 8 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  4.30 
95% Confidence Interval  16.55 to 7.96 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in nausea and vomiting at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 9 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  7.37 
95% Confidence Interval  7.57 to 22.32 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 10 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  12.51 
95% Confidence Interval  1.28 to 26.30 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in dyspnea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 11 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  9.90 
95% Confidence Interval  5.70 to 25.49 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in insomnia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 12 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  13.63 
95% Confidence Interval  4.81 to 32.07 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in appetite loss at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 13 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  4.67 
95% Confidence Interval  11.62 to 20.96 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in constipation at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 14 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  1.28 
95% Confidence Interval  15.1 to 12.54 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in diarrhea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 15 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  5.43 
95% Confidence Interval  4.67 to 15.53 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in financial difficulties at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 16 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  15.83 
95% Confidence Interval  32.34 to 0.67 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in global QoL at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 17 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  11.58 
95% Confidence Interval  24.12 to 0.96 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in physical functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 18 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  18.65 
95% Confidence Interval  35.47 to 1.83 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in role functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 19 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  13.92 
95% Confidence Interval  29.16 to 1.32 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in emotional functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 20 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  7.10 
95% Confidence Interval  20.97 to 6.77 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in cognitive functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 21 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  9.62 
95% Confidence Interval  28.28 to 9.04 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in social functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 22 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  16.14 
95% Confidence Interval  1.27 to 33.54 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in fatigue at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 23 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  1.80 
95% Confidence Interval  18.78 to 15.18 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in nausea and vomiting at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 24 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  16.59 
95% Confidence Interval  3.22 to 36.39 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 25 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  10.39 
95% Confidence Interval  5.68 to 26.47 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in dyspnea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 26 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  1.59 
95% Confidence Interval  20.19 to 23.36 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in insomnia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 27 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  16.24 
95% Confidence Interval  7.62 to 40.1 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in appetite loss at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 28 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  2.76 
95% Confidence Interval  17.49 to 23.02 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in constipation at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 29 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  2.87 
95% Confidence Interval  16.29 to 22.03 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in diarrhea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 30 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  5.56 
95% Confidence Interval  9.81 to 20.92 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in financial difficulties at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 31 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  5.97 
95% Confidence Interval  19.52 to 7.57 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in global QoL at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 32 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  5.64 
95% Confidence Interval  19.75 to 8.46 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in physical functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 33 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  17.53 
95% Confidence Interval  39.11 to 4.05 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in role functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 34 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  12.25 
95% Confidence Interval  26.5 to 2.00 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in emotional functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 35 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  6.99 
95% Confidence Interval  23.13 to 9.15 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in cognitive functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 36 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  7.09 
95% Confidence Interval  30.48 to 16.31 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in social functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 37 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  10.88 
95% Confidence Interval  5.86 to 27.63 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in fatigue at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 38 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  11.10 
95% Confidence Interval  24.11 to 1.91 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in nausea and vomiting at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 39 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  5.13 
95% Confidence Interval  24.26 to 14.00 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 40 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  5.13 
95% Confidence Interval  14.18 to 24.44 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in dyspnea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 41 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  6.33 
95% Confidence Interval  26.25 to 13.59 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in insomnia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 42 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  9.03 
95% Confidence Interval  15.26 to 33.32 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in appetite loss at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 43 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  0.56 
95% Confidence Interval  25.71 to 26.82 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in constipation at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 44 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  1.97 
95% Confidence Interval  24.07 to 28.01 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in diarrhea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 45 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  9.48 
95% Confidence Interval  5.89 to 24.86 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in financial difficulties at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 46 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  20.01 
95% Confidence Interval  43.19 to 3.17 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in global QoL at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 47 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  8.57 
95% Confidence Interval  27.24 to 10.10 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in physical functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 48 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  16.07 
95% Confidence Interval  41.10 to 8.96 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in role functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 49 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  24.11 
95% Confidence Interval  42.72 to 5.50 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in emotional functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 50 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  9.52 
95% Confidence Interval  29.66 to 10.61 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in cognitive functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 51 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  20.24 
95% Confidence Interval  47.93 to 7.46 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in social functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 52 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  25.00 
