AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00219557
• Collaborator: (none)
• Enrollment: 111
• Locations: 38
• Arms: 2
• Actual Duration (Months): 32.3
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms	Drug: Gemcitabine; Drug: AG-013736; Drug: Gemcitabine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A RANDOMIZED PHASE 2 STUDY OF THE ANTI-ANGIOGENESIS AGENT AG-013736 IN COMBINATION WITH GEMCITABINE IN PATIENTS WITH CHEMOTHERAPY-NAIVE ADVANCED PANCREATIC CANCER PRECEDED BY A PHASE 1 PORTION
• Actual Study Start Date: Jul 5, 2005
• Actual Primary Completion Date: Mar 14, 2008
• Actual Study Completion Date: Mar 14, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Gemcitabine	Drug: Gemcitabine; Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
Experimental: Axitinib [AG-013736] plus gemcitabine	Drug: AG-013736; Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.; Drug: Gemcitabine; Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Outcome Measures

Primary Outcome Measures

1. Overall Survival (OS) [Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant]

   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).

Secondary Outcome Measures

1. Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT) [Phase 1 baseline up to Week 4]

   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.

2. Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT) [Phase 1 Baseline up to Week 4]

   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.

3. Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736) [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]

4. Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736) [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]

   AUC (0-24) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 24 hours (0-24).

5. Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736) [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]

   Tmax was based on the actual time points when the samples were collected.

6. Plasma Decay Half-life (t1/2) of Axitinib (AG-013736) [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]

   Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

7. Maximum Observed Plasma Concentration (Cmax) of Gemcitabine [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]

8. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine [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]

   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 - ∞).

9. Plasma Decay Half-life (t1/2) of Gemcitabine [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]

   Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

10. Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2 [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]

    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.

11. Percentage of Participants With Overall Response (OR) [Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks]

    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.

12. Duration of Response (DR) [Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks]

    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.

13. Progression-free Survival (PFS) [Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks]

    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").

14. One Year Survival Probability [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]

    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.

15. 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 [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).]

    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.

16. 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 [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).]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas

• no prior therapy for metastatic disease

Exclusion Criteria:

• patients with locally advanced disease who are candidates for radiation therapy.

• uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Bay Medical Oncology/Hematology Medical Associates Inc.	Antioch	California	United States	94509
2	Alta Bates Comprehensive Cancer Center	Berkeley	California	United States	94704
3	Bay Area Cancer Research Group	Concord	California	United States	94520
4	East Bay Medical Oncology/Hematology Medical Associates, Inc.	Concord	California	United States	94520
5	Hematology Oncology, P.C.	Stamford	Connecticut	United States	06902-3628
6	Jackson Memorial Hospital & Clinics	Miami	Florida	United States	33136
7	University of Miami Hospital & clinics	Miami	Florida	United States	33136
8	H Lee Moffitt Cancer Center & Research Institute	Tampa	Florida	United States	33612-9497
9	Maine Center for Cancer Medicine and Blood Disorders	Biddeford	Maine	United States	04005
10	Maine Center for Cancer Medicine and Blood Disorders	Brunswick	Maine	United States	04011
11	Maine Center for Cancer Medicine and Blood Disorders	Scarborough	Maine	United States	04074
12	Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research	Saint Louis	Missouri	United States	63141
13	Arch Medical Services, Inc. d/b/a The Center for Cancer Care and Research	Washington	Missouri	United States	63090
14	Southeast Nebraska Cancer Center, Southeast Nebraska Hematology and Oncology Consultants, P.C.	Lincoln	Nebraska	United States	68510
15	Piedmont Hematology Oncology Association	Winston-Salem	North Carolina	United States	27103
16	Piedmont Hematology Oncology Associates	Winston-Salem	North Carolina	United States	27292
17	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792
18	Universitair Ziekenhuis Gent/Dienst Gastroenterologie	Gent		Belgium	9000
19	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
20	Cancer Care Manitoba	Winnipeg	Manitoba	Canada	R2H 2A6
21	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
22	Sault Area Hospital	Sault Ste Marie	Ontario	Canada	P6A 2C4
23	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9
24	CHUM, Hopital Saint-Luc	Montreal	Quebec	Canada	H2X 3J4
25	Service Oncologie Medicale	Saint-Herblain	Saint Herblain Cedex	France	44805
26	Hopital La Timone	Marseille		France	13005
27	Hopital de la Pitie Salpetriere	Paris Cedex 13		France	75651
28	Institut Claudius Regaud	Toulouse		France	31052
29	Medizinische Klinik mit Schwerpunkt Haematologie und Onkologie, Charité-Universitaetsmedizin Berlin	Berlin		Germany	13353
30	Fondazione IRCCS, Istituto Nazionale Tumori, Oncologia Medica B	Milano		Italy	20133
31	Unita Operativa, Oncologia Medica, Istituto di Medicina Interna e Geriatria	Roma		Italy	00168
32	Hospital Universitario Vall D´Hebron	Barcelona		Spain	08035
33	Hospital Clinic I Provincial de Barcelona	Barcelona		Spain	08036
34	Hospital Universitario Virgen Del Rocio	Sevilla		Spain	41013
35	Cancer Research Uk Clinical Centre	Southampton	Hampshire	United Kingdom	SO16 6YD
36	Department of Cancer Studies & Molecular Medicine	Leicester	Leicestershire	United Kingdom	LE1 5WW
37	Western General Hospitals Nhs Trust	Edinburgh		United Kingdom	EH4 2XU
38	Hammersmith Hospital	London		United Kingdom	W12 OHS

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00219557
• Other Study ID Numbers: A4061016; 2005-000053-30
• First Posted: Sep 22, 2005
• Last Update Posted: May 14, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Pfizer: Randomized Phase 2 Study of AG-013736 in Combination with Gemcitabine versus Gemcitabine Alone in Advanced Pancreatic Cancer
• Additional relevant MeSH terms: Pancreatic Neoplasms; Gemcitabine; Axitinib

Study Results

Participant Flow

Arm/Group Title	Axitinib + Gemcitabine (Phase 1 Lead-In)	Axitinib + Gemcitabine	Gemcitabine
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
Period Title: Phase 1
STARTED	0	69	34
Treated	0	68	31
COMPLETED	0	0	1
NOT COMPLETED	0	69	33

Baseline Characteristics

Arm/Group Title	Axitinib + Gemcitabine (Phase 1 Lead-In)	Axitinib + Gemcitabine	Gemcitabine	Total
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 Participants	8	69	34	111
Age, Customized (Count of Participants)
18 years to 44 years	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 (Count of 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%

Outcome Measures

1. Primary Outcome

Title	Overall Survival (OS)
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

Outcome Measure Data

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
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.
Measure Participants	69	34
Median (95% Confidence Interval) [Days]	210	171

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
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
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.758
	Confidence Interval	(2-Sided) 95%; 0.490 to 1.170
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
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

Outcome Measure Data

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)
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.
Measure Participants	6
Number [participants]	0 0%

3. Secondary Outcome

Title	Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
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

Outcome Measure Data

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)
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.
Measure Participants	6
Number [participants]	0 0%

4. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)
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

Outcome Measure Data

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)
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.
Measure Participants	6
Mean (Standard Deviation) [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)
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

Outcome Measure Data

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)
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.
Measure Participants	6
Mean (Standard Deviation) [ng*hr/mL]	282.34 (135.27)

6. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)
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

Outcome Measure Data

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)
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.
Measure Participants	6
Median (Full Range) [hr]	1.52

7. Secondary Outcome

Title	Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)
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

Outcome Measure Data

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)
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.
Measure Participants	6
Mean (Standard Deviation) [hr]	2.97 (1.95)

8. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of Gemcitabine
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

Outcome Measure Data

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)
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.
Measure Participants	5
Mean (Standard Deviation) [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
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

Outcome Measure Data

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)
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.
Measure Participants	5
Mean (Standard Deviation) [ng*hr/mL]	13656.00 (4142.16)

10. Secondary Outcome

Title	Plasma Decay Half-life (t1/2) of Gemcitabine
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

Outcome Measure Data

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)
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.
Measure Participants	5
Mean (Standard Deviation) [hr]	0.310 (0.028)

11. Secondary Outcome

Title	Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2
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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Percentage of Participants With Overall Response (OR)
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

Outcome Measure Data

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
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.
Measure Participants	69	34
Number (95% Confidence Interval) [Percentage of Participants]	7.2 90%	2.9 4.2%

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
Statistical Test of Hypothesis	p-Value	0.661
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Difference in response rate
	Estimated Value	4.3
	Confidence Interval	(2-Sided) 95%; -4.0 to 12.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Duration of Response (DR)
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

Outcome Measure Data

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
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.
Measure Participants	5	1
Median (95% Confidence Interval) [Days]	379	155

14. Secondary Outcome

Title	Progression-free Survival (PFS)
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

Outcome Measure Data

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
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.
Measure Participants	69	34
Number (95% Confidence Interval) [Days]	116	113

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
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
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.9648
	Confidence Interval	(2-Sided) 95%; 0.5400 to 1.7300
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	One Year Survival Probability
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

Outcome Measure Data

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
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.
Measure Participants	69	34
Number (95% Confidence Interval) [Percent chance of survival]	36.81	23.53

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
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).

