Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00471146
First received: May 7, 2007
Last updated: June 14, 2012
Last verified: June 2012
Results First Received: February 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Carcinoma, Pancreatic Ductal
Interventions: Drug: AG-013736
Drug: Gemcitabine
Drug: placebo

  Participant Flow
  Hide 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.

Pre-Assignment 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 Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) in cycles of 4 weeks. Gemcitabine 1000 mg per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Participant Flow:   Overall Study
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
STARTED     314     316  
Treated     305     308  
COMPLETED     142     142  
NOT COMPLETED     172     174  
Adverse Event                 32                 33  
Withdrawal by Subject                 14                 11  
Death                 11                 12  
Lost to Follow-up                 4                 2  
Protocol Violation                 2                 2  
Objective progression or relapse                 84                 87  
Global deterioration of health status                 12                 14  
Randomized but not treated                 9                 8  
Unspecified                 4                 5  



  Baseline Characteristics
  Hide 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 Axitinib (AG-013736) tablet 5 mg orally BID 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.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 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     Placebo + Gemcitabine     Total  
Number of Participants  
[units: participants]
  314     316     630  
Age, Customized  
[units: Participants]
     
Less than 65 years     203     179     382  
Greater than or equal to 65 years     111     137     248  
Gender  
[units: Participants]
     
Female     123     128     251  
Male     191     188     379  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline until death or at least 1 year after the randomization of last participant ]

Measure Type Primary
Measure Title Overall Survival (OS)
Measure Description Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame Baseline until death or at least 1 year after the randomization of last participant  
Safety Issue No  

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.
Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID 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.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Measured Values
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
Number of Participants Analyzed  
[units: participants]
  314     316  
Overall Survival (OS)  
[units: Weeks]
Median ( 95% Confidence Interval )
  36.9  
  ( 30.1 to 41.1 )  
  35.8  
  ( 30.0 to 44.8 )  


Statistical Analysis 1 for Overall Survival (OS)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.5436
Hazard Ratio (HR) [4] 1.014
95% Confidence Interval ( 0.786 to 1.309 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  One-sided log-rank test at alpha = 0.025 significance level was used.
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline until disease progression or at least 1 year after the randomization of last participant ]

Measure Type Secondary
Measure Title Progression Free Survival (PFS)
Measure Description Time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. 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 Baseline until disease progression or at least 1 year after the randomization of last participant  
Safety Issue No  

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.
ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID 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.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Measured Values
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
Number of Participants Analyzed  
[units: participants]
  314     316  
Progression Free Survival (PFS)  
[units: Weeks]
Median ( 95% Confidence Interval )
  19.1  
  ( 17.1 to 24.4 )  
  18.9  
  ( 16.2 to 22.6 )  


Statistical Analysis 1 for Progression Free Survival (PFS)
Groups [1] All groups
Method [2] Log Rank
P Value [3] 0.5203
Hazard Ratio (HR) [4] 1.006
95% Confidence Interval ( 0.779 to 1.298 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  One-sided log-rank test at alpha = 0.025 significance level was used.The p-value was not adjusted for multiple testing.
[4] Other relevant estimation information:
  No text entered.



3.  Secondary:   Percentage of Participants With Objective Response (OR)   [ Time Frame: Baseline, every 8 weeks until tumor progression or death ]

Measure Type Secondary
Measure Title Percentage of Participants With Objective 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 response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Time Frame Baseline, every 8 weeks until tumor progression or death  
Safety Issue No  

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.
ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID 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.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Measured Values
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
Number of Participants Analyzed  
[units: participants]
  314     316  
Percentage of Participants With Objective Response (OR)  
[units: Percentage of participants]
Number ( 95% Confidence Interval )
  4.9  
  ( 2.5 to 8.3 )  
  1.6  
  ( 0.4 to 4.0 )  


Statistical Analysis 1 for Percentage of Participants With Objective Response (OR)
Groups [1] All groups
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.038
Risk Ratio (RR) [4] 3.2
95% Confidence Interval ( 1.0 to 10.1 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Differences in OR between treatment arms was analyzed by 1-sided Cochran-Mantel-Haenszel (CMH) test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline until death or at least 1 year after the randomization of last participant ]

Measure Type Secondary
Measure Title Duration of Response (DR)
Measure Description Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. 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) divided by 7.
Time Frame Baseline until death or at least 1 year after the randomization of last participant  
Safety Issue No  

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.
DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).

Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID 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.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Measured Values
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
Number of Participants Analyzed  
[units: participants]
  12     4  
Duration of Response (DR)  
[units: Weeks]
Median ( 95% Confidence Interval )
  33.1  
  ( 16.1 to 33.1 )  
  NA  
  ( NA to NA ) [1]
[1] Median duration of response for placebo+gemcitabine arm did not reach at the time of data cut-off.

No statistical analysis provided for Duration of Response (DR)



5.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Measure Type Secondary
Measure Title Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
Measure Description EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.
Time Frame Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal  
Safety Issue No  

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.
ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID 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.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Measured Values
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
Number of Participants Analyzed  
[units: participants]
  314     316  
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score  
[units: Units on a scale]
Mean ± Standard Deviation
   
