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AG-013736 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 : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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: AG-013736
Enrollment 111
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In) Axitinib + Gemcitabine Gemcitabine
Hide Arm/Group Description Axitinib (AG-013736) 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 (AG-013736) 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 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Period Title: Phase 1
Started 8 0 0
Completed 1 0 0
Not Completed 7 0 0
Reason Not Completed
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 Title: Phase 2
Started 0 69 34
Treated 0 68 31
Completed 0 0 1
Not Completed 0 69 33
Reason Not Completed
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
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In) Axitinib + Gemcitabine Gemcitabine Total
Hide Arm/Group Description Axitinib (AG-013736) 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 (AG-013736) 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 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 8 69 34 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 69 participants 34 participants 111 participants
18 years to 44 years
0
   0.0%
2
   2.9%
4
  11.8%
6
   5.4%
45 years to 64 years
5
  62.5%
31
  44.9%
20
  58.8%
56
  50.5%
Greater than or equal to 65 years
3
  37.5%
36
  52.2%
10
  29.4%
49
  44.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 69 participants 34 participants 111 participants
Female
1
  12.5%
34
  49.3%
18
  52.9%
53
  47.7%
Male
7
  87.5%
35
  50.7%
16
  47.1%
58
  52.3%
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the date of randomization plus 1. 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 of Phase 2 to death or until at least 1 year after the randomization of the last participant
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Axitinib + Gemcitabine Gemcitabine
Hide Arm/Group Description:
Axitinib (AG-013736) 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 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Overall Number of Participants Analyzed 69 34
Median (95% Confidence Interval)
Unit of Measure: Days
210
(162 to 308)
171
(125 to 267)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments Differences in OS between treatment arms was analyzed by the stratified log-rank 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1026
Comments One-sided log-rank test at alpha = 0.1 significance level was used.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.758
Confidence Interval (2-Sided) 95%
0.490 to 1.170
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
Hide Description Dose of axitinib (AG-013736) 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 non hematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.
Time Frame Phase 1 baseline up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In)
Hide Arm/Group Description:
Axitinib (AG-013736) 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.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
Hide 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 non hematological toxicities for >= 7 days (except alopecia) or >= Gr 1 hemoptysis or >=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.
Time Frame Phase 1 Baseline up to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In)
Hide Arm/Group Description:
Axitinib (AG-013736) 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.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
0
4.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 1 Pharmacokinetic (PK) evaluable population included all ITT participants who completed PK blood sampling on at least 1 day.
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In)
Hide Arm/Group Description:
Axitinib (AG-013736) 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.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: nanogram/milliliter (ng/mL)
45.08  (34.32)
5.Secondary Outcome
Title Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)
Hide Description AUC (0-24) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 24 hours (0-24).
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In)
Hide Arm/Group Description:
Axitinib (AG-013736) 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.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
282.34  (135.27)
6.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)
Hide Description Tmax was based on the actual time points when the samples were collected.
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In)
Hide Arm/Group Description:
Axitinib (AG-013736) 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.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: hr
1.52
(0.50 to 2.20)
7.Secondary Outcome
Title Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In)
Hide Arm/Group Description:
Axitinib (AG-013736) 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.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: hr
2.97  (1.95)
8.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Gemcitabine
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In)
Hide Arm/Group Description:
Axitinib (AG-013736) 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.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: ng/mL
27280.0  (12599.1)
9.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine
Hide Description AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Time Frame 0 (pre-dose), 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In)
Hide Arm/Group Description:
Axitinib (AG-013736) 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.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
13656.00  (4142.16)
10.Secondary Outcome
Title Plasma Decay Half-life (t1/2) of Gemcitabine
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 0 (pre-dose), 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In)
Hide Arm/Group Description:
Axitinib (AG-013736) 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.
Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: hr
0.310  (0.028)
11.Secondary Outcome
Title Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2
Hide Description Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.
Time Frame Phase 2 Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 80 weeks
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Percentage of Participants With Overall Response (OR)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Axitinib + Gemcitabine Gemcitabine
Hide Arm/Group Description:
Axitinib (AG-013736) 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 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Overall Number of Participants Analyzed 69 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
7.2
(2.4 to 16.1)
2.9
(0.1 to 15.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments Difference in percent of participants with overall response expressed as response rate, was used for calculation of 95% confidence interval (CI).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.661
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in response rate
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
-4.0 to 12.7
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Duration of Response (DR)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subgroup of participants from Phase 2 ITT population, with a confirmed objective tumor response (CR or PR).
Arm/Group Title Axitinib + Gemcitabine Gemcitabine
Hide Arm/Group Description:
Axitinib (AG-013736) 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 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Overall Number of Participants Analyzed 5 1
Median (95% Confidence Interval)
Unit of Measure: Days
379
(136 to 379)
155 [1] 
(NA to NA)
[1]
95% CI was not estimable because only one participant was evaluable.
14.Secondary Outcome
Title Progression-free Survival (PFS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Axitinib + Gemcitabine Gemcitabine
Hide Arm/Group Description:
Axitinib (AG-013736) 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 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Overall Number of Participants Analyzed 69 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Days
116
(109 to 160)
113
(68 to 205)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments Differences in PFS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are ECOG performance status (less than equal to 1 or 2) and extent of disease (locally advanced or metastatic).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4466
Comments One-sided log-rank test at alpha = 0.1 significance level was used.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.9648
Confidence Interval (2-Sided) 95%
0.5400 to 1.7300
Estimation Comments [Not Specified]
15.Secondary Outcome
Title One Year Survival Probability
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Axitinib + Gemcitabine Gemcitabine
Hide Arm/Group Description:
Axitinib (AG-013736) 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 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Overall Number of Participants Analyzed 69 34
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent chance of survival
36.81
(25.71 to 47.93)
23.53
(11.48 to 38.01)
16.Secondary Outcome
Title Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study
Hide Description EORTC QLQ-C30: 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 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 Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Axitinib + Gemcitabine Gemcitabine
Hide Arm/Group Description:
Axitinib (AG-013736) 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 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Overall Number of Participants Analyzed 65 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Global QoL: Baseline Number Analyzed 65 participants 27 participants
55.60  (27.18) 54.32  (21.10)
Physical Functioning: Baseline Number Analyzed 65 participants 27 participants
76.90  (24.73) 82.22  (14.44)
Role Functioning: Baseline Number Analyzed 65 participants 26 participants
62.56  (33.21) 60.26  (35.30)
Emotional Functioning: Baseline Number Analyzed 65 participants 27 participants
67.22  (26.17) 66.98  (23.96)
Cognitive Functioning: Baseline Number Analyzed 65 participants 27 participants
82.82  (23.93) 82.10  (19.57)
Social Functioning: Baseline Number Analyzed 65 participants 26 participants
67.44  (33.00) 70.51  (29.56)
Fatigue: Baseline Number Analyzed 65 participants 27 participants
43.50  (29.78) 42.80  (25.73)
Nausea and Vomiting: Baseline Number Analyzed 65 participants 27 participants
19.74  (28.24) 13.58  (20.17)
Pain: Baseline Number Analyzed 65 participants 27 participants
40.00  (33.31) 37.04  (31.80)
Dyspnea: Baseline Number Analyzed 64 participants 27 participants
12.50  (21.82) 16.05  (26.75)
Insomnia: Baseline Number Analyzed 65 participants 27 participants
31.28  (31.66) 39.51  (39.26)
Appetite loss: Baseline Number Analyzed 65 participants 27 participants
41.03  (40.30) 33.33  (34.59)
Constipation: Baseline Number Analyzed 65 participants 27 participants
34.87  (37.93) 38.27  (38.90)
Diarrhea: Baseline Number Analyzed 65 participants 27 participants
20.00  (27.51) 16.05  (28.30)
Financial Difficulties: Baseline Number Analyzed 64 participants 27 participants
10.42  (19.59) 28.40  (41.04)
Global QoL: Change at C2 D1 Number Analyzed 49 participants 20 participants
-5.10  (21.17) 3.33  (16.97)
Physical Functioning: Change at C2 D1 Number Analyzed 51 participants 21 participants
-5.07  (18.85) 0.95  (16.23)
Role Functioning: Change at C2 D1 Number Analyzed 51 participants 19 participants
0.33  (25.93) 9.65  (29.56)
Emotional Functioning: Change at C2 D1 Number Analyzed 52 participants 21 participants
3.21  (21.34) 7.94  (17.77)
Cognitive Functioning: Change at C2 D1 Number Analyzed 52 participants 21 participants
-3.53  (21.48) 1.59  (18.93)
Social Functioning: Change at C2 D1 Number Analyzed 52 participants 20 participants
-4.17  (29.50) -0.83  (28.85)
Fatigue: Change at C2 D1 Number Analyzed 51 participants 21 participants
1.42  (21.74) -8.99  (26.67)
Nausea and Vomiting: Change at C2 D1 Number Analyzed 51 participants 21 participants
-5.88  (26.84) -1.59  (12.81)
Pain: Change at C2 D1 Number Analyzed 52 participants 21 participants
-9.29  (27.89) -16.67  (31.62)
Dyspnea: Change at C2 D1 Number Analyzed 50 participants 21 participants
9.33  (26.97) -3.17  (25.61)
Insomnia: Change at C2 D1 Number Analyzed 51 participants 21 participants
-9.15  (28.35) -19.05  (34.27)
Appetite loss: Change at C2 D1 Number Analyzed 51 participants 21 participants
-0.65  (35.58) -14.29  (35.86)
Constipation: Change at C2 D1 Number Analyzed 52 participants 21 participants
-9.62  (32.56) -14.29  (29.00)
Diarrhea: Change at C2 D1 Number Analyzed 52 participants 21 participants
-1.28  (29.49) 0.00  (18.26)
Financial Difficulties: Change at C2 D1 Number Analyzed 50 participants 21 participants
0.67  (19.62) -4.76  (19.11)
Global QoL: Change at C3 D1 Number Analyzed 40 participants 15 participants
-9.17  (30.36) 6.67  (15.17)
Physical Functioning: Change at C3 D1 Number Analyzed 42 participants 15 participants
-8.13  (21.46) 3.44  (18.73)
Role Functioning: Change at C3 D1 Number Analyzed 42 participants 14 participants
-5.56  (27.71) 13.10  (25.47)
Emotional Functioning: Change at C3 D1 Number Analyzed 41 participants 15 participants
-1.69  (26.80) 12.22  (19.89)
Cognitive Functioning: Change at C3 D1 Number Analyzed 41 participants 15 participants
-4.88  (24.79) 2.22  (16.51)
Social Functioning: Change at C3 D1 Number Analyzed 41 participants 15 participants
-4.07  (32.66) 5.56  (24.93)
Fatigue: Change at C3 D1 Number Analyzed 42 participants 14 participants
7.41  (28.61) -8.73  (26.57)
Nausea and Vomiting: Change at C3 D1 Number Analyzed 42 participants 13 participants
-4.37  (29.00) -2.56  (16.45)
Pain: Change at C3 D1 Number Analyzed 42 participants 15 participants
-6.75  (33.75) -23.33  (30.08)
Dyspnea: Change at C3 D1 Number Analyzed 41 participants 14 participants
3.25  (27.69) -7.14  (19.30)
Insomnia: Change at C3 D1 Number Analyzed 42 participants 14 participants
-10.32  (34.13) -11.90  (38.36)
Appetite loss: Change at C3 D1 Number Analyzed 42 participants 13 participants
11.11  (39.42) -5.13  (29.96)
Constipation: Change at C3 D1 Number Analyzed 41 participants 15 participants
-10.57  (32.86) -13.33  (35.19)
Diarrhea: Change at C3 D1 Number Analyzed 41 participants 15 participants
7.32  (32.07) 4.44  (30.52)
Financial Difficulties: Change at C3 D1 Number Analyzed 40 participants 15 participants
3.33  (24.81) -2.22  (26.63)
Global QoL: Change at C4 D1 Number Analyzed 30 participants 12 participants
-6.67  (21.04) -1.03  (15.27)
Physical Functioning: Change at C4 D1 Number Analyzed 32 participants 13 participants
-6.67  (23.15) -1.03  (15.36)
Role Functioning: Change at C4 D1 Number Analyzed 32 participants 12 participants
-7.81  (29.63) 9.72  (36.56)
Emotional Functioning: Change at C4 D1 Number Analyzed 31 participants 12 participants
-3.23  (22.64) 9.03  (36.56)
Cognitive Functioning: Change at C4 D1 Number Analyzed 31 participants 12 participants
-6.99  (25.74) 0.00  (15.89)
Social Functioning: Change at C4 D1 Number Analyzed 31 participants 11 participants
-8.60  (35.45) -1.52  (24.10)
Fatigue: Change at C4 D1 Number Analyzed 32 participants 13 participants
7.47  (25.19) -3.42  (25.41)
Nausea and Vomiting: Change at C4 D1 Number Analyzed 32 participants 13 participants
-4.69  (19.96) 6.41  (18.68)
Pain: Change at C4 D1 Number Analyzed 32 participants 13 participants
-16.67  (29.02) -11.54  (28.37)
Dyspnea: Change at C4 D1 Number Analyzed 31 participants 13 participants
0.00  (28.54) -5.13  (29.96)
Insomnia: Change at C4 D1 Number Analyzed 32 participants 13 participants
-11.46  (28.85) -5.13  (32.90)
Appetite loss: Change at C4 D1 Number Analyzed 32 participants 12 participants
6.25  (36.35) -2.78  (33.21)
Constipation: Change at C4 D1 Number Analyzed 30 participants 12 participants
-24.44  (37.07) -25.00  (40.51)
Diarrhea: Change at C4 D1 Number Analyzed 31 participants 12 participants
7.53  (39.17) 5.56  (34.33)
Financial Difficulties: Change at C4 D1 Number Analyzed 29 participants 12 participants
1.15  (22.68) -8.33  (20.72)
Global QoL: Change at C5 D1 Number Analyzed 26 participants 7 participants
-9.29  (27.82) 10.71  (21.36)
Physical Functioning: Change at C5 D1 Number Analyzed 28 participants 8 participants
-8.57  (23.08) 0.00  (22.25)
Role Functioning: Change at C5 D1 Number Analyzed 28 participants 7 participants
-8.93  (29.22) 7.14  (28.64)
Emotional Functioning: Change at C5 D1 Number Analyzed 28 participants 7 participants
-3.87  (22.96) 20.24  (14.32)
Cognitive Functioning: Change at C5 D1 Number Analyzed 28 participants 7 participants
-2.38  (24.73) 7.14  (16.27)
Social Functioning: Change at C5 D1 Number Analyzed 28 participants 7 participants
-15.48  (33.92) 4.76  (23.00)
Fatigue: Change at C5 D1 Number Analyzed 28 participants 8 participants
9.72  (28.59) -15.28  (17.76)
Nausea and Vomiting: Change at C5 D1 Number Analyzed 28 participants 8 participants
0.00  (26.06) -6.25  (15.27)
Pain: Change at C5 D1 Number Analyzed 28 participants 8 participants
-5.36  (34.26) -25.00  (26.73)
Dyspnea: Change at C5 D1 Number Analyzed 28 participants 8 participants
9.52  (27.00) -12.50  (24.80)
Insomnia: Change at C5 D1 Number Analyzed 28 participants 8 participants
-19.05  (35.63) -29.17  (33.03)
Appetite loss: Change at C5 D1 Number Analyzed 28 participants 8 participants
0.00  (42.55) -20.83  (43.42)
Constipation: Change at C5 D1 Number Analyzed 28 participants 7 participants
-21.43  (35.39) -33.33  (38.49)
Diarrhea: Change at C5 D1 Number Analyzed 28 participants 7 participants
7.14  (33.16) -4.76  (29.99)
Financial Difficulties: Change at C5 D1 Number Analyzed 27 participants 6 participants
0.00  (22.65) 0.00  (36.51)
Global QoL: Change at C6 D1 Number Analyzed 17 participants 3 participants
-14.22  (20.36) -5.56  (12.73)
Physical Functioning: Change at C6 D1 Number Analyzed 19 participants 2 participants
-6.32  (25.38) 6.67  (18.86)
Role Functioning: Change at C6 D1 Number Analyzed 19 participants 2 participants
-9.65  (27.95) 16.67  (47.14)
Emotional Functioning: Change at C6 D1 Number Analyzed 19 participants 3 participants
2.19  (15.92) 8.33  (14.43)