95% Confidence Interval  3.23 to 46.77 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in fatigue at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 53 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  6.25 
95% Confidence Interval  13.49 to 25.99 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in nausea and vomiting at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 54 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  19.64 
95% Confidence Interval  7.12 to 46.41 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 55 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  22.02 
95% Confidence Interval  0.38 to 43.66 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in dyspnea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 56 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  10.12 
95% Confidence Interval  18.49 to 38.73 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in insomnia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 57 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  20.83 
95% Confidence Interval  13.98 to 55.65 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in appetite loss at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 58 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  11.90 
95% Confidence Interval  19.02 to 42.83 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in constipation at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 59 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  11.90 
95% Confidence Interval  16.13 to 39.94 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in diarrhea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 60 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  0.00 
95% Confidence Interval  23.38 to 23.38 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in financial difficulties at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 61 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  8.66 
95% Confidence Interval  34.53 to 17.21 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in global QoL at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 62 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  12.98 
95% Confidence Interval  52.01 to 26.04 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in physical functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 63 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  26.32 
95% Confidence Interval  71.87 to 19.24 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in role functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 64 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  6.14 
95% Confidence Interval  26.59 to 14.31 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in emotional functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 65 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  11.99 
95% Confidence Interval  35.46 to 11.48 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in cognitive functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 66 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  14.04 
95% Confidence Interval  20.97 to 49.04 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in social functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 67 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  23.39 
95% Confidence Interval  15.83 to 62.61 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in fatigue at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 68 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  3.95 
95% Confidence Interval  30.84 to 38.73 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in nausea and vomiting at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 69 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  24.56 
95% Confidence Interval  13.08 to 62.20 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 70 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  1.85 
95% Confidence Interval  38.65 to 34.94 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in dyspnea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 71 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  9.65 
95% Confidence Interval  37.43 to 56.73 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in insomnia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 72 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  13.16 
95% Confidence Interval  71.22 to 97.54 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in appetite loss at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 73 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  22.81 
95% Confidence Interval  22.61 to 68.22 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in constipation at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 74 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  1.75 
95% Confidence Interval  39.10 to 35.59 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in diarrhea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 75 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  23.98 
95% Confidence Interval  1.09 to 46.86 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in financial difficulties at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 76 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  12.04 
95% Confidence Interval  39.03 to 63.11 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in global QoL at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 77 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  18.89 
95% Confidence Interval  20.74 to 58.52 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in physical functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 78 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  48.33 
95% Confidence Interval  111.94 to 15.28 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in role functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 79 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  0.93 
95% Confidence Interval  22.59 to 20.74 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in emotional functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 80 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  7.22 
95% Confidence Interval  24.98 to 39.43 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in cognitive functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 81 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  10.00 
95% Confidence Interval  57.71 to 77.71 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in social functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 82 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  17.04 
95% Confidence Interval  58.87 to 24.79 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in fatigue at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 83 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  15.00 
95% Confidence Interval  43.10 to 13.10 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in nausea and vomiting at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 84 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  7.78 
95% Confidence Interval  41.75 to 57.30 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 85 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  16.67 
95% Confidence Interval  53.79 to 20.46 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in dyspnea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 86 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  21.11 
95% Confidence Interval  73.14 to 30.92 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in insomnia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 87 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  32.22 
95% Confidence Interval  115.58 to 51.13 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in appetite loss at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 88 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  53.33 
95% Confidence Interval  18.60 to 125.26 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in constipation at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 89 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  3.33 
95% Confidence Interval  34.92 to 41.58 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in diarrhea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 90 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  6.67 
95% Confidence Interval  34.3 to 20.96 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in financial difficulties at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 91 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  20.83 
95% Confidence Interval  58.94 to 100.60 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in global QoL at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 92 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  9.33 
95% Confidence Interval  44.54 to 63.20 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in physical functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 93 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  20.00 
95% Confidence Interval  35.30 to 75.30 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in role functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 94 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  7.50 
95% Confidence Interval  51.66 to 36.66 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in emotional functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 95 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  16.67 
95% Confidence Interval  36.06 to 69.39 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in cognitive functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 96 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  5.00 
