Pancreatic Neoplasms
Conditions
Keywords
Randomized Phase 2 Study of AG-013736 in Combination with Gemcitabine versus Gemcitabine Alone in Advanced Pancreatic Cancer
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.
Interventions
DRUGGemcitabine
Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
DRUGAG-013736
Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 | — |
| 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). |
| 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. |
| 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. |
| 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 | — |
| 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 - ∞). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Belgium, Canada, France, Germany, Italy, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Axitinib + Gemcitabine (Phase 1 Lead-In) 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. | 8 |
| Axitinib + Gemcitabine 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. | 69 |
| Gemcitabine Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. | 34 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Phase 1 | Adverse Event | 2 | 0 | 0 |
| Phase 1 | Lack of Efficacy | 3 | 0 | 0 |
| Phase 1 | Started chemotherapy at other institute | 1 | 0 | 0 |
| Phase 1 | Withdrawal by Subject | 1 | 0 | 0 |
| Phase 2 | Adverse Event | 0 | 22 | 2 |
| Phase 2 | Death | 0 | 8 | 2 |
| Phase 2 | Lack of Efficacy | 0 | 21 | 15 |
| Phase 2 | Other | 0 | 8 | 6 |
| Phase 2 | Treatment not received | 0 | 1 | 3 |
| Phase 2 | Withdrawal by Subject | 0 | 9 | 5 |
Baseline characteristics
| Characteristic | Axitinib + Gemcitabine (Phase 1 Lead-In) | Axitinib + Gemcitabine | Gemcitabine | Total |
|---|---|---|---|---|
| Age, Customized 18 years to 44 years | 0 Participants | 2 Participants | 4 Participants | 6 Participants |
| Age, Customized 45 years to 64 years | 5 Participants | 31 Participants | 20 Participants | 56 Participants |
| Age, Customized Greater than or equal to 65 years | 3 Participants | 36 Participants | 10 Participants | 49 Participants |
| Sex: Female, Male Female | 1 Participants | 34 Participants | 18 Participants | 53 Participants |
| Sex: Female, Male Male | 7 Participants | 35 Participants | 16 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 8 | 67 / 68 | 26 / 31 |
| serious Total, serious adverse events | 3 / 8 | 35 / 68 | 10 / 31 |
Outcome results
Primary
Overall Survival (OS)
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
Population: 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 | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib + Gemcitabine | Overall Survival (OS) | 210 Days |
| Gemcitabine | Overall Survival (OS) | 171 Days |
Comparison: 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).p-value: 0.102695% CI: [0.49, 1.17]Log Rank
Secondary
Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)
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
Population: Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Axitinib + Gemcitabine | Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736) | 282.34 ng*hr/mL | Standard Deviation 135.27 |
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Axitinib + Gemcitabine | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine | 13656.00 ng*hr/mL | Standard Deviation 4142.16 |
Secondary
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
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).
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C11 D1 | 44.44 units on a scale | Standard Deviation 50.92 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Baseline | 37.52 units on a scale | Standard Deviation 27.88 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C4 D1 | -18.30 units on a scale | Standard Deviation 26.9 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C4 D1 | -7.47 units on a scale | Standard Deviation 26.57 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C4 D1 | 16.09 units on a scale | Standard Deviation 35.21 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C4 D1 | 1.72 units on a scale | Standard Deviation 19.59 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C4 D1 | 12.82 units on a scale | Standard Deviation 31.02 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C4 D1 | -1.92 units on a scale | Standard Deviation 49.51 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C4 D1 | -5.30 units on a scale | Standard Deviation 27.88 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C4 D1 | -6.90 units on a scale | Standard Deviation 25.79 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C4 D1 | -9.52 units on a scale | Standard Deviation 33.77 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C4 D1 | 1.15 units on a scale | Standard Deviation 39.32 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C4 D1 | 9.20 units on a scale | Standard Deviation 29.07 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C4 D1 | 11.88 units on a scale | Standard Deviation 28.59 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C4 D1 | -2.78 units on a scale | Standard Deviation 41.61 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C4 D1 | 10.26 units on a scale | Standard Deviation 53.97 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C5 D1 | -7.26 units on a scale | Standard Deviation 27.99 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C5 D1 | 0.00 units on a scale | Standard Deviation 45.22 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C5 D1 | 13.46 units on a scale | Standard Deviation 30.92 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C5 D1 | 3.85 units on a scale | Standard Deviation 19.04 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C5 D1 | 14.00 units on a scale | Standard Deviation 28.74 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C5 D1 | -2.67 units on a scale | Standard Deviation 51.52 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C5 D1 | -1.75 units on a scale | Standard Deviation 20.71 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C5 D1 | -5.13 units on a scale | Standard Deviation 24.39 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C5 D1 | -3.85 units on a scale | Standard Deviation 28.79 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C5 D1 | -1.33 units on a scale | Standard Deviation 28.02 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C5 D1 | 10.26 units on a scale | Standard Deviation 36.84 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C5 D1 | 10.04 units on a scale | Standard Deviation 28.55 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C5 D1 | 0.00 units on a scale | Standard Deviation 35.44 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C5 D1 | 20.00 units on a scale | Standard Deviation 41.94 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C6 D1 | -3.76 units on a scale | Standard Deviation 24.06 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C6 D1 | -4.90 units on a scale | Standard Deviation 50.95 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C6 D1 | 13.73 units on a scale | Standard Deviation 25.16 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C6 D1 | 1.96 units on a scale | Standard Deviation 11.61 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C6 D1 | 23.96 units on a scale | Standard Deviation 31.6 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C6 D1 | -11.46 units on a scale | Standard Deviation 42.04 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C6 D1 | -7.69 units on a scale | Standard Deviation 30.14 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C6 D1 | -1.96 units on a scale | Standard Deviation 24.92 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C6 D1 | 3.92 units on a scale | Standard Deviation 35.12 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C6 D1 | 1.96 units on a scale | Standard Deviation 27.56 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C6 D1 | 4.90 units on a scale | Standard Deviation 31.05 