Outcome Measure Data

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

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-8.44
	Confidence Interval	(2-Sided) 95%; -19.06 to 2.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.02
	Confidence Interval	(2-Sided) 95%; -15.4 to 3.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-9.32
	Confidence Interval	(2-Sided) 95%; -23.77 to 5.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.73
	Confidence Interval	(2-Sided) 95%; -15.25 to 5.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.11
	Confidence Interval	(2-Sided) 95%; -15.83 to 5.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.33
	Confidence Interval	(2-Sided) 95%; -18.72 to 12.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10.41
	Confidence Interval	(2-Sided) 95%; -1.62 to 22.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.30
	Confidence Interval	(2-Sided) 95%; -16.55 to 7.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.37
	Confidence Interval	(2-Sided) 95%; -7.57 to 22.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.51
	Confidence Interval	(2-Sided) 95%; -1.28 to 26.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.90
	Confidence Interval	(2-Sided) 95%; -5.70 to 25.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	13.63
	Confidence Interval	(2-Sided) 95%; -4.81 to 32.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.67
	Confidence Interval	(2-Sided) 95%; -11.62 to 20.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.28
	Confidence Interval	(2-Sided) 95%; -15.1 to 12.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.43
	Confidence Interval	(2-Sided) 95%; -4.67 to 15.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-15.83
	Confidence Interval	(2-Sided) 95%; -32.34 to 0.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.58
	Confidence Interval	(2-Sided) 95%; -24.12 to 0.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-18.65
	Confidence Interval	(2-Sided) 95%; -35.47 to -1.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-13.92
	Confidence Interval	(2-Sided) 95%; -29.16 to 1.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.10
	Confidence Interval	(2-Sided) 95%; -20.97 to 6.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-9.62
	Confidence Interval	(2-Sided) 95%; -28.28 to 9.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.14
	Confidence Interval	(2-Sided) 95%; -1.27 to 33.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.80
	Confidence Interval	(2-Sided) 95%; -18.78 to 15.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.59
	Confidence Interval	(2-Sided) 95%; -3.22 to 36.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10.39
	Confidence Interval	(2-Sided) 95%; -5.68 to 26.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.59
	Confidence Interval	(2-Sided) 95%; -20.19 to 23.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.24
	Confidence Interval	(2-Sided) 95%; -7.62 to 40.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.76
	Confidence Interval	(2-Sided) 95%; -17.49 to 23.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.87
	Confidence Interval	(2-Sided) 95%; -16.29 to 22.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.56
	Confidence Interval	(2-Sided) 95%; -9.81 to 20.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.97
	Confidence Interval	(2-Sided) 95%; -19.52 to 7.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.64
	Confidence Interval	(2-Sided) 95%; -19.75 to 8.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-17.53
	Confidence Interval	(2-Sided) 95%; -39.11 to 4.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-12.25
	Confidence Interval	(2-Sided) 95%; -26.5 to 2.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.99
	Confidence Interval	(2-Sided) 95%; -23.13 to 9.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.09
	Confidence Interval	(2-Sided) 95%; -30.48 to 16.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10.88
	Confidence Interval	(2-Sided) 95%; -5.86 to 27.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.10
	Confidence Interval	(2-Sided) 95%; -24.11 to 1.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.13
	Confidence Interval	(2-Sided) 95%; -24.26 to 14.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.13
	Confidence Interval	(2-Sided) 95%; -14.18 to 24.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.33
	Confidence Interval	(2-Sided) 95%; -26.25 to 13.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.03
	Confidence Interval	(2-Sided) 95%; -15.26 to 33.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 95%; -25.71 to 26.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.97
	Confidence Interval	(2-Sided) 95%; -24.07 to 28.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.48
	Confidence Interval	(2-Sided) 95%; -5.89 to 24.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-20.01
	Confidence Interval	(2-Sided) 95%; -43.19 to 3.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-8.57
	Confidence Interval	(2-Sided) 95%; -27.24 to 10.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-16.07
	Confidence Interval	(2-Sided) 95%; -41.10 to 8.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-24.11
	Confidence Interval	(2-Sided) 95%; -42.72 to -5.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-9.52
	Confidence Interval	(2-Sided) 95%; -29.66 to 10.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-20.24
	Confidence Interval	(2-Sided) 95%; -47.93 to 7.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	25.00
	Confidence Interval	(2-Sided) 95%; 3.23 to 46.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.25
	Confidence Interval	(2-Sided) 95%; -13.49 to 25.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	19.64
	Confidence Interval	(2-Sided) 95%; -7.12 to 46.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	22.02
	Confidence Interval	(2-Sided) 95%; 0.38 to 43.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10.12
	Confidence Interval	(2-Sided) 95%; -18.49 to 38.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	20.83
	Confidence Interval	(2-Sided) 95%; -13.98 to 55.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.90
	Confidence Interval	(2-Sided) 95%; -19.02 to 42.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.90
	Confidence Interval	(2-Sided) 95%; -16.13 to 39.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -23.38 to 23.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-8.66
	Confidence Interval	(2-Sided) 95%; -34.53 to 17.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-12.98
	Confidence Interval	(2-Sided) 95%; -52.01 to 26.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-26.32
	Confidence Interval	(2-Sided) 95%; -71.87 to 19.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.14
	Confidence Interval	(2-Sided) 95%; -26.59 to 14.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.99
	Confidence Interval	(2-Sided) 95%; -35.46 to 11.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	14.04
	Confidence Interval	(2-Sided) 95%; -20.97 to 49.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	23.39
	Confidence Interval	(2-Sided) 95%; -15.83 to 62.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.95
	Confidence Interval	(2-Sided) 95%; -30.84 to 38.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	24.56
	Confidence Interval	(2-Sided) 95%; -13.08 to 62.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.85
	Confidence Interval	(2-Sided) 95%; -38.65 to 34.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.65
	Confidence Interval	(2-Sided) 95%; -37.43 to 56.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	13.16
	Confidence Interval	(2-Sided) 95%; -71.22 to 97.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	22.81
	Confidence Interval	(2-Sided) 95%; -22.61 to 68.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.75
	Confidence Interval	(2-Sided) 95%; -39.10 to 35.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	23.98
	Confidence Interval	(2-Sided) 95%; 1.09 to 46.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.04
	Confidence Interval	(2-Sided) 95%; -39.03 to 63.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	18.89
	Confidence Interval	(2-Sided) 95%; -20.74 to 58.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-48.33
	Confidence Interval	(2-Sided) 95%; -111.94 to 15.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.93
	Confidence Interval	(2-Sided) 95%; -22.59 to 20.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.22
	Confidence Interval	(2-Sided) 95%; -24.98 to 39.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10.00
	Confidence Interval	(2-Sided) 95%; -57.71 to 77.71
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-17.04
	Confidence Interval	(2-Sided) 95%; -58.87 to 24.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-15.00
	Confidence Interval	(2-Sided) 95%; -43.10 to 13.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.78