Cognitive Functioning: Change at C6 D1 Number Analyzed 19 participants 3 participants
-0.88  (18.82) 11.11  (9.62)
Social Functioning: Change at C6 D1 Number Analyzed 19 participants 3 participants
-2.63  (27.92) -16.67  (16.67)
Fatigue: Change at C6 D1 Number Analyzed 19 participants 2 participants
6.73  (24.19) -16.67  (39.28)
Nausea and Vomiting: Change at C6 D1 Number Analyzed 19 participants 2 participants
-4.39  (22.80) -8.33  (11.79)
Pain: Change at C6 D1 Number Analyzed 19 participants 3 participants
-8.77  (30.11) -33.33  (16.67)
Dyspnea: Change at C6 D1(n=18,2) Number Analyzed 18 participants 2 participants
-1.85  (21.30) 0.00  (47.14)
Insomnia: Change at C6 D1 Number Analyzed 19 participants 2 participants
-7.02  (30.59) -16.67  (23.57)
Appetite loss: Change at C6 D1(n=19,2) Number Analyzed 19 participants 2 participants
-3.51  (53.16) -16.67  (70.71)
Constipation: Change at C6 D1 Number Analyzed 19 participants 3 participants
-10.53  (35.23) -33.33  (33.33)
Diarrhea: Change at C6 D1 Number Analyzed 19 participants 3 participants
-1.75  (28.27) 0.00  (33.33)
Financial Difficulties: Change at C6 D1 Number Analyzed 19 participants 3 participants
1.75  (13.49) -22.22  (38.49)
Global QoL: Change at C7 D1 Number Analyzed 9 participants 3 participants
-4.63  (37.76) -16.67  (14.43)
Physical Functioning: Change at C7 D1 Number Analyzed 10 participants 2 participants
-3.33  (24.80) -22.22  (36.72)
Role Functioning: Change at C7 D1 Number Analyzed 10 participants 2 participants
-15.00  (30.88) 33.33  (70.71)
Emotional Functioning: Change at C7 D1 Number Analyzed 10 participants 3 participants
-8.33  (13.03) -7.41  (21.58)
Cognitive Functioning: Change at C7 D1 Number Analyzed 10 participants 3 participants
1.67  (24.15) -5.56  (9.62)
Social Functioning: Change at C7 D1 Number Analyzed 10 participants 2 participants
-15.00  (41.16) -25.00  (11.79)
Fatigue: Change at C7 D1 Number Analyzed 10 participants 3 participants
-2.22  (25.01) 14.81  (42.07)
Nausea and Vomiting: Change at C7D1 Number Analyzed 10 participants 3 participants
1.67  (21.44) 16.67  (0.00)
Pain: Change at C7 D1 Number Analyzed 10 participants 3 participants
-3.33  (32.20) -11.11  (41.94)
Dyspnea: Change at C7 D1 Number Analyzed 10 participants 3 participants
16.67  (23.57) 33.33  (33.33)
Insomnia: Change at C7 D1 Number Analyzed 10 participants 3 participants
-10.00  (35.31) 11.11  (38.49)
Appetite loss: Change at C7 D1 Number Analyzed 10 participants 3 participants
-10.00  (58.90) 22.22  (50.92)
Constipation: Change at C7 D1 Number Analyzed 10 participants 3 participants
-13.33  (47.66) -66.67  (57.74)
Diarrhea: Change at C7 D1 Number Analyzed 10 participants 3 participants
3.33  (29.19) 0.00  (0.00)
Financial Difficulties: Change at C7 D1 Number Analyzed 10 participants 3 participants
-6.67  (21.08) 0.00  (0.00)
Global QoL: Change at C8 D1 Number Analyzed 10 participants 1 participants
-12.50  (33.62) -33.33 [1]   (NA)
Physical Functioning Change at C8 D1 Number Analyzed 10 participants 1 participants
-10.67  (22.71) -20.00 [1]   (NA)
Role Functioning: Change at C8 D1 Number Analyzed 10 participants 1 participants
-13.33  (23.31) -33.33 [1]   (NA)
Emotional Functioning: Change at C8 D1 Number Analyzed 10 participants 1 participants
-7.50  (18.61) 0.00 [1]   (NA)
Cognitive Functioning: Change at C8 D1 Number Analyzed 10 participants 1 participants
0.00  (22.22) -16.67 [1]   (NA)
Social Functioning: Change at C8 D1 Number Analyzed 10 participants 1 participants
-11.67  (34.29) -16.67 [1]   (NA)
Fatigue: Change at C8 D1 Number Analyzed 10 participants 1 participants
4.44  (25.23) 2.22 [1]   (NA)
Nausea and Vomiting: Change at C8 D1 Number Analyzed 10 participants 1 participants
0.00  (19.25) 16.67 [1]   (NA)
Pain: Change at C8 D1 Number Analyzed 10 participants 1 participants
-8.33  (37.06) -16.67 [1]   (NA)
Dyspnea: Change at C8 D1 Number Analyzed 9 participants 1 participants
14.81  (29.40) 33.33 [1]   (NA)
Insomnia: Change at C8 D1 Number Analyzed 10 participants 1 participants
-20.00  (47.66) 0.00 [1]   (NA)
Appetite loss: Change at C8 D1 Number Analyzed 10 participants 1 participants
-3.33  (48.30) 33.33 [1]   (NA)
Constipation: Change at C8 D1 Number Analyzed 10 participants 1 participants
-3.33  (29.19) 0.00 [1]   (NA)
Diarrhea: Change at C8 D1 Number Analyzed 10 participants 1 participants
6.67  (37.84) -66.67 [1]   (NA)
Financial Difficulties: Change at C8 D1 Number Analyzed 10 participants 1 participants
-3.33  (18.92) 0.00 [1]   (NA)
Global QoL: Change at C9 D1 Number Analyzed 8 participants 1 participants
-17.71  (36.03) -33.33 [1]   (NA)
Physical Functioning: Change at C9 D1 Number Analyzed 8 participants 1 participants
-6.67  (20.16) -40.00 [1]   (NA)
Role Functioning: Change at C9 D1 Number Analyzed 8 participants 1 participants
-29.17  (24.80) -33.33 [1]   (NA)
Emotional Functioning: Change at C9 D1 Number Analyzed 8 participants 1 participants
-3.13  (13.32) -8.33 [1]   (NA)
Cognitive Functioning: Change at C9 D1 Number Analyzed 8 participants 1 participants
-2.08  (28.78) -33.33 [1]   (NA)
Social Functioning: Change at C9 D1 Number Analyzed 8 participants 1 participants
-6.25  (47.09) -33.33 [1]   (NA)
Fatigue: Change at C9 D1 Number Analyzed 8 participants 1 participants
18.06  (33.56) 33.33 [1]   (NA)
Nausea and Vomiting: Change at C9 D1 Number Analyzed 8 participants 1 participants
-8.33  (17.82) 16.67 [1]   (NA)
Pain: Change at C9 D1 Number Analyzed 8 participants 1 participants
0.00  (30.86) 0.00 [1]   (NA)
Dyspnea: Change at C9 D1 Number Analyzed 7 participants 1 participants
19.05  (26.23) 33.33 [1]   (NA)
Insomnia: Change at C9 D1 Number Analyzed 8 participants 1 participants
-4.17  (33.03) 0.00 [1]   (NA)
Appetite loss: Change at C9 D1 Number Analyzed 8 participants 1 participants
8.33  (63.62) 33.33 [1]   (NA)
Constipation: Change at C9 D1 Number Analyzed 8 participants 1 participants
-8.33  (38.83) 0.00 [1]   (NA)
Diarrhea: Change at C9 D1 Number Analyzed 8 participants 1 participants
12.50  (43.42) -66.67 [1]   (NA)
Financial Difficulties: Change at C9 D1 Number Analyzed 8 participants 1 participants
-4.17  (21.36) 0.00 [1]   (NA)
Global QoL: Change at C10 D1 Number Analyzed 7 participants 1 participants
-16.67  (21.52) -33.33 [1]   (NA)
Physical Functioning: Change at C10 D1 Number Analyzed 7 participants 1 participants
-19.05  (13.01) -46.67 [1]   (NA)
Role Functioning: Change at C10 D1 Number Analyzed 7 participants 1 participants
-23.81  (21.21) -50.00 [1]   (NA)
Emotional Functioning: Change at C10 D1 Number Analyzed 7 participants 1 participants
-20.24  (23.00) -16.67 [1]   (NA)
Cognitive Functioning: Change at C10 D1 Number Analyzed 7 participants 1 participants
-9.52  (21.21) -33.33 [1]   (NA)
Social Functioning: Change at C10 D1 Number Analyzed 7 participants 1 participants
-21.43  (31.50) -50.00 [1]   (NA)
Fatigue: Change at C10 D1 Number Analyzed 7 participants 1 participants
25.40  (24.61) 55.56 [1]   (NA)
Nausea and Vomiting: Change at C10 D1 Number Analyzed 7 participants 1 participants
0.00  (25.46) 16.67 [1]   (NA)
Pain: Change at C10 D1 Number Analyzed 7 participants 1 participants
11.90  (35.63) 16.67 [1]   (NA)
Dyspnea: Change at C10 D1 Number Analyzed 6 participants 1 participants
22.22  (27.22) 33.33 [1]   (NA)
Insomnia: Change at C10 D1 Number Analyzed 7 participants 1 participants
4.76  (23.00) 0.00 [1]   (NA)
Appetite loss: Change at C10 D1 Number Analyzed 7 participants 1 participants
23.81  (46.00) 33.33 [1]   (NA)
Constipation: Change at C10 D1 Number Analyzed 7 participants 1 participants
-19.05  (37.80) 0.00 [1]   (NA)
Diarrhea: Change at C10 D1 Number Analyzed 7 participants 1 participants
9.52  (31.71) -66.67 [1]   (NA)
Financial Difficulties: Change at C10 D1 Number Analyzed 7 participants 1 participants
-4.76  (23.00) 0.00 [1]   (NA)
Global QoL: Change at C11 D1 Number Analyzed 3 participants 1 participants
-38.89  (53.58) -33.33 [1]   (NA)
Physical Functioning: Change at C11 D1 Number Analyzed 3 participants 1 participants
-24.44  (36.72) -40.00 [1]   (NA)
Role Functioning: Change at C11 D1 Number Analyzed 3 participants 1 participants
-38.89  (53.58) -66.67 [1]   (NA)
Emotional Functioning: Change at C11 D1 Number Analyzed 3 participants 1 participants
-25.00  (52.04) -8.33 [1]   (NA)
Cognitive Functioning: Change at C11 D1 Number Analyzed 3 participants 1 participants
-27.78  (63.10) -33.33 [1]   (NA)
Social Functioning: Change at C11 D1 Number Analyzed 3 participants 1 participants
-38.89  (53.58) -66.67 [1]   (NA)
Fatigue: Change at C11 D1 Number Analyzed 3 participants 1 participants
37.04  (46.26) 22.22 [1]   (NA)
Nausea and Vomiting: Change at C11 D1 Number Analyzed 3 participants 1 participants
27.78  (63.10) 16.67 [1]   (NA)
Pain: Change at C11 D1 Number Analyzed 3 participants 1 participants
22.22  (69.39) -16.67 [1]   (NA)
Dyspnea: Change at C11 D1 Number Analyzed 3 participants 1 participants
22.22  (69.39) 33.33 [1]   (NA)
Insomnia: Change at C11 D1 Number Analyzed 3 participants 1 participants
22.22  (69.39) 0.00 [1]   (NA)
Appetite loss: Change at C11 D1 Number Analyzed 3 participants 1 participants
44.44  (50.92) 0.00 [1]   (NA)
Constipation: Change at C11 D1 Number Analyzed 3 participants 1 participants
0.00  (33.33) 0.00 [1]   (NA)
Diarrhea: Change at C11 D1 Number Analyzed 3 participants 1 participants
11.11  (19.25) -66.67 [1]   (NA)
Financial Difficulties: Change at C11 D1 Number Analyzed 3 participants 1 participants
-11.11  (19.25) 0.00 [1]   (NA)
Global QoL: Change at C12 D1 Number Analyzed 3 participants 0 participants
-11.11  (17.35)
Physical Functioning: Change at C12 D1 Number Analyzed 3 participants 0 participants
-6.67  (6.67)
Role Functioning: Change at C12 D1 Number Analyzed 3 participants 0 participants
-11.11  (19.25)
Emotional Functioning: Change at C12 D1 Number Analyzed 3 participants 0 participants
-2.78  (20.97)
Cognitive Functioning: Change at C12 D1 Number Analyzed 3 participants 0 participants
0.00  (16.67)
Social Functioning: Change at C12 D1 Number Analyzed 3 participants 0 participants
-5.56  (9.62)
Fatigue: Change at C12 D1 Number Analyzed 3 participants 0 participants
7.41  (12.83)
Nausea and Vomiting: Change at C12 D1 Number Analyzed 3 participants 0 participants
16.67  (60.09)
Pain: Change at C12 D1 Number Analyzed 3 participants 0 participants
-5.56  (9.62)
Dyspnea: Change at C12 D1 Number Analyzed 2 participants 0 participants
0.00  (0.00)
Insomnia: Change at C12 D1 Number Analyzed 3 participants 0 participants
-11.11  (19.25)
Appetite loss: Change at C12 D1 Number Analyzed 3 participants 0 participants
22.22  (19.25)
Constipation: Change at C12 D1 Number Analyzed 3 participants 0 participants
-22.22  (38.49)
Diarrhea: Change at C12 D1 Number Analyzed 3 participants 0 participants
22.22  (19.25)
Financial Difficulties: Change at C12 D1 Number Analyzed 3 participants 0 participants
-11.11  (19.25)
Global QoL: Change at C13 D1 Number Analyzed 2 participants 0 participants
-50.00  (35.36)
Physical Functioning: Change at C13 D1 Number Analyzed 2 participants 0 participants
-23.33  (33.00)
Role Functioning: Change at C13 D1 Number Analyzed 2 participants 0 participants
-41.67  (35.36)
Emotional Functioning: Change at C13 D1 Number Analyzed 2 participants 0 participants
-8.33  (11.79)
Cognitive Functioning: Change at C13 D1 Number Analyzed 2 participants 0 participants
0.00  (0.00)
Social Functioning: Change at C13 D1 Number Analyzed 2 participants 0 participants
-8.33  (35.36)
Fatigue: Change at C13 D1 Number Analyzed 2 participants 0 participants
33.33  (47.14)
Nausea and Vomiting: Change at C13 D1 Number Analyzed 2 participants 0 participants
-8.33  (35.36)
Pain: Change at C13 D1 Number Analyzed 2 participants 0 participants
41.67  (58.93)
Dyspnea: Change at C13 D1 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
Insomnia: Change at C13 D1 Number Analyzed 2 participants 0 participants
0.00  (0.00)
Appetite loss: Change at C13 D1 Number Analyzed 2 participants 0 participants
33.33  (47.14)
Constipation: Change at C13 D1 Number Analyzed 2 participants 0 participants
-16.67  (23.57)
Diarrhea: Change at C13 D1 Number Analyzed 2 participants 0 participants
16.67  (23.57)
Financial Difficulties: Change at C13 D1 Number Analyzed 2 participants 0 participants
-16.67  (23.57)
Global QoL: Change at C14 D1 Number Analyzed 1 participants 0 participants
-16.67 [1]   (NA)
Physical Functioning: Change at C14 D1 Number Analyzed 1 participants 0 participants
-6.67 [1]   (NA)
Role Functioning: Change at C14 D1 Number Analyzed 1 participants 0 participants
-33.33 [1]   (NA)
Emotional Functioning: Change at C14 D1 Number Analyzed 1 participants 0 participants
-8.33 [1]   (NA)
Cognitive Functioning: Change at C14 D1 Number Analyzed 1 participants 0 participants
16.67 [1]   (NA)
Social Functioning: Change at C14 D1 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
Fatigue: Change at C14 D1 Number Analyzed 1 participants 0 participants
22.22 [1]   (NA)
Nausea and Vomiting: Change at C14 D1 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
Pain: Change at C14 D1 Number Analyzed 1 participants 0 participants
16.67 [1]   (NA)
Dyspnea: Change at C14 D1 Number Analyzed 1 participants 0 participants
33.33 [1]   (NA)
Insomnia: Change at C14 D1 Number Analyzed 1 participants 0 participants
-33.33 [1]   (NA)
Appetite loss: Change at C14 D1 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
Constipation: Change at C14 D1 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
Diarrhea: Change at C14 D1 Number Analyzed 1 participants 0 participants
33.33 [1]   (NA)
Financial Difficulties: Change at C14 D1 Number Analyzed 1 participants 0 participants
-33.33 [1]   (NA)
Global QoL: Change at EoS Number Analyzed 2 participants 1 participants
-54.17  (29.46) 0.00 [1]   (NA)
Physical Functioning: Change at EoS Number Analyzed 2 participants 1 participants
-70.00  (4.71) 0.00 [1]   (NA)
Role Functioning: Change at EoS Number Analyzed 2 participants 1 participants
-33.33  (23.57) 0.00 [1]   (NA)
Emotional Functioning: Change at EoS Number Analyzed 2 participants 1 participants
-66.67  (35.36) -25.00 [1]   (NA)
Cognitive Functioning: Change at EoS Number Analyzed 2 participants 1 participants
-66.67  (0.00) 0.00 [1]   (NA)
Social Functioning: Change at EoS Number Analyzed 2 participants 1 participants
-83.33  (23.57) 0.00 [1]   (NA)
Fatigue: Change at EoS Number Analyzed 2 participants 1 participants
55.56  (15.71) -11.11 [1]   (NA)
Nausea and Vomiting: Change at EoS Number Analyzed 2 participants 1 participants
33.33  (23.57) 0.00 [1]   (NA)
Pain: Change at EoS Number Analyzed 2 participants 1 participants
41.67  (82.50) 16.67 [1]   (NA)
Dyspnea: Change at EoS Number Analyzed 2 participants 1 participants
83.33  (23.57) 0.00 [1]   (NA)
Insomnia: Change at EoS Number Analyzed 2 participants 1 participants
66.67  (47.14) 33.33 [1]   (NA)
Appetite loss: Change at EoS Number Analyzed 2 participants 1 participants
50.00  (70.71) 0.00 [1]   (NA)
Constipation: Change at EoS Number Analyzed 2 participants 1 participants
-16.67  (117.85) 0.00 [1]   (NA)
Diarrhea: Change at EoS Number Analyzed 2 participants 1 participants
33.33  (47.14) 0.00 [1]   (NA)
Financial Difficulties: Change at EoS Number Analyzed 2 participants 1 participants
-16.67  (23.57) 0.00 [1]   (NA)
[1]
Standard deviation was not calculated because only one participant was evaluable.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in global QoL at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.44
Confidence Interval (2-Sided) 95%
-19.06 to 2.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in physical functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.02
Confidence Interval (2-Sided) 95%
-15.4 to 3.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in role functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.32
Confidence Interval (2-Sided) 95%
-23.77 to 5.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in emotional functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.73
Confidence Interval (2-Sided) 95%
-15.25 to 5.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cognitive functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.11
Confidence Interval (2-Sided) 95%
-15.83 to 5.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in social functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.33
Confidence Interval (2-Sided) 95%
-18.72 to 12.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fatigue at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.41
Confidence Interval (2-Sided) 95%
-1.62 to 22.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in nausea and vomiting at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.30
Confidence Interval (2-Sided) 95%
-16.55 to 7.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.37
Confidence Interval (2-Sided) 95%
-7.57 to 22.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in dyspnea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.51
Confidence Interval (2-Sided) 95%
-1.28 to 26.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in insomnia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.90
Confidence Interval (2-Sided) 95%
-5.70 to 25.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in appetite loss at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.63
Confidence Interval (2-Sided) 95%
-4.81 to 32.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in constipation at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.67
Confidence Interval (2-Sided) 95%
-11.62 to 20.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in diarrhea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.28
Confidence Interval (2-Sided) 95%
-15.1 to 12.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in financial difficulties at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.43
Confidence Interval (2-Sided) 95%
-4.67 to 15.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in global QoL at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.83
Confidence Interval (2-Sided) 95%
-32.34 to 0.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in physical functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.58
Confidence Interval (2-Sided) 95%
-24.12 to 0.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in role functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.65
Confidence Interval (2-Sided) 95%
-35.47 to -1.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in emotional functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.92