Physical functioning: Baseline (n=295, 289)     77.445  ± 20.3052     78.546  ± 18.9192  
Physical functioning: Change at C2 D1 (n=233, 233)     -2.713  ± 16.7682     -3.261  ± 15.0742  
Physical functioning: Change at C3 D1 (n=173, 179)     -5.897  ± 19.3522     -1.565  ± 16.2738  
Physical functioning: Change at C4 D1 (n=134, 133)     -5.671  ± 18.8623     -1.453  ± 17.1209  
Physical functioning: Change at C5 D1 (n=96, 82)     -2.498  ± 21.8687     -0.076  ± 16.9709  
Physical functioning: Change at C6 D1 (n=59, 58)     -5.193  ± 19.6995     -1.719  ± 15.5260  
Physical functioning: Change at C7 D1 (n=38, 37)     -1.924  ± 14.2726     0.011  ± 18.9261  
Physical functioning: Change at C8 D1 (n=15, 21)     -4.000  ± 16.8759     0.014  ± 13.8428  
Physical functioning: Change at C9 D1 (n=9, 9)     0.033  ± 15.2534     -12.578  ± 20.9490  
Physical functioning: Change at C10 D1 (n=3, 4)     6.667  ± 17.5754     -1.675  ± 22.0563  
Physical functioning: Change at C11 D1 (n=1, 1)     0.000  ± NA [1]   -6.600  ± NA [1]
Physical functioning: Change at C12 D1 (n=1, 0)     0.000  ± NA [1]   NA  ± NA [2]
Physical functioning: Change at C13 D1 (n=1, 0)     0.000  ± NA [1]   NA  ± NA [2]
Physical functioning:Change at followup (n=67, 70)     -17.713  ± 23.8263     -11.523  ± 21.0513  
Role functioning: Baseline (n=297, 295)     66.3  ± 30.09     68.1  ± 30.72  
Role functioning: Change at C2 D1 (n=239, 242)     -2.2  ± 30.95     -2.8  ± 25.75  
Role functioning: Change at C3 D1 (n=177, 185)     -4.6  ± 32.65     1.5  ± 26.90  
Role functioning: Change at C4 D1 (n=135, 136)     -4.3  ± 32.13     1.2  ± 27.18  
Role functioning: Change at C5 D1 (n=99, 81)     -0.5  ± 34.95     -2.7  ± 29.63  
Role functioning: Change at C6 D1 (n=60, 58)     -4.4  ± 29.25     -2.3  ± 24.27  
Role functioning: Change at C7 D1 (n=38, 37)     -3.1  ± 25.07     -1.3  ± 26.75  
Role functioning: Change at C8 D1 (n=16, 21)     -6.2  ± 20.05     0.0  ± 31.63  
Role functioning: Change at C9 D1 (n=9, 9)     1.9  ± 28.21     -20.4  ± 33.11  
Role functioning: Change at C10 D1 (n=3, 4)     5.6  ± 9.64     -4.2  ± 28.46  
Role functioning: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   -50.0  ± NA [1]
Role functioning: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Role functioning: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Role functioning: Change at follow-up (n=66, 72)     -20.0  ± 31.52     -14.1  ± 32.34  
Emotional functioning (EF): Baseline (n=294, 287)     70.8  ± 22.01     71.7  ± 22.47  
EF: Change at C2 D1 (n=233, 229)     5.0  ± 21.48     5.0  ± 18.92  
EF: Change at C3 D1 (n=170, 180)     3.7  ± 20.19     3.4  ± 18.95  
EF: Change at C4 D1 (n=134, 131)     3.0  ± 22.54     5.2  ± 21.12  
EF: Change at C5 D1 (n=96, 80)     4.3  ± 21.09     5.9  ± 17.24  
EF: Change at C6 D1 (n=60, 56)     4.0  ± 19.31     6.7  ± 17.43  
EF: Change at C7 D1 (n=37, 34)     0.0  ± 18.84     3.2  ± 16.28  
EF: Change at C8 D1 (n=17, 19)     -2.9  ± 22.05     5.3  ± 14.74  
EF: Change at C9 D1 (n=9, 9)     3.7  ± 16.72     -4.6  ± 15.07  
EF: Change at C10 D1 (n=3, 4)     13.9  ± 12.73     2.1  ± 18.50  
EF: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   -16.6  ± NA [1]
EF: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
EF: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
EF: Change at follow-up (n=65, 71)     -7.3  ± 23.51     -2.7  ± 23.14  
Cognitive Functioning (CF): Baseline (n=293, 288)     78.7  ± 22.26     80.9  ± 21.50  
CF: Change at C2 D1 (n=234, 234)     -1.1  ± 19.86     -0.3  ± 17.74  
CF: Change at C3 D1 (n=172, 179)     -2.1  ± 20.43     -0.9  ± 18.67  
CF: Change at C4 D1 (n=134, 134)     -4.2  ± 19.98     2.0  ± 18.62  
CF: Change at C5 D1 (n=97, 80)     -1.4  ± 20.21     1.7  ± 18.86  
CF: Change at C6 D1 (n=60, 56)     -3.1  ± 19.27     -4.5  ± 19.97  
CF: Change at C7 D1 (n=38, 34)     -4.4  ± 18.45     0.5  ± 14.50  
CF: Change at C8 D1 (n=17, 17)     -8.8  ± 22.15     -2.9  ± 23.74  
CF: Change at C9 D1 (n=9, 9)     -0.0  ± 25.03     -1.8  ± 24.22  
CF: Change at C10 D1 (n=3, 4)     -5.6  ± 9.64     8.3  ± 28.88  
CF: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
CF: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
CF: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
CF: Change at follow-up (n=65, 71)     -12.6  ± 25.01     -7.5  ± 25.47  
Social functioning: Baseline (n=289, 286)     68.9  ± 27.98     69.7  ± 28.83  
Social functioning: Change at C2 D1 (n=232, 230)     1.3  ± 24.73     0.9  ± 26.35  
Social functioning: Change at C3 D1 (n=169, 178)     -1.3  ± 29.38     3.2  ± 27.31  
Social functioning: Change at C4 D1 (n=132, 134)     0.1  ± 25.51     0.6  ± 26.83  
Social functioning: Change at C5 D1 (n=95, 80)     2.1  ± 27.31     0.8  ± 27.93  
Social functioning: Change at C6 D1 (n=58, 56)     -4.9  ± 28.79     1.5  ± 29.52  
Social functioning: Change at C7 D1 (n=37, 35)     -5.4  ± 20.05     2.4  ± 29.47  
Social functioning: Change at C8 D1 (n=17, 19)     4.9  ± 29.91     -1.7  ± 27.72  
Social functioning: Change at C9 D1 (n=9, 9)     -0.0  ± 32.29     -1.8  ± 28.20  
Social functioning: Change at C10 D1 (n=3, 4)     5.6  ± 9.64     12.5  ± 43.83  
Social functioning: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   33.4  ± NA [1]
Social functioning: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Social functioning: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Social functioning: Change at follow-up (n=64, 70)     -13.3  ± 33.75     -2.6  ± 33.88  
Fatigue: Baseline (n=293, 289)     41.0  ± 23.87     40.1  ± 25.12  
Fatigue: Change at C2 D1 (n=227, 228)     2.8  ± 21.15     2.1  ± 20.12  
Fatigue: Change at C3 D1 (n=170, 181)     3.4  ± 21.94     -0.9  ± 21.76  
Fatigue: Change at C4 D1 (n=132, 132)     5.6  ± 23.97     -1.1  ± 22.77  
Fatigue: Change at C5 D1 (n=97, 80)     -0.0  ± 24.39     1.1  ± 21.92  
Fatigue: Change at C6 D1 (n=60, 57)     5.0  ± 21.31     0.0  ± 21.22  
Fatigue: Change at C7 D1 (n=38, 36)     1.8  ± 20.61     2.2  ± 19.12  
Fatigue: Change at C8 D1 (n=17, 20)     7.2  ± 22.89     4.4  ± 22.05  
Fatigue: Change at C9 D1 (n=9, 9)     -6.2  ± 21.63     14.8  ± 24.21  
Fatigue: Change at C10 D1 (n=3, 4)     -11.1  ± 19.28     -5.5  ± 27.98  
Fatigue: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   11.1  ± NA [1]
Fatigue: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Fatigue: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Fatigue: Change at follow-up (n=63, 71)     13.1  ± 25.93     12.1  ± 25.95  
Nausea and vomiting: Baseline (n=295, 294)     12.9  ± 19.19     13.1  ± 19.75  
Nausea and vomiting: Change at C2 D1 (n=238, 239)     3.7  ± 20.69     2.9  ± 22.93  
Nausea and vomiting: Change at C3 D1 (n=176, 185)     1.9  ± 20.38     -0.4  ± 19.54  
Nausea and vomiting: Change at C4 D1 (n=133, 135)     3.5  ± 20.82     0.4  ± 19.68  
Nausea and vomiting: Change at C5 D1 (n=98, 81)     4.6  ± 22.16     1.0  ± 18.88  
Nausea and vomiting: Change at C6 D1 (n=60, 59)     6.9  ± 22.61     2.8  ± 20.33  
Nausea and vomiting: Change at C7 D1 (n=38, 37)     1.3  ± 19.52     2.7  ± 20.24  
Nausea and vomiting: Change at C8 D1 (n=17, 21)     -4.9  ± 18.41     0.8  ± 22.66  
Nausea and vomiting: Change at C9 D1 (n=9, 9)     -13.0  ± 32.02     -5.6  ± 18.64  
Nausea and vomiting: Change at C10 D1 (n=3, 4)     -11.1  ± 19.23     8.3  ± 9.58  
Nausea and vomiting: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
Nausea and vomiting: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Nausea and vomiting: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Nausea and vomiting: Change at followup (n=68, 73)     9.8  ± 25.63     7.5  ± 22.40  
Pain: Baseline (n=291, 291)     40.7  ± 30.16     36.9  ± 29.57  
Pain: Change at C2 D1 (n=231, 234)     -10.1  ± 29.47     -7.9  ± 25.28  
Pain: Change at C3 D1 (n=169, 181)     -13.6  ± 29.81     -11.2  ± 26.63  
Pain: Change at C4 D1 (n=131, 135)     -12.2  ± 32.48     -7.8  ± 27.14  
Pain: Change at C5 D1 (n=97, 80)     -10.5  ± 32.75     -6.9  ± 26.21  