95% Confidence Interval  76.36 to 86.36 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in social functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 97 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  17.78 
95% Confidence Interval  77.63 to 42.08 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in fatigue at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 98 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  16.67 
95% Confidence Interval  62.33 to 28.99 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in nausea and vomiting at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 99 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  8.33 
95% Confidence Interval  79.59 to 96.26 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 100 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  18.52 
95% Confidence Interval  89.98 to 52.94 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in dyspnea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 101 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  20.00 
95% Confidence Interval  133.08 to 93.08 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in insomnia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 102 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  36.67 
95% Confidence Interval  151.27 to 77.94 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in appetite loss at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 103 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  3.33 
95% Confidence Interval  72.58 to 65.91 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in constipation at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 104 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  73.33 
95% Confidence Interval  16.45 to 163.12 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in diarrhea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 105 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  3.33 
95% Confidence Interval  48.23 to 41.56 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in financial difficulties at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 106 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  15.62 
95% Confidence Interval  74.75 to 106.00 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in global QoL at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 107 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  33.33 
95% Confidence Interval  17.22 to 83.89 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in physical functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 108 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  4.17 
95% Confidence Interval  58.04 to 66.37 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in role functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 109 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  5.21 
95% Confidence Interval  28.19 to 38.61 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in emotional functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 110 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  31.25 
95% Confidence Interval  40.94 to 103.44 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in cognitive functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 111 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  27.08 
95% Confidence Interval  91.02 to 145.18 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in social functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 112 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  15.28 
95% Confidence Interval  99.46 to 68.90 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in fatigue at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 113 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  25.00 
95% Confidence Interval  69.69 to 19.69 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in nausea and vomiting at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 114 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  0.00 
95% Confidence Interval  77.40 to 77.40 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 115 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  14.29 
95% Confidence Interval  82.89 to 54.32 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in dyspnea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 116 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  4.17 
95% Confidence Interval  87.02 to 78.69 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in insomnia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 117 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  25.00 
95% Confidence Interval  184.57 to 134.57 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in appetite loss at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 118 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  8.33 
95% Confidence Interval  105.73 to 89.06 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in constipation at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 119 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  79.17 
95% Confidence Interval  29.72 to 188.06 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in diarrhea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 120 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  4.17 
95% Confidence Interval  57.74 to 49.41 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in financial difficulties at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant estimation information: 
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Statistical Analysis 121 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  16.67 
95% Confidence Interval  39.62 to 72.95 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in global QoL at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 122 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  27.62 
95% Confidence Interval  6.42 to 61.66 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in physical functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 123 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  26.19 
95% Confidence Interval  29.28 to 81.66 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in role functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 124 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  3.57 
95% Confidence Interval  63.74 to 56.6 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in emotional functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 125 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  23.81 
95% Confidence Interval  31.66 to 79.28 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in cognitive functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 126 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  28.57 
95% Confidence Interval  53.82 to 110.96 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in social functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 127 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  30.16 
95% Confidence Interval  94.53 to 34.21 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in fatigue at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 128 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  16.67 
95% Confidence Interval  83.26 to 49.93 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in nausea and vomiting at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 129 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  4.76 
95% Confidence Interval  97.98 to 88.45 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 130 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  11.11 
95% Confidence Interval  86.68 to 64.46 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in dyspnea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 131 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  4.76 
95% Confidence Interval  55.41 to 64.93 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in insomnia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 132 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  9.52 
95% Confidence Interval  129.86 to 110.82 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in appetite loss at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 133 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  19.05 
95% Confidence Interval  117.92 to 79.82 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in constipation at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 134 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  76.19 
95% Confidence Interval  6.75 to 159.13 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in diarrhea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 135 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  4.76 
95% Confidence Interval  64.93 to 55.41 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in financial difficulties at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 136 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  5.56 
95% Confidence Interval  271.74 to 260.62 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in global QoL at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 137 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  15.56 
95% Confidence Interval  166.87 to 197.98 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in physical functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant estimation information: 
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Statistical Analysis 138 for Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQC30) Score at Day 1 of Every Cycle and End of Study
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Mean Difference (Final Values) ^{[3]}  27.78 
95% Confidence Interval  238.4 to 293.96 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

For change in role functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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