Confidence Interval (2-Sided) 95%
-29.16 to 1.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cognitive functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.10
Confidence Interval (2-Sided) 95%
-20.97 to 6.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in social functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.62
Confidence Interval (2-Sided) 95%
-28.28 to 9.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fatigue at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.14
Confidence Interval (2-Sided) 95%
-1.27 to 33.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in nausea and vomiting at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.80
Confidence Interval (2-Sided) 95%
-18.78 to 15.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.59
Confidence Interval (2-Sided) 95%
-3.22 to 36.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in dyspnea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.39
Confidence Interval (2-Sided) 95%
-5.68 to 26.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in insomnia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
-20.19 to 23.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in appetite loss at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.24
Confidence Interval (2-Sided) 95%
-7.62 to 40.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in constipation at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.76
Confidence Interval (2-Sided) 95%
-17.49 to 23.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in diarrhea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.87
Confidence Interval (2-Sided) 95%
-16.29 to 22.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in financial difficulties at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.56
Confidence Interval (2-Sided) 95%
-9.81 to 20.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in global QoL at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.97
Confidence Interval (2-Sided) 95%
-19.52 to 7.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in physical functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.64
Confidence Interval (2-Sided) 95%
-19.75 to 8.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in role functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.53
Confidence Interval (2-Sided) 95%
-39.11 to 4.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in emotional functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.25
Confidence Interval (2-Sided) 95%
-26.5 to 2.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cognitive functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.99
Confidence Interval (2-Sided) 95%
-23.13 to 9.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in social functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.09
Confidence Interval (2-Sided) 95%
-30.48 to 16.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fatigue at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.88
Confidence Interval (2-Sided) 95%
-5.86 to 27.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in nausea and vomiting at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.10
Confidence Interval (2-Sided) 95%
-24.11 to 1.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.13
Confidence Interval (2-Sided) 95%
-24.26 to 14.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in dyspnea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.13
Confidence Interval (2-Sided) 95%
-14.18 to 24.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in insomnia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.33
Confidence Interval (2-Sided) 95%
-26.25 to 13.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in appetite loss at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.03
Confidence Interval (2-Sided) 95%
-15.26 to 33.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in constipation at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.56
Confidence Interval (2-Sided) 95%
-25.71 to 26.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in diarrhea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.97
Confidence Interval (2-Sided) 95%
-24.07 to 28.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in financial difficulties at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.48
Confidence Interval (2-Sided) 95%
-5.89 to 24.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in global QoL at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.01
Confidence Interval (2-Sided) 95%
-43.19 to 3.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in physical functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.57
Confidence Interval (2-Sided) 95%
-27.24 to 10.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in role functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.07
Confidence Interval (2-Sided) 95%
-41.10 to 8.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in emotional functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.11
Confidence Interval (2-Sided) 95%
-42.72 to -5.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cognitive functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.52
Confidence Interval (2-Sided) 95%
-29.66 to 10.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in social functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.24
Confidence Interval (2-Sided) 95%
-47.93 to 7.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fatigue at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.00
Confidence Interval (2-Sided) 95%
3.23 to 46.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in nausea and vomiting at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.25
Confidence Interval (2-Sided) 95%
-13.49 to 25.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 19.64
Confidence Interval (2-Sided) 95%
-7.12 to 46.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in dyspnea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.02
Confidence Interval (2-Sided) 95%
0.38 to 43.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in insomnia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.12
Confidence Interval (2-Sided) 95%
-18.49 to 38.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in appetite loss at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.83
Confidence Interval (2-Sided) 95%
-13.98 to 55.65
Estimation Comments [Not Specified]
Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in constipation at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.90
Confidence Interval (2-Sided) 95%
-19.02 to 42.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in diarrhea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.90
Confidence Interval (2-Sided) 95%
-16.13 to 39.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in financial difficulties at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-23.38 to 23.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in global QoL at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.66
Confidence Interval (2-Sided) 95%
-34.53 to 17.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in physical functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.98
Confidence Interval (2-Sided) 95%
-52.01 to 26.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in role functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -26.32
Confidence Interval (2-Sided) 95%
-71.87 to 19.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in emotional functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.14
Confidence Interval (2-Sided) 95%
-26.59 to 14.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cognitive functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.99
Confidence Interval (2-Sided) 95%
-35.46 to 11.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 66
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in social functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.04
Confidence Interval (2-Sided) 95%
-20.97 to 49.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 67
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fatigue at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 23.39
Confidence Interval (2-Sided) 95%
-15.83 to 62.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 68
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in nausea and vomiting at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.95
Confidence Interval (2-Sided) 95%
-30.84 to 38.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 69
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 24.56
Confidence Interval (2-Sided) 95%
-13.08 to 62.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 70
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in dyspnea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.85
Confidence Interval (2-Sided) 95%
-38.65 to 34.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 71
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in insomnia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.65
Confidence Interval (2-Sided) 95%
-37.43 to 56.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 72
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in appetite loss at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.16
Confidence Interval (2-Sided) 95%
-71.22 to 97.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 73
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in constipation at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.81
Confidence Interval (2-Sided) 95%
-22.61 to 68.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 74
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in diarrhea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.75
Confidence Interval (2-Sided) 95%
-39.10 to 35.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 75
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in financial difficulties at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 23.98
Confidence Interval (2-Sided) 95%
1.09 to 46.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 76
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in global QoL at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.04
Confidence Interval (2-Sided) 95%
-39.03 to 63.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 77
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in physical functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 18.89
Confidence Interval (2-Sided) 95%
-20.74 to 58.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 78
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in role functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -48.33
Confidence Interval (2-Sided) 95%
-111.94 to 15.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 79
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in emotional functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.93
Confidence Interval (2-Sided) 95%
-22.59 to 20.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 80
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cognitive functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.22
Confidence Interval (2-Sided) 95%
-24.98 to 39.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 81
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in social functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.00
Confidence Interval (2-Sided) 95%
-57.71 to 77.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 82
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fatigue at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.04
Confidence Interval (2-Sided) 95%
-58.87 to 24.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 83
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in nausea and vomiting at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.00
Confidence Interval (2-Sided) 95%
-43.10 to 13.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 84
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.78
Confidence Interval (2-Sided) 95%
-41.75 to 57.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 85
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in dyspnea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.67
Confidence Interval (2-Sided) 95%
-53.79 to 20.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 86
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in insomnia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.11
Confidence Interval (2-Sided) 95%
-73.14 to 30.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 87
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in appetite loss at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -32.22
Confidence Interval (2-Sided) 95%
-115.58 to 51.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 88
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in constipation at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 53.33
Confidence Interval (2-Sided) 95%
-18.60 to 125.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 89
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in diarrhea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.33
Confidence Interval (2-Sided) 95%
-34.92 to 41.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 90
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in financial difficulties at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.67
Confidence Interval (2-Sided) 95%
-34.3 to 20.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 91
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in global QoL at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.83
Confidence Interval (2-Sided) 95%
-58.94 to 100.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 92
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in physical functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.33
Confidence Interval (2-Sided) 95%
-44.54 to 63.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 93
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in role functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.00
Confidence Interval (2-Sided) 95%
-35.30 to 75.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 94
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in emotional functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.50
Confidence Interval (2-Sided) 95%
-51.66 to 36.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 95
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cognitive functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.67
Confidence Interval (2-Sided) 95%
-36.06 to 69.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 96
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in social functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.00
Confidence Interval (2-Sided) 95%
-76.36 to 86.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 97
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fatigue at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.78
Confidence Interval (2-Sided) 95%
-77.63 to 42.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 98
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in nausea and vomiting at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.67
Confidence Interval (2-Sided) 95%
-62.33 to 28.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 99
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.33
Confidence Interval (2-Sided) 95%
-79.59 to 96.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 100
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in dyspnea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.52
Confidence Interval (2-Sided) 95%
-89.98 to 52.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 101
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in insomnia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -20.00
Confidence Interval (2-Sided) 95%
-133.08 to 93.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 102
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in appetite loss at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -36.67
Confidence Interval (2-Sided) 95%
-151.27 to 77.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 103
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in constipation at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.33
Confidence Interval (2-Sided) 95%
-72.58 to 65.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 104
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in diarrhea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 73.33
Confidence Interval (2-Sided) 95%
-16.45 to 163.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 105
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in financial difficulties at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.33
Confidence Interval (2-Sided) 95%
-48.23 to 41.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 106
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in global QoL at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.62
Confidence Interval (2-Sided) 95%
-74.75 to 106.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 107
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in physical functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 33.33
Confidence Interval (2-Sided) 95%
-17.22 to 83.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 108
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in role functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.17
Confidence Interval (2-Sided) 95%
-58.04 to 66.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 109
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in emotional functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.21
Confidence Interval (2-Sided) 95%
-28.19 to 38.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 110
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cognitive functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 31.25
Confidence Interval (2-Sided) 95%
-40.94 to 103.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 111
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in social functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 27.08
Confidence Interval (2-Sided) 95%
-91.02 to 145.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 112
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fatigue at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.28
Confidence Interval (2-Sided) 95%