Pain: Change at C6 D1 (n=59, 58)     -11.9  ± 27.51     -7.5  ± 29.48  
Pain: Change at C7 D1 (n=38, 35)     -14.0  ± 27.81     -9.5  ± 24.67  
Pain: Change at C8 D1 (n=17, 20)     -9.8  ± 26.39     -6.7  ± 29.32  
Pain: Change at C9 D1 (n=9, 9)     -22.2  ± 43.29     -5.6  ± 39.08  
Pain: Change at C10 D1 (n=3, 4)     -33.3  ± 33.30     -4.2  ± 45.88  
Pain: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   -33.3  ± NA [1]
Pain: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Pain: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Pain: Change at follow-up (n=66, 72)     3.3  ± 37.01     3.5  ± 31.14  
Dyspnoea: Baseline (n=295, 295)     16.1  ± 22.30     14.8  ± 23.55  
Dyspnoea: Change at C2 D1 (n=238, 240)     5.5  ± 23.58     2.1  ± 20.91  
Dyspnoea: Change at C3 D1 (n=175, 186)     5.7  ± 26.84     3.9  ± 24.67  
Dyspnoea: Change at C4 D1 (n=135, 135)     7.7  ± 26.99     4.4  ± 21.08  
Dyspnoea: Change at C5 D1 (n=98, 82)     4.4  ± 26.05     2.8  ± 18.29  
Dyspnoea: Change at C6 D1 (n=60, 59)     9.4  ± 26.09     -0.0  ± 16.37  
Dyspnoea: Change at C7 D1 (n=37, 37)     6.3  ± 24.63     5.4  ± 20.05  
Dyspnoea: Change at C8 D1 (n=16, 21)     4.2  ± 20.62     12.7  ± 24.66  
Dyspnoea: Change at C9 D1 (n=9, 9)     11.1  ± 47.14     14.8  ± 29.39  
Dyspnoea: Change at C10 D1 (n=3, 4)     -11.1  ± 50.92     0.0  ± 27.19  
Dyspnoea: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
Dyspnoea: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Dyspnoea: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Dyspnoea: Change at follow-up (n=68, 73)     13.2  ± 28.30     8.7  ± 24.23  
Insomnia: Baseline (n=297, 295)     36.8  ± 31.95     32.2  ± 32.17  
Insomnia: Change at C2 D1 (n=240, 241)     -13.6  ± 33.55     -7.3  ± 33.16  
Insomnia: Change at C3 D1 (n=178, 185)     -13.5  ± 33.33     -8.7  ± 33.30  
Insomnia: Change at C4 D1 (n=134, 134)     -12.7  ± 38.52     -11.2  ± 27.41  
Insomnia: Change at C5 D1 (n=99, 82)     -14.5  ± 33.05     -7.3  ± 28.70  
Insomnia: Change at C6 D1 (n=60, 59)     -8.3  ± 30.46     -2.3  ± 30.86  
Insomnia: Change at C7 D1 (n=37, 37)     -11.7  ± 36.19     -2.7  ± 19.84  
Insomnia: Change at C8 D1 (n=17, 21)     5.9  ± 35.82     -3.2  ± 20.82  
Insomnia: Change at C9 D1 (n=9, 9)     -14.8  ± 24.23     -0.0  ± 23.56  
Insomnia: Change at C10 D1 (n=3, 4)     11.1  ± 19.23     -0.0  ± 27.23  
Insomnia: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   33.3  ± NA [1]
Insomnia: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Insomnia: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Insomnia: Change at follow-up (n=68, 73)     1.5  ± 36.63     1.4  ± 28.02  
Loss of appetite: Baseline (n=297, 295)     39.6  ± 35.49     37.5  ± 33.36  
Loss of appetite: Change at C2 D1 (n=240, 240)     -2.1  ± 34.24     -2.6  ± 27.91  
Loss of appetite: Change at C3 D1 (n=178, 186)     -1.3  ± 31.57     -5.9  ± 31.50  
Loss of appetite: Change at C4 D1 (n=135, 135)     0.0  ± 35.27     -6.7  ± 29.88  
Loss of appetite: Change at C5 D1 (n=99, 82)     1.7  ± 35.76     -4.5  ± 30.44  
Loss of appetite: Change at C6 D1 (n=60, 59)     2.8  ± 33.22     -4.5  ± 29.34  
Loss of appetite: Change at C7 D1 (n=38, 37)     0.9  ± 35.92     -7.2  ± 27.37  
Loss of appetite: Change at C8 D1 (n=17, 20)     7.8  ± 25.07     -1.7  ± 29.57  
Loss of appetite: Change at C9 D1 (n=9, 9)     -14.8  ± 29.41     -7.4  ± 36.44  
Loss of appetite: Change at C10 D1 (n=3, 4)     -22.2  ± 19.23     0.0  ± 38.48  
Loss of appetite: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   33.3  ± NA [1]
Loss of appetite: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Loss of appetite: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Loss of appetite: Change at follow-up (n=67, 73)     7.0  ± 39.17     7.8  ± 36.24  
Constipation: Baseline (n=293, 289)     30.7  ± 32.13     29.6  ± 32.66  
Constipation: Change at C2 D1 (n=234, 235)     -4.8  ± 32.18     -2.8  ± 33.21  
Constipation: Change at C3 D1 (n =173, 181)     -7.3  ± 32.12     -6.1  ± 36.43  
Constipation: Change at C4 D1 (n=134, 135)     -6.5  ± 35.99     -10.6  ± 36.80  
Constipation: Change at C5 D1 (n=97, 80)     -11.0  ± 33.59     -8.7  ± 29.88  
Constipation: Change at C6 D1 (n=60, 58)     -5.6  ± 37.42     -9.8  ± 32.45  
Constipation: Change at C7 D1 (n=38, 36)     -2.6  ± 31.37     -13.0  ± 32.15  
Constipation: Change at C8 D1 (n=17, 20)     0.0  ± 28.87     -16.7  ± 39.74  
Constipation: Change at C9 D1 (n=9, 9)     -18.5  ± 33.79     -29.6  ± 35.14  
Constipation: Change at C10 D1 (n=3, 4)     -11.1  ± 19.23     -50.0  ± 43.04  
Constipation: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   -66.7  ± NA [1]
Constipation: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Constipation: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Constipation: Change at follow-up (n=66, 71)     5.1  ± 42.27     -6.1  ± 35.77  
Diarrhoea: Baseline (n=294, 290)     14.3  ± 21.68     13.7  ± 24.19  
Diarrhoea: Change at C2 D1 (n=235, 235)     1.7  ± 25.73     0.3  ± 21.78  
Diarrhoea: Change at C3 D1 (n=173, 182)     9.4  ± 28.66     0.2  ± 23.10  
Diarrhoea: Change at C4 D1 (n=134, 136)     7.7  ± 28.00     -1.5  ± 22.53  
Diarrhoea: Change at C5 D1 (n=96, 81)     11.8  ± 27.35     1.2  ± 27.10  
Diarrhoea: Change at C6 D1 (n=60, 58)     20.0  ± 33.72     1.7  ± 28.22  
Diarrhoea: Change at C7 D1 (n=38, 36)     14.9  ± 32.60     2.8  ± 23.05  
Diarrhoea: Change at C8 D1 (n=17, 20)     25.5  ± 38.24     1.7  ± 27.52  
Diarrhoea: Change at C9 D1 (n=9, 9)     37.0  ± 45.47     22.2  ± 33.35  
Diarrhoea: Change at C10 D1 (n=3, 4)     22.2  ± 50.91     16.7  ± 19.23  
Diarrhoea: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
Diarrhoea: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Diarrhoea: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Diarrhoea: Change at follow-up (n=66, 71)     2.5  ± 29.41     2.8  ± 25.03  
Financial difficulties (FD): Baseline (n=292, 285)     24.7  ± 30.41     23.0  ± 30.83  
FD:Change at C2 D1 (n=233, 228)     -3.1  ± 22.95     -4.5  ± 23.29  
FD: Change at C3 D1 (n=171, 176)     -7.2  ± 26.94     -3.4  ± 23.39  
FD: Change at C4 D1 (n=133, 133)     -5.5  ± 26.33     -3.3  ± 23.52  
FD: Change at C5 D1 (n=96, 80)     -4.9  ± 21.62     1.3  ± 25.68  
FD: Change at C6 D1 (n=60, 56)     -3.9  ± 24.61     -1.8  ± 28.02  
FD: Change at C7 D1 (n=37, 34)     -2.7  ± 24.06     -3.9  ± 32.60  
FD: Change at C8 D1 (n=17, 17)     2.0  ± 14.28     2.0  ± 34.31  
FD: Change at C9 D1 (n=9, 9)     7.4  ± 22.23     3.7  ± 45.49  
FD: Change at C10 D1 (n=3, 4)     0.0  ± 0.00     25.0  ± 41.94  
FD: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   66.7  ± NA [1]
FD: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
FD: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
FD: Change at follow-up (n=65, 70)     6.7  ± 29.59     -0.5  ± 21.61  
GHS/Quality of Life (QoL): Baseline (n=292, 288)     54.2  ± 22.34     57.1  ± 23.14  
GHS/QoL:Change at C2 D1 (n=234, 233)     2.2  ± 23.36     1.9  ± 22.39  
GHS/QoL:Change at C3 D1 (n=168, 180)     -0.3  ± 25.42     5.7  ± 21.45  
GHS/QoL:Change at C4 D1(n=132, 132)     0.1  ± 23.79     2.8  ± 21.54  
GHS/QoL:Change at C5 D1 (n=96, 81)     1.5  ± 22.63     2.7  ± 18.35  
GHS/QoL:Change at C6 D1 (n=60, 57)     0.8  ± 21.41     3.2  ± 23.40  
GHS/QoL:Change at C7 D1 (n=38, 35)     2.6  ± 23.01     2.1  ± 22.35  
GHS/QoL:Change at C8 D1 (n=17, 19)     -1.0  ± 23.73     1.3  ± 23.76  
GHS/QoL:Change at C9 D1 (n=9, 9)     7.4  ± 16.89     -8.3  ± 20.39  
GHS/QoL: Change at C10 D1 (n=3, 4)     22.3  ± 19.28     -0.0  ± 32.59  
GHS/QoL: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
GHS/QoL: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
GHS/QoL: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
GHS/QoL:Change at follow-up (n=65, 71)     -9.1  ± 26.06     -6.7  ± 24.50  
[1] Standard deviation was not estimable since only one participant was evaluable.
[2] Data was not analyzed as no participants were evaluable for the particular cycle.