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C6 D1 | 16.34 units on a scale | Standard Deviation 30.4 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C6 D1 | -4.44 units on a scale | Standard Deviation 45.19 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C6 D1 | 12.50 units on a scale | Standard Deviation 54.26 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C7 D1 | -3.70 units on a scale | Standard Deviation 22.09 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C7 D1 | -14.81 units on a scale | Standard Deviation 31.67 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C7 D1 | 5.56 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C7 D1 | 5.56 units on a scale | Standard Deviation 11.79 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C7 D1 | 5.56 units on a scale | Standard Deviation 26.35 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C7 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C7 D1 | -7.41 units on a scale | Standard Deviation 22.22 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C7 D1 | -3.70 units on a scale | Standard Deviation 30.93 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C7 D1 | 5.56 units on a scale | Standard Deviation 25 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C7 D1 | 8.64 units on a scale | Standard Deviation 25.93 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C7 D1 | 4.17 units on a scale | Standard Deviation 27.82 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C7 D1 | 14.81 units on a scale | Standard Deviation 55.56 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C8 D1 | 3.70 units on a scale | Standard Deviation 48.43 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C8 D1 | 14.81 units on a scale | Standard Deviation 22.74 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C8 D1 | 9.26 units on a scale | Standard Deviation 12.11 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C8 D1 | 22.22 units on a scale | Standard Deviation 37.27 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C8 D1 | 3.70 units on a scale | Standard Deviation 27.36 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C8 D1 | -3.70 units on a scale | Standard Deviation 26.06 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C8 D1 | -7.41 units on a scale | Standard Deviation 40.06 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C8 D1 | -11.11 units on a scale | Standard Deviation 33.33 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C8 D1 | 11.11 units on a scale | Standard Deviation 26.35 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C8 D1 | 11.11 units on a scale | Standard Deviation 35.14 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C8 D1 | 4.17 units on a scale | Standard Deviation 45.21 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C8 D1 | 11.11 units on a scale | Standard Deviation 64.55 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C9 D1 | 0.00 units on a scale | Standard Deviation 30.43 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C9 D1 | 14.29 units on a scale | Standard Deviation 39 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C9 D1 | 23.81 units on a scale | Standard Deviation 25.2 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C9 D1 | 9.52 units on a scale | Standard Deviation 16.27 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C9 D1 | 2.38 units on a scale | Standard Deviation 24.4 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C9 D1 | -13.33 units on a scale | Standard Deviation 29.81 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C9 D1 | -11.11 units on a scale | Standard Deviation 34.43 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C9 D1 | 4.76 units on a scale | Standard Deviation 35.63 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C9 D1 | 14.29 units on a scale | Standard Deviation 26.23 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C9 D1 | 23.81 units on a scale | Standard Deviation 34.5 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C9 D1 | 31.75 units on a scale | Standard Deviation 33.6 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C9 D1 | -16.67 units on a scale | Standard Deviation 40.82 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C9 D1 | 19.05 units on a scale | Standard Deviation 42.41 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C10 D1 | 8.33 units on a scale | Standard Deviation 25.28 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C10 D1 | 25.00 units on a scale | Standard Deviation 25.28 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C10 D1 | 27.78 units on a scale | Standard Deviation 22.77 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C10 D1 | 2.78 units on a scale | Standard Deviation 16.39 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C10 D1 | 25.00 units on a scale | Standard Deviation 29.34 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C10 D1 | 13.89 units on a scale | Standard Deviation 30.58 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C10 D1 | -13.33 units on a scale | Standard Deviation 29.81 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C10 D1 | 0.00 units on a scale | Standard Deviation 21.08 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C10 D1 | 27.78 units on a scale | Standard Deviation 25.09 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C10 D1 | 16.67 units on a scale | Standard Deviation 18.26 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C10 D1 | 25.00 units on a scale | Standard Deviation 39.09 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C10 D1 | 37.04 units on a scale | Standard Deviation 28.69 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C10 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C10 D1 | 33.33 units on a scale | Standard Deviation 42.16 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C11 D1 | 5.56 units on a scale | Standard Deviation 47.39 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C11 D1 | 38.89 units on a scale | Standard Deviation 53.58 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C11 D1 | 50.00 units on a scale | Standard Deviation 44.1 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C11 D1 | 16.67 units on a scale | Standard Deviation 44.1 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C11 D1 | 50.00 units on a scale | Standard Deviation 44.1 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C11 D1 | -33.33 units on a scale | Standard Deviation 47.14 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C13 D1 | 20.83 units on a scale | Standard Deviation 5.89 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C13 D1 | 16.67 units on a scale | Standard Deviation 7.86 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C13 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C14 D1 | 33.