-99.46 to 68.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 113
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in nausea and vomiting at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -25.00
Confidence Interval (2-Sided) 95%
-69.69 to 19.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 114
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-77.40 to 77.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 115
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in dyspnea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.29
Confidence Interval (2-Sided) 95%
-82.89 to 54.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 116
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in insomnia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.17
Confidence Interval (2-Sided) 95%
-87.02 to 78.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 117
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in appetite loss at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -25.00
Confidence Interval (2-Sided) 95%
-184.57 to 134.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 118
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in constipation at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.33
Confidence Interval (2-Sided) 95%
-105.73 to 89.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 119
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in diarrhea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 79.17
Confidence Interval (2-Sided) 95%
-29.72 to 188.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 120
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in financial difficulties at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.17
Confidence Interval (2-Sided) 95%
-57.74 to 49.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 121
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in global QoL at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.67
Confidence Interval (2-Sided) 95%
-39.62 to 72.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 122
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in physical functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 27.62
Confidence Interval (2-Sided) 95%
-6.42 to 61.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 123
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in role functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 26.19
Confidence Interval (2-Sided) 95%
-29.28 to 81.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 124
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in emotional functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.57
Confidence Interval (2-Sided) 95%
-63.74 to 56.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 125
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cognitive functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 23.81
Confidence Interval (2-Sided) 95%
-31.66 to 79.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 126
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in social functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 28.57
Confidence Interval (2-Sided) 95%
-53.82 to 110.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 127
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fatigue at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -30.16
Confidence Interval (2-Sided) 95%
-94.53 to 34.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 128
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in nausea and vomiting at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.67
Confidence Interval (2-Sided) 95%
-83.26 to 49.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 129
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.76
Confidence Interval (2-Sided) 95%
-97.98 to 88.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 130
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in dyspnea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.11
Confidence Interval (2-Sided) 95%
-86.68 to 64.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 131
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in insomnia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.76
Confidence Interval (2-Sided) 95%
-55.41 to 64.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 132
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in appetite loss at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.52
Confidence Interval (2-Sided) 95%
-129.86 to 110.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 133
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in constipation at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.05
Confidence Interval (2-Sided) 95%
-117.92 to 79.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 134
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in diarrhea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 76.19
Confidence Interval (2-Sided) 95%
-6.75 to 159.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 135
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in financial difficulties at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.76
Confidence Interval (2-Sided) 95%
-64.93 to 55.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 136
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in global QoL at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.56
Confidence Interval (2-Sided) 95%
-271.74 to 260.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 137
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in physical functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.56
Confidence Interval (2-Sided) 95%
-166.87 to 197.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 138
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in role functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 27.78
Confidence Interval (2-Sided) 95%
-238.4 to 293.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 139
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in emotional functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.67
Confidence Interval (2-Sided) 95%
-275.22 to 241.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 140
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cognitive functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.56
Confidence Interval (2-Sided) 95%
-307.94 to 319.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 141
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in social functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 27.78
Confidence Interval (2-Sided) 95%
-238.40 to 293.96
Estimation Comments [Not Specified]
Hide Statistical Analysis 142
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fatigue at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.81
Confidence Interval (2-Sided) 95%
-215.01 to 244.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 143
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in nausea and vomiting at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.11
Confidence Interval (2-Sided) 95%
-302.38 to 324.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 144
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 38.89
Confidence Interval (2-Sided) 95%
-305.85 to 383.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 145
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in dyspnea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.11
Confidence Interval (2-Sided) 95%
-355.85 to 333.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 146
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in insomnia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.22
Confidence Interval (2-Sided) 95%
-322.52 to 366.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 147
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in appetite loss at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 44.44
Confidence Interval (2-Sided) 95%
-208.53 to 297.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 148
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in constipation at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-165.61 to 165.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 149
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in diarrhea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 77.78
Confidence Interval (2-Sided) 95%
-17.84 to 173.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 150
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in financial difficulties at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.11
Confidence Interval (2-Sided) 95%
-106.73 to 84.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 151
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in global QoL at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -54.17
Confidence Interval (2-Sided) 95%
-512.66 to 404.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 152
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in physical functioning at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -70.00
Confidence Interval (2-Sided) 95%
-143.36 to 3.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 153
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in role functioning at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -33.33
Confidence Interval (2-Sided) 95%
-400.13 to 333.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 154
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in emotional functioning at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -41.67
Confidence Interval (2-Sided) 95%
-591.86 to 508.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 155
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cognitive functioning at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -66.67
Confidence Interval (2-Sided) 95%
-66.67 to -66.67
Estimation Comments [Not Specified]
Hide Statistical Analysis 156
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in social functioning at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -83.33
Confidence Interval (2-Sided) 95%
-450.13 to 283.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 157
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fatigue at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 66.67
Confidence Interval (2-Sided) 95%
-177.86 to 311.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 158
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in nausea and vomiting at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 33.33
Confidence Interval (2-Sided) 95%
-333.46 to 400.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 159
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pain at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.00
Confidence Interval (2-Sided) 95%
-1258.79 to 1308.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 160
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in dyspnea at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 83.33
Confidence Interval (2-Sided) 95%
-283.46 to 450.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 161
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in insomnia at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 33.33
Confidence Interval (2-Sided) 95%
-700.26 to 766.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 162
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in appetite loss at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 50.00
Confidence Interval (2-Sided) 95%
-1050.39 to 1150.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 163
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in constipation at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.67
Confidence Interval (2-Sided) 95%
-1850.65 to 1817.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 164
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in diarrhea at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 33.33
Confidence Interval (2-Sided) 95%
-700.26 to 766.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 165
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in financial difficulties at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -16.67
Confidence Interval (2-Sided) 95%
-383.46 to 350.13
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study
Hide 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 on functioning scales=better functioning; higher scores on the symptom scales=more symptoms.
Time Frame Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Axitinib + Gemcitabine Gemcitabine
Hide Arm/Group Description:
Axitinib (AG-013736) 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 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
Overall Number of Participants Analyzed 59 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pancreatic Pain: Baseline Number Analyzed 59 participants 27 participants
37.52  (27.88) 38.89  (21.18)
Eating Related Items: Baseline Number Analyzed 59 participants 27 participants
40.40  (35.18) 33.95  (27.92)
Altered Bowel Habits: Baseline Number Analyzed 59 participants 27 participants
22.32  (26.19) 25.31  (28.26)
Jaundice: Baseline Number Analyzed 59 participants 26 participants
9.89  (18.34) 15.38  (23.06)
Body Image: Baseline Number Analyzed 59 participants 27 participants
31.64  (29.80) 26.54  (25.84)
Health Care Satisfaction: Baseline Number Analyzed 59 participants 27 participants
79.38  (27.57) 69.75  (25.33)
Sexual Functioning: Baseline Number Analyzed 56 participants 23 participants
44.35  (34.42) 57.97  (37.56)
Ascites: Baseline Number Analyzed 59 participants 27 participants
37.29  (31.00) 25.93  (25.04)
Indigestion: Baseline Number Analyzed 59 participants 27 participants
24.86  (28.09) 30.86  (34.50)
Flatulence: Baseline Number Analyzed 59 participants 27 participants
35.59  (32.67) 39.51  (29.29)
Cachexia: Baseline Number Analyzed 59 participants 27 participants
33.62  (25.43) 31.48  (23.72)
Side Effects: Baseline Number Analyzed 59 participants 26 participants
27.78  (24.80) 27.35  (21.77)
Fear of Future Health: Baseline Number Analyzed 58 participants 27 participants
63.22  (31.03) 59.26  (33.76)
Ability to Plan Future: Baseline Number Analyzed 59 participants 27 participants
39.55  (35.27) 41.98  (36.51)
Pancreatic Pain: Change at C2 D1 Number Analyzed 44 participants 22 participants
-11.05  (25.39) -13.64  (22.05)
Eating Related Items: Change at C2 D1 Number Analyzed 44 participants 22 participants
-0.38  (34.19) -3.79  (27.67)
Altered Bowel Habits: Change at C2 D1 Number Analyzed 44 participants 22 participants
8.33  (28.19) -11.36  (22.05)
Jaundice: Change at C2 D1 Number Analyzed 44 participants 21 participants
0.00  (20.65) -12.70  (25.22)
Body Image: Change at C2 D1 Number Analyzed 44 participants 21 participants
7.95  (26.53) -7.14  (25.04)
Health Care Satisfaction: Change at C2 D1 Number Analyzed 43 participants 21 participants
0.39  (34.60) -3.97  (37.60)
Sexual Functioning: Change at C2 D1 Number Analyzed 39 participants 17 participants
-2.56  (22.14) 18.63  (38.59)
Ascites: Change at C2 D1 Number Analyzed 43 participants 22 participants
-10.85  (36.89) -3.03  (22.79)
Indigestion: Change at C2 D1 Number Analyzed 43 participants 22 participants
-4.65  (24.75) -10.61  (37.64)
Flatulence: Change at C2 D1 Number Analyzed 44 participants 22 participants
5.30  (34.43) -9.09  (21.04)
Cachexia: Change at C2 D1 Number Analyzed 44 participants 22 participants
9.47  (19.15) -3.03  (17.55)
Side Effects: Change at C2 D1 Number Analyzed 44 participants 21 participants
7.70  (16.39) -3.17  (20.90)
Fear of Future Health: Change at C2 D1 Number Analyzed 43 participants 21 participants
-2.33  (23.45) 0.00  (31.62)
Ability to Plan Future: Change at C2 D1 Number Analyzed 44 participants 20 participants
4.55  (35.65) -1.67  (27.52)
Pancreatic Pain: Change at C3 D1 Number Analyzed 38 participants 16 participants
-8.92  (24.62) -23.78  (20.61)
Eating Related Items: Change at C3 D1 Number Analyzed 38 participants 16 participants
3.07  (37.34) -10.42  (28.46)
Altered Bowel Habits: Change at C3 D1 Number Analyzed 38 participants 16 participants
10.53  (31.34) -8.33  (31.03)
Jaundice: Change at C3 D1 Number Analyzed 38 participants 16 participants
2.19  (13.52) -9.38  (26.51)
Body Image: Change at C3 D1 Number Analyzed 37 participants 16 participants
13.51  (30.89) -5.21  (29.01)
Health Care Satisfaction: Change at C3 D1 Number Analyzed 37 participants 16 participants
-5.41  (40.07) 5.21  (24.88)
Sexual Functioning: Change at C3 D1 Number Analyzed 32 participants 15 participants
-3.13  (21.77) -4.44  (31.79)
Ascites: Change at C3 D1 Number Analyzed 38 participants 16 participants
-2.63  (28.35) -4.17  (23.96)
Indigestion: Change at C3 D1 Number Analyzed 37 participants 15 participants
-4.50  (34.39) -15.56  (37.52)
Flatulence: Change at C3 D1 Number Analyzed 38 participants 16 participants
9.65  (37.09) 6.25  (27.81)
Cachexia: Change at C3 D1 Number Analyzed 38 participants 16 participants
14.47  (24.56) 5.21  (17.97)
Side Effects: Change at C3 D1 Number Analyzed 38 participants 16 participants
11.55  (27.41) -7.64  (26.28)
Fear of Future Health: Change at C3 D1 Number Analyzed 35 participants 15 participants
-2.86  (34.65) -2.22  (42.66)
Ability to Plan Future: Change at C3 D1 Number Analyzed 37 participants 16 participants
9.01  (43.50) -12.50  (34.16)
Pancreatic Pain: Change at C4 D1 Number Analyzed 29 participants 13 participants
-18.30  (26.90) -14.10  (22.92)
Eating Related Items: Change at C4 D1 Number Analyzed 29 participants 13 participants
-7.47  (26.57) 5.13  (36.88)
Altered Bowel Habits: Change at C4 D1 Number Analyzed 29 participants 13 participants
16.09  (35.21) 3.85  (28.99)
Jaundice: Change at C4 D1 Number Analyzed 29 participants 12 participants
1.72  (19.59) -11.11  (16.41)
Body Image: Change at C4 D1 Number Analyzed 26 participants 13 participants
12.82  (31.02) 8.97  (26.01)
Health Care Satisfaction: Change at C4 D1 Number Analyzed 26 participants 13 participants
-1.92  (49.51) -8.97  (29.36)
Sexual Functioning: Change at C4 D1 Number Analyzed 22 participants 12 participants
-5.30  (27.88) -2.78  (40.72)
Ascites: Change at C4 D1 Number Analyzed 29 participants 13 participants
-6.90  (25.79) 2.56  (28.74)
Indigestion: Change at C4 D1 Number Analyzed 28 participants 13 participants
-9.52  (33.77) -2.56  (37.17)
Flatulence: Change at C4 D1 Number Analyzed 29 participants 13 participants
1.15  (39.32) -2.56  (25.32)
Cachexia: Change at C4 D1 Number Analyzed 29 participants 13 participants