No statistical analysis provided for Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score



6.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Measure Type Secondary
Measure Title Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
Measure Description QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from ‘1=not at all’ to 4=’very much’ and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.
Time Frame Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal  
Safety Issue No  

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.
ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID 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.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Measured Values
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
Number of Participants Analyzed  
[units: participants]
  314     316  
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score  
[units: Units on a scale]
Mean ± Standard Deviation
   
Pancreatic Pain: Baseline (n=246, 250)     41.6  ± 27.16     40.0  ± 25.54  
Pancreatic Pain: Change at C2 D1 (n=191, 197)     -10.9  ± 24.38     -10.1  ± 22.93  
Pancreatic Pain: Change at C3 D1 (n=141, 153)     -16.3  ± 25.51     -11.2  ± 24.92  
Pancreatic Pain: Change at C4 D1 (n=99, 111)     -13.2  ± 28.70     -11.4  ± 26.16  
Pancreatic Pain: Change at C5 D1 (n=67, 64)     -15.8  ± 28.06     -13.0  ± 23.85  
Pancreatic Pain: Change at C6 D1 (n=41, 43)     -15.9  ± 25.47     -13.0  ± 24.62  
Pancreatic Pain: Change at C7 D1 (n=25, 25)     -15.3  ± 28.02     -15.0  ± 25.69  
Pancreatic Pain: Change at C8 D1 (n=11, 11)     -7.6  ± 27.76     -9.8  ± 30.01  
Pancreatic Pain: Change at C9 D1 (n=6, 6)     -29.2  ± 31.06     0.0  ± 15.81  
Pancreatic Pain: Change at C10 D1 (n=2, 3)     -20.9  ± 29.49     5.6  ± 26.79  
Pancreatic Pain: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
Pancreatic Pain: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Pancreatic Pain: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Pancreatic Pain: Change at follow-up (n=47, 46)     -3.5  ± 29.59     -3.6  ± 28.80  
Hepatic: Baseline (n=245, 254)     10.2  ± 17.21     10.8  ± 17.59  
Hepatic: Change at C2 D1 (n=193, 205)     0.3  ± 18.24     -2.0  ± 17.67  
Hepatic: Change at C3 D1 (n=142, 157)     -1.4  ± 16.78     -2.5  ± 18.60  
Hepatic: Change at C4 D1 (n=99, 112)     -2.5  ± 18.34     -2.4  ± 18.15  
Hepatic: Change at C5 D1 (n=68, 64)     1.0  ± 17.49     -2.6  ± 16.60  
Hepatic: Change at C6 D1 (n=40, 41)     0.4  ± 15.34     -3.2  ± 17.57  
Hepatic: Change at C7 D1 (n=25, 24)     -0.7  ± 16.30     -4.9  ± 18.70  
Hepatic: Change at C8 D1 (n=11, 12)     -4.5  ± 13.10     -4.2  ± 12.57  
Hepatic: Change at C9 D1 (n=6, 5)     -11.1  ± 13.60     -13.3  ± 13.94  
Hepatic: Change at C10 D1 (n=2, 2)     -16.7  ± 23.55     -8.4  ± 11.81  
Hepatic: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
Hepatic: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Hepatic: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Hepatic: Change at follow-up (n=47, 48)     2.8  ± 23.38     -1.4  ± 23.27  
Digestive Symptom: Baseline (n=250, 255)     34.3  ± 30.78     33.9  ± 31.05  
Digestive Symptom: Change at C2 D1 (n=195, 206)     2.8  ± 29.15     0.6  ± 26.72  
Digestive Symptom: Change at C3 D1 (n=144, 159)     -1.2  ± 31.58     -4.3  ± 32.97  
Digestive Symptom: Change at C4 D1 (n=100, 114)     0.5  ± 30.57     -4.5  ± 30.90  
Digestive Symptom: Change at C5 D1 (n=69, 65)     1.4  ± 32.80     -3.6  ± 36.14  
Digestive Symptom: Change at C6 D1 (n=40, 45)     3.3  ± 30.23     0.4  ± 35.97  
Digestive Symptom: Change at C7 D1 (n=25, 26)     -6.0  ± 30.76     -1.3  ± 24.91  
Digestive Symptom: Change at C8 D1 (n=11, 14)     4.5  ± 42.87     17.9  ± 23.07  
Digestive Symptom: Change at C9 D1 (n=6, 6)     -13.9  ± 46.44     22.2  ± 25.10  
Digestive Symptom: Change at C10 D1 (n=2, 3)     -33.3  ± 47.09     11.1  ± 19.23  
Digestive Symptom: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   66.7  ± NA [1]
Digestive Symptom: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Digestive Symptom: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Digestive Symptom: Change at follow-up (n=47, 47)     6.0  ± 38.14     2.8  ± 35.83  
Sexuality: Baseline (n=217, 232)     56.8  ± 36.90     55.5  ± 38.04  
Sexuality: Change at C2 D1 (n=157, 181)     -0.5  ± 37.81     -4.0  ± 33.17  
Sexuality: Change at C3 D1 (n=118, 139)     -4.9  ± 37.70     -3.0  ± 32.25  
Sexuality: Change at C4 D1 (n=85, 100)     -4.1  ± 38.40     3.0  ± 29.90  
Sexuality: Change at C5 D1 (n=55, 58)     -1.5  ± 34.30     -5.2  ± 29.32  
Sexuality: Change at C6 D1 (n=30, 38)     12.2  ± 29.67     -11.4  ± 33.58  
Sexuality: Change at C7 D1 (n=19, 21)     4.4  ± 35.06     -7.1  ± 31.88  
Sexuality: Change at C8 D1 (n=8, 10)     12.5  ± 24.82     -15.0  ± 26.59  
Sexuality: Change at C9 D1 (n=4, 6)     25.0  ± 31.93     0.0  ± 23.55  
Sexuality: Change at C10 D1 (n=0, 3)     NA  ± NA [2]   11.1  ± 19.28  
Sexuality: Change at C11 D1 (n=0, 1)     NA  ± NA [2]   33.3  ± NA [1]
Sexuality: Change at C12 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Sexuality: Change at C13 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Sexuality: Change at follow-up (n=36, 41)     -3.2  ± 41.18     -23.2  ± 42.31  
Health care(HC)satisfaction: Baseline (n=241, 247)     78.0  ± 26.66     78.3  ± 23.94  
HC satisfaction: Change at C2 D1 (n=182, 194)     0.1  ± 27.73     1.8  ± 24.13  
HC satisfaction: Change at C3 D1 (n=135, 149)     0.2  ± 31.54     5.4  ± 24.98  
HC satisfaction: Change at C4 D1 (n=97, 108)     -4.3  ± 34.88     -0.2  ± 26.52  
HC satisfaction: Change at C5 D1 (n=66, 59)     1.0  ± 29.66     0.8  ± 28.77  
HC satisfaction: Change at C6 D1 (n=40, 39)     -6.7  ± 26.91     -0.4  ± 27.96  
HC satisfaction: Change at C7 D1 (n=27, 20)     -4.3  ± 22.44     6.7  ± 33.06  
HC satisfaction: Change at C8 D1 (n=12, 11)     -16.7  ± 52.23     7.6  ± 20.22  
HC satisfaction: Change at C9 D1 (n=6, 6)     16.7  ± 47.14     -5.6  ± 17.23  
HC satisfaction: Change at C10 D1 (n=2, 3)     -33.3  ± 0.0     5.6  ± 9.64  
HC satisfaction: Change at C11 D1 (n=1, 1)     -33.3  ± NA [1]   0.0  ± NA [1]
HC satisfaction: Change at C12 D1 (n=1, 0)     -33.3  ± NA [1]   NA  ± NA [2]
HC satisfaction: Change at C13 D1(n=1, 0)     -33.3  ± NA [1]   NA  ± NA [2]
HC satisfaction: Change at follow-up (n=46, 45)     -0.7  ± 29.39     -2.2  ± 31.50  
Body Image: Baseline (n=249, 251)     28.5  ± 28.46     28.8  ± 28.67  
Body Image: Change at C2 D1 (n=189, 200)     4.9  ± 23.11     -0.2  ± 26.78  
Body Image: Change at C3 D1 (n=142, 149)     4.9  ± 22.26     2.1  ± 26.16  
Body Image: Change at C4 D1 (n=97, 111)     6.7  ± 26.20     0.9  ± 26.48  
Body Image: Change at C5 D1 (n=70, 62)     4.8  ± 26.33     -0.3  ± 25.87  
Body Image: Change at C6 D1 (n=40, 42)     8.3  ± 28.24     -0.8  ± 33.92  
Body Image: Change at C7 D1 (n=25, 24)     12.0  ± 27.43     -5.6  ± 33.22  
Body Image: Change at C8 D1 (n=11, 12)     21.2  ± 42.23     11.1  ± 32.04  
Body Image: Change at C9 D1 (n=6, 6)     33.3  ± 52.69     8.3  ± 46.87  
Body Image: Change at C10 D1 (n=2, 3)     -8.3  ± 11.74     5.6  ± 78.77  
Body Image: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   -50.0  ± NA [1]
Body Image: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Body Image: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Body Image: Change at follow-up (n=47, 45)     13.1  ± 30.67     11.5  ± 24.56  
Altered Bowel Habit: Baseline (n=250, 255)     20.3  ± 22.92     21.2  ± 25.72  
Altered Bowel Habit: Change at C2 D1 (n=193, 204)     3.0  ± 24.19     1.5  ± 22.21  
Altered Bowel Habit: Change at C3 D1 (n=143, 156)     6.2  ± 26.37     2.5  ± 24.67  
Altered Bowel Habit: Change at C4 D1 (n=98, 114)     6.6  ± 25.52     4.8  ± 22.14  
Altered Bowel Habit: Change at C5 D1 (n=68, 63)     8.3  ± 33.15     1.3  ± 24.56  
Altered Bowel Habit: Change at C6 D1 (n=40, 43)     9.6  ± 30.63     2.3  ± 28.07  
Altered Bowel Habit: Change at C7 D1 (n=25, 25)     6.0  ± 25.40     1.3  ± 30.77  
Altered Bowel Habit: Change at C8 D1 (n=11, 13)     1.5  ± 29.29     7.7  ± 38.86  