	Confidence Interval	(2-Sided) 95%; -41.75 to 57.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-16.67
	Confidence Interval	(2-Sided) 95%; -53.79 to 20.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-21.11
	Confidence Interval	(2-Sided) 95%; -73.14 to 30.92
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-32.22
	Confidence Interval	(2-Sided) 95%; -115.58 to 51.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	53.33
	Confidence Interval	(2-Sided) 95%; -18.60 to 125.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.33
	Confidence Interval	(2-Sided) 95%; -34.92 to 41.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.67
	Confidence Interval	(2-Sided) 95%; -34.3 to 20.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	20.83
	Confidence Interval	(2-Sided) 95%; -58.94 to 100.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.33
	Confidence Interval	(2-Sided) 95%; -44.54 to 63.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	20.00
	Confidence Interval	(2-Sided) 95%; -35.30 to 75.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.50
	Confidence Interval	(2-Sided) 95%; -51.66 to 36.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.67
	Confidence Interval	(2-Sided) 95%; -36.06 to 69.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.00
	Confidence Interval	(2-Sided) 95%; -76.36 to 86.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-17.78
	Confidence Interval	(2-Sided) 95%; -77.63 to 42.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-16.67
	Confidence Interval	(2-Sided) 95%; -62.33 to 28.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.33
	Confidence Interval	(2-Sided) 95%; -79.59 to 96.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-18.52
	Confidence Interval	(2-Sided) 95%; -89.98 to 52.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-20.00
	Confidence Interval	(2-Sided) 95%; -133.08 to 93.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-36.67
	Confidence Interval	(2-Sided) 95%; -151.27 to 77.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.33
	Confidence Interval	(2-Sided) 95%; -72.58 to 65.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	73.33
	Confidence Interval	(2-Sided) 95%; -16.45 to 163.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.33
	Confidence Interval	(2-Sided) 95%; -48.23 to 41.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	15.62
	Confidence Interval	(2-Sided) 95%; -74.75 to 106.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	33.33
	Confidence Interval	(2-Sided) 95%; -17.22 to 83.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.17
	Confidence Interval	(2-Sided) 95%; -58.04 to 66.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.21
	Confidence Interval	(2-Sided) 95%; -28.19 to 38.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	31.25
	Confidence Interval	(2-Sided) 95%; -40.94 to 103.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	27.08
	Confidence Interval	(2-Sided) 95%; -91.02 to 145.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-15.28
	Confidence Interval	(2-Sided) 95%; -99.46 to 68.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-25.00
	Confidence Interval	(2-Sided) 95%; -69.69 to 19.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -77.40 to 77.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-14.29
	Confidence Interval	(2-Sided) 95%; -82.89 to 54.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.17
	Confidence Interval	(2-Sided) 95%; -87.02 to 78.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-25.00
	Confidence Interval	(2-Sided) 95%; -184.57 to 134.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-8.33
	Confidence Interval	(2-Sided) 95%; -105.73 to 89.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	79.17
	Confidence Interval	(2-Sided) 95%; -29.72 to 188.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.17
	Confidence Interval	(2-Sided) 95%; -57.74 to 49.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.67
	Confidence Interval	(2-Sided) 95%; -39.62 to 72.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	27.62
	Confidence Interval	(2-Sided) 95%; -6.42 to 61.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	26.19
	Confidence Interval	(2-Sided) 95%; -29.28 to 81.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.57
	Confidence Interval	(2-Sided) 95%; -63.74 to 56.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	23.81
	Confidence Interval	(2-Sided) 95%; -31.66 to 79.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	28.57
	Confidence Interval	(2-Sided) 95%; -53.82 to 110.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-30.16
	Confidence Interval	(2-Sided) 95%; -94.53 to 34.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-16.67
	Confidence Interval	(2-Sided) 95%; -83.26 to 49.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.76
	Confidence Interval	(2-Sided) 95%; -97.98 to 88.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.11
	Confidence Interval	(2-Sided) 95%; -86.68 to 64.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.76
	Confidence Interval	(2-Sided) 95%; -55.41 to 64.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-9.52
	Confidence Interval	(2-Sided) 95%; -129.86 to 110.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-19.05
	Confidence Interval	(2-Sided) 95%; -117.92 to 79.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	76.19
	Confidence Interval	(2-Sided) 95%; -6.75 to 159.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.76
	Confidence Interval	(2-Sided) 95%; -64.93 to 55.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-5.56
	Confidence Interval	(2-Sided) 95%; -271.74 to 260.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	15.56
	Confidence Interval	(2-Sided) 95%; -166.87 to 197.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	27.78
	Confidence Interval	(2-Sided) 95%; -238.4 to 293.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-16.67
	Confidence Interval	(2-Sided) 95%; -275.22 to 241.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.56
	Confidence Interval	(2-Sided) 95%; -307.94 to 319.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	27.78
	Confidence Interval	(2-Sided) 95%; -238.40 to 293.96
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	14.81
	Confidence Interval	(2-Sided) 95%; -215.01 to 244.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.11
	Confidence Interval	(2-Sided) 95%; -302.38 to 324.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	38.89
	Confidence Interval	(2-Sided) 95%; -305.85 to 383.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.11
	Confidence Interval	(2-Sided) 95%; -355.85 to 333.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	22.22
	Confidence Interval	(2-Sided) 95%; -322.52 to 366.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	44.44
	Confidence Interval	(2-Sided) 95%; -208.53 to 297.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -165.61 to 165.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	77.78
	Confidence Interval	(2-Sided) 95%; -17.84 to 173.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.11
	Confidence Interval	(2-Sided) 95%; -106.73 to 84.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-54.17
	Confidence Interval	(2-Sided) 95%; -512.66 to 404.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-70.00
	Confidence Interval	(2-Sided) 95%; -143.36 to 3.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-33.33
	Confidence Interval	(2-Sided) 95%; -400.13 to 333.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-41.67
	Confidence Interval	(2-Sided) 95%; -591.86 to 508.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-66.67
	Confidence Interval	(2-Sided) 95%; -66.67 to -66.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-83.33
	Confidence Interval	(2-Sided) 95%; -450.13 to 283.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	66.67
	Confidence Interval	(2-Sided) 95%; -177.86 to 311.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	33.33
	Confidence Interval	(2-Sided) 95%; -333.46 to 400.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	25.00
	Confidence Interval	(2-Sided) 95%; -1258.79 to 1308.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	83.33
	Confidence Interval	(2-Sided) 95%; -283.46 to 450.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	33.33
	Confidence Interval	(2-Sided) 95%; -700.26 to 766.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	50.00
	Confidence Interval	(2-Sided) 95%; -1050.39 to 1150.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-16.67
	Confidence Interval	(2-Sided) 95%; -1850.65 to 1817.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	33.33
	Confidence Interval	(2-Sided) 95%; -700.26 to 766.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-16.67
	Confidence Interval	(2-Sided) 95%; -383.46 to 350.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
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).