9.20  (29.07) -3.85  (24.68)
Side Effects: Change at C4 D1 Number Analyzed 29 participants 12 participants
11.88  (28.59) -3.24  (19.88)
Fear of Future Health: Change at C4 D1 Number Analyzed 24 participants 13 participants
-2.78  (41.61) 5.13  (38.12)
Ability to Plan Future: Change at C4 D1 Number Analyzed 26 participants 13 participants
10.26  (53.97) -5.13  (46.84)
Pancreatic Pain: Change at C5 D1 Number Analyzed 26 participants 9 participants
-7.26  (27.99) -18.52  (24.22)
Eating Related Items: Change at C5 D1 Number Analyzed 26 participants 9 participants
0.00  (45.22) -7.41  (26.50)
Altered Bowel Habits: Change at C5 D1 Number Analyzed 26 participants 9 participants
13.46  (30.92) -14.81  (29.40)
Jaundice: Change at C5 D1 Number Analyzed 26 participants 9 participants
3.85  (19.04) -20.37  (36.11)
Body Image: Change at C5 D1 Number Analyzed 25 participants 9 participants
14.00  (28.74) -11.11  (39.97)
Health Care Satisfaction: Change at C5 D1 Number Analyzed 25 participants 9 participants
-2.67  (51.52) 7.41  (34.47)
Sexual Functioning: Change at C5 D1 Number Analyzed 19 participants 9 participants
-1.75  (20.71) 1.85  (24.22)
Ascites: Change at C5 D1 Number Analyzed 26 participants 9 participants
-5.13  (24.39) -11.11  (40.82)
Indigestion: Change at C5 D1 Number Analyzed 26 participants 9 participants
-3.85  (28.79) -25.93  (49.38)
Flatulence: Change at C5 D1 Number Analyzed 25 participants 9 participants
-1.33  (28.02) -11.11  (40.82)
Cachexia: Change at C5 D1 Number Analyzed 26 participants 9 participants
10.26  (36.84) -5.56  (18.63)
Side Effects: Change at C5 D1 Number Analyzed 26 participants 9 participants
10.04  (28.55) -11.73  (17.22)
Fear of Future Health: Change at C5 D1 Number Analyzed 24 participants 9 participants
0.00  (35.44) 14.81  (29.40)
Ability to Plan Future: Change at C5 D1 Number Analyzed 25 participants 9 participants
20.00  (41.94) -11.11  (16.67)
Pancreatic Pain: Change at C6 D1 Number Analyzed 17 participants 4 participants
-3.76  (24.06) -12.50  (30.81)
Eating Related Items: Change at C6 D1 Number Analyzed 17 participants 4 participants
-4.90  (50.95) 8.33  (21.52)
Altered Bowel Habits: Change at C6 D1 Number Analyzed 17 participants 4 participants
13.73  (25.16) -8.33  (28.87)
Jaundice: Change at C6 D1 Number Analyzed 17 participants 4 participants
1.96  (11.61) -16.67  (45.13)
Body Image: Change at C6 D1 Number Analyzed 16 participants 4 participants
23.96  (31.60) 0.00  (0.00)
Health Care Satisfaction: Change at C6 D1 Number Analyzed 16 participants 4 participants
-11.46  (42.04) -25.00  (21.52)
Sexual Functioning: Change at C6 D1 Number Analyzed 13 participants 4 participants
-7.69  (30.14) -20.83  (49.77)
Ascites: Change at C6 D1 Number Analyzed 17 participants 4 participants
-1.96  (24.92) -8.33  (31.91)
Indigestion: Change at C6 D1 Number Analyzed 17 participants 4 participants
3.92  (35.12) -16.67  (19.25)
Flatulence: Change at C6 D1 Number Analyzed 17 participants 4 participants
1.96  (27.56) -8.33  (16.67)
Cachexia: Change at C6 D1 Number Analyzed 17 participants 4 participants
4.90  (31.05) -20.83  (15.96)
Side Effects: Change at C6 D1 Number Analyzed 17 participants 4 participants
16.34  (30.40) -22.22  (15.71)
Fear of Future Health: Change at C6 D1 Number Analyzed 15 participants 4 participants
-4.44  (45.19) 0.00  (0.00)
Ability to Plan Future: Change at C6 D1 Number Analyzed 16 participants 4 participants
12.50  (54.26) 16.67  (63.83)
Pancreatic Pain: Change at C7 D1 Number Analyzed 9 participants 2 participants
-3.70  (22.09) -16.67  (11.79)
Eating Related Items: Change at C7 D1 Number Analyzed 9 participants 2 participants
-14.81  (31.67) 8.33  (11.79)
Altered Bowel Habits: Change at C7 D1 Number Analyzed 9 participants 2 participants
5.56  (23.57) 25.00  (58.93)
Jaundice: Change at C7 D1 Number Analyzed 9 participants 2 participants
5.56  (11.79) -41.67  (58.93)
Body Image: Change at C7 D1 Number Analyzed 9 participants 2 participants
16.67  (41.67) -25.00  (58.93)
Health Care Satisfaction: Change at C7 D1 Number Analyzed 9 participants 2 participants
5.56  (26.35) -33.33  (0.00)
Sexual Functioning: Change at C7 D1 Number Analyzed 7 participants 2 participants
-9.52  (18.90) -41.67  (11.79)
Ascites: Change at C7 D1 Number Analyzed 9 participants 2 participants
0.00  (0.00) 0.00  (0.00)
Indigestion: Change at C7 D1 Number Analyzed 9 participants 2 participants
-7.41  (22.22) 0.00  (0.00)
Flatulence: Change at C7 D1 Number Analyzed 9 participants 2 participants
-3.70  (30.93) -16.67  (23.57)
Cachexia: Change at C7 D1 Number Analyzed 9 participants 2 participants
5.56  (25.00) -8.33  (35.36)
Side Effects: Change at C7 D1 Number Analyzed 9 participants 2 participants
8.64  (25.93) -22.22  (31.43)
Fear of Future Health: Change at C7 D1 Number Analyzed 8 participants 2 participants
4.17  (27.82) -16.67  (70.71)
Ability to Plan Future: Change at C7 D1 Number Analyzed 9 participants 2 participants
14.81  (55.56) 33.33  (47.14)
Pancreatic Pain: Change at C8 D1 Number Analyzed 9 participants 1 participants
-1.54  (25.99) -25.00 [1]   (NA)
Eating Related Items: Change at C8 D1 Number Analyzed 9 participants 1 participants
3.70  (48.43) 16.67 [1]   (NA)
Altered Bowel Habits: Change at C8 D1 Number Analyzed 9 participants 1 participants
14.81  (22.74) -33.33 [1]   (NA)
Jaundice: Change at C8 D1 Number Analyzed 9 participants 1 participants
9.26  (12.11) -83.33 [1]   (NA)
Body Image: Change at C8 D1 Number Analyzed 9 participants 1 participants
22.22  (37.27) 16.67 [1]   (NA)
Health Care Satisfaction: Change at C8 D1 Number Analyzed 9 participants 1 participants
3.70  (27.36) -33.33 [1]   (NA)
Sexual Functioning: Change at C8 D1 Number Analyzed 7 participants 1 participants
-7.14  (13.11) 0.00 [1]   (NA)
Ascites: Change at C8 D1 Number Analyzed 9 participants 1 participants
-3.70  (26.06) 0.00 [1]   (NA)
Indigestion: Change at C8 D1 Number Analyzed 9 participants 1 participants
-7.41  (40.06) 0.00 [1]   (NA)
Flatulence: Change at C8 D1 Number Analyzed 9 participants 1 participants
-11.11  (33.33) -33.33 [1]   (NA)
Cachexia: Change at C8 D1 Number Analyzed 9 participants 1 participants
11.11  (26.35) -16.67 [1]   (NA)
Side Effects: Change at C8 D1 Number Analyzed 9 participants 1 participants
11.11  (35.14) 0.00 [1]   (NA)
Fear of Future Health: Change at C8 D1 Number Analyzed 8 participants 1 participants
4.17  (45.21) 33.33 [1]   (NA)
Ability to Plan Future: Change at C8 D1 Number Analyzed 9 participants 1 participants
11.11  (64.55) 66.67 [1]   (NA)
Pancreatic Pain: Change at C9 D1 Number Analyzed 7 participants 1 participants
0.00  (30.43) -16.67 [1]   (NA)
Eating Related Items: Change at C9 D1 Number Analyzed 7 participants 1 participants
14.29  (39.00) 0.00 [1]   (NA)
Altered Bowel Habits: Change at C9 D1 Number Analyzed 7 participants 1 participants
23.81  (25.20) -50.00 [1]   (NA)
Jaundice: Change at C9 D1 Number Analyzed 7 participants 1 participants
9.52  (16.27) -66.67 [1]   (NA)
Body Image: Change at C9 D1 Number Analyzed 7 participants 1 participants
28.57  (35.63) 0.00 [1]   (NA)
Health Care Satisfaction: Change at C9 D1 Number Analyzed 7 participants 1 participants
2.38  (24.40) -33.33 [1]   (NA)
Sexual Functioning: Change at C9 D1 Number Analyzed 5 participants 1 participants
-13.33  (29.81) 0.00 [1]   (NA)
Ascites: Change at C9 D1 Number Analyzed 6 participants 1 participants
-11.11  (34.43) 33.33 [1]   (NA)
Indigestion: Change at C9 D1 Number Analyzed 7 participants 1 participants
4.76  (35.63) 0.00 [1]   (NA)
Flatulence: Change at C9 D1 Number Analyzed 7 participants 1 participants
14.29  (26.23) 0.00 [1]   (NA)
Cachexia: Change at C9 D1 Number Analyzed 7 participants 1 participants
23.81  (34.50) 0.00 [1]   (NA)
Side Effects: Change at C9 D1 Number Analyzed 7 participants 1 participants
31.75  (33.60) 0.00 [1]   (NA)
Fear of Future Health: Change at C9 D1 Number Analyzed 6 participants 1 participants
-16.67  (40.82) 33.33 [1]   (NA)
Ability to Plan Future: Change at C9 D1 Number Analyzed 7 participants 1 participants
19.05  (42.41) 33.33 [1]   (NA)
Pancreatic Pain: Change at C10 D1 Number Analyzed 6 participants 1 participants
8.33  (25.28) -16.67 [1]   (NA)
Eating Related Items: Change at C10 D1 Number Analyzed 6 participants 1 participants
25.00  (25.28) 0.00 [1]   (NA)
Altered Bowel Habits: Change at C10 D1 Number Analyzed 6 participants 1 participants
27.78  (22.77) -50.00 [1]   (NA)
Jaundice: Change at C10 D1 Number Analyzed 6 participants 1 participants
2.78  (16.39) -83.33 [1]   (NA)
Body Image: Change at C10 D1 Number Analyzed 6 participants 1 participants
25.00  (29.34) 0.00 [1]   (NA)
Health Care Satisfaction: Change at C10 D1 Number Analyzed 6 participants 1 participants
13.89  (30.58) -33.33 [1]   (NA)
Sexual Functioning: Change at C10 D1 Number Analyzed 5 participants 1 participants
-13.33  (29.81) -33.33 [1]   (NA)
Ascites: Change at C10 D1 Number Analyzed 6 participants 1 participants
0.00  (21.08) 33.33 [1]   (NA)
Indigestion: Change at C10 D1 Number Analyzed 6 participants 1 participants
27.78  (25.09) 0.00 [1]   (NA)
Flatulence: Change at C10 D1 Number Analyzed 6 participants 1 participants
16.67  (18.26) 0.00 [1]   (NA)
Cachexia: Change at C10 D1 Number Analyzed 6 participants 1 participants
25.00  (39.09) 16.67 [1]   (NA)
Side Effects: Change at C10 D1 Number Analyzed 6 participants 1 participants
37.04  (28.69) 11.11 [1]   (NA)
Fear of Future Health: Change at C10 D1 Number Analyzed 5 participants 1 participants
0.00  (0.00) 33.33 [1]   (NA)
Ability to Plan Future: Change at C10 D1 Number Analyzed 6 participants 1 participants
33.33  (42.16) 33.33 [1]   (NA)
Pancreatic Pain: Change at C11 D1 Number Analyzed 3 participants 1 participants
5.56  (47.39) -8.33 [1]   (NA)
Eating Related Items: Change at C11 D1 Number Analyzed 3 participants 1 participants
38.89  (53.58) 33.33 [1]   (NA)
Altered Bowel Habits: Change at C11 D1 Number Analyzed 3 participants 1 participants
50.00  (44.10) -16.67 [1]   (NA)
Jaundice: Change at C11 D1 Number Analyzed 3 participants 1 participants
16.67  (44.10) -83.33 [1]   (NA)
Body Image: Change at C11 D1 Number Analyzed 3 participants 1 participants
50.00  (44.10) 16.67 [1]   (NA)
Health Care Satisfaction: Change at C11 D1 Number Analyzed 3 participants 1 participants
27.78  (25.46) -16.67 [1]   (NA)
Sexual Functioning: Change at C11 D1 Number Analyzed 2 participants 1 participants
-33.33  (47.14) -33.33 [1]   (NA)
Ascites: Change at C11 D1 Number Analyzed 3 participants 1 participants
22.22  (38.49) 33.33 [1]   (NA)
Indigestion: Change at C11 D1 Number Analyzed 3 participants 1 participants
11.11  (19.25) 0.00 [1]   (NA)
Flatulence: Change at C11 D1 Number Analyzed 3 participants 1 participants
11.11  (19.25) 0.00 [1]   (NA)
Cachexia: Change at C11 D1 Number Analyzed 3 participants 1 participants
55.56  (25.46) 16.67 [1]   (NA)
Side Effects: Change at C11 D1 Number Analyzed 3 participants 1 participants
55.56  (50.92) 11.11 [1]   (NA)
Fear of Future Health: Change at C11 D1 Number Analyzed 2 participants 1 participants
0.00  (0.00) 33.33 [1]   (NA)
Ability to Plan Future: Change at C11 D1 Number Analyzed 3 participants 1 participants
44.44  (50.92) 66.67 [1]   (NA)
Pancreatic Pain: Change at C12 D1 Number Analyzed 3 participants 0 participants
-5.56  (20.97)
Eating Related Items: Change at C12 D1 Number Analyzed 3 participants 0 participants
16.67  (16.67)
Altered Bowel Habits: Change at C12 D1 Number Analyzed 3 participants 0 participants
27.78  (34.69)
Jaundice: Change at C12 D1 Number Analyzed 3 participants 0 participants
0.00  (0.00)
Body Image: Change at C12 D1 Number Analyzed 3 participants 0 participants
16.67  (16.67)
Health Care Satisfaction: Change at C12 D1 Number Analyzed 3 participants 0 participants
-5.56  (41.94)
Sexual Functioning: Change at C12 D1 Number Analyzed 3 participants 0 participants
0.00  (66.67)
Ascites: Change at C12 D1 Number Analyzed 3 participants 0 participants
-22.22  (19.25)
Indigestion: Change at C12 D1 Number Analyzed 3 participants 0 participants
0.00  (0.00)
Flatulence: Change at C12 D1 Number Analyzed 3 participants 0 participants
0.00  (0.00)
Cachexia: Change at C12 D1 Number Analyzed 3 participants 0 participants
33.33  (28.87)
Side Effects: Change at C12 D1(n=3,0) Number Analyzed 3 participants 0 participants
33.33  (40.06)
Fear of Future Health: Change at C12 D1 Number Analyzed 3 participants 0 participants
0.00  (0.00)
Ability to Plan Future: Change at C12 D1 Number Analyzed 3 participants 0 participants
0.00  (0.00)
Pancreatic Pain: Change at C13 D1 Number Analyzed 2 participants 0 participants
20.83  (5.89)
Eating Related Items: Change at C13 D1 Number Analyzed 2 participants 0 participants
58.33  (58.93)
Altered Bowel Habits: Change at C13 D1 Number Analyzed 2 participants 0 participants
8.33  (11.79)
Jaundice: Change at C13 D1 Number Analyzed 2 participants 0 participants
25.00  (35.36)
Body Image: Change at C13 D1 Number Analyzed 2 participants 0 participants
41.67  (58.93)
Health Care Satisfaction: Change at C13 D1 Number Analyzed 2 participants 0 participants
-16.67  (23.57)
Sexual Functioning: Change at C13 D1 Number Analyzed 2 participants 0 participants
-50.00  (23.57)
Ascites: Change at C13 D1 Number Analyzed 2 participants 0 participants
16.67  (23.57)
Indigestion: Change at C13 D1 Number Analyzed 2 participants 0 participants
0.00  (0.00)
Flatulence: Change at C13 D1 Number Analyzed 2 participants 0 participants
16.67  (23.57)
Cachexia: Change at C13 D1 Number Analyzed 2 participants 0 participants
33.33  (47.14)
Side Effects: Change at C13 D1 Number Analyzed 2 participants 0 participants
16.67  (7.86)
Fear of Future Health: Change at C13 D1 Number Analyzed 2 participants 0 participants
0.00  (0.00)
Ability to Plan Future: Change at C13 D1 Number Analyzed 2 participants 0 participants
16.67  (23.57)
Pancreatic Pain: Change at C14 D1 Number Analyzed 1 participants 0 participants
-8.33 [1]   (NA)
Eating Related Items: Change at C14 D1 Number Analyzed 1 participants 0 participants
16.67 [1]   (NA)
Altered Bowel Habits: Change at C14 D1 Number Analyzed 1 participants 0 participants
33.33 [1]   (NA)
Jaundice: Change at C14 D1 Number Analyzed 1 participants 0 participants
33.33 [1]   (NA)
Body Image: Change at C14 D1 Number Analyzed 1 participants 0 participants
33.33 [1]   (NA)
Health Care Satisfaction: Change at C14 D1 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
Sexual Functioning: Change at C14 D1 Number Analyzed 1 participants 0 participants
-33.33 [1]   (NA)
Ascites: Change at C14 D1 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
Indigestion: Change at C14 D1 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
Flatulence: Change at C14 D1 Number Analyzed 1 participants 0 participants
33.33 [1]   (NA)
Cachexia: Change at C14 D1 Number Analyzed 1 participants 0 participants
50.00 [1]   (NA)
Side Effects: Change at C14 D1 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
Fear of Future Health: Change at C14 D1 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
Ability to Plan Future: Change at C14 D1 Number Analyzed 1 participants 0 participants
0.00 [1]   (NA)
Pancreatic Pain: Change at EoS Number Analyzed 2 participants 1 participants
58.33  (35.36) 0.00 [1]   (NA)
Eating Related Items: Change at EoS Number Analyzed 2 participants 1 participants
25.00  (82.50) 0.00 [1]   (NA)
Altered Bowel Habits: Change at EoS Number Analyzed 2 participants 1 participants
83.33  (23.57) 0.00 [1]   (NA)
Jaundice: Change at EoS Number Analyzed 2 participants 1 participants
8.33  (11.79) 0.00 [1]   (NA)
Body Image: Change at EoS Number Analyzed 2 participants 1 participants
66.67  (0.00) -16.67 [1]   (NA)
Health Care Satisfaction: Change at EoS Number Analyzed 1 participants 1 participants
0.00 [1]   (NA) 33.33 [1]   (NA)
Sexual Functioning: Change at EoS Number Analyzed 1 participants 1 participants
0.00 [1]   (NA) 33.33 [1]   (NA)
Ascites: Change at EoS Number Analyzed 2 participants 1 participants
33.33  (47.14) 33.33 [1]   (NA)
Indigestion: Change at EoS Number Analyzed 2 participants 1 participants
33.33  (47.14) 33.33 [1]   (NA)
Flatulence: Change at EoS Number Analyzed 2 participants 1 participants
83.33  (23.57) 0.00 [1]   (NA)
Cachexia: Change at EoS Number Analyzed 2 participants 1 participants
66.67  (0.00) 0.00 [1]   (NA)
Side Effects: Change at EoS Number Analyzed 2 participants 1 participants
19.44  (90.35) -11.11 [1]   (NA)
Fear of Future Health: Change at EoS Number Analyzed 1 participants 1 participants
33.33 [1]   (NA) -33.33 [1]   (NA)
Ability to Plan Future: Change at EoS Number Analyzed 1 participants 1 participants
66.67 [1]   (NA) 33.33 [1]   (NA)
[1]
Standard deviation was not calculated because only one participant was evaluable.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pancreatic pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.59
Confidence Interval (2-Sided) 95%
-10.11 to 15.29
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in eating related items at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.41
Confidence Interval (2-Sided) 95%
-13.39 to 20.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in altered bowel habits at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 19.70
Confidence Interval (2-Sided) 95%
5.96 to 33.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in jaundice at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.70
Confidence Interval (2-Sided) 95%
0.93 to 24.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in body image at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.10
Confidence Interval (2-Sided) 95%
1.28 to 28.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in health care satisfaction at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.36
Confidence Interval (2-Sided) 95%
-14.59 to 23.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in sexual functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.19
Confidence Interval (2-Sided) 95%
-37.53 to -4.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ascites at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.82
Confidence Interval (2-Sided) 95%
-25.04 to 9.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in indigestion at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.95
Confidence Interval (2-Sided) 95%
-9.59 to 21.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in flatulence at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.39
Confidence Interval (2-Sided) 95%
-1.61 to 30.40