Altered Bowel Habit: Change at C9 D1 (n=6, 6)     13.9  ± 32.35     -5.6  ± 51.27  
Altered Bowel Habit: Change at C10 D1 (n=2, 3)     -8.3  ± 35.36     -16.7  ± 72.62  
Altered Bowel Habit: Change at C11 D1 (n=1, 1)     16.7  ± NA [1]   -100.0  ± NA [1]
Altered Bowel Habit: Change at C12 D1 (n=1, 0)     16.7  ± NA [1]   NA  ± NA [2]
Altered Bowel Habit: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Altered Bowel Habit: Change at followup (n=47, 48)     6.0  ± 29.36     5.9  ± 21.33  
Ascites: Baseline (n=250, 256)     38.7  ± 32.98     32.9  ± 30.61  
Ascites: Change at C2 D1 (n=197, 207)     -8.6  ± 33.32     -3.4  ± 29.65  
Ascites: Change at C3 D1 (n=144, 158)     -8.3  ± 33.34     -5.1  ± 28.70  
Ascites: Change at C4 D1 (n=101, 114)     -5.0  ± 36.64     -0.3  ± 26.05  
Ascites: Change at C5 D1 (n=71, 65)     -8.5  ± 34.15     -0.5  ± 29.17  
Ascites: Change at C6 D1 (n=42, 45)     -3.2  ± 31.08     -2.2  ± 32.10  
Ascites: Change at C7 D1 (n=26, 26)     -14.1  ± 32.91     -12.8  ± 23.25  
Ascites: Change at C8 D1 (n=11, 14)     -18.2  ± 43.12     -11.9  ± 28.05  
Ascites: Change at C9 D1 (n=6, 6)     -11.1  ± 34.42     -16.7  ± 34.95  
Ascites: Change at C10 D1 (n=2, 3)     -16.7  ± 23.55     22.2  ± 38.51  
Ascites: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   33.3  ± NA [1]
Ascites: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Ascites: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Ascites: Change at follow-up (n=48, 48)     5.6  ± 35.96     -2.1  ± 26.11  
Indigestion: Baseline (n=252, 257)     29.4  ± 30.38     24.0  ± 28.55  
Indigestion: Change at C2 D1 (n=198, 208)     -0.3  ± 26.87     -2.4  ± 24.29  
Indigestion: Change at C3 D1 (n=144, 159)     0.2  ± 30.16     -5.2  ± 25.59  
Indigestion: Change at C4 D1 (n=101, 115)     -4.0  ± 24.63     -4.1  ± 25.80  
Indigestion: Change at C5 D1 (n=71, 65)     0.5  ± 29.01     -4.6  ± 22.72  
Indigestion: Change at C6 D1 (n=41, 45)     1.6  ± 31.58     -1.5  ± 24.57  
Indigestion: Change at C7 D1 (n=26, 26)     -3.8  ± 19.60     -1.3  ± 17.59  
Indigestion: Change at C8 D1 (n=11, 14)     0.0  ± 21.06     2.4  ± 20.53  
Indigestion: Change at C9 D1 (n=6, 6)     -5.6  ± 25.07     11.1  ± 27.23  
Indigestion: Change at C10 D1 (n=2, 3)     -16.7  ± 23.55     22.2  ± 19.23  
Indigestion: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
Indigestion: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Indigestion: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Indigestion: Change at follow-up (n=48, 48)     7.6  ± 30.94     1.4  ± 30.73  
Flatulence: Baseline (n=249, 256)     37.9  ± 32.34     34.0  ± 31.31  
Flatulence: Change at C2 D1 (n=197, 206)     1.2  ± 29.81     2.6  ± 31.82  
Flatulence: Change at C3 D1 (n=146, 159)     3.2  ± 33.07     0.2  ± 34.48  
Flatulence: Change at C4 D1 (n=101, 115)     -1.3  ± 33.65     2.3  ± 32.07  
Flatulence: Change at C5 D1 (n=70, 65)     -1.0  ± 32.60     1.0  ± 31.17  
Flatulence: Change at C6 D1 (n=41, 45)     -1.6  ± 26.83     -1.5  ± 29.27  
Flatulence: Change at C7 D1 (n=25, 26)     -1.3  ± 26.31     -3.8  ± 23.71  
Flatulence: Change at C8 D1 (n=10, 14)     -10.0  ± 35.34     2.4  ± 27.62  
Flatulence: Change at C9 D1 (n=5, 6)     0.0  ± 0.00     5.6  ± 13.59  
Flatulence: Change at C10 D1 (n=1, 3)     33.3  ± NA [1]   -11.1  ± 19.23  
Flatulence: Change at C11 D1 (n=0, 1)     NA  ± NA [2]   0.0  ± NA [1]
Flatulence: Change at C12 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Flatulence: Change at C13 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Flatulence: Change at follow-up (n=48, 46)     -0.7  ± 35.41     2.2  ± 34.00  
Cachexia: Baseline (n=251, 253)     33.1  ± 27.62     33.6  ± 26.84  
Cachexia: Change at C2 D1 (n=197, 205)     4.2  ± 24.26     0.6  ± 21.63  
Cachexia: Change at C3 D1 (n=145, 157)     4.6  ± 25.87     -3.3  ± 21.13  
Cachexia: Change at C4 D1 (n=101, 112)     1.2  ± 26.37     -6.2  ± 24.82  
Cachexia: Change at C5 D1 (n=70, 64)     0.5  ± 28.37     -8.3  ± 24.48  
Cachexia: Change at C6 D1 (n=40, 44)     -2.1  ± 24.80     -5.3  ± 24.84  
Cachexia: Change at C7 D1 (n=24, 26)     -0.7  ± 24.31     -5.1  ± 25.27  
Cachexia: Change at C8 D1 (n=10, 14)     15.0  ± 34.64     -4.7  ± 21.12  
Cachexia: Change at C9 D1 (n=5, 6)     16.7  ± 31.16     2.8  ± 19.47  
Cachexia: Change at C10 D1 (n=1, 3)     0.0  ± NA [1]   0.0  ± 28.87  
Cachexia: Change at C11 D1 (n=0, 1)     NA  ± NA [2]   -16.6  ± NA [1]
Cachexia: Change at C12 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Cachexia: Change at C13 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Cachexia: Change at follow-up (n=48, 47)     8.0  ± 31.69     6.4  ± 30.79  
Side Effects: Baseline (n=209, 226)     24.9  ± 21.21     27.4  ± 23.08  
Side Effects: Change at C2 D1 (n=159, 181)     11.2  ± 23.11     5.8  ± 22.06  
Side Effects: Change at C3 D1 (n=113, 137)     13.0  ± 24.67     4.7  ± 22.18  
Side Effects: Change at C4 D1 (n=80, 102)     10.1  ± 20.64     4.9  ± 22.48  
Side Effects: Change at C5 D1 (n=54, 59)     7.4  ± 25.55     3.6  ± 23.84  
Side Effects: Change at C6 D1 (n=29, 40)     8.1  ± 26.72     -1.4  ± 25.32  
Side Effects: Change at C7 D1 (n=17, 22)     15.0  ± 20.77     -1.0  ± 19.38  
Side Effects: Change at C8 D1 (n=8, 11)     9.7  ± 19.19     -3.0  ± 22.83  
Side Effects: Change at C9 D1 (n=3, 6)     14.8  ± 23.15     -1.9  ± 27.60  
Side Effects: Change at C10 D1 (n=0, 3)     NA  ± NA [2]   0.0  ± 40.12  
Side Effects: Change at C11 D1 (n=0, 1)     NA  ± NA [2]   -33.4  ± NA [1]
Side Effects: Change at C12 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Side Effects: Change at C13 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Side Effects: Change at follow-up (n=42, 42)     18.8  ± 24.37     13.2  ± 27.80  
Fear of Future Health (FH): Baseline (n=252, 250))     59.3  ± 31.33     61.1  ± 33.07  
Fear of FH: Change at C2 D1 (n=192, 201)     -3.5  ± 31.82     -9.6  ± 28.80  
Fear of FH: Change at C3 D1 (n=145, 155)     -0.9  ± 34.02     -11.6  ± 30.07  
Fear of FH: Change at C4 D1 (n=103, 113)     -4.5  ± 32.70     -15.9  ± 30.90  
Fear of FH: Change at C5 D1 (n=71, 64)     -0.5  ± 31.12     -10.9  ± 29.74  
Fear of FH: Change at C6 D1 (n=42, 44)     -4.8  ± 30.86     -14.4  ± 32.47  
Fear of FH: Change at C7 D1 (n=27, 25)     -6.2  ± 22.72     -13.3  ± 33.34  
Fear of FH: Change at C8 D1 (n=12, 12)     2.8  ± 30.02     5.6  ± 27.84  
Fear of FH: Change at C9 D1 (n=6, 6)     16.7  ± 27.90     16.7  ± 34.96  
Fear of FH: Change at C10 D1 (n=2, 3)     -16.7  ± 23.62     11.1  ± 50.96  
Fear of FH: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
Fear of FH: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Fear of FH: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Fear of FH:Change at follow-up (n=48, 45)     5.6  ± 28.63     -4.4  ± 38.67  
Future Plan ability: Baseline (n=250, 249)     34.3  ± 33.59     38.0  ± 34.40  
Future Plan ability: Change at C2 D1 (n=192, 198)     6.1  ± 38.19     -0.3  ± 34.58  
Future Plan ability:Change at C3 D1 (n=142, 153)     3.5  ± 39.65     0.4  ± 36.68  
Future Plan ability:Change at C4 D1 (n=101, 112)     5.6  ± 36.55     0.3  ± 37.04  
Future Plan ability:Change at C5 D1 (n=70, 62)     0.9  ± 34.05     -3.8  ± 39.17  
Future Plan ability:Change at C6 D1 (n=42, 42)     4.8  ± 34.99     0.8  ± 46.27  
Future Plan ability: Change at C7 D1 (n=26, 24)     2.6  ± 28.18     -7.0  ± 36.76  
Future Plan ability: Change at C8 D1 (n=11, 11)     6.1  ± 32.74     3.0  ± 43.36  
Future Plan ability: Change at C9 D1 (n=5, 6)     0.0  ± 23.55     0.0  ± 55.78  
Future Plan ability: Change at C10 D1 (n=1, 3)     0.0  ± NA [1]   -11.1  ± 69.43  
Future Plan ability: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   -66.7  ± NA [1]
Future Plan ability: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Future Plan ability: Change at C13 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Future Plan ability: Change at followup (n=48, 45)     21.5  ± 35.40     5.2  ± 38.25  
[1] Standard deviation was not estimable since only one participant was evaluable.
[2] Data was not analyzed as no participants were evaluable for the particular cycle.