Outcome Measure Data

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
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.
Measure Participants	59	27
Pancreatic Pain: Baseline	37.52 (27.88)	38.89 (21.18)
Eating Related Items: Baseline	40.40 (35.18)	33.95 (27.92)
Altered Bowel Habits: Baseline	22.32 (26.19)	25.31 (28.26)
Jaundice: Baseline	9.89 (18.34)	15.38 (23.06)
Body Image: Baseline	31.64 (29.80)	26.54 (25.84)
Health Care Satisfaction: Baseline	79.38 (27.57)	69.75 (25.33)
Sexual Functioning: Baseline	44.35 (34.42)	57.97 (37.56)
Ascites: Baseline	37.29 (31.00)	25.93 (25.04)
Indigestion: Baseline	24.86 (28.09)	30.86 (34.50)
Flatulence: Baseline	35.59 (32.67)	39.51 (29.29)
Cachexia: Baseline	33.62 (25.43)	31.48 (23.72)
Side Effects: Baseline	27.78 (24.80)	27.35 (21.77)
Fear of Future Health: Baseline	63.22 (31.03)	59.26 (33.76)
Ability to Plan Future: Baseline	39.55 (35.27)	41.98 (36.51)
Pancreatic Pain: Change at C2 D1	-11.05 (25.39)	-13.64 (22.05)
Eating Related Items: Change at C2 D1	-0.38 (34.19)	-3.79 (27.67)
Altered Bowel Habits: Change at C2 D1	8.33 (28.19)	-11.36 (22.05)
Jaundice: Change at C2 D1	0.00 (20.65)	-12.70 (25.22)
Body Image: Change at C2 D1	7.95 (26.53)	-7.14 (25.04)
Health Care Satisfaction: Change at C2 D1	0.39 (34.60)	-3.97 (37.60)
Sexual Functioning: Change at C2 D1	-2.56 (22.14)	18.63 (38.59)
Ascites: Change at C2 D1	-10.85 (36.89)	-3.03 (22.79)
Indigestion: Change at C2 D1	-4.65 (24.75)	-10.61 (37.64)
Flatulence: Change at C2 D1	5.30 (34.43)	-9.09 (21.04)
Cachexia: Change at C2 D1	9.47 (19.15)	-3.03 (17.55)
Side Effects: Change at C2 D1	7.70 (16.39)	-3.17 (20.90)
Fear of Future Health: Change at C2 D1	-2.33 (23.45)	0.00 (31.62)
Ability to Plan Future: Change at C2 D1	4.55 (35.65)	-1.67 (27.52)
Pancreatic Pain: Change at C3 D1	-8.92 (24.62)	-23.78 (20.61)
Eating Related Items: Change at C3 D1	3.07 (37.34)	-10.42 (28.46)
Altered Bowel Habits: Change at C3 D1	10.53 (31.34)	-8.33 (31.03)
Jaundice: Change at C3 D1	2.19 (13.52)	-9.38 (26.51)
Body Image: Change at C3 D1	13.51 (30.89)	-5.21 (29.01)
Health Care Satisfaction: Change at C3 D1	-5.41 (40.07)	5.21 (24.88)
Sexual Functioning: Change at C3 D1	-3.13 (21.77)	-4.44 (31.79)
Ascites: Change at C3 D1	-2.63 (28.35)	-4.17 (23.96)
Indigestion: Change at C3 D1	-4.50 (34.39)	-15.56 (37.52)
Flatulence: Change at C3 D1	9.65 (37.09)	6.25 (27.81)
Cachexia: Change at C3 D1	14.47 (24.56)	5.21 (17.97)
Side Effects: Change at C3 D1	11.55 (27.41)	-7.64 (26.28)
Fear of Future Health: Change at C3 D1	-2.86 (34.65)	-2.22 (42.66)
Ability to Plan Future: Change at C3 D1	9.01 (43.50)	-12.50 (34.16)
Pancreatic Pain: Change at C4 D1	-18.30 (26.90)	-14.10 (22.92)
Eating Related Items: Change at C4 D1	-7.47 (26.57)	5.13 (36.88)
Altered Bowel Habits: Change at C4 D1	16.09 (35.21)	3.85 (28.99)
Jaundice: Change at C4 D1	1.72 (19.59)	-11.11 (16.41)
Body Image: Change at C4 D1	12.82 (31.02)	8.97 (26.01)
Health Care Satisfaction: Change at C4 D1	-1.92 (49.51)	-8.97 (29.36)
Sexual Functioning: Change at C4 D1	-5.30 (27.88)	-2.78 (40.72)
Ascites: Change at C4 D1	-6.90 (25.79)	2.56 (28.74)
Indigestion: Change at C4 D1	-9.52 (33.77)	-2.56 (37.17)
Flatulence: Change at C4 D1	1.15 (39.32)	-2.56 (25.32)
Cachexia: Change at C4 D1	9.20 (29.07)	-3.85 (24.68)
Side Effects: Change at C4 D1	11.88 (28.59)	-3.24 (19.88)
Fear of Future Health: Change at C4 D1	-2.78 (41.61)	5.13 (38.12)
Ability to Plan Future: Change at C4 D1	10.26 (53.97)	-5.13 (46.84)
Pancreatic Pain: Change at C5 D1	-7.26 (27.99)	-18.52 (24.22)
Eating Related Items: Change at C5 D1	0.00 (45.22)	-7.41 (26.50)
Altered Bowel Habits: Change at C5 D1	13.46 (30.92)	-14.81 (29.40)
Jaundice: Change at C5 D1	3.85 (19.04)	-20.37 (36.11)
Body Image: Change at C5 D1	14.00 (28.74)	-11.11 (39.97)
Health Care Satisfaction: Change at C5 D1	-2.67 (51.52)	7.41 (34.47)
Sexual Functioning: Change at C5 D1	-1.75 (20.71)	1.85 (24.22)
Ascites: Change at C5 D1	-5.13 (24.39)	-11.11 (40.82)
Indigestion: Change at C5 D1	-3.85 (28.79)	-25.93 (49.38)
Flatulence: Change at C5 D1	-1.33 (28.02)	-11.11 (40.82)
Cachexia: Change at C5 D1	10.26 (36.84)	-5.56 (18.63)
Side Effects: Change at C5 D1	10.04 (28.55)	-11.73 (17.22)
Fear of Future Health: Change at C5 D1	0.00 (35.44)	14.81 (29.40)
Ability to Plan Future: Change at C5 D1	20.00 (41.94)	-11.11 (16.67)
Pancreatic Pain: Change at C6 D1	-3.76 (24.06)	-12.50 (30.81)
Eating Related Items: Change at C6 D1	-4.90 (50.95)	8.33 (21.52)
Altered Bowel Habits: Change at C6 D1	13.73 (25.16)	-8.33 (28.87)
Jaundice: Change at C6 D1	1.96 (11.61)	-16.67 (45.13)
Body Image: Change at C6 D1	23.96 (31.60)	0.00 (0.00)
Health Care Satisfaction: Change at C6 D1	-11.46 (42.04)	-25.00 (21.52)
Sexual Functioning: Change at C6 D1	-7.69 (30.14)	-20.83 (49.77)
Ascites: Change at C6 D1	-1.96 (24.92)	-8.33 (31.91)
Indigestion: Change at C6 D1	3.92 (35.12)	-16.67 (19.25)
Flatulence: Change at C6 D1	1.96 (27.56)	-8.33 (16.67)
Cachexia: Change at C6 D1	4.90 (31.05)	-20.83 (15.96)
Side Effects: Change at C6 D1	16.34 (30.40)	-22.22 (15.71)
Fear of Future Health: Change at C6 D1	-4.44 (45.19)	0.00 (0.00)
Ability to Plan Future: Change at C6 D1	12.50 (54.26)	16.67 (63.83)
Pancreatic Pain: Change at C7 D1	-3.70 (22.09)	-16.67 (11.79)
Eating Related Items: Change at C7 D1	-14.81 (31.67)	8.33 (11.79)
Altered Bowel Habits: Change at C7 D1	5.56 (23.57)	25.00 (58.93)
Jaundice: Change at C7 D1	5.56 (11.79)	-41.67 (58.93)
Body Image: Change at C7 D1	16.67 (41.67)	-25.00 (58.93)
Health Care Satisfaction: Change at C7 D1	5.56 (26.35)	-33.33 (0.00)
Sexual Functioning: Change at C7 D1	-9.52 (18.90)	-41.67 (11.79)
Ascites: Change at C7 D1	0.00 (0.00)	0.00 (0.00)
Indigestion: Change at C7 D1	-7.41 (22.22)	0.00 (0.00)
Flatulence: Change at C7 D1	-3.70 (30.93)	-16.67 (23.57)
Cachexia: Change at C7 D1	5.56 (25.00)	-8.33 (35.36)
Side Effects: Change at C7 D1	8.64 (25.93)	-22.22 (31.43)
Fear of Future Health: Change at C7 D1	4.17 (27.82)	-16.67 (70.71)
Ability to Plan Future: Change at C7 D1	14.81 (55.56)	33.33 (47.14)