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C14 D1 | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C14 D1 | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Flatulence: Baseline | 35.59 units on a scale | Standard Deviation 32.67 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C7 D1 | 16.67 units on a scale | Standard Deviation 41.67 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C7 D1 | -9.52 units on a scale | Standard Deviation 18.9 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C8 D1 | -1.54 units on a scale | Standard Deviation 25.99 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C8 D1 | -7.14 units on a scale | Standard Deviation 13.11 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C9 D1 | 28.57 units on a scale | Standard Deviation 35.63 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C11 D1 | 27.78 units on a scale | Standard Deviation 25.46 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C11 D1 | 22.22 units on a scale | Standard Deviation 38.49 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C11 D1 | 11.11 units on a scale | Standard Deviation 19.25 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C11 D1 | 11.11 units on a scale | Standard Deviation 19.25 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C11 D1 | 55.56 units on a scale | Standard Deviation 25.46 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C11 D1 | 55.56 units on a scale | Standard Deviation 50.92 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C11 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C12 D1 | -5.56 units on a scale | Standard Deviation 20.97 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C12 D1 | 16.67 units on a scale | Standard Deviation 16.67 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C12 D1 | 27.78 units on a scale | Standard Deviation 34.69 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C12 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C12 D1 | 16.67 units on a scale | Standard Deviation 16.67 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C12 D1 | -5.56 units on a scale | Standard Deviation 41.94 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C12 D1 | 0.00 units on a scale | Standard Deviation 66.67 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C12 D1 | -22.22 units on a scale | Standard Deviation 19.25 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C12 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C12 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C12 D1 | 33.33 units on a scale | Standard Deviation 28.87 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C12 D1(n=3,0) | 33.33 units on a scale | Standard Deviation 40.06 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C12 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C12 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C13 D1 | 58.33 units on a scale | Standard Deviation 58.93 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C13 D1 | 8.33 units on a scale | Standard Deviation 11.79 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C13 D1 | 25.00 units on a scale | Standard Deviation 35.36 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C13 D1 | 41.67 units on a scale | Standard Deviation 58.93 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C13 D1 | -16.67 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C13 D1 | -50.00 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C13 D1 | 16.67 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C13 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C13 D1 | 16.67 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C13 D1 | 33.33 units on a scale | Standard Deviation 47.14 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C13 D1 | 16.67 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C14 D1 | -8.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C14 D1 | 16.67 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C14 D1 | 33.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C14 D1 | 33.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C14 D1 | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C14 D1 | -33.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C14 D1 | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C14 D1 | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C14 D1 | 33.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C14 D1 | 50.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C14 D1 | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at EoS | 58.33 units on a scale | Standard Deviation 35.36 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at EoS | 25.00 units on a scale | Standard Deviation 82.5 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at EoS | 83.33 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at EoS | 8.33 units on a scale | Standard Deviation 11.79 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at EoS | 66.67 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at EoS | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at EoS | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Ascites: Change at EoS | 33.33 units on a scale | Standard Deviation 47.14 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at EoS | 33.33 units on a scale | Standard Deviation 47.14 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at EoS | 83.33 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at EoS | 66.67 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at EoS | 19.44 units on a scale | Standard Deviation 90.35 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at EoS | 33.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at EoS | 66.67 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Baseline | 40.40 units on a scale | Standard Deviation 35.18 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Baseline | 22.32 units on a scale | Standard Deviation 26.19 |
| Axitinib + Gemcitabine | 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 | Jaundice: Baseline | 9.89 units on a scale | Standard Deviation 18.34 |
| Axitinib + Gemcitabine | 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 | Body Image: Baseline | 31.64 units on a scale | Standard Deviation 29.8 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Baseline | 79.38 units on a scale | Standard Deviation 27.57 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Baseline | 44.35 units on a scale | Standard Deviation 34.42 |
| Axitinib + Gemcitabine | 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 | Ascites: Baseline | 37.29 units on a scale | Standard Deviation 31 |
| Axitinib + Gemcitabine | 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 | Indigestion: Baseline | 24.86 units on a scale | Standard Deviation 28.09 |
| Axitinib + Gemcitabine | 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 | Cachexia: Baseline | 33.62 units on a scale | Standard Deviation 25.43 |
| Axitinib + Gemcitabine | 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 | Side Effects: Baseline | 27.78 units on a scale | Standard Deviation 24.8 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Baseline | 63.22 units on a scale | Standard Deviation 31.03 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Baseline | 39.55 units on a scale | Standard Deviation 35.27 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C2 D1 | -11.05 units on a scale | Standard Deviation 25.39 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C2 D1 | -0.38 units on a scale | Standard Deviation 34.19 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C2 D1 | 8.33 units on a scale | Standard Deviation 28.19 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C2 D1 | 0.00 units on a scale | Standard Deviation 20.65 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C2 D1 | 7.95 units on a scale | Standard Deviation 26.53 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C2 D1 | 0.39 units on a scale | Standard Deviation 34.6 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C2 D1 | -2.56 units on a scale | Standard Deviation 22.14 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C2 D1 | -10.85 units on a scale | Standard Deviation 36.89 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C2 D1 | -4.65 units on a scale | Standard Deviation 24.75 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C2 D1 | 5.30 units on a scale | Standard Deviation 34.43 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C2 D1 | 9.47 units on a scale | Standard Deviation 19.15 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C2 D1 | 7.70 units on a scale | Standard Deviation 16.39 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C2 D1 | -2.33 units on a scale | Standard Deviation 23.45 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C2 D1 | 4.55 units on a scale | Standard Deviation 35.65 |
| Axitinib + Gemcitabine | 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 | Pancreatic Pain: Change at C3 D1 | -8.92 units on a scale | Standard Deviation 24.62 |
| Axitinib + Gemcitabine | 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 | Eating Related Items: Change at C3 D1 | 3.07 units on a scale | Standard Deviation 37.34 |
