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
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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 ] 
Measure Type  Primary 

Measure Title  Overall Survival (OS) 
Measure Description  Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the the date of randomization plus 1. Death was determined from adverse event data (where outcome was death) or from followup contact data (where the participant current status was death). 
Time Frame  Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant 
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 intent to treat (ITT) population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized. 
Reporting Groups
Description  

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. 
Measured Values
Axitinib + Gemcitabine  Gemcitabine  

Participants Analyzed [Units: Participants] 
69  34 
Overall Survival (OS) [Units: Days] Median (95% Confidence Interval) 
210 (162 to 308) 
171 (125 to 267) 
Statistical Analysis 1 for Overall Survival (OS)
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Log Rank 
P Value ^{[4]}  0.1026 
Hazard Ratio (HR) ^{[5]}  0.758 
95% Confidence Interval  0.490 to 1.170 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Differences in OS between treatment arms was analyzed by the stratified logrank test where the stratification factors are Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to 1 or 2) and extent of disease (locally advanced or metastatic).  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
Onesided logrank test at alpha = 0.1 significance level was used.  
[5]  Other relevant estimation information: 
No text entered. 
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 ] 
Measure Type  Secondary 

Measure Title  Dose Confirmation of Axitinib (AG013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT) 
Measure Description  Dose of axitinib (AG013736) was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or nonhematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG013736) dosing within 14 days of stopping due to treatment related toxicity. 
Time Frame  Phase 1 baseline up to Week 4 
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 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. 
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. 
Measured Values
Axitinib + Gemcitabine (Phase 1 LeadIn)  

Participants Analyzed [Units: Participants] 
6 
Dose Confirmation of Axitinib (AG013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT) [Units: Participants] 
0 
No statistical analysis provided for Dose Confirmation of Axitinib (AG013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
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 ] 
Measure Type  Secondary 

Measure Title  Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT) 
Measure Description  Dose of gemcitabine was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (>=) Gr 3 anemia or nonhematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG013736) dosing within 14 days of stopping due to treatment related toxicity. 
Time Frame  Phase 1 Baseline up to Week 4 
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 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. 
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. 
Measured Values
Axitinib + Gemcitabine (Phase 1 LeadIn)  

Participants Analyzed [Units: Participants] 
6 
Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT) [Units: Participants] 
0 
No statistical analysis provided for Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
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 ] 
Measure Type  Secondary 

Measure Title  Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG013736) 
Measure Description  No text entered. 
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 
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 1 Pharmacokinetic (PK) evaluable population included all ITT participants who completed PK blood sampling on at least 1 day. 
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. 
Measured Values
Axitinib + Gemcitabine (Phase 1 LeadIn)  

Participants Analyzed [Units: Participants] 
6 
Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG013736) [Units: Nanogram/milliliter (ng/mL)] Mean (Standard Deviation) 
45.08 (34.32) 
No statistical analysis provided for Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG013736)
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 ] 
Measure Type  Secondary 

Measure Title  Area Under the Curve From Time Zero to 24 Hours [AUC (024)] of Axitinib (AG013736) 
Measure Description  AUC (024) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to 24 hours (024). 
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 
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 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. 
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. 
Measured Values
Axitinib + Gemcitabine (Phase 1 LeadIn)  

Participants Analyzed [Units: Participants] 
6 
Area Under the Curve From Time Zero to 24 Hours [AUC (024)] of Axitinib (AG013736) [Units: ng*hr/mL] Mean (Standard Deviation) 
282.34 (135.27) 
No statistical analysis provided for Area Under the Curve From Time Zero to 24 Hours [AUC (024)] of Axitinib (AG013736)
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 ] 
Measure Type  Secondary 

Measure Title  Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG013736) 
Measure Description  Tmax was based on the actual time points when the samples were collected. 
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 
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 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. 
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. 
Measured Values
Axitinib + Gemcitabine (Phase 1 LeadIn)  

Participants Analyzed [Units: Participants] 
6 
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG013736) [Units: Hr] Median (Full Range) 
1.52 (0.50 to 2.20) 
No statistical analysis provided for Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG013736)
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 ] 
Measure Type  Secondary 

Measure Title  Plasma Decay Halflife (t1/2) of Axitinib (AG013736) 
Measure Description  Plasma decay halflife is the time measured for the plasma concentration to decrease by one half. 
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 
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 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. 
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. 
Measured Values
Axitinib + Gemcitabine (Phase 1 LeadIn)  

Participants Analyzed [Units: Participants] 
6 
Plasma Decay Halflife (t1/2) of Axitinib (AG013736) [Units: Hr] Mean (Standard Deviation) 
2.97 (1.95) 
No statistical analysis provided for Plasma Decay Halflife (t1/2) of Axitinib (AG013736)
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 ] 
Measure Type  Secondary 

Measure Title  Maximum Observed Plasma Concentration (Cmax) of Gemcitabine 
Measure Description  No text entered. 
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 
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 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. 
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. 
Measured Values
Axitinib + Gemcitabine (Phase 1 LeadIn)  

Participants Analyzed [Units: Participants] 
5 
Maximum Observed Plasma Concentration (Cmax) of Gemcitabine [Units: ng/mL] Mean (Standard Deviation) 
27280.0 (12599.1) 
No statistical analysis provided for Maximum Observed Plasma Concentration (Cmax) of Gemcitabine
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 ] 
Measure Type  Secondary 