No statistical analysis provided for Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score



7.  Secondary:   Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Measure Type Secondary
Measure Title Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score
Measure Description BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; ‘0=No pain and 10=Pain as bad as you can imagine’. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.
Time Frame Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal  
Safety Issue No  

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.
ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID 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.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Measured Values
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
Number of Participants Analyzed  
[units: participants]
  314     316  
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score  
[units: Units on a scale]
Mean ± Standard Deviation
   
Worst Pain: Baseline (n=247, 250)     3.8  ± 2.84     3.7  ± 2.96  
Worst Pain: Change at C2 D1 (n=192, 200)     -0.7  ± 3.04     -0.9  ± 2.84  
Worst Pain: Change at C3 D1 (n=138, 151)     -1.5  ± 3.09     -0.9  ± 2.83  
Worst Pain: Change at C4 D1 (n=99, 113)     -1.0  ± 3.41     -0.9  ± 3.09  
Worst Pain: Change at C5 D1 (n=69, 64)     -1.1  ± 3.43     -1.2  ± 3.08  
Worst Pain: Change at C6 D1 (n=41, 43)     -0.9  ± 2.98     -1.0  ± 3.17  
Worst Pain: Change at C7 D1 (n=25, 26)     -0.8  ± 2.27     -0.9  ± 3.50  
Worst Pain: Change at C8 D1 (n=12, 13)     0.8  ± 2.56     -1.5  ± 3.20  
Worst Pain: Change at C9 D1(n=6, 6)     -1.8  ± 1.94     -1.3  ± 1.51  
Worst Pain: Change at C10 D1 (n=2, 3)     -2.0  ± 2.83     -0.3  ± 2.31  
Worst Pain: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
Worst Pain: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Worst Pain: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -4.0  ± NA [1]
Worst Pain: Change at follow-up (n=47, 46)     0.5  ± 3.08     0.0  ± 3.21  
Pain in Last 24 Hours (hrs): Baseline (n=246, 248)     1.8  ± 1.92     1.7  ± 1.93  
Pain in Last 24 hrs: Change at C2 D1 (n=193, 197)     -0.2  ± 2.21     -0.3  ± 1.92  
Pain in Last 24 hrs: Change at C3 D1 (n=138, 150)     -0.6  ± 2.01     -0.3  ± 1.88  
Pain in Last 24 hrs: Change at C4 D1 (n=99, 112)     -0.3  ± 2.15     -0.0  ± 1.96  
Pain in Last 24 hrs: Change at C5 D1 (n=69, 63)     -0.3  ± 2.41     -0.2  ± 2.04  
Pain in Last 24 hrs: Change at C6 D1 (n=40, 43)     -0.2  ± 2.07     -0.1  ± 1.64  
Pain in Last 24 hrs: Change at C7 D1 (n=25, 26)     0.4  ± 1.47     -0.0  ± 2.46  
Pain in Last 24 hrs: Change at C8 D1 (n=12, 13)     1.3  ± 2.34     -0.2  ± 1.41  
Pain in Last 24 hrs: Change at C9 D1 (n=6, 6)     -0.3  ± 1.37     0.2  ± 1.60  
Pain in Last 24 hrs: Change at C10 D1 (n=2, 3)     -1.5  ± 2.12     0.3  ± 0.58  
Pain in Last 24 hrs: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   4.0  ± NA [1]
Pain in Last 24 hrs: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Pain in Last 24 hrs: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -1.0  ± NA [1]
Pain in Last 24 hrs: Change at followup (n=48, 45)     0.4  ± 2.70     0.8  ± 2.58  
Pain on the Average: Baseline (n=246, 248)     2.9  ± 2.16     2.8  ± 2.27  
Pain on the Average: Change at C2 D1 (n=195, 198)     -0.5  ± 2.02     -0.5  ± 2.29  
Pain on the Average: Change at C3 D1 (n=140, 149)     -0.8  ± 2.48     -0.5  ± 2.10  
Pain on the Average: Change at C4 D1 (n=99, 113)     -0.7  ± 2.44     -0.6  ± 2.03  
Pain on the Average: Change at C5 D1 (n=69, 63)     -0.7  ± 2.48     -0.6  ± 2.29  
Pain on the Average: Change at C6 D1 (n=40, 43)     -0.5  ± 2.07     -0.9  ± 2.12  
Pain on the Average: Change at C7 D1 (n=25, 26)     -0.3  ± 1.46     -0.5  ± 2.97  
Pain on the Average: Change at C8 D1 (n=12, 13)     1.0  ± 2.00     -1.4  ± 1.94  
Pain on the Average: Change at C9 D1 (n=6, 6)     -1.7  ± 1.51     -1.7  ± 1.86  
Pain on the Average: Change at C10 D1 (n=2, 3)     -2.0  ± 2.83     -1.0  ± 2.65  
Pain on the Average: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   -3.0  ± NA [1]
Pain on the Average: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Pain on the Average: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -2.0  ± NA [1]
Pain on the Average: Change at followup (n=48, 45)     0.6  ± 2.70     0.4  ± 2.74  
Pain Right Now: Baseline (n=248, 249)     2.1  ± 2.13     2.1  ± 2.36  
Pain Right Now: Change at C2 D1 (n=196, 200)     -0.4  ± 2.23     -0.5  ± 2.37  
Pain Right Now: Change at C3 D1 (n=140, 150)     -0.8  ± 2.31     -0.6  ± 2.06  
Pain Right Now: Change at C4 D1 (n=99, 113)     -0.6  ± 2.26     -0.5  ± 2.45  
Pain Right Now: Change at C5 D1 (n=68, 63)     -0.5  ± 2.76     -0.3  ± 2.65  
Pain Right Now: Change at C6 D1 (n=40, 43)     -0.5  ± 1.96     -0.5  ± 2.14  
Pain Right Now: Change at C7 D1 (n=25, 26)     0.1  ± 1.66     -0.2  ± 3.26  
Pain Right Now: Change at C8 D1 (n=12, 13)     1.1  ± 1.93     -0.6  ± 1.56  
Pain Right Now: Change at C9 D1 (n=6, 6)     -1.5  ± 1.76     -0.3  ± 0.52  
Pain Right Now: Change at C10 D1 (n=2, 3)     -2.0  ± 2.83     0.7  ± 1.15  
Pain Right Now: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   5.0  ± NA [1]
Pain Right Now: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Pain Right Now: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -5.0  ± NA [1]
Pain Right Now: Change at follow-up (n=48, 46)     0.4  ± 2.64     -0.0  ± 2.67  
Relief Pain Treatment (Tx): Baseline (n=226, 221)     7.8  ± 12.09     6.9  ± 9.71  
Relief Pain Tx: Change at C2 D1 (n=164, 165)     0.6  ± 13.96     0.4  ± 11.48  
Relief Pain Tx: Change at C3 D1 (n=122, 124)     -2.1  ± 13.10     0.1  ± 9.16  
Relief Pain Tx: Change at C4 D1 (n=88, 92)     -1.7  ± 13.51     -0.9  ± 17.56  
Relief Pain Tx: Change at C5 D1 (n=59, 51)     -2.9  ± 16.35     1.8  ± 11.62  
Relief Pain Tx: Change at C6 D1 (n=34, 33)     -1.6  ± 11.90     0.5  ± 4.28  
Relief Pain Tx: Change at C7 D1 (n=21, 18)     1.0  ± 2.78     -3.2  ± 19.65  
Relief Pain Tx: Change at C8 D1 (n=10, 8)     -5.0  ± 21.20     -11.6  ± 28.16  
Relief Pain Tx: Change at C9 D1 (n=5, 5)     -14.0  ± 28.99     -16.6  ± 35.44  
Relief Pain Tx: Change at C10 D1 (n=1, 2)     6.0  ± NA [1]   0.0  ± 1.41  
Relief Pain Tx: Change at C11 D1 (n=0, 1)     NA  ± NA [2]   0.0  ± NA [1]
Relief Pain Tx: Change at C12 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Relief Pain Tx: Change at C13 D1 (n=0, 0)     NA  ± NA [2]   NA  ± NA [2]
Relief Pain Tx: Change at follow-up (n=43, 36)     0.2  ± 3.82     -0.4  ± 5.08  
General Activity: Baseline (n=243, 243)     3.2  ± 3.11     3.0  ± 3.01  
General Activity: Change at C2 D1 (n=190, 193)     -0.6  ± 2.96     -0.7  ± 2.55  
General Activity: Change at C3 D1 (n=135, 143)     -1.1  ± 3.47     -0.7  ± 2.61  
General Activity: Change at C4 D1 (n=97, 109)     -0.4  ± 3.10     -0.8  ± 2.53  
General Activity: Change at C5 D1 (n=66, 62)     -0.8  ± 3.64     -0.5  ± 2.51  
General Activity: Change at C6 D1 (n=40, 41)     -0.6  ± 3.82     -0.7  ± 2.62  
General Activity: Change at C7 D1 (n=25, 25)     -0.5  ± 2.87     -0.4  ± 2.84  
General Activity: Change at C8 D1 (n=12, 12)     0.1  ± 2.07     -0.8  ± 2.70  
General Activity: Change at C9 D1 (n=6, 6)     -2.2  ± 2.71     0.3  ± 3.72  
General Activity: Change at C10 D1 (n=2, 3)     -2.5  ± 3.54     3.0  ± 5.29  
General Activity: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   1.0  ± NA [1]
General Activity: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
General Activity: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -1.0  ± NA [1]
General Activity: Change at follow-up (n=47, 44)     1.0  ± 4.32     0.0  ± 3.63  
Mood: Baseline (n=243, 241)     3.0  ± 2.92     2.8  ± 2.77  
Mood: Change at C2 D1 (n=191, 191)     -0.6  ± 2.74     -0.2  ± 2.46  
Mood: Change at C3 D1 (n=135, 141)     -1.0  ± 3.39     -0.5  ± 2.51  
Mood: Change at C4 D1 (n=98, 106)     -0.3  ± 3.22     -0.9  ± 2.81  
Mood: Change at C5 D1 (n=66, 61)     -0.7  ± 3.66     -0.9  ± 2.59  
Mood: Change at C6 D1 (n=40, 41)     -0.6  ± 3.23     -0.8  ± 2.93  