| Axitinib + Gemcitabine | 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 | Altered Bowel Habits: Change at C3 D1 | 10.53 units on a scale | Standard Deviation 31.34 |
| Axitinib + Gemcitabine | 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 | Jaundice: Change at C3 D1 | 2.19 units on a scale | Standard Deviation 13.52 |
| Axitinib + Gemcitabine | 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 | Body Image: Change at C3 D1 | 13.51 units on a scale | Standard Deviation 30.89 |
| Axitinib + Gemcitabine | 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 | Health Care Satisfaction: Change at C3 D1 | -5.41 units on a scale | Standard Deviation 40.07 |
| Axitinib + Gemcitabine | 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 | Sexual Functioning: Change at C3 D1 | -3.13 units on a scale | Standard Deviation 21.77 |
| Axitinib + Gemcitabine | 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 | Ascites: Change at C3 D1 | -2.63 units on a scale | Standard Deviation 28.35 |
| Axitinib + Gemcitabine | 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 | Indigestion: Change at C3 D1 | -4.50 units on a scale | Standard Deviation 34.39 |
| Axitinib + Gemcitabine | 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 | Flatulence: Change at C3 D1 | 9.65 units on a scale | Standard Deviation 37.09 |
| Axitinib + Gemcitabine | 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 | Cachexia: Change at C3 D1 | 14.47 units on a scale | Standard Deviation 24.56 |
| Axitinib + Gemcitabine | 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 | Side Effects: Change at C3 D1 | 11.55 units on a scale | Standard Deviation 27.41 |
| Axitinib + Gemcitabine | 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 | Fear of Future Health: Change at C3 D1 | -2.86 units on a scale | Standard Deviation 34.65 |
| Axitinib + Gemcitabine | 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 | Ability to Plan Future: Change at C3 D1 | 9.01 units on a scale | Standard Deviation 43.5 |
| Gemcitabine | 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 | Pancreatic Pain: Baseline | 38.89 units on a scale | Standard Deviation 21.18 |
| Gemcitabine | 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 | Ascites: Change at EoS | 33.33 units on a scale | — |
| Gemcitabine | 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 | Eating Related Items: Baseline | 33.95 units on a scale | Standard Deviation 27.92 |
| Gemcitabine | 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 | Altered Bowel Habits: Change at C7 D1 | 25.00 units on a scale | Standard Deviation 58.93 |
| Gemcitabine | 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 | Altered Bowel Habits: Baseline | 25.31 units on a scale | Standard Deviation 28.26 |
| Gemcitabine | 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 | Sexual Functioning: Change at C10 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Jaundice: Baseline | 15.38 units on a scale | Standard Deviation 23.06 |
| Gemcitabine | 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 | Jaundice: Change at C7 D1 | -41.67 units on a scale | Standard Deviation 58.93 |
| Gemcitabine | 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 | Body Image: Baseline | 26.54 units on a scale | Standard Deviation 25.84 |
| Gemcitabine | 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 | Body Image: Change at C7 D1 | -25.00 units on a scale | Standard Deviation 58.93 |
| Gemcitabine | 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 | Health Care Satisfaction: Baseline | 69.75 units on a scale | Standard Deviation 25.33 |
| Gemcitabine | 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 | Sexual Functioning: Change at C7 D1 | -41.67 units on a scale | Standard Deviation 11.79 |
| Gemcitabine | 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 | Sexual Functioning: Baseline | 57.97 units on a scale | Standard Deviation 37.56 |
| Gemcitabine | 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 | Health Care Satisfaction: Change at C7 D1 | -33.33 units on a scale | Standard Deviation 0 |
| Gemcitabine | 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 | Ascites: Baseline | 25.93 units on a scale | Standard Deviation 25.04 |
| Gemcitabine | 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 | Ascites: Change at C10 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Indigestion: Baseline | 30.86 units on a scale | Standard Deviation 34.5 |
| Gemcitabine | 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 | Ascites: Change at C7 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Gemcitabine | 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 | Cachexia: Baseline | 31.48 units on a scale | Standard Deviation 23.72 |
| Gemcitabine | 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 | Eating Related Items: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Side Effects: Baseline | 27.35 units on a scale | Standard Deviation 21.77 |
| Gemcitabine | 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 | Indigestion: Change at C7 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Gemcitabine | 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 | Fear of Future Health: Baseline | 59.26 units on a scale | Standard Deviation 33.76 |
| Gemcitabine | 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 | Indigestion: Change at C10 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Ability to Plan Future: Baseline | 41.98 units on a scale | Standard Deviation 36.51 |
| Gemcitabine | 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 | Flatulence: Change at C7 D1 | -16.67 units on a scale | Standard Deviation 23.57 |
| Gemcitabine | 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 | Pancreatic Pain: Change at C2 D1 | -13.64 units on a scale | Standard Deviation 22.05 |
| Gemcitabine | 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 | Pancreatic Pain: Change at C8 D1 | -25.00 units on a scale | — |
| Gemcitabine | 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 | Eating Related Items: Change at C2 D1 | -3.79 units on a scale | Standard Deviation 27.67 |
| Gemcitabine | 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 | Cachexia: Change at C7 D1 | -8.33 units on a scale | Standard Deviation 35.36 |
| Gemcitabine | 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 | Altered Bowel Habits: Change at C2 D1 | -11.36 units on a scale | Standard Deviation 22.05 |
| Gemcitabine | 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 | Flatulence: Change at C10 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Jaundice: Change at C2 D1 | -12.70 units on a scale | Standard Deviation 25.22 |
| Gemcitabine | 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 | Side Effects: Change at C7 D1 | -22.22 units on a scale | Standard Deviation 31.43 |
| Gemcitabine | 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 | Body Image: Change at C2 D1 | -7.14 units on a scale | Standard Deviation 25.04 |
| Gemcitabine | 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 | Fear of Future Health: Change at EoS | -33.33 units on a scale | — |
| Gemcitabine | 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 | Health Care Satisfaction: Change at C2 D1 | -3.97 units on a scale | Standard Deviation 37.6 |
| Gemcitabine | 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 | Fear of Future Health: Change at C7 D1 | -16.67 units on a scale | Standard Deviation 70.71 |
| Gemcitabine | 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 | Sexual Functioning: Change at C2 D1 | 18.63 units on a scale | Standard Deviation 38.59 |
| Gemcitabine | 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 | Cachexia: Change at C10 D1 | 16.67 units on a scale | — |
| Gemcitabine | 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 | Ascites: Change at C2 D1 | -3.03 units on a scale | Standard Deviation 22.79 |