Pancreatic Pain: Change at C8 D1	-1.54 (25.99)	-25.00 (NA)
Eating Related Items: Change at C8 D1	3.70 (48.43)	16.67 (NA)
Altered Bowel Habits: Change at C8 D1	14.81 (22.74)	-33.33 (NA)
Jaundice: Change at C8 D1	9.26 (12.11)	-83.33 (NA)
Body Image: Change at C8 D1	22.22 (37.27)	16.67 (NA)
Health Care Satisfaction: Change at C8 D1	3.70 (27.36)	-33.33 (NA)
Sexual Functioning: Change at C8 D1	-7.14 (13.11)	0.00 (NA)
Ascites: Change at C8 D1	-3.70 (26.06)	0.00 (NA)
Indigestion: Change at C8 D1	-7.41 (40.06)	0.00 (NA)
Flatulence: Change at C8 D1	-11.11 (33.33)	-33.33 (NA)
Cachexia: Change at C8 D1	11.11 (26.35)	-16.67 (NA)
Side Effects: Change at C8 D1	11.11 (35.14)	0.00 (NA)
Fear of Future Health: Change at C8 D1	4.17 (45.21)	33.33 (NA)
Ability to Plan Future: Change at C8 D1	11.11 (64.55)	66.67 (NA)
Pancreatic Pain: Change at C9 D1	0.00 (30.43)	-16.67 (NA)
Eating Related Items: Change at C9 D1	14.29 (39.00)	0.00 (NA)
Altered Bowel Habits: Change at C9 D1	23.81 (25.20)	-50.00 (NA)
Jaundice: Change at C9 D1	9.52 (16.27)	-66.67 (NA)
Body Image: Change at C9 D1	28.57 (35.63)	0.00 (NA)
Health Care Satisfaction: Change at C9 D1	2.38 (24.40)	-33.33 (NA)
Sexual Functioning: Change at C9 D1	-13.33 (29.81)	0.00 (NA)
Ascites: Change at C9 D1	-11.11 (34.43)	33.33 (NA)
Indigestion: Change at C9 D1	4.76 (35.63)	0.00 (NA)
Flatulence: Change at C9 D1	14.29 (26.23)	0.00 (NA)
Cachexia: Change at C9 D1	23.81 (34.50)	0.00 (NA)
Side Effects: Change at C9 D1	31.75 (33.60)	0.00 (NA)
Fear of Future Health: Change at C9 D1	-16.67 (40.82)	33.33 (NA)
Ability to Plan Future: Change at C9 D1	19.05 (42.41)	33.33 (NA)
Pancreatic Pain: Change at C10 D1	8.33 (25.28)	-16.67 (NA)
Eating Related Items: Change at C10 D1	25.00 (25.28)	0.00 (NA)
Altered Bowel Habits: Change at C10 D1	27.78 (22.77)	-50.00 (NA)
Jaundice: Change at C10 D1	2.78 (16.39)	-83.33 (NA)
Body Image: Change at C10 D1	25.00 (29.34)	0.00 (NA)
Health Care Satisfaction: Change at C10 D1	13.89 (30.58)	-33.33 (NA)
Sexual Functioning: Change at C10 D1	-13.33 (29.81)	-33.33 (NA)
Ascites: Change at C10 D1	0.00 (21.08)	33.33 (NA)
Indigestion: Change at C10 D1	27.78 (25.09)	0.00 (NA)
Flatulence: Change at C10 D1	16.67 (18.26)	0.00 (NA)
Cachexia: Change at C10 D1	25.00 (39.09)	16.67 (NA)
Side Effects: Change at C10 D1	37.04 (28.69)	11.11 (NA)
Fear of Future Health: Change at C10 D1	0.00 (0.00)	33.33 (NA)
Ability to Plan Future: Change at C10 D1	33.33 (42.16)	33.33 (NA)
Pancreatic Pain: Change at C11 D1	5.56 (47.39)	-8.33 (NA)
Eating Related Items: Change at C11 D1	38.89 (53.58)	33.33 (NA)
Altered Bowel Habits: Change at C11 D1	50.00 (44.10)	-16.67 (NA)
Jaundice: Change at C11 D1	16.67 (44.10)	-83.33 (NA)
Body Image: Change at C11 D1	50.00 (44.10)	16.67 (NA)
Health Care Satisfaction: Change at C11 D1	27.78 (25.46)	-16.67 (NA)
Sexual Functioning: Change at C11 D1	-33.33 (47.14)	-33.33 (NA)
Ascites: Change at C11 D1	22.22 (38.49)	33.33 (NA)
Indigestion: Change at C11 D1	11.11 (19.25)	0.00 (NA)
Flatulence: Change at C11 D1	11.11 (19.25)	0.00 (NA)
Cachexia: Change at C11 D1	55.56 (25.46)	16.67 (NA)
Side Effects: Change at C11 D1	55.56 (50.92)	11.11 (NA)
Fear of Future Health: Change at C11 D1	0.00 (0.00)	33.33 (NA)
Ability to Plan Future: Change at C11 D1	44.44 (50.92)	66.67 (NA)
Pancreatic Pain: Change at C12 D1	-5.56 (20.97)
Eating Related Items: Change at C12 D1	16.67 (16.67)
Altered Bowel Habits: Change at C12 D1	27.78 (34.69)
Jaundice: Change at C12 D1	0.00 (0.00)
Body Image: Change at C12 D1	16.67 (16.67)
Health Care Satisfaction: Change at C12 D1	-5.56 (41.94)
Sexual Functioning: Change at C12 D1	0.00 (66.67)
Ascites: Change at C12 D1	-22.22 (19.25)
Indigestion: Change at C12 D1	0.00 (0.00)
Flatulence: Change at C12 D1	0.00 (0.00)
Cachexia: Change at C12 D1	33.33 (28.87)
Side Effects: Change at C12 D1(n=3,0)	33.33 (40.06)
Fear of Future Health: Change at C12 D1	0.00 (0.00)
Ability to Plan Future: Change at C12 D1	0.00 (0.00)
Pancreatic Pain: Change at C13 D1	20.83 (5.89)
Eating Related Items: Change at C13 D1	58.33 (58.93)
Altered Bowel Habits: Change at C13 D1	8.33 (11.79)
Jaundice: Change at C13 D1	25.00 (35.36)
Body Image: Change at C13 D1	41.67 (58.93)
Health Care Satisfaction: Change at C13 D1	-16.67 (23.57)
Sexual Functioning: Change at C13 D1	-50.00 (23.57)
Ascites: Change at C13 D1	16.67 (23.57)
Indigestion: Change at C13 D1	0.00 (0.00)
Flatulence: Change at C13 D1	16.67 (23.57)
Cachexia: Change at C13 D1	33.33 (47.14)
Side Effects: Change at C13 D1	16.67 (7.86)
Fear of Future Health: Change at C13 D1	0.00 (0.00)
Ability to Plan Future: Change at C13 D1	16.67 (23.57)
Pancreatic Pain: Change at C14 D1	-8.33 (NA)
Eating Related Items: Change at C14 D1	16.67 (NA)
Altered Bowel Habits: Change at C14 D1	33.33 (NA)
Jaundice: Change at C14 D1	33.33 (NA)
Body Image: Change at C14 D1	33.33 (NA)
Health Care Satisfaction: Change at C14 D1	0.00 (NA)
Sexual Functioning: Change at C14 D1	-33.33 (NA)
Ascites: Change at C14 D1	0.00 (NA)
Indigestion: Change at C14 D1	0.00 (NA)
Flatulence: Change at C14 D1	33.33 (NA)
Cachexia: Change at C14 D1	50.00 (NA)
Side Effects: Change at C14 D1	0.00 (NA)
Fear of Future Health: Change at C14 D1	0.00 (NA)
Ability to Plan Future: Change at C14 D1	0.00 (NA)
Pancreatic Pain: Change at EoS	58.33 (35.36)	0.00 (NA)
Eating Related Items: Change at EoS	25.00 (82.50)	0.00 (NA)
Altered Bowel Habits: Change at EoS	83.33 (23.57)	0.00 (NA)
Jaundice: Change at EoS	8.33 (11.79)	0.00 (NA)
Body Image: Change at EoS	66.67 (0.00)	-16.67 (NA)
Health Care Satisfaction: Change at EoS	0.00 (NA)	33.33 (NA)
Sexual Functioning: Change at EoS	0.00 (NA)	33.33 (NA)
Ascites: Change at EoS	33.33 (47.14)	33.33 (NA)
Indigestion: Change at EoS	33.33 (47.14)	33.33 (NA)
Flatulence: Change at EoS	83.33 (23.57)	0.00 (NA)
Cachexia: Change at EoS	66.67 (0.00)	0.00 (NA)
Side Effects: Change at EoS	19.44 (90.35)	-11.11 (NA)
Fear of Future Health: Change at EoS	33.33 (NA)	-33.33 (NA)
Ability to Plan Future: Change at EoS	66.67 (NA)	33.33 (NA)