Mood: Change at C7 D1 (n=25, 25)     0.0  ± 2.54     -0.2  ± 3.18  
Mood: Change at C8 D1 (n=12, 12)     0.6  ± 1.31     -1.1  ± 3.12  
Mood: Change at C9 D1 (n=6, 6)     -1.3  ± 1.97     -0.8  ± 3.31  
Mood: Change at C10 D1 (n=2, 3)     -1.0  ± 1.41     3.3  ± 1.53  
Mood: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   5.0  ± NA [1]
Mood: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Mood: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -3.0  ± NA [1]
Mood: Change at follow-up (n=47, 44)     0.9  ± 3.65     0.2  ± 3.62  
Walking Ability: Baseline (n=242, 243)     2.2  ± 2.78     2.3  ± 2.81  
Walking Ability: Change at C2 D1 (n=189, 194)     0.1  ± 2.84     -0.1  ± 2.61  
Walking Ability: Change at C3 D1 (n=133, 143)     -0.2  ± 3.41     -0.3  ± 2.52  
Walking Ability: Change at C4 D1 (n=97, 108)     0.3  ± 3.32     -0.4  ± 2.64  
Walking Ability: Change at C5 D1 (n=66, 62)     0.1  ± 3.49     -0.3  ± 2.37  
Walking Ability: Change at C6 D1 (n=41, 41)     0.5  ± 2.86     -0.2  ± 2.24  
Walking Ability: Change at C7 D1 (n=25, 25)     1.1  ± 2.67     -0.1  ± 2.42  
Walking Ability: Change at C8 D1 (n=12, 12)     0.7  ± 2.46     -1.3  ± 2.42  
Walking Ability: Change at C9 D1 (n=6, 6)     -1.0  ± 3.52     0.2  ± 4.62  
Walking Ability: Change at C10 D1 (n=2, 3)     -2.0  ± 2.83     1.3  ± 5.51  
Walking Ability: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   0.0  ± NA [1]
Walking Ability: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Walking Ability: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -2.0  ± NA [1]
Walking Ability: Change at follow-up (n=47, 45)     0.9  ± 4.13     0.7  ± 3.27  
Normal Work: Baseline (n=240, 240)     3.5  ± 3.34     3.2  ± 3.23  
Normal Work: Change at C2 D1 (n=187, 191)     -0.4  ± 3.24     -0.1  ± 3.16  
Normal Work: Change at C3 D1 (n=133, 139)     -0.6  ± 3.33     -0.4  ± 2.67  
Normal Work: Change at C4 D1 (n=96, 107)     -0.2  ± 3.15     -0.7  ± 2.90  
Normal Work: Change at C5 D1 (n=65, 61)     -0.7  ± 3.86     -0.6  ± 2.71  
Normal Work: Change at C6 D1 (n=39, 41)     0.2  ± 3.62     -0.2  ± 3.12  
Normal Work: Change at C7 D1 (n=25, 24)     0.5  ± 2.76     -0.4  ± 2.52  
Normal Work: Change at C8 D1 (n=12, 12)     -0.3  ± 3.70     -0.1  ± 3.37  
Normal Work: Change at C9 D1 (n=6, 6)     -1.5  ± 3.51     3.5  ± 4.32  
Normal Work: Change at C10 D1 (n=2, 3)     -0.5  ± 0.71     1.3  ± 3.51  
Normal Work: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   2.0  ± NA [1]
Normal Work: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Normal Work: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -2.0  ± NA [1]
Normal Work: Change at follow-up (n=46, 43)     1.0  ± 4.54     0.3  ± 3.90  
Relations: Baseline (n=244, 242)     2.3  ± 2.93     1.9  ± 2.44  
Relations: Change at C2 D1 (n=190, 193)     -0.3  ± 2.82     0.0  ± 2.18  
Relations: Change at C3 D1 (n=136, 142)     -0.4  ± 3.81     -0.0  ± 2.16  
Relations: Change at C4 D1 (n=98, 108)     -0.2  ± 3.36     -0.1  ± 2.52  
Relations: Change at C5 D1 (n=66, 62)     -0.6  ± 3.11     -0.1  ± 2.27  
Relations: Change at C6 D1 (n=40, 41)     -0.3  ± 4.01     -0.1  ± 2.76  
Relations: Change at C7 D1 (n=25, 25)     0.8  ± 3.32     -0.7  ± 2.44  
Relations: Change at C8 D1 (n=12, 12)     0.6  ± 2.61     -0.9  ± 2.35  
Relations: Change at C9 D1 (n=6, 6)     -1.2  ± 2.93     0.8  ± 4.88  
Relations: Change at C10 D1 (n=2, 3)     1.0  ± 1.41     2.7  ± 2.52  
Relations: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   2.0  ± NA [1]
Relations: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Relations: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -2.0  ± NA [1]
Relations: Change at follow-up (n=47, 45)     0.7  ± 3.94     0.8  ± 3.56  
Sleep: Baseline (n=244, 242)     3.3  ± 3.16     3.2  ± 3.17  
Sleep: Change at C2 D1 (n=191, 193)     -1.1  ± 3.36     -0.9  ± 2.73  
Sleep: Change at C3 D1 (n=136, 142)     -1.6  ± 3.52     -1.1  ± 2.89  
Sleep: Change at C4 D1 (n=98, 107)     -1.2  ± 3.29     -1.2  ± 3.02  
Sleep: Change at C5 D1 (n=66, 62)     -1.3  ± 4.06     -0.8  ± 3.37  
Sleep: Change at C6 D1(n=39, 41)     -1.5  ± 3.22     -0.8  ± 3.62  
Sleep: Change at C7 D1 (n=25, 25)     -0.2  ± 3.61     -0.6  ± 2.81  
Sleep: Change at C8 D1 (n=12, 12)     0.6  ± 2.71     -1.2  ± 3.51  
Sleep: Change at C9 D1 (n=6, 6)     -2.3  ± 3.20     0.3  ± 2.07  
Sleep: Change at C10 D1 (n=2, 3)     1.0  ± 1.41     0.7  ± 3.51  
Sleep: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   4.0  ± NA [1]
Sleep: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Sleep: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -5.0  ± NA [1]
Sleep: Change at follow-up (n=47, 44)     0.5  ± 3.65     -0.3  ± 3.54  
Enjoyment of Life: Baseline (n=242, 240)     3.5  ± 3.34     3.4  ± 3.17  
Enjoyment of Life: Change at C2 D1 (n=191, 191)     -0.6  ± 2.99     -0.5  ± 2.89  
Enjoyment of Life: Change at C3 D1 (n=134, 142)     -0.7  ± 3.64     -0.7  ± 2.77  
Enjoyment of Life: Change at C4 D1 (n=98, 107)     -0.6  ± 3.58     -0.9  ± 2.70  
Enjoyment of Life: Change at C5 D1 (n=66, 62)     -0.6  ± 4.03     -0.8  ± 3.07  
Enjoyment of Life: Change at C6 D1 (n=40, 41)     -0.4  ± 3.87     -1.0  ± 3.17  
Enjoyment of Life: Change at C7 D1 (n=25, 25)     0.4  ± 3.53     -0.9  ± 2.28  
Enjoyment of Life: Change at C8 D1 (n=12, 12)     0.8  ± 2.98     -0.8  ± 2.53  
Enjoyment of Life: Change at C9 D1 (n=6, 6)     -0.5  ± 5.01     0.2  ± 2.86  
Enjoyment of Life: Change at C10 D1 (n=2, 3)     0.5  ± 0.71     2.3  ± 5.51  
Enjoyment of Life: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   -1.0  ± NA [1]
Enjoyment of Life: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Enjoyment of Life: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -4.0  ± NA [1]
Enjoyment of Life: Change at follow-up (n=47, 43)     0.2  ± 3.68     -0.2  ± 3.99  
Combined Pain Intensity(PI): Baseline (n=248, 251)     2.7  ± 1.98     2.6  ± 2.12  
Combined PI: Change at C2 D1 (n=196, 202)     -0.4  ± 1.97     -0.5  ± 1.97  
Combined PI: Change at C3 D1 (n=140, 151)     -0.9  ± 2.15     -0.6  ± 1.88  
Combined PI: Change at C4 D1 (n=99, 114)     -0.6  ± 2.19     -0.5  ± 1.99  
Combined PI: Change at C5 D1 (n=69, 64)     -0.6  ± 2.46     -0.6  ± 2.19  
Combined PI: Change at C6 D1 (n=41, 43)     -0.5  ± 1.92     -0.6  ± 1.89  
Combined PI: Change at C7 D1 (n=25, 27)     -0.1  ± 1.48     -0.4  ± 2.78  
Combined PI: Change at C8 D1 (n=12, 13)     1.0  ± 2.01     -0.9  ± 1.76  
Combined PI: Change at C9 D1 (n=6, 6)     -1.3  ± 1.51     -0.8  ± 1.11  
Combined PI: Change at C10 D1 (n=2, 3)     -1.9  ± 2.69     -0.1  ± 1.44  
Combined PI: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   1.5  ± NA [1]
Combined PI: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Combined PI: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -3.0  ± NA [1]
Combined PI:Change follow-up (n=48, 47)     0.5  ± 2.34     0.2  ± 2.56  
Combined Pain Interference(Pf):Baseline(n=244,243)     3.0  ± 2.64     2.8  ± 2.52  
Combined Pf: Change at C2 D1 (n=191, 194)     -0.5  ± 2.44     -0.4  ± 1.97  
Combined Pf: Change at C3 D1 (n=136,143)     -0.8  ± 2.99     -0.5  ± 2.01  
Combined Pf: Change at C4 D1 (n=98,109)     -0.4  ± 2.62     -0.7  ± 2.12  
Combined Pf: Change at C5 D1 (n=66, 62)     -0.6  ± 3.18     -0.6  ± 2.07  
Combined Pf: Change at C6 D1 (n=41, 41)     -0.4  ± 2.92     -0.6  ± 2.38  
Combined Pf: Change at C7 D1 (n=25, 25)     0.3  ± 2.32     -0.5  ± 2.10  
Combined Pf: Change at C8 D1 (n=12, 12)     0.4  ± 1.84     -0.9  ± 2.15  
Combined Pf: Change at C9 D1 (n=6, 6)     -1.4  ± 2.69     0.7  ± 2.86  
Combined Pf: Change at C10 D1 (n=2, 3)     -0.5  ± 0.71     2.1  ± 2.90  
Combined Pf: Change at C11 D1 (n=1, 1)     0.0  ± NA [1]   1.9  ± NA [1]
Combined Pf: Change at C12 D1 (n=1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Combined Pf: Change at C13 D1 (n=1, 1)     0.0  ± NA [1]   -2.7  ± NA [1]
Combined Pf: Change at follow-up (n=47, 45)     0.7  ± 3.55     0.3  ± 3.40  
[1] Standard deviation was not estimable since only one participant was evaluable.
[2] Data was not analyzed as no participants were evaluable for the particular cycle.