| Gemcitabine | 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 | Ability to Plan Future: Change at C7 D1 | 33.33 units on a scale | Standard Deviation 47.14 |
| Gemcitabine | 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 | Indigestion: Change at C2 D1 | -10.61 units on a scale | Standard Deviation 37.64 |
| Gemcitabine | 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 | Sexual Functioning: Change at C8 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Flatulence: Change at C2 D1 | -9.09 units on a scale | Standard Deviation 21.04 |
| Gemcitabine | 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 | Eating Related Items: Change at C8 D1 | 16.67 units on a scale | — |
| Gemcitabine | 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 | Cachexia: Change at C2 D1 | -3.03 units on a scale | Standard Deviation 17.55 |
| Gemcitabine | 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 | Side Effects: Change at C10 D1 | 11.11 units on a scale | — |
| Gemcitabine | 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 | Side Effects: Change at C2 D1 | -3.17 units on a scale | Standard Deviation 20.9 |
| Gemcitabine | 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 | Altered Bowel Habits: Change at C8 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Fear of Future Health: Change at C2 D1 | 0.00 units on a scale | Standard Deviation 31.62 |
| Gemcitabine | 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 | Altered Bowel Habits: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Ability to Plan Future: Change at C2 D1 | -1.67 units on a scale | Standard Deviation 27.52 |
| Gemcitabine | 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 | Jaundice: Change at C8 D1 | -83.33 units on a scale | — |
| Gemcitabine | 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 | Pancreatic Pain: Change at C3 D1 | -23.78 units on a scale | Standard Deviation 20.61 |
| Gemcitabine | 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 | Fear of Future Health: Change at C10 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Body Image: Change at C8 D1 | 16.67 units on a scale | — |
| Gemcitabine | 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 | Altered Bowel Habits: Change at C3 D1 | -8.33 units on a scale | Standard Deviation 31.03 |
| Gemcitabine | 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 | Indigestion: Change at EoS | 33.33 units on a scale | — |
| Gemcitabine | 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 | Jaundice: Change at C3 D1 | -9.38 units on a scale | Standard Deviation 26.51 |
| Gemcitabine | 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 | Health Care Satisfaction: Change at C8 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Body Image: Change at C3 D1 | -5.21 units on a scale | Standard Deviation 29.01 |
| Gemcitabine | 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 | Ability to Plan Future: Change at C10 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Health Care Satisfaction: Change at C3 D1 | 5.21 units on a scale | Standard Deviation 24.88 |
| Gemcitabine | 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 | Ascites: Change at C8 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Sexual Functioning: Change at C3 D1 | -4.44 units on a scale | Standard Deviation 31.79 |
| Gemcitabine | 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 | Sexual Functioning: Change at C11 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Ascites: Change at C3 D1 | -4.17 units on a scale | Standard Deviation 23.96 |
| Gemcitabine | 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 | Indigestion: Change at C8 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Indigestion: Change at C3 D1 | -15.56 units on a scale | Standard Deviation 37.52 |
| Gemcitabine | 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 | Pancreatic Pain: Change at C11 D1 | -8.33 units on a scale | — |
| Gemcitabine | 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 | Flatulence: Change at C3 D1 | 6.25 units on a scale | Standard Deviation 27.81 |
| Gemcitabine | 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 | Flatulence: Change at C8 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Cachexia: Change at C3 D1 | 5.21 units on a scale | Standard Deviation 17.97 |
| Gemcitabine | 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 | Jaundice: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Side Effects: Change at C3 D1 | -7.64 units on a scale | Standard Deviation 26.28 |
| Gemcitabine | 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 | Cachexia: Change at C8 D1 | -16.67 units on a scale | — |
| Gemcitabine | 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 | Fear of Future Health: Change at C3 D1 | -2.22 units on a scale | Standard Deviation 42.66 |
| Gemcitabine | 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 | Eating Related Items: Change at C11 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Ability to Plan Future: Change at C3 D1 | -12.50 units on a scale | Standard Deviation 34.16 |
| Gemcitabine | 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 | Side Effects: Change at C8 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Pancreatic Pain: Change at C4 D1 | -14.10 units on a scale | Standard Deviation 22.92 |
| Gemcitabine | 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 | Ascites: Change at C11 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Eating Related Items: Change at C4 D1 | 5.13 units on a scale | Standard Deviation 36.88 |
| Gemcitabine | 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 | Fear of Future Health: Change at C8 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Altered Bowel Habits: Change at C4 D1 | 3.85 units on a scale | Standard Deviation 28.99 |
| Gemcitabine | 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 | Altered Bowel Habits: Change at C11 D1 | -16.67 units on a scale | — |
| Gemcitabine | 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 | Jaundice: Change at C4 D1 | -11.11 units on a scale | Standard Deviation 16.41 |
| Gemcitabine | 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 | Ability to Plan Future: Change at C8 D1 | 66.67 units on a scale | — |
| Gemcitabine | 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 | Body Image: Change at C4 D1 | 8.97 units on a scale | Standard Deviation 26.01 |
| Gemcitabine | 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 | Side Effects: Change at EoS | -11.11 units on a scale | — |
| Gemcitabine | 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 | Health Care Satisfaction: Change at C4 D1 | -8.97 units on a scale | Standard Deviation 29.36 |
| Gemcitabine | 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 | Pancreatic Pain: Change at C9 D1 | -16.67 units on a scale | — |
| Gemcitabine | 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 | Sexual Functioning: Change at C4 D1 | -2.78 units on a scale | Standard Deviation 40.72 |
| Gemcitabine | 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 | Jaundice: Change at C11 D1 | -83.33 units on a scale | — |
| Gemcitabine | 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 | Ascites: Change at C4 D1 | 2.56 units on a scale | Standard Deviation 28.74 |
| Gemcitabine | 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 | Eating Related Items: Change at C9 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Indigestion: Change at C4 D1 | -2.56 units on a scale | Standard Deviation 37.17 |
| Gemcitabine | 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 | Indigestion: Change at C11 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Flatulence: Change at C4 D1 | -2.56 units on a scale | Standard Deviation 25.32 |
| Gemcitabine | 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 | Altered Bowel Habits: Change at C9 D1 | -50.00 units on a scale | — |
| Gemcitabine | 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 | Cachexia: Change at C4 D1 | -3.85 units on a scale | Standard Deviation 24.68 |