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cachexia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.50
Confidence Interval (2-Sided) 95%
2.78 to 22.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in side effects at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.88
Confidence Interval (2-Sided) 95%
1.36 to 20.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fear of future health at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.33
Confidence Interval (2-Sided) 95%
-16.36 to 11.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ability to plan future at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.21
Confidence Interval (2-Sided) 95%
-11.78 to 24.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pancreatic pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.87
Confidence Interval (2-Sided) 95%
0.79 to 28.94
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in eating related items at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.49
Confidence Interval (2-Sided) 95%
-7.45 to 34.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in altered bowel habits at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 18.86
Confidence Interval (2-Sided) 95%
0.17 to 37.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in jaundice at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.57
Confidence Interval (2-Sided) 95%
0.66 to 22.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in body image at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 18.72
Confidence Interval (2-Sided) 95%
0.49 to 36.95
Estimation Comments [Not Specified]
Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in health care satisfaction at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.61
Confidence Interval (2-Sided) 95%
-32.40 to 11.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in sexual functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
-14.63 to 17.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ascites at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
-14.70 to 17.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in indigestion at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.05
Confidence Interval (2-Sided) 95%
-10.65 to 32.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in flatulence at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.40
Confidence Interval (2-Sided) 95%
-17.33 to 24.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cachexia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.27
Confidence Interval (2-Sided) 95%
-4.40 to 22.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in side effects at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 19.19
Confidence Interval (2-Sided) 95%
2.99 to 35.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fear of future health at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-23.70 to 22.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ability to plan future at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 21.51
Confidence Interval (2-Sided) 95%
-3.10 to 46.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pancreatic pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.19
Confidence Interval (2-Sided) 95%
-21.57 to 13.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in eating related items at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.60
Confidence Interval (2-Sided) 95%
-32.86 to 7.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in altered bowel habits at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.25
Confidence Interval (2-Sided) 95%
-10.33 to 34.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in jaundice at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.84
Confidence Interval (2-Sided) 95%
-0.18 to 25.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in body image at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.85
Confidence Interval (2-Sided) 95%
-16.45 to 24.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in health care satisfaction at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.05
Confidence Interval (2-Sided) 95%
-23.23 to 37.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in sexual functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.53
Confidence Interval (2-Sided) 95%
-26.55 to 21.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ascites at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.46
Confidence Interval (2-Sided) 95%
-27.48 to 8.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in indigestion at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.96
Confidence Interval (2-Sided) 95%
-30.62 to 16.70
Estimation Comments [Not Specified]
Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in flatulence at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.71
Confidence Interval (2-Sided) 95%
-20.37 to 27.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cachexia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.04
Confidence Interval (2-Sided) 95%
-5.73 to 31.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in side effects at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.12
Confidence Interval (2-Sided) 95%
-3.23 to 33.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fear of future health at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.91
Confidence Interval (2-Sided) 95%
-36.18 to 20.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ability to plan future at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.38
Confidence Interval (2-Sided) 95%
-20.24 to 51.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pancreatic pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.25
Confidence Interval (2-Sided) 95%
-10.09 to 32.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in eating related items at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.41
Confidence Interval (2-Sided) 95%
-25.22 to 40.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in altered bowel habits at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 28.28
Confidence Interval (2-Sided) 95%
4.23 to 52.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in jaundice at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 24.22
Confidence Interval (2-Sided) 95%
5.09 to 43.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in body image at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.11
Confidence Interval (2-Sided) 95%
-0.16 to 50.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in health care satisfaction at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.07
Confidence Interval (2-Sided) 95%
-47.95 to 27.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in sexual functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.61
Confidence Interval (2-Sided) 95%
-21.78 to 14.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ascites at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.98
Confidence Interval (2-Sided) 95%
-17.02 to 28.99
Estimation Comments [Not Specified]
Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in indigestion at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.08
Confidence Interval (2-Sided) 95%
-5.39 to 49.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in flatulence at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.78
Confidence Interval (2-Sided) 95%
-15.33 to 34.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cachexia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 15.81
Confidence Interval (2-Sided) 95%
-10.43 to 42.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in side effects at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 21.77
Confidence Interval (2-Sided) 95%
1.11 to 42.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fear of future health at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.81
Confidence Interval (2-Sided) 95%
-41.91 to 12.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ability to plan future at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 31.11
Confidence Interval (2-Sided) 95%
1.60 to 60.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pancreatic pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.74
Confidence Interval (2-Sided) 95%
-20.62 to 38.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in eating related items at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.24
Confidence Interval (2-Sided) 95%
-68.52 to 42.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in altered bowel habits at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.06
Confidence Interval (2-Sided) 95%
-7.93 to 52.05
Estimation Comments [Not Specified]
Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in jaundice at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 18.63
Confidence Interval (2-Sided) 95%
-5.64 to 42.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in body image at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 23.96
Confidence Interval (2-Sided) 95%
-9.93 to 57.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in health care satisfaction at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.54
Confidence Interval (2-Sided) 95%
-32.70 to 59.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in sexual functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.14
Confidence Interval (2-Sided) 95%
-29.46 to 55.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ascites at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.37
Confidence Interval (2-Sided) 95%
-24.04 to 36.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in indigestion at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.59
Confidence Interval (2-Sided) 95%
-17.94 to 59.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 66
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in flatulence at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10.29
Confidence Interval (2-Sided) 95%
-20.12 to 40.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 67
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cachexia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.74
Confidence Interval (2-Sided) 95%
-8.22 to 59.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 68
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in side effects at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 38.56
Confidence Interval (2-Sided) 95%
5.32 to 71.81
Estimation Comments [Not Specified]
Hide Statistical Analysis 69
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fear of future health at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.44
Confidence Interval (2-Sided) 95%
-53.14 to 44.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 70
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ability to plan future at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.17
Confidence Interval (2-Sided) 95%
-69.90 to 61.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 71
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pancreatic pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.96
Confidence Interval (2-Sided) 95%
-24.52 to 50.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 72
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in eating related items at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -23.15
Confidence Interval (2-Sided) 95%
-76.41 to 30.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 73
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in altered bowel habits at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.44
Confidence Interval (2-Sided) 95%
-71.89 to 33.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 74
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in jaundice at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 47.22
Confidence Interval (2-Sided) 95%
7.31 to 87.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 75
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in body image at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 41.67
Confidence Interval (2-Sided) 95%
-36.00 to 119.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 76
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in health care satisfaction at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 38.89
Confidence Interval (2-Sided) 95%
-5.05 to 82.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 77
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in sexual functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 32.14
Confidence Interval (2-Sided) 95%
-2.09 to 66.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 78
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in indigestion at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.41
Confidence Interval (2-Sided) 95%
-44.46 to 29.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 79
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in flatulence at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.96
Confidence Interval (2-Sided) 95%
-40.45 to 66.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 80
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cachexia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.89
Confidence Interval (2-Sided) 95%
-32.71 to 60.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 81
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in side effects at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 30.86
Confidence Interval (2-Sided) 95%
-16.16 to 77.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 82
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fear of future health at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.83
Confidence Interval (2-Sided) 95%
-44.95 to 86.62
Estimation Comments [Not Specified]
Hide Statistical Analysis 83
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ability to plan future at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.52
Confidence Interval (2-Sided) 95%
-115.22 to 78.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 84
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pancreatic pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 23.46
Confidence Interval (2-Sided) 95%
-39.71 to 86.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 85
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in eating related items at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.96
Confidence Interval (2-Sided) 95%
-130.69 to 104.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 86
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in altered bowel habits at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 48.15
Confidence Interval (2-Sided) 95%
-7.12 to 103.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 87
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in jaundice at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 92.59
Confidence Interval (2-Sided) 95%
63.16 to 122.02
Estimation Comments [Not Specified]
Hide Statistical Analysis 88
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in body image at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.56
Confidence Interval (2-Sided) 95%
-85.03 to 96.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 89
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in health care satisfaction at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 37.04
Confidence Interval (2-Sided) 95%
-29.46 to 103.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 90
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in sexual functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.14
Confidence Interval (2-Sided) 95%
-41.45 to 27.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 91
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ascites at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.70
Confidence Interval (2-Sided) 95%
-67.04 to 59.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 92
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in indigestion at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.41
Confidence Interval (2-Sided) 95%
-104.79 to 89.97
Estimation Comments [Not Specified]
Hide Statistical Analysis 93
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in flatulence at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 22.22
Confidence Interval (2-Sided) 95%
-58.80 to 103.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 94
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cachexia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 27.78
Confidence Interval (2-Sided) 95%
-36.28 to 91.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 95
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in side effects at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.11
Confidence Interval (2-Sided) 95%
-74.30 to 96.52
Estimation Comments [Not Specified]
Hide Statistical Analysis 96
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fear of future health at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.17
Confidence Interval (2-Sided) 95%
-142.55 to 84.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 97
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ability to plan future at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -55.56
Confidence Interval (2-Sided) 95%
-212.46 to 101.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 98
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pancreatic pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.67
Confidence Interval (2-Sided) 95%
-62.93 to 96.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 99
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in eating related items at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.29
Confidence Interval (2-Sided) 95%
-87.74 to 116.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 100
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in altered bowel habits at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 73.81
Confidence Interval (2-Sided) 95%
7.90 to 139.72
Estimation Comments [Not Specified]
Hide Statistical Analysis 101
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in jaundice at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 76.19
Confidence Interval (2-Sided) 95%
33.64 to 118.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 102
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in body image at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 28.57
Confidence Interval (2-Sided) 95%
-64.64 to 121.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 103