Measure Title  Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0  ∞)] of Gemcitabine 
Measure Description  AUC (0  ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0  ∞). It is obtained from AUC (0  t) plus AUC (t  ∞). 
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 
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 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. 
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. 
Measured Values
Axitinib + Gemcitabine (Phase 1 LeadIn)  

Participants Analyzed [Units: Participants] 
5 
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0  ∞)] of Gemcitabine [Units: ng*hr/mL] Mean (Standard Deviation) 
13656.00 (4142.16) 
No statistical analysis provided for Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0  ∞)] of Gemcitabine
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 ] 
Measure Type  Secondary 

Measure Title  Plasma Decay Halflife (t1/2) of Gemcitabine 
Measure Description  Plasma decay halflife is the time measured for the plasma concentration to decrease by one half. 
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 
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 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. 
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. 
Measured Values
Axitinib + Gemcitabine (Phase 1 LeadIn)  

Participants Analyzed [Units: Participants] 
5 
Plasma Decay Halflife (t1/2) of Gemcitabine [Units: Hr] Mean (Standard Deviation) 
0.310 (0.028) 
No statistical analysis provided for Plasma Decay Halflife (t1/2) of Gemcitabine
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 ] 
Measure Type  Secondary 

Measure Title  Percentage of Participants With Overall Response (OR) 
Measure Description  Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions. 
Time Frame  Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks 
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 included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized. 
Reporting Groups
Description  

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. 
Measured Values
Axitinib + Gemcitabine  Gemcitabine  

Participants Analyzed [Units: Participants] 
69  34 
Percentage of Participants With Overall Response (OR) [Units: Percentage of Participants] Number (95% Confidence Interval) 
7.2 (2.4 to 16.1) 
2.9 (0.1 to 15.3) 
Statistical Analysis 1 for Percentage of Participants With Overall Response (OR)
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Fisher Exact 
P Value ^{[4]}  0.661 
Difference in response rate ^{[5]}  4.3 
95% Confidence Interval  4.0 to 12.7 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Difference in percent of participants with overall response expressed as response rate, was used for calculation of 95% confidence interval (CI).  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
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 ] 
Measure Type  Secondary 

Measure Title  Duration of Response (DR) 
Measure Description  Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response. 
Time Frame  Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks 
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. 

Subgroup of participants from Phase 2 ITT population, with a confirmed objective tumor response (CR or PR). 
Reporting Groups
Description  

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. 
Measured Values
Axitinib + Gemcitabine  Gemcitabine  

Participants Analyzed [Units: Participants] 
5  1 
Duration of Response (DR) [Units: Days] Median (95% Confidence Interval) 
379 (136 to 379) 
155 ^{[1] } 
[1]  95% CI was not estimable because only one participant was evaluable. 

No statistical analysis provided for Duration of Response (DR)
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 ] 
Measure Type  Secondary 

Measure Title  Progressionfree Survival (PFS) 
Measure Description  Time in days from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of randomization plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death"). 
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 
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 included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized. 
Reporting Groups
Description  

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. 
Measured Values
Axitinib + Gemcitabine  Gemcitabine  

Participants Analyzed [Units: Participants] 
69  34 
Progressionfree Survival (PFS) [Units: Days] Number (95% Confidence Interval) 
116 (109 to 160) 
113 (68 to 205) 
Statistical Analysis 1 for Progressionfree Survival (PFS)
Groups ^{[1]}  All groups 

Statistical Test Type ^{[2]}  Superiority or Other 
Statistical Method ^{[3]}  Log Rank 
P Value ^{[4]}  0.4466 
Hazard Ratio (HR) ^{[5]}  0.9648 
95% Confidence Interval  0.5400 to 1.7300 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

Differences in PFS between treatment arms was analyzed by the stratified logrank test where the stratification factors are ECOG performance status (less than equal to 1 or 2) and extent of disease (locally advanced or metastatic).  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
Onesided logrank test at alpha = 0.1 significance level was used.  
[5]  Other relevant estimation information: 
No text entered. 
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 ] 
Measure Type  Secondary 

Measure Title  One Year Survival Probability 
Measure Description  One year survival probability was defined as the probability of survival at one year after the date of randomization based on the Kaplan Meier estimate. 
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 
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 included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized. 
Reporting Groups
Description  

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. 
Measured Values
Axitinib + Gemcitabine  Gemcitabine  

Participants Analyzed [Units: Participants] 
69  34 
One Year Survival Probability [Units: Percent chance of survival] Number (95% Confidence Interval) 
36.81 (25.71 to 47.93) 
23.53 (11.48 to 38.01) 
No statistical analysis provided for One Year Survival Probability
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). ] 
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: 
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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: 
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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: 
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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: 
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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: 
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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: 
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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: 
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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: 
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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: 
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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: 
No text entered. 
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: 
No text entered. 
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: 
No text entered. 
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: 
No text entered.  
[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: 
No text entered.  
[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: 
No text entered. 
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: 
No text entered.  
[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: 
No text entered.  
[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: 
No text entered.  
[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: 
No text entered.  
[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: 
No text entered. 
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: 
No text entered.  
[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: 
No text entered.  
[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: 
No text entered.  
[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: 
No text entered.  
[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: 
No text entered. 
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: 
No text entered. 
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: 
No text entered. 
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]} 