| Gemcitabine | 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 | Body Image: Change at C11 D1 | 16.67 units on a scale | — |
| Gemcitabine | 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 | Side Effects: Change at C4 D1 | -3.24 units on a scale | Standard Deviation 19.88 |
| Gemcitabine | 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 | Jaundice: Change at C9 D1 | -66.67 units on a scale | — |
| Gemcitabine | 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 | Fear of Future Health: Change at C4 D1 | 5.13 units on a scale | Standard Deviation 38.12 |
| Gemcitabine | 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 | Body Image: Change at C9 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Ability to Plan Future: Change at C4 D1 | -5.13 units on a scale | Standard Deviation 46.84 |
| Gemcitabine | 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 | Health Care Satisfaction: Change at C11 D1 | -16.67 units on a scale | — |
| Gemcitabine | 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 | Pancreatic Pain: Change at C5 D1 | -18.52 units on a scale | Standard Deviation 24.22 |
| Gemcitabine | 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 | Health Care Satisfaction: Change at C9 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Eating Related Items: Change at C5 D1 | -7.41 units on a scale | Standard Deviation 26.5 |
| Gemcitabine | 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 | Body Image: Change at EoS | -16.67 units on a scale | — |
| Gemcitabine | 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 | Altered Bowel Habits: Change at C5 D1 | -14.81 units on a scale | Standard Deviation 29.4 |
| Gemcitabine | 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 | Sexual Functioning: Change at C9 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Jaundice: Change at C5 D1 | -20.37 units on a scale | Standard Deviation 36.11 |
| Gemcitabine | 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 | Fear of Future Health: Change at C11 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Body Image: Change at C5 D1 | -11.11 units on a scale | Standard Deviation 39.97 |
| Gemcitabine | 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 | Ascites: Change at C9 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Health Care Satisfaction: Change at C5 D1 | 7.41 units on a scale | Standard Deviation 34.47 |
| Gemcitabine | 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 | Health Care Satisfaction: Change at EoS | 33.33 units on a scale | — |
| Gemcitabine | 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 | Sexual Functioning: Change at C5 D1 | 1.85 units on a scale | Standard Deviation 24.22 |
| Gemcitabine | 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 | Indigestion: Change at C9 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Ascites: Change at C5 D1 | -11.11 units on a scale | Standard Deviation 40.82 |
| Gemcitabine | 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 | Flatulence: Change at C11 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Indigestion: Change at C5 D1 | -25.93 units on a scale | Standard Deviation 49.38 |
| Gemcitabine | 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 | Flatulence: Change at C9 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Flatulence: Change at C5 D1 | -11.11 units on a scale | Standard Deviation 40.82 |
| Gemcitabine | 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 | Flatulence: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Cachexia: Change at C5 D1 | -5.56 units on a scale | Standard Deviation 18.63 |
| Gemcitabine | 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 | Cachexia: Change at C9 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Side Effects: Change at C5 D1 | -11.73 units on a scale | Standard Deviation 17.22 |
| Gemcitabine | 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 | Cachexia: Change at C11 D1 | 16.67 units on a scale | — |
| Gemcitabine | 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 | Fear of Future Health: Change at C5 D1 | 14.81 units on a scale | Standard Deviation 29.4 |
| Gemcitabine | 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 | Side Effects: Change at C9 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Ability to Plan Future: Change at C5 D1 | -11.11 units on a scale | Standard Deviation 16.67 |
| Gemcitabine | 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 | Ability to Plan Future: Change at EoS | 33.33 units on a scale | — |
| Gemcitabine | 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 | Pancreatic Pain: Change at C6 D1 | -12.50 units on a scale | Standard Deviation 30.81 |
| Gemcitabine | 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 | Fear of Future Health: Change at C9 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Eating Related Items: Change at C6 D1 | 8.33 units on a scale | Standard Deviation 21.52 |
| Gemcitabine | 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 | Side Effects: Change at C11 D1 | 11.11 units on a scale | — |
| Gemcitabine | 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 | Altered Bowel Habits: Change at C6 D1 | -8.33 units on a scale | Standard Deviation 28.87 |
| Gemcitabine | 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 | Ability to Plan Future: Change at C9 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Jaundice: Change at C6 D1 | -16.67 units on a scale | Standard Deviation 45.13 |
| Gemcitabine | 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 | Sexual Functioning: Change at EoS | 33.33 units on a scale | — |
| Gemcitabine | 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 | Body Image: Change at C6 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Gemcitabine | 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 | Pancreatic Pain: Change at C10 D1 | -16.67 units on a scale | — |
| Gemcitabine | 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 | Health Care Satisfaction: Change at C6 D1 | -25.00 units on a scale | Standard Deviation 21.52 |
| Gemcitabine | 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 | Pancreatic Pain: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Sexual Functioning: Change at C6 D1 | -20.83 units on a scale | Standard Deviation 49.77 |
| Gemcitabine | 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 | Eating Related Items: Change at C10 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Ascites: Change at C6 D1 | -8.33 units on a scale | Standard Deviation 31.91 |
| Gemcitabine | 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 | Ability to Plan Future: Change at C11 D1 | 66.67 units on a scale | — |
| Gemcitabine | 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 | Indigestion: Change at C6 D1 | -16.67 units on a scale | Standard Deviation 19.25 |
| Gemcitabine | 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 | Altered Bowel Habits: Change at C10 D1 | -50.00 units on a scale | — |
| Gemcitabine | 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 | Flatulence: Change at C6 D1 | -8.33 units on a scale | Standard Deviation 16.67 |
| Gemcitabine | 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 | Flatulence: Baseline | 39.51 units on a scale | Standard Deviation 29.29 |
| Gemcitabine | 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 | Cachexia: Change at C6 D1 | -20.83 units on a scale | Standard Deviation 15.96 |
| Gemcitabine | 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 | Jaundice: Change at C10 D1 | -83.33 units on a scale | — |
| Gemcitabine | 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 | Side Effects: Change at C6 D1 | -22.22 units on a scale | Standard Deviation 15.71 |
| Gemcitabine | 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 | Eating Related Items: Change at C3 D1 | -10.42 units on a scale | Standard Deviation 28.46 |