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in health care satisfaction at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 35.71
Confidence Interval (2-Sided) 95%
-28.11 to 99.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 104
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in sexual functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -13.33
Confidence Interval (2-Sided) 95%
-104.01 to 77.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 105
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ascites at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -44.44
Confidence Interval (2-Sided) 95%
-140.03 to 51.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 106
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in indigestion at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.76
Confidence Interval (2-Sided) 95%
-88.45 to 97.98
Estimation Comments [Not Specified]
Hide Statistical Analysis 107
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in flatulence at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 14.29
Confidence Interval (2-Sided) 95%
-54.32 to 82.89
Estimation Comments [Not Specified]
Hide Statistical Analysis 108
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cachexia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 23.81
Confidence Interval (2-Sided) 95%
-66.45 to 114.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 109
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in side effects at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 31.75
Confidence Interval (2-Sided) 95%
-56.14 to 119.63
Estimation Comments [Not Specified]
Hide Statistical Analysis 110
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in fear of future health at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -50.00
Confidence Interval (2-Sided) 95%
-163.35 to 63.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 111
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ability to plan future at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.29
Confidence Interval (2-Sided) 95%
-125.23 to 96.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 112
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pancreatic pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.00
Confidence Interval (2-Sided) 95%
-45.18 to 95.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 113
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in eating related items at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.00
Confidence Interval (2-Sided) 95%
-45.18 to 95.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 114
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in altered bowel habits at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 77.78
Confidence Interval (2-Sided) 95%
14.55 to 141.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 115
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in jaundice at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 86.11
Confidence Interval (2-Sided) 95%
40.61 to 131.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 116
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in body image at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.00
Confidence Interval (2-Sided) 95%
-56.48 to 106.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 117
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in health care satisfaction at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 47.22
Confidence Interval (2-Sided) 95%
-37.69 to 132.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 118
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in sexual functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.00
Confidence Interval (2-Sided) 95%
-70.68 to 110.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 119
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ascites at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -33.33
Confidence Interval (2-Sided) 95%
-91.87 to 25.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 120
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in indigestion at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 27.78
Confidence Interval (2-Sided) 95%
-41.89 to 97.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 121
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in flatulence at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 16.67
Confidence Interval (2-Sided) 95%
-34.03 to 67.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 122
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cachexia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.33
Confidence Interval (2-Sided) 95%
-100.19 to 116.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 123
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in side effects at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.93
Confidence Interval (2-Sided) 95%
-53.73 to 105.58
Estimation Comments [Not Specified]
Hide Statistical Analysis 124
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ability to plan future at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-117.07 to 117.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 125
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pancreatic pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.89
Confidence Interval (2-Sided) 95%
-221.53 to 249.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 126
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in eating related items at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.56
Confidence Interval (2-Sided) 95%
-260.62 to 271.74
Estimation Comments [Not Specified]
Hide Statistical Analysis 127
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in altered bowel habits at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 66.67
Confidence Interval (2-Sided) 95%
-152.41 to 285.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 128
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in jaundice at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 100.00
Confidence Interval (2-Sided) 95%
-119.08 to 319.08
Estimation Comments [Not Specified]
Hide Statistical Analysis 129
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in body image at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 33.33
Confidence Interval (2-Sided) 95%
-185.75 to 252.41
Estimation Comments [Not Specified]
Hide Statistical Analysis 130
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in health care satisfaction at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 44.44
Confidence Interval (2-Sided) 95%
-82.04 to 170.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 131
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in sexual functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-733.59 to 733.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 132
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ascites at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.11
Confidence Interval (2-Sided) 95%
-202.34 to 180.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 133
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in indigestion at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.11
Confidence Interval (2-Sided) 95%
-84.50 to 106.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 134
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in flatulence at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.11
Confidence Interval (2-Sided) 95%
-84.50 to 106.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 135
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in cachexia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 38.89
Confidence Interval (2-Sided) 95%
-87.60 to 165.37
Estimation Comments [Not Specified]
Hide Statistical Analysis 136
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in side effects at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 44.44
Confidence Interval (2-Sided) 95%
-208.53 to 297.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 137
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ability to plan future at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.22
Confidence Interval (2-Sided) 95%
-275.19 to 230.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 138
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in pancreatic pain at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 58.33
Confidence Interval (2-Sided) 95%
-491.86 to 608.53
Estimation Comments [Not Specified]
Hide Statistical Analysis 139
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in eating related items at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 25.00
Confidence Interval (2-Sided) 95%
-1258.79 to 1308.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 140
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in altered bowel habits at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 83.33
Confidence Interval (2-Sided) 95%
-283.46 to 450.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 141
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in jaundice at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.33
Confidence Interval (2-Sided) 95%
-175.06 to 191.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 142
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in ascites at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-733.59 to 733.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 143
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in indigestion at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-733.59 to 733.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 144
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in flatulence at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 83.33
Confidence Interval (2-Sided) 95%
-283.46 to 450.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 145
Statistical Analysis Overview Comparison Group Selection Axitinib + Gemcitabine, Gemcitabine
Comments For change in side effects at EoS, mean change difference was used to compare the two treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 30.56
Confidence Interval (2-Sided) 95%
-1375.5 to 1436.61
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Axitinib + Gemcitabine (Phase 1 Lead-In) Axitinib + Gemcitabine Gemcitabine
Hide Arm/Group Description Axitinib (AG-013736) 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 (AG-013736) 5 mg tablet orally twice daily (BID) from Day 1 of Cycle 1 (28 days) and all subsequent cycles (28 days). Gemcitabine 1000 mg/m^2 30-minute infusion on Day 1, 8 and 15 of each cycle. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
All-Cause Mortality
Axitinib + Gemcitabine (Phase 1 Lead-In) Axitinib + Gemcitabine Gemcitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Axitinib + Gemcitabine (Phase 1 Lead-In) Axitinib + Gemcitabine Gemcitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/8 (37.50%)   35/68 (51.47%)   10/31 (32.26%) 
Blood and lymphatic system disorders       
Anaemia * 1  1/8 (12.50%)  4/68 (5.88%)  1/31 (3.23%) 
Disseminated intravascular coagulation * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Thrombocytopenia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Cardiac disorders       
Atrial fibrillation * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Atrial flutter * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Myocardial infarction * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Pericardial effusion * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Tachycardia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Ear and labyrinth disorders       
Tinnitus * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Gastrointestinal disorders       
Abdominal distension * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Abdominal pain * 1  0/8 (0.00%)  5/68 (7.35%)  0/31 (0.00%) 
Abdominal pain upper * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Abdominal strangulated hernia * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Colitis ischaemic * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Constipation * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Diarrhoea * 1  0/8 (0.00%)  3/68 (4.41%)  0/31 (0.00%) 
Duodenal obstruction * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Gastric haemorrhage * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Gastrointestinal haemorrhage * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Haematemesis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Intestinal ischaemia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Intestinal obstruction * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Melaena * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Nausea * 1  0/8 (0.00%)  2/68 (2.94%)  2/31 (6.45%) 
Oral pain * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Peritonitis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Pneumatosis intestinalis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Rectal haemorrhage * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Small intestinal haemorrhage * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Small intestinal obstruction * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Vomiting * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
General disorders       
Asthenia * 1  0/8 (0.00%)  4/68 (5.88%)  0/31 (0.00%) 
Chest pain * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Device occlusion * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Disease progression * 1  0/8 (0.00%)  6/68 (8.82%)  0/31 (0.00%) 
Fatigue * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
General physical health deterioration * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Pain * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Multi-organ failure * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Pyrexia * 1  0/8 (0.00%)  1/68 (1.47%)  3/31 (9.68%) 
Hepatobiliary disorders       
Cholangitis * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Cholestasis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Gallbladder obstruction * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Jaundice cholestatic * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Infections and infestations       
Empyema * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Enterobacter bacteraemia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Liver abscess * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Lower respiratory tract infection * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Lung abscess * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Lung infection * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Oral candidiasis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Pneumonia * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Sepsis * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Septic shock * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Infection * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Investigations       
Blood pressure increased * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Platelet count decreased * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Metabolism and nutrition disorders       
Cachexia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Dehydration * 1  0/8 (0.00%)  3/68 (4.41%)  2/31 (6.45%) 
Failure to thrive * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Hypocalcaemia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Hypokalaemia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Hyponatraemia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Hypophagia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Lactic acidosis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Nervous system disorders       
Convulsion * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Headache * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Neuromyopathy * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Syncope * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Transient ischaemic attack * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Psychiatric disorders       
Confusional state * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Mental status changes * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Renal and urinary disorders       
Renal impairment * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea * 1  0/8 (0.00%)  6/68 (8.82%)  0/31 (0.00%) 
Epistaxis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Hypoxia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Pneumothorax * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Pulmonary embolism * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Vascular disorders       
Deep vein thrombosis * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Post thrombotic syndrome * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Thrombosis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Axitinib + Gemcitabine (Phase 1 Lead-In) Axitinib + Gemcitabine Gemcitabine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/8 (87.50%)   67/68 (98.53%)   26/31 (83.87%) 
Blood and lymphatic system disorders       
Anaemia * 1  4/8 (50.00%)  16/68 (23.53%)  7/31 (22.58%) 
Granulocytopenia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Iron deficiency anaemia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Leukopenia * 1  2/8 (25.00%)  3/68 (4.41%)  0/31 (0.00%) 
Neutropenia * 1  2/8 (25.00%)  15/68 (22.06%)  6/31 (19.35%) 
Thrombocytopenia * 1  4/8 (50.00%)  10/68 (14.71%)  2/31 (6.45%) 
Thrombocytosis * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Lymphopenia * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Cardiac disorders       
Atrial fibrillation * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Cardiogenic shock * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Cyanosis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Pericardial effusion * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Sinus tachycardia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Tachycardia * 1  0/8 (0.00%)  1/68 (1.47%)  2/31 (6.45%) 
Ear and labyrinth disorders       
Ear pain * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Tinnitus * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Vertigo * 1  1/8 (12.50%)  1/68 (1.47%)  0/31 (0.00%) 
Eye disorders       