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.59
	Confidence Interval	(2-Sided) 95%; -10.11 to 15.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.41
	Confidence Interval	(2-Sided) 95%; -13.39 to 20.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	19.70
	Confidence Interval	(2-Sided) 95%; 5.96 to 33.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.70
	Confidence Interval	(2-Sided) 95%; 0.93 to 24.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	15.10
	Confidence Interval	(2-Sided) 95%; 1.28 to 28.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.36
	Confidence Interval	(2-Sided) 95%; -14.59 to 23.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-21.19
	Confidence Interval	(2-Sided) 95%; -37.53 to -4.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.82
	Confidence Interval	(2-Sided) 95%; -25.04 to 9.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.95
	Confidence Interval	(2-Sided) 95%; -9.59 to 21.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	14.39
	Confidence Interval	(2-Sided) 95%; -1.61 to 30.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.50
	Confidence Interval	(2-Sided) 95%; 2.78 to 22.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10.88
	Confidence Interval	(2-Sided) 95%; 1.36 to 20.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.33
	Confidence Interval	(2-Sided) 95%; -16.36 to 11.71
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.21
	Confidence Interval	(2-Sided) 95%; -11.78 to 24.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	14.87
	Confidence Interval	(2-Sided) 95%; 0.79 to 28.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	13.49
	Confidence Interval	(2-Sided) 95%; -7.45 to 34.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	18.86
	Confidence Interval	(2-Sided) 95%; 0.17 to 37.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.57
	Confidence Interval	(2-Sided) 95%; 0.66 to 22.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	18.72
	Confidence Interval	(2-Sided) 95%; 0.49 to 36.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-10.61
	Confidence Interval	(2-Sided) 95%; -32.40 to 11.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.32
	Confidence Interval	(2-Sided) 95%; -14.63 to 17.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.54
	Confidence Interval	(2-Sided) 95%; -14.70 to 17.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.05
	Confidence Interval	(2-Sided) 95%; -10.65 to 32.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.40
	Confidence Interval	(2-Sided) 95%; -17.33 to 24.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.27
	Confidence Interval	(2-Sided) 95%; -4.40 to 22.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	19.19
	Confidence Interval	(2-Sided) 95%; 2.99 to 35.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.63
	Confidence Interval	(2-Sided) 95%; -23.70 to 22.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	21.51
	Confidence Interval	(2-Sided) 95%; -3.10 to 46.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.19
	Confidence Interval	(2-Sided) 95%; -21.57 to 13.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-12.60
	Confidence Interval	(2-Sided) 95%; -32.86 to 7.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.25
	Confidence Interval	(2-Sided) 95%; -10.33 to 34.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.84
	Confidence Interval	(2-Sided) 95%; -0.18 to 25.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.85
	Confidence Interval	(2-Sided) 95%; -16.45 to 24.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.05
	Confidence Interval	(2-Sided) 95%; -23.23 to 37.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.53
	Confidence Interval	(2-Sided) 95%; -26.55 to 21.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-9.46
	Confidence Interval	(2-Sided) 95%; -27.48 to 8.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.96
	Confidence Interval	(2-Sided) 95%; -30.62 to 16.70
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.71
	Confidence Interval	(2-Sided) 95%; -20.37 to 27.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	13.04
	Confidence Interval	(2-Sided) 95%; -5.73 to 31.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	15.12
	Confidence Interval	(2-Sided) 95%; -3.23 to 33.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.91
	Confidence Interval	(2-Sided) 95%; -36.18 to 20.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	15.38
	Confidence Interval	(2-Sided) 95%; -20.24 to 51.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.25
	Confidence Interval	(2-Sided) 95%; -10.09 to 32.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.41
	Confidence Interval	(2-Sided) 95%; -25.22 to 40.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	28.28
	Confidence Interval	(2-Sided) 95%; 4.23 to 52.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	24.22
	Confidence Interval	(2-Sided) 95%; 5.09 to 43.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	25.11
	Confidence Interval	(2-Sided) 95%; -0.16 to 50.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-10.07
	Confidence Interval	(2-Sided) 95%; -47.95 to 27.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.61
	Confidence Interval	(2-Sided) 95%; -21.78 to 14.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.98
	Confidence Interval	(2-Sided) 95%; -17.02 to 28.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	22.08
	Confidence Interval	(2-Sided) 95%; -5.39 to 49.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.78
	Confidence Interval	(2-Sided) 95%; -15.33 to 34.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	15.81
	Confidence Interval	(2-Sided) 95%; -10.43 to 42.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	21.77
	Confidence Interval	(2-Sided) 95%; 1.11 to 42.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-14.81
	Confidence Interval	(2-Sided) 95%; -41.91 to 12.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	31.11
	Confidence Interval	(2-Sided) 95%; 1.60 to 60.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.74
	Confidence Interval	(2-Sided) 95%; -20.62 to 38.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-13.24
	Confidence Interval	(2-Sided) 95%; -68.52 to 42.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	22.06
	Confidence Interval	(2-Sided) 95%; -7.93 to 52.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	18.63
	Confidence Interval	(2-Sided) 95%; -5.64 to 42.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	23.96
	Confidence Interval	(2-Sided) 95%; -9.93 to 57.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	13.54
	Confidence Interval	(2-Sided) 95%; -32.70 to 59.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	13.14
	Confidence Interval	(2-Sided) 95%; -29.46 to 55.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	6.37
	Confidence Interval	(2-Sided) 95%; -24.04 to 36.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	20.59
	Confidence Interval	(2-Sided) 95%; -17.94 to 59.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	10.29
	Confidence Interval	(2-Sided) 95%; -20.12 to 40.71
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	25.74
	Confidence Interval	(2-Sided) 95%; -8.22 to 59.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	38.56
	Confidence Interval	(2-Sided) 95%; 5.32 to 71.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.44
	Confidence Interval	(2-Sided) 95%; -53.14 to 44.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-4.17
	Confidence Interval	(2-Sided) 95%; -69.90 to 61.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.96
	Confidence Interval	(2-Sided) 95%; -24.52 to 50.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-23.15
	Confidence Interval	(2-Sided) 95%; -76.41 to 30.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-19.44
	Confidence Interval	(2-Sided) 95%; -71.89 to 33.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	47.22
	Confidence Interval	(2-Sided) 95%; 7.31 to 87.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	41.67
	Confidence Interval	(2-Sided) 95%; -36.00 to 119.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	38.89
	Confidence Interval	(2-Sided) 95%; -5.05 to 82.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	32.14
	Confidence Interval	(2-Sided) 95%; -2.09 to 66.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.41
	Confidence Interval	(2-Sided) 95%; -44.46 to 29.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.96
	Confidence Interval	(2-Sided) 95%; -40.45 to 66.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	13.89
	Confidence Interval	(2-Sided) 95%; -32.71 to 60.49
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	30.86
	Confidence Interval	(2-Sided) 95%; -16.16 to 77.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	20.83
	Confidence Interval	(2-Sided) 95%; -44.95 to 86.62
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-18.52
	Confidence Interval	(2-Sided) 95%; -115.22 to 78.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	23.46
	Confidence Interval	(2-Sided) 95%; -39.71 to 86.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-12.96
	Confidence Interval	(2-Sided) 95%; -130.69 to 104.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	48.15
	Confidence Interval	(2-Sided) 95%; -7.12 to 103.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	92.59
	Confidence Interval	(2-Sided) 95%; 63.16 to 122.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.56
	Confidence Interval	(2-Sided) 95%; -85.03 to 96.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	37.04
	Confidence Interval	(2-Sided) 95%; -29.46 to 103.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.14
	Confidence Interval	(2-Sided) 95%; -41.45 to 27.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.70
	Confidence Interval	(2-Sided) 95%; -67.04 to 59.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-7.41
	Confidence Interval	(2-Sided) 95%; -104.79 to 89.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	22.22
	Confidence Interval	(2-Sided) 95%; -58.80 to 103.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	27.78
	Confidence Interval	(2-Sided) 95%; -36.28 to 91.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.11
	Confidence Interval	(2-Sided) 95%; -74.30 to 96.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-29.17
	Confidence Interval	(2-Sided) 95%; -142.55 to 84.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-55.56
	Confidence Interval	(2-Sided) 95%; -212.46 to 101.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.67
	Confidence Interval	(2-Sided) 95%; -62.93 to 96.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	14.29
	Confidence Interval	(2-Sided) 95%; -87.74 to 116.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	73.81
	Confidence Interval	(2-Sided) 95%; 7.90 to 139.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	76.19
	Confidence Interval	(2-Sided) 95%; 33.64 to 118.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	28.57
	Confidence Interval	(2-Sided) 95%; -64.64 to 121.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	35.71
	Confidence Interval	(2-Sided) 95%; -28.11 to 99.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-13.33
	Confidence Interval	(2-Sided) 95%; -104.01 to 77.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-44.44
	Confidence Interval	(2-Sided) 95%; -140.03 to 51.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.76
	Confidence Interval	(2-Sided) 95%; -88.45 to 97.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	14.29
	Confidence Interval	(2-Sided) 95%; -54.32 to 82.89
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	23.81
	Confidence Interval	(2-Sided) 95%; -66.45 to 114.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	31.75
	Confidence Interval	(2-Sided) 95%; -56.14 to 119.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-50.00
	Confidence Interval	(2-Sided) 95%; -163.35 to 63.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-14.29
	Confidence Interval	(2-Sided) 95%; -125.23 to 96.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	25.00
	Confidence Interval	(2-Sided) 95%; -45.18 to 95.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	25.00
	Confidence Interval	(2-Sided) 95%; -45.18 to 95.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	77.78
	Confidence Interval	(2-Sided) 95%; 14.55 to 141.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	86.11
	Confidence Interval	(2-Sided) 95%; 40.61 to 131.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	25.00
	Confidence Interval	(2-Sided) 95%; -56.48 to 106.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	47.22
	Confidence Interval	(2-Sided) 95%; -37.69 to 132.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	20.00
	Confidence Interval	(2-Sided) 95%; -70.68 to 110.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-33.33
	Confidence Interval	(2-Sided) 95%; -91.87 to 25.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	27.78
	Confidence Interval	(2-Sided) 95%; -41.89 to 97.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	16.67
	Confidence Interval	(2-Sided) 95%; -34.03 to 67.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.33
	Confidence Interval	(2-Sided) 95%; -100.19 to 116.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	25.93