| Gemcitabine | 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 | Fear of Future Health: Change at C6 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Gemcitabine | 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 | Body Image: Change at C10 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Ability to Plan Future: Change at C6 D1 | 16.67 units on a scale | Standard Deviation 63.83 |
| Gemcitabine | 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 | Cachexia: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Pancreatic Pain: Change at C7 D1 | -16.67 units on a scale | Standard Deviation 11.79 |
| Gemcitabine | 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 | Health Care Satisfaction: Change at C10 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Eating Related Items: Change at C7 D1 | 8.33 units on a scale | Standard Deviation 11.79 |
Comparison: For change in pancreatic pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-10.11, 15.29]
Comparison: For change in eating related items at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-13.39, 20.2]
Comparison: For change in altered bowel habits at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [5.96, 33.43]
Comparison: For change in jaundice at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [0.93, 24.47]
Comparison: For change in body image at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [1.28, 28.91]
Comparison: For change in health care satisfaction at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-14.59, 23.3]
Comparison: For change in sexual functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-37.53, -4.85]
Comparison: For change in ascites at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-25.04, 9.4]
Comparison: For change in indigestion at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-9.59, 21.5]
Comparison: For change in flatulence at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-1.61, 30.4]
Comparison: For change in cachexia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [2.78, 22.22]
Comparison: For change in side effects at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [1.36, 20.39]
Comparison: For change in fear of future health at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-16.36, 11.71]
Comparison: For change in ability to plan future at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-11.78, 24.2]
Comparison: For change in pancreatic pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [0.79, 28.94]
Comparison: For change in eating related items at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-7.45, 34.42]
Comparison: For change in altered bowel habits at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [0.17, 37.55]
Comparison: For change in jaundice at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [0.66, 22.48]
Comparison: For change in body image at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [0.49, 36.95]
Comparison: For change in health care satisfaction at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-32.4, 11.17]
Comparison: For change in sexual functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-14.63, 17.27]
Comparison: For change in ascites at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-14.7, 17.78]
Comparison: For change in indigestion at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-10.65, 32.75]
Comparison: For change in flatulence at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-17.33, 24.13]
Comparison: For change in cachexia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-4.4, 22.93]
Comparison: For change in side effects at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [2.99, 35.39]
Comparison: For change in fear of future health at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-23.7, 22.43]
Comparison: For change in ability to plan future at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-3.1, 46.12]
Comparison: For change in pancreatic pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-21.57, 13.19]
Comparison: For change in eating related items at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-32.86, 7.66]
Comparison: For change in altered bowel habits at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-10.33, 34.82]
Comparison: For change in jaundice at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-0.18, 25.85]
Comparison: For change in body image at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-16.45, 24.14]
Comparison: For change in health care satisfaction at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-23.23, 37.34]
Comparison: For change in sexual functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-26.55, 21.5]
Comparison: For change in ascites at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-27.48, 8.56]
Comparison: For change in indigestion at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-30.62, 16.7]
Comparison: For change in flatulence at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-20.37, 27.8]
Comparison: For change in cachexia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-5.73, 31.81]
Comparison: For change in side effects at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-3.23, 33.46]
Comparison: For change in fear of future health at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-36.18, 20.37]
Comparison: For change in ability to plan future at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-20.24, 51.01]
Comparison: For change in pancreatic pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-10.09, 32.59]
Comparison: For change in eating related items at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-25.22, 40.03]
Comparison: For change in altered bowel habits at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [4.23, 52.32]
Comparison: For change in jaundice at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [5.09, 43.34]
Comparison: For change in body image at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-0.16, 50.38]
Comparison: For change in health care satisfaction at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-47.95, 27.8]
Comparison: For change in sexual functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-21.78, 14.57]
Comparison: For change in ascites at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-17.02, 28.99]
Comparison: For change in indigestion at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-5.39, 49.55]
Comparison: For change in flatulence at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-15.33, 34.89]
Comparison: For change in cachexia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-10.43, 42.06]
Comparison: For change in side effects at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [1.11, 42.43]
Comparison: For change in fear of future health at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-41.91, 12.28]
Comparison: For change in ability to plan future at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [1.6, 60.62]
Comparison: For change in pancreatic pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-20.62, 38.1]
Comparison: For change in eating related items at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-68.52, 42.05]
Comparison: For change in altered bowel habits at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-7.93, 52.05]
Comparison: For change in jaundice at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-5.64, 42.89]
Comparison: For change in body image at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-9.93, 57.84]
Comparison: For change in health care satisfaction at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-32.7, 59.78]
Comparison: For change in sexual functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-29.46, 55.74]
Comparison: For change in ascites at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-24.04, 36.79]
Comparison: For change in indigestion at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-17.94, 59.12]
Comparison: For change in flatulence at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-20.12, 40.71]