Blepharitis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Conjunctivitis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Eyelid oedema * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Photopsia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Vitreous floaters * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Gastrointestinal disorders       
Abdominal discomfort * 1  1/8 (12.50%)  0/68 (0.00%)  2/31 (6.45%) 
Abdominal distension * 1  0/8 (0.00%)  4/68 (5.88%)  1/31 (3.23%) 
Abdominal hernia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Abdominal pain * 1  2/8 (25.00%)  16/68 (23.53%)  8/31 (25.81%) 
Abdominal pain upper * 1  1/8 (12.50%)  11/68 (16.18%)  1/31 (3.23%) 
Abdominal tenderness * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Aphthous stomatitis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Ascites * 1  1/8 (12.50%)  3/68 (4.41%)  5/31 (16.13%) 
Constipation * 1  2/8 (25.00%)  18/68 (26.47%)  7/31 (22.58%) 
Diarrhoea * 1  4/8 (50.00%)  35/68 (51.47%)  8/31 (25.81%) 
Dry mouth * 1  0/8 (0.00%)  5/68 (7.35%)  1/31 (3.23%) 
Duodenal ulcer * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Dyspepsia * 1  0/8 (0.00%)  9/68 (13.24%)  4/31 (12.90%) 
Dysphagia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Flatulence * 1  1/8 (12.50%)  5/68 (7.35%)  2/31 (6.45%) 
Gastric Ulcer * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Gastritis * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Gastrointestinal haemorrhage * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Gastrooesophageal reflux disease * 1  2/8 (25.00%)  1/68 (1.47%)  1/31 (3.23%) 
Gingival pain * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Gingival swelling * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Haematochezia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Haemorrhoids * 1  0/8 (0.00%)  5/68 (7.35%)  0/31 (0.00%) 
Inguinal hernia * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Intestinal haemorrhage * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Lip ulceration * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Mesenteric artery stenosis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Nausea * 1  3/8 (37.50%)  30/68 (44.12%)  15/31 (48.39%) 
Oral pain * 1  0/8 (0.00%)  6/68 (8.82%)  0/31 (0.00%) 
Peptic ulcer haemorrhage * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Proctalgia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Rectal haemorrhage * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Sensitivity of teeth * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Small intestinal obstruction * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Steatorrhoea * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Stomatitis * 1  1/8 (12.50%)  12/68 (17.65%)  2/31 (6.45%) 
Tongue coated * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Tongue disorder * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Toothache * 1  2/8 (25.00%)  2/68 (2.94%)  0/31 (0.00%) 
Vomiting * 1  2/8 (25.00%)  29/68 (42.65%)  12/31 (38.71%) 
General disorders       
Adverse drug reaction * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Asthenia * 1  1/8 (12.50%)  22/68 (32.35%)  4/31 (12.90%) 
Catheter site pain * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Chest pain * 1  1/8 (12.50%)  5/68 (7.35%)  0/31 (0.00%) 
Chills * 1  0/8 (0.00%)  5/68 (7.35%)  3/31 (9.68%) 
Device occlusion * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Disease progression * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Face oedema * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Fatigue * 1  7/8 (87.50%)  29/68 (42.65%)  10/31 (32.26%) 
Feeling cold * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
General physical health deterioration * 1  1/8 (12.50%)  1/68 (1.47%)  0/31 (0.00%) 
Hyperpyrexia * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Influenza like illness * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Infusion related reaction * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Infusion site pain * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Malaise * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Mass * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Mucosal dryness * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Mucosal inflammation * 1  3/8 (37.50%)  12/68 (17.65%)  2/31 (6.45%) 
Oedema * 1  0/8 (0.00%)  6/68 (8.82%)  0/31 (0.00%) 
Oedema peripheral * 1  1/8 (12.50%)  11/68 (16.18%)  8/31 (25.81%) 
Pain * 1  0/8 (0.00%)  10/68 (14.71%)  2/31 (6.45%) 
Performance status decreased * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Pyrexia * 1  1/8 (12.50%)  12/68 (17.65%)  7/31 (22.58%) 
Hepatobiliary disorders       
Bile duct obstruction * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Bile duct stenosis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Cholangitis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Cholecystitis * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Cholestasis * 1  1/8 (12.50%)  1/68 (1.47%)  1/31 (3.23%) 
Cytolytic hepatitis * 1  3/8 (37.50%)  1/68 (1.47%)  1/31 (3.23%) 
Hepatotoxicity * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Hyperbilirubinaemia * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Jaundice * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Immune system disorders       
Hypersensitivity * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Infections and infestations       
Bacteraemia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Bronchitis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Candidiasis * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Cellulitis * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Diverticulitis * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Escherichia sepsis * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Folliculitis * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Gastroenteritis * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Gingival abscess * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Herpes ophthalmic * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Hordeolum * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Infected skin ulcer * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Infection * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Influenza * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Localised infection * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Nasopharyngitis * 1  2/8 (25.00%)  1/68 (1.47%)  0/31 (0.00%) 
Oral candidiasis * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Oral herpes * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Oropharyngeal candidiasis * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Periodontal infection * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Pneumonia * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Staphylococcal infection * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Upper respiratory tract infection * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Urinary tract infection * 1  1/8 (12.50%)  9/68 (13.24%)  3/31 (9.68%) 
Vulvovaginal candidiasis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Wound infection * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Injury, poisoning and procedural complications       
Contusion * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Drug toxicity * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Excoriation * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Fall * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Joint sprain * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Muscle strain * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Periorbital haematoma * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Procedural pain * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Sunburn * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Investigations       
Alanine aminotransferase * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Alanine aminotransferase increased * 1  0/8 (0.00%)  3/68 (4.41%)  1/31 (3.23%) 
Aspartate aminotransferase * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Aspartate aminotransferase increased * 1  0/8 (0.00%)  2/68 (2.94%)  2/31 (6.45%) 
Blood albumin decreased * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Blood albumin increased * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Blood alkaline phosphatase * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Blood alkaline phosphatase increased * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Blood bilirubin increased * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Blood creatinine increased * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Blood glucose * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Blood glucose increased * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Blood lactate dehydrogenase increased * 1  1/8 (12.50%)  1/68 (1.47%)  0/31 (0.00%) 
Blood potassium decreased * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Blood pressure increased * 1  0/8 (0.00%)  3/68 (4.41%)  0/31 (0.00%) 
Blood sodium decreased * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Blood thyroid stimulating hormone increased * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Haemoglobin * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Haemoglobin decreased * 1  0/8 (0.00%)  5/68 (7.35%)  2/31 (6.45%) 
Heart rate increased * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
International normalised ratio * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Neutrophil count * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Neutrophil count decreased * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Platelet count decreased * 1  0/8 (0.00%)  4/68 (5.88%)  0/31 (0.00%) 
Prothrombin time prolonged * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Transaminases increased * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Weight decreased * 1  1/8 (12.50%)  16/68 (23.53%)  4/31 (12.90%) 
Metabolism and nutrition disorders       
Anorexia * 1  3/8 (37.50%)  0/68 (0.00%)  0/31 (0.00%) 
Cachexia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Decreased appetite * 1  1/8 (12.50%)  29/68 (42.65%)  10/31 (32.26%) 
Dehydration * 1  1/8 (12.50%)  4/68 (5.88%)  0/31 (0.00%) 
Diabetes mellitus inadequate control * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Failure to thrive * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Hyperglycaemia * 1  0/8 (0.00%)  3/68 (4.41%)  0/31 (0.00%) 
Hyperkalaemia * 1  0/8 (0.00%)  2/68 (2.94%)  2/31 (6.45%) 
Hypernatraemia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Hypoalbuminaemia * 1  1/8 (12.50%)  2/68 (2.94%)  0/31 (0.00%) 
Hypocalcaemia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Hypoglycaemia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Hypokalaemia * 1  0/8 (0.00%)  11/68 (16.18%)  4/31 (12.90%) 
Hypomagnesaemia * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders       
Arthralgia * 1  1/8 (12.50%)  1/68 (1.47%)  0/31 (0.00%) 
Back pain * 1  2/8 (25.00%)  12/68 (17.65%)  2/31 (6.45%) 
Bone pain * 1  1/8 (12.50%)  2/68 (2.94%)  0/31 (0.00%) 
Flank pain * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Joint swelling * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Mobility decreased * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Muscle atrophy * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Muscle spasms * 1  1/8 (12.50%)  1/68 (1.47%)  0/31 (0.00%) 
Muscular weakness * 1  1/8 (12.50%)  3/68 (4.41%)  0/31 (0.00%) 
Musculoskeletal chest pain * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Musculoskeletal pain * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Myalgia * 1  0/8 (0.00%)  3/68 (4.41%)  0/31 (0.00%) 
Myositis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Pain in extremity * 1  0/8 (0.00%)  6/68 (8.82%)  3/31 (9.68%) 
Spinal osteoarthritis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Trigger finger * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Malignant pleural effusion * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Tumour pain * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Nervous system disorders       
Aphasia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Ataxia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Balance disorder * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Cerebral ischaemia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Dizziness * 1  0/8 (0.00%)  8/68 (11.76%)  3/31 (9.68%) 
Dysarthria * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Dysgeusia * 1  1/8 (12.50%)  7/68 (10.29%)  2/31 (6.45%) 
Dyskinesia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Facial paresis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Headache * 1  1/8 (12.50%)  9/68 (13.24%)  2/31 (6.45%) 
Hypoaesthesia * 1  0/8 (0.00%)  5/68 (7.35%)  0/31 (0.00%) 
Lethargy * 1  0/8 (0.00%)  6/68 (8.82%)  0/31 (0.00%) 
Neuropathy * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Neuropathy peripheral * 1  1/8 (12.50%)  3/68 (4.41%)  0/31 (0.00%) 
Paraesthesia * 1  1/8 (12.50%)  1/68 (1.47%)  1/31 (3.23%) 
Peripheral sensory neuropathy * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Sensory loss * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Somnolence * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Syncope * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Tremor * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Psychiatric disorders       
Agitation * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Anxiety * 1  0/8 (0.00%)  9/68 (13.24%)  3/31 (9.68%) 
Confusional state * 1  0/8 (0.00%)  2/68 (2.94%)  2/31 (6.45%) 
Delirium * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Depressed mood * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Depression * 1  2/8 (25.00%)  7/68 (10.29%)  2/31 (6.45%) 
Insomnia * 1  2/8 (25.00%)  6/68 (8.82%)  0/31 (0.00%) 
Restlessness * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Sleep disorder * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Renal and urinary disorders       
Chromaturia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Dysuria * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Haematuria * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Haemoglobinuria * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Nocturia * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Oliguria * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Proteinuria * 1  0/8 (0.00%)  6/68 (8.82%)  0/31 (0.00%) 
Renal failure acute * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Urinary incontinence * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Urinary retention * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Urine flow decreased * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Reproductive system and breast disorders       
Erectile dysfunction * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Metrorrhagia * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Vaginal haemorrhage * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Vulvovaginal dryness * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Vulvovaginal erythema * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough * 1  2/8 (25.00%)  5/68 (7.35%)  3/31 (9.68%) 
Dyspnoea * 1  2/8 (25.00%)  15/68 (22.06%)  5/31 (16.13%) 
Dyspnoea exertional * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Epistaxis * 1  2/8 (25.00%)  8/68 (11.76%)  0/31 (0.00%) 
Haemoptysis * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Hiccups * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Nasal dryness * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Orthopnoea * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Pleural effusion * 1  0/8 (0.00%)  3/68 (4.41%)  1/31 (3.23%) 
Pleuritic pain * 1  0/8 (0.00%)  1/68 (1.47%)  1/31 (3.23%) 
Pneumonitis * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Pulmonary oedema * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Respiratory distress * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Rhinorrhoea * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Upper-airway cough syndrome * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia * 1  1/8 (12.50%)  10/68 (14.71%)  0/31 (0.00%) 
Decubitus ulcer * 1  0/8 (0.00%)  4/68 (5.88%)  0/31 (0.00%) 
Dry Skin * 1  1/8 (12.50%)  0/68 (0.00%)  0/31 (0.00%) 
Erythema * 1  0/8 (0.00%)  2/68 (2.94%)  1/31 (3.23%) 
Hyperhidrosis * 1  1/8 (12.50%)  2/68 (2.94%)  3/31 (9.68%) 
Livedo reticularis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Night sweats * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
Palmar erythema * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  2/8 (25.00%)  1/68 (1.47%)  0/31 (0.00%) 
Petechiae * 1  0/8 (0.00%)  2/68 (2.94%)  0/31 (0.00%) 
Photosensitivity reaction * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Pruritus * 1  2/8 (25.00%)  6/68 (8.82%)  1/31 (3.23%) 
Pruritus generalised * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Rash * 1  0/8 (0.00%)  12/68 (17.65%)  2/31 (6.45%) 
Rash generalised * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Skin lesion * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Urticaria * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Surgical and medical procedures       
Pancreaticoduodenectomy * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Vascular disorders       
Deep vein thrombosis * 1  0/8 (0.00%)  4/68 (5.88%)  2/31 (6.45%) 
Haemorrhage * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Hot flush * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Hypertension * 1  4/8 (50.00%)  16/68 (23.53%)  0/31 (0.00%) 
Pallor * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Shock * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Thrombophlebitis * 1  0/8 (0.00%)  1/68 (1.47%)  0/31 (0.00%) 
Thrombosis * 1  0/8 (0.00%)  0/68 (0.00%)  1/31 (3.23%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.1
Population pharmacokinetics was not presented, as the data was not available for the single study and data of other axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00219557    
Other Study ID Numbers: A4061016
2005-000053-30 ( EudraCT Number )
First Submitted: September 13, 2005
First Posted: September 22, 2005
Results First Submitted: February 25, 2012
Results First Posted: August 24, 2012
Last Update Posted: May 14, 2019