	Confidence Interval	(2-Sided) 95%; -53.73 to 105.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -117.07 to 117.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	13.89
	Confidence Interval	(2-Sided) 95%; -221.53 to 249.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	5.56
	Confidence Interval	(2-Sided) 95%; -260.62 to 271.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	66.67
	Confidence Interval	(2-Sided) 95%; -152.41 to 285.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	100.00
	Confidence Interval	(2-Sided) 95%; -119.08 to 319.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	33.33
	Confidence Interval	(2-Sided) 95%; -185.75 to 252.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	44.44
	Confidence Interval	(2-Sided) 95%; -82.04 to 170.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -733.59 to 733.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-11.11
	Confidence Interval	(2-Sided) 95%; -202.34 to 180.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.11
	Confidence Interval	(2-Sided) 95%; -84.50 to 106.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	11.11
	Confidence Interval	(2-Sided) 95%; -84.50 to 106.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	38.89
	Confidence Interval	(2-Sided) 95%; -87.60 to 165.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	44.44
	Confidence Interval	(2-Sided) 95%; -208.53 to 297.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-22.22
	Confidence Interval	(2-Sided) 95%; -275.19 to 230.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	58.33
	Confidence Interval	(2-Sided) 95%; -491.86 to 608.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	25.00
	Confidence Interval	(2-Sided) 95%; -1258.79 to 1308.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	83.33
	Confidence Interval	(2-Sided) 95%; -283.46 to 450.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.33
	Confidence Interval	(2-Sided) 95%; -175.06 to 191.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -733.59 to 733.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -733.59 to 733.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	83.33
	Confidence Interval	(2-Sided) 95%; -283.46 to 450.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	30.56
	Confidence Interval	(2-Sided) 95%; -1375.5 to 1436.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Axitinib + Gemcitabine (Phase 1 Lead-In)		Axitinib + Gemcitabine		Gemcitabine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/8 (37.5%)		35/68 (51.5%)		10/31 (32.3%)
Blood and lymphatic system disorders
Anaemia	1/8 (12.5%)		4/68 (5.9%)		1/31 (3.2%)
Disseminated intravascular coagulation	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Thrombocytopenia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Cardiac disorders
Atrial fibrillation	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Atrial flutter	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Myocardial infarction	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Pericardial effusion	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Tachycardia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Ear and labyrinth disorders
Tinnitus	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Gastrointestinal disorders
Abdominal distension	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Abdominal pain	0/8 (0%)		5/68 (7.4%)		0/31 (0%)
Abdominal pain upper	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Abdominal strangulated hernia	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Colitis ischaemic	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Constipation	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Diarrhoea	0/8 (0%)		3/68 (4.4%)		0/31 (0%)
Duodenal obstruction	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Gastric haemorrhage	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Gastrointestinal haemorrhage	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Haematemesis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Intestinal ischaemia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Intestinal obstruction	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Melaena	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Nausea	0/8 (0%)		2/68 (2.9%)		2/31 (6.5%)
Oral pain	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Peritonitis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Pneumatosis intestinalis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Rectal haemorrhage	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Small intestinal haemorrhage	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Small intestinal obstruction	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Vomiting	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
General disorders
Asthenia	0/8 (0%)		4/68 (5.9%)		0/31 (0%)
Chest pain	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Device occlusion	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Disease progression	0/8 (0%)		6/68 (8.8%)		0/31 (0%)
Fatigue	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
General physical health deterioration	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Pain	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Multi-organ failure	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Pyrexia	0/8 (0%)		1/68 (1.5%)		3/31 (9.7%)
Hepatobiliary disorders
Cholangitis	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Cholestasis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Gallbladder obstruction	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Jaundice cholestatic	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Infections and infestations
Empyema	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Enterobacter bacteraemia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Liver abscess	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Lower respiratory tract infection	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Lung abscess	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Lung infection	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Oral candidiasis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Pneumonia	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Sepsis	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Septic shock	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Infection	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Investigations
Blood pressure increased	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Platelet count decreased	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Metabolism and nutrition disorders
Cachexia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Dehydration	0/8 (0%)		3/68 (4.4%)		2/31 (6.5%)
Failure to thrive	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Hypocalcaemia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Hypokalaemia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Hyponatraemia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Hypophagia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Lactic acidosis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Nervous system disorders
Convulsion	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Headache	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Neuromyopathy	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Syncope	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Transient ischaemic attack	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Psychiatric disorders
Confusional state	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Mental status changes	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Renal and urinary disorders
Renal impairment	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/8 (0%)		6/68 (8.8%)		0/31 (0%)
Epistaxis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Hypoxia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Pneumothorax	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Pulmonary embolism	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Vascular disorders
Deep vein thrombosis	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Post thrombotic syndrome	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Thrombosis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Axitinib + Gemcitabine (Phase 1 Lead-In)		Axitinib + Gemcitabine		Gemcitabine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/8 (87.5%)		67/68 (98.5%)		26/31 (83.9%)
Blood and lymphatic system disorders
Anaemia	4/8 (50%)		16/68 (23.5%)		7/31 (22.6%)
Granulocytopenia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Iron deficiency anaemia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Leukopenia	2/8 (25%)		3/68 (4.4%)		0/31 (0%)
Neutropenia	2/8 (25%)		15/68 (22.1%)		6/31 (19.4%)
Thrombocytopenia	4/8 (50%)		10/68 (14.7%)		2/31 (6.5%)
Thrombocytosis	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Lymphopenia	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Cardiac disorders
Atrial fibrillation	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Cardiogenic shock	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Cyanosis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Pericardial effusion	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Sinus tachycardia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Tachycardia	0/8 (0%)		1/68 (1.5%)		2/31 (6.5%)
Ear and labyrinth disorders
Ear pain	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Tinnitus	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Vertigo	1/8 (12.5%)		1/68 (1.5%)		0/31 (0%)
Eye disorders
Blepharitis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Conjunctivitis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Eyelid oedema	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Photopsia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Vitreous floaters	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Gastrointestinal disorders
Abdominal discomfort	1/8 (12.5%)		0/68 (0%)		2/31 (6.5%)
Abdominal distension	0/8 (0%)		4/68 (5.9%)		1/31 (3.2%)
Abdominal hernia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Abdominal pain	2/8 (25%)		16/68 (23.5%)		8/31 (25.8%)
Abdominal pain upper	1/8 (12.5%)		11/68 (16.2%)		1/31 (3.2%)
Abdominal tenderness	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Aphthous stomatitis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Ascites	1/8 (12.5%)		3/68 (4.4%)		5/31 (16.1%)
Constipation	2/8 (25%)		18/68 (26.5%)		7/31 (22.6%)
Diarrhoea	4/8 (50%)		35/68 (51.5%)		8/31 (25.8%)
Dry mouth	0/8 (0%)		5/68 (7.4%)		1/31 (3.2%)
Duodenal ulcer	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Dyspepsia	0/8 (0%)		9/68 (13.2%)		4/31 (12.9%)
Dysphagia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Flatulence	1/8 (12.5%)		5/68 (7.4%)		2/31 (6.5%)
Gastric Ulcer	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Gastritis	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Gastrointestinal haemorrhage	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Gastrooesophageal reflux disease	2/8 (25%)		1/68 (1.5%)		1/31 (3.2%)
Gingival pain	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Gingival swelling	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Haematochezia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Haemorrhoids	0/8 (0%)		5/68 (7.4%)		0/31 (0%)
Inguinal hernia	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Intestinal haemorrhage	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Lip ulceration	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Mesenteric artery stenosis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Nausea	3/8 (37.5%)		30/68 (44.1%)		15/31 (48.4%)
Oral pain	0/8 (0%)		6/68 (8.8%)		0/31 (0%)
Peptic ulcer haemorrhage	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Proctalgia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Rectal haemorrhage	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Sensitivity of teeth	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Small intestinal obstruction	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Steatorrhoea	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Stomatitis	1/8 (12.5%)		12/68 (17.6%)		2/31 (6.5%)
Tongue coated	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Tongue disorder	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Toothache	2/8 (25%)		2/68 (2.9%)		0/31 (0%)
Vomiting	2/8 (25%)		29/68 (42.6%)		12/31 (38.7%)
General disorders
Adverse drug reaction	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Asthenia	1/8 (12.5%)		22/68 (32.4%)		4/31 (12.9%)
Catheter site pain	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Chest pain	1/8 (12.5%)		5/68 (7.4%)		0/31 (0%)
Chills	0/8 (0%)		5/68 (7.4%)		3/31 (9.7%)
Device occlusion	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Disease progression	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Face oedema	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Fatigue	7/8 (87.5%)		29/68 (42.6%)		10/31 (32.3%)
Feeling cold	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
General physical health deterioration	1/8 (12.5%)		1/68 (1.5%)		0/31 (0%)