No statistical analysis provided for Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score



8.  Secondary:   Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Measure Type Secondary
Measure Title Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile
Measure Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal  
Safety Issue No  

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.
ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID 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.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Measured Values
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
Number of Participants Analyzed  
[units: participants]
  314     316  
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile  
[units: Units on a scale]
Mean ± Standard Deviation
   
Baseline (n=289, 290)     0.665  ± 0.2709     0.690  ± 0.2479  
Change at C2 D1 (n=231, 240)     0.050  ± 0.2699     0.020  ± 0.2033  
Change at C3 D1 (n=171, 178)     0.053  ± 0.2528     0.028  ± 0.2362  
Change at C4 D1 (n=128, 131)     0.010  ± 0.2730     0.050  ± 0.2209  
Change at C5 D1 (n=94, 80)     0.010  ± 0.2889     0.044  ± 0.2092  
Change at C6 D1 (n=57, 57)     0.001  ± 0.2489     0.058  ± 0.2294  
Change at C7 D1 (n=37, 36)     0.049  ± 0.1891     0.075  ± 0.1838  
Change at C8 D1 (n=17, 20)     -0.021  ± 0.2366     0.071  ± 0.2188  
Change at C9 D1 (n=9, 9)     0.049  ± 0.1878     0.121  ± 0.3006  
Change at C10 D1 (n=3, 4)     0.181  ± 0.2206     0.208  ± 0.3034  
Change at C11 D1 (n=1, 1)     0.000  ± NA [1]   0.058  ± NA [1]
Change at C12 D1 (n=1, 0)     0.000  ± NA [1]   NA  ± NA [2]
Change at C13 D1 (n=1, 1)     0.000  ± NA [1]   0.470  ± NA [1]
Change at follow-up (n=65, 73)     -0.148  ± 0.3637     -0.080  ± 0.3243  
[1] Standard deviation was not estimable since only one participant was evaluable.
[2] Data was not analyzed as no participants were evaluable for the particular cycle.

No statistical analysis provided for Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile



9.  Secondary:   Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score   [ Time Frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal ]

Measure Type Secondary
Measure Title Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score
Measure Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Time Frame Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal  
Safety Issue No  

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.
ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.

Reporting Groups
  Description
Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID 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.
Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Measured Values
    Axitinib + Gemcitabine     Placebo + Gemcitabine  
Number of Participants Analyzed  
[units: participants]
  314     316  
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score  
[units: Millimeter (mm)]
Mean ± Standard Deviation
   
Baseline (n= 277, 281)     60.6  ± 23.67     62.6  ± 23.09  
Change at Cycle 2 Day 1 (n= 223, 226)     1.0  ± 19.64     -0.4  ± 20.42  
Change at Cycle 3 Day 1 (n= 161, 171)     2.6  ± 22.30     1.1  ± 20.25  
Change at Cycle 4 Day 1 (n=122, 128)     0.5  ± 22.38     3.2  ± 19.81  
Change at Cycle 5 Day 1 (n= 90, 79)     -0.3  ± 22.83     1.9  ± 19.40  
Change at Cycle 6 Day 1 (n= 56, 56)     1.0  ± 24.63     3.7  ± 21.84  
Change at Cycle 7 Day 1 (n= 36, 35)     2.6  ± 25.82     4.1  ± 22.52  
Change at Cycle 8 Day 1 (n= 16, 19)     3.8  ± 23.21     9.6  ± 28.55  
Change at Cycle 9 Day 1 (n= 9, 9)     22.2  ± 24.93     7.7  ± 20.00  
Change at Cycle 10 Day 1 (n= 3, 4)     20.0  ± 26.46     6.3  ± 24.62  
Change at Cycle 11 Day 1 (n= 1, 1)     0.0  ± NA [1]   30.0  ± NA [1]
Change at Cycle 12 Day 1 (n= 1, 0)     0.0  ± NA [1]   NA  ± NA [2]
Change at Cycle 13 Day 1 (n= 1, 1)     0.0  ± NA [1]   36.0  ± NA [1]
Change at follow-up (n= 62, 68)     -6.3  ± 24.07     -4.8  ± 22.79  
[1] Standard deviation was not estimable since only one participant was evaluable.
[2] Data was not analyzed as no participants were evaluable for the particular cycle.

No statistical analysis provided for Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score



10.  Secondary:   Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)   [ Time Frame: Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00471146     History of Changes
Other Study ID Numbers: A4061028
Study First Received: May 7, 2007
Results First Received: February 25, 2012
Last Updated: June 14, 2012
Health Authority: United States: Food and Drug Administration