Hyperpyrexia	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Influenza like illness	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Infusion related reaction	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Infusion site pain	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Malaise	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Mass	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Mucosal dryness	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Mucosal inflammation	3/8 (37.5%)		12/68 (17.6%)		2/31 (6.5%)
Oedema	0/8 (0%)		6/68 (8.8%)		0/31 (0%)
Oedema peripheral	1/8 (12.5%)		11/68 (16.2%)		8/31 (25.8%)
Pain	0/8 (0%)		10/68 (14.7%)		2/31 (6.5%)
Performance status decreased	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Pyrexia	1/8 (12.5%)		12/68 (17.6%)		7/31 (22.6%)
Hepatobiliary disorders
Bile duct obstruction	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Bile duct stenosis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Cholangitis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Cholecystitis	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Cholestasis	1/8 (12.5%)		1/68 (1.5%)		1/31 (3.2%)
Cytolytic hepatitis	3/8 (37.5%)		1/68 (1.5%)		1/31 (3.2%)
Hepatotoxicity	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Hyperbilirubinaemia	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Jaundice	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Immune system disorders
Hypersensitivity	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Infections and infestations
Bacteraemia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Bronchitis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Candidiasis	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Cellulitis	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Diverticulitis	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Escherichia sepsis	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Folliculitis	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Gastroenteritis	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Gingival abscess	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Herpes ophthalmic	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Hordeolum	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Infected skin ulcer	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Infection	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Influenza	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Localised infection	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Nasopharyngitis	2/8 (25%)		1/68 (1.5%)		0/31 (0%)
Oral candidiasis	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Oral herpes	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Oropharyngeal candidiasis	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Periodontal infection	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Pneumonia	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Staphylococcal infection	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Upper respiratory tract infection	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Urinary tract infection	1/8 (12.5%)		9/68 (13.2%)		3/31 (9.7%)
Vulvovaginal candidiasis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Wound infection	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Injury, poisoning and procedural complications
Contusion	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Drug toxicity	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Excoriation	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Fall	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Joint sprain	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Muscle strain	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Periorbital haematoma	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Procedural pain	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Sunburn	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Investigations
Alanine aminotransferase	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Alanine aminotransferase increased	0/8 (0%)		3/68 (4.4%)		1/31 (3.2%)
Aspartate aminotransferase	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Aspartate aminotransferase increased	0/8 (0%)		2/68 (2.9%)		2/31 (6.5%)
Blood albumin decreased	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Blood albumin increased	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Blood alkaline phosphatase	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Blood alkaline phosphatase increased	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Blood bilirubin increased	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Blood creatinine increased	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Blood glucose	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Blood glucose increased	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Blood lactate dehydrogenase increased	1/8 (12.5%)		1/68 (1.5%)		0/31 (0%)
Blood potassium decreased	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Blood pressure increased	0/8 (0%)		3/68 (4.4%)		0/31 (0%)
Blood sodium decreased	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Blood thyroid stimulating hormone increased	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Haemoglobin	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Haemoglobin decreased	0/8 (0%)		5/68 (7.4%)		2/31 (6.5%)
Heart rate increased	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
International normalised ratio	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Neutrophil count	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Neutrophil count decreased	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Platelet count decreased	0/8 (0%)		4/68 (5.9%)		0/31 (0%)
Prothrombin time prolonged	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Transaminases increased	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Weight decreased	1/8 (12.5%)		16/68 (23.5%)		4/31 (12.9%)
Metabolism and nutrition disorders
Anorexia	3/8 (37.5%)		0/68 (0%)		0/31 (0%)
Cachexia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Decreased appetite	1/8 (12.5%)		29/68 (42.6%)		10/31 (32.3%)
Dehydration	1/8 (12.5%)		4/68 (5.9%)		0/31 (0%)
Diabetes mellitus inadequate control	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Failure to thrive	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Hyperglycaemia	0/8 (0%)		3/68 (4.4%)		0/31 (0%)
Hyperkalaemia	0/8 (0%)		2/68 (2.9%)		2/31 (6.5%)
Hypernatraemia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Hypoalbuminaemia	1/8 (12.5%)		2/68 (2.9%)		0/31 (0%)
Hypocalcaemia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Hypoglycaemia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Hypokalaemia	0/8 (0%)		11/68 (16.2%)		4/31 (12.9%)
Hypomagnesaemia	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/8 (12.5%)		1/68 (1.5%)		0/31 (0%)
Back pain	2/8 (25%)		12/68 (17.6%)		2/31 (6.5%)
Bone pain	1/8 (12.5%)		2/68 (2.9%)		0/31 (0%)
Flank pain	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Joint swelling	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Mobility decreased	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Muscle atrophy	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Muscle spasms	1/8 (12.5%)		1/68 (1.5%)		0/31 (0%)
Muscular weakness	1/8 (12.5%)		3/68 (4.4%)		0/31 (0%)
Musculoskeletal chest pain	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Musculoskeletal pain	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Myalgia	0/8 (0%)		3/68 (4.4%)		0/31 (0%)
Myositis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Pain in extremity	0/8 (0%)		6/68 (8.8%)		3/31 (9.7%)
Spinal osteoarthritis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Trigger finger	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Tumour pain	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Nervous system disorders
Aphasia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Ataxia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Balance disorder	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Cerebral ischaemia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Dizziness	0/8 (0%)		8/68 (11.8%)		3/31 (9.7%)
Dysarthria	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Dysgeusia	1/8 (12.5%)		7/68 (10.3%)		2/31 (6.5%)
Dyskinesia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Facial paresis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Headache	1/8 (12.5%)		9/68 (13.2%)		2/31 (6.5%)
Hypoaesthesia	0/8 (0%)		5/68 (7.4%)		0/31 (0%)
Lethargy	0/8 (0%)		6/68 (8.8%)		0/31 (0%)
Neuropathy	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Neuropathy peripheral	1/8 (12.5%)		3/68 (4.4%)		0/31 (0%)
Paraesthesia	1/8 (12.5%)		1/68 (1.5%)		1/31 (3.2%)
Peripheral sensory neuropathy	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Sensory loss	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Somnolence	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Syncope	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Tremor	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Psychiatric disorders
Agitation	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Anxiety	0/8 (0%)		9/68 (13.2%)		3/31 (9.7%)
Confusional state	0/8 (0%)		2/68 (2.9%)		2/31 (6.5%)
Delirium	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Depressed mood	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Depression	2/8 (25%)		7/68 (10.3%)		2/31 (6.5%)
Insomnia	2/8 (25%)		6/68 (8.8%)		0/31 (0%)
Restlessness	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Sleep disorder	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Renal and urinary disorders
Chromaturia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Dysuria	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Haematuria	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Haemoglobinuria	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Nocturia	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Oliguria	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Proteinuria	0/8 (0%)		6/68 (8.8%)		0/31 (0%)
Renal failure acute	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Urinary incontinence	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Urinary retention	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Urine flow decreased	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Reproductive system and breast disorders
Erectile dysfunction	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Metrorrhagia	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Vaginal haemorrhage	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Vulvovaginal dryness	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Vulvovaginal erythema	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	2/8 (25%)		5/68 (7.4%)		3/31 (9.7%)
Dyspnoea	2/8 (25%)		15/68 (22.1%)		5/31 (16.1%)
Dyspnoea exertional	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Epistaxis	2/8 (25%)		8/68 (11.8%)		0/31 (0%)
Haemoptysis	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Hiccups	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Nasal dryness	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Orthopnoea	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Pleural effusion	0/8 (0%)		3/68 (4.4%)		1/31 (3.2%)
Pleuritic pain	0/8 (0%)		1/68 (1.5%)		1/31 (3.2%)
Pneumonitis	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Pulmonary oedema	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Respiratory distress	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Rhinorrhoea	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Upper-airway cough syndrome	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Skin and subcutaneous tissue disorders
Alopecia	1/8 (12.5%)		10/68 (14.7%)		0/31 (0%)
Decubitus ulcer	0/8 (0%)		4/68 (5.9%)		0/31 (0%)
Dry Skin	1/8 (12.5%)		0/68 (0%)		0/31 (0%)
Erythema	0/8 (0%)		2/68 (2.9%)		1/31 (3.2%)
Hyperhidrosis	1/8 (12.5%)		2/68 (2.9%)		3/31 (9.7%)
Livedo reticularis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Night sweats	0/8 (0%)		0/68 (0%)		1/31 (3.2%)
Palmar erythema	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Palmar-plantar erythrodysaesthesia syndrome	2/8 (25%)		1/68 (1.5%)		0/31 (0%)
Petechiae	0/8 (0%)		2/68 (2.9%)		0/31 (0%)
Photosensitivity reaction	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Pruritus	2/8 (25%)		6/68 (8.8%)		1/31 (3.2%)
Pruritus generalised	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Rash	0/8 (0%)		12/68 (17.6%)		2/31 (6.5%)
Rash generalised	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Skin lesion	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Urticaria	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Surgical and medical procedures
Pancreaticoduodenectomy	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Vascular disorders
Deep vein thrombosis	0/8 (0%)		4/68 (5.9%)		2/31 (6.5%)
Haemorrhage	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Hot flush	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Hypertension	4/8 (50%)		16/68 (23.5%)		0/31 (0%)
Pallor	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Shock	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Thrombophlebitis	0/8 (0%)		1/68 (1.5%)		0/31 (0%)
Thrombosis	0/8 (0%)		0/68 (0%)		1/31 (3.2%)

Limitations/Caveats

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.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.