Comparison: For change in cachexia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-8.22, 59.69]
Comparison: For change in side effects at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [5.32, 71.81]
Comparison: For change in fear of future health at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-53.14, 44.25]
Comparison: For change in ability to plan future at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-69.9, 61.57]
Comparison: For change in pancreatic pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-24.52, 50.45]
Comparison: For change in eating related items at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-76.41, 30.11]
Comparison: For change in altered bowel habits at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-71.89, 33]
Comparison: For change in jaundice at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [7.31, 87.13]
Comparison: For change in body image at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-36, 119.34]
Comparison: For change in health care satisfaction at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-5.05, 82.83]
Comparison: For change in sexual functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-2.09, 66.37]
Comparison: For change in indigestion at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-44.46, 29.64]
Comparison: For change in flatulence at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-40.45, 66.37]
Comparison: For change in cachexia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-32.71, 60.49]
Comparison: For change in side effects at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-16.16, 77.89]
Comparison: For change in fear of future health at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-44.95, 86.62]
Comparison: For change in ability to plan future at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-115.22, 78.19]
Comparison: For change in pancreatic pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-39.71, 86.63]
Comparison: For change in eating related items at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-130.69, 104.76]
Comparison: For change in altered bowel habits at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-7.12, 103.42]
Comparison: For change in jaundice at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [63.16, 122.02]
Comparison: For change in body image at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-85.03, 96.14]
Comparison: For change in health care satisfaction at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-29.46, 103.54]
Comparison: For change in sexual functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-41.45, 27.16]
Comparison: For change in ascites at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-67.04, 59.64]
Comparison: For change in indigestion at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-104.79, 89.97]
Comparison: For change in flatulence at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-58.8, 103.25]
Comparison: For change in cachexia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-36.28, 91.83]
Comparison: For change in side effects at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-74.3, 96.52]
Comparison: For change in fear of future health at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-142.55, 84.21]
Comparison: For change in ability to plan future at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-212.46, 101.35]
Comparison: For change in pancreatic pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-62.93, 96.26]
Comparison: For change in eating related items at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-87.74, 116.31]
Comparison: For change in altered bowel habits at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [7.9, 139.72]
Comparison: For change in jaundice at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [33.64, 118.74]
Comparison: For change in body image at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-64.64, 121.79]
Comparison: For change in health care satisfaction at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-28.11, 99.53]
Comparison: For change in sexual functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-104.01, 77.34]
Comparison: For change in ascites at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-140.03, 51.14]
Comparison: For change in indigestion at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-88.45, 97.98]
Comparison: For change in flatulence at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-54.32, 82.89]
Comparison: For change in cachexia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-66.45, 114.07]
Comparison: For change in side effects at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-56.14, 119.63]
Comparison: For change in fear of future health at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-163.35, 63.35]
Comparison: For change in ability to plan future at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-125.23, 96.66]
Comparison: For change in pancreatic pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-45.18, 95.18]
Comparison: For change in eating related items at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-45.18, 95.18]
Comparison: For change in altered bowel habits at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [14.55, 141]
Comparison: For change in jaundice at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [40.61, 131.61]
Comparison: For change in body image at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-56.48, 106.48]
Comparison: For change in health care satisfaction at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-37.69, 132.13]
Comparison: For change in sexual functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-70.68, 110.68]
Comparison: For change in ascites at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-91.87, 25.2]
Comparison: For change in indigestion at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-41.89, 97.45]
Comparison: For change in flatulence at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-34.03, 67.36]
Comparison: For change in cachexia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-100.19, 116.86]
Comparison: For change in side effects at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-53.73, 105.58]
Comparison: For change in ability to plan future at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-117.07, 117.07]
Comparison: For change in pancreatic pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-221.53, 249.31]
Comparison: For change in eating related items at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-260.62, 271.74]
Comparison: For change in altered bowel habits at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-152.41, 285.75]
Comparison: For change in jaundice at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-119.08, 319.08]
Comparison: For change in body image at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-185.75, 252.41]
Comparison: For change in health care satisfaction at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-82.04, 170.93]
Comparison: For change in sexual functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-733.59, 733.59]
Comparison: For change in ascites at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-202.34, 180.12]
Comparison: For change in indigestion at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-84.5, 106.73]
Comparison: For change in flatulence at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-84.5, 106.73]
Comparison: For change in cachexia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-87.6, 165.37]
Comparison: For change in side effects at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-208.53, 297.42]
Comparison: For change in ability to plan future at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-275.19, 230.75]
Comparison: For change in pancreatic pain at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-491.86, 608.53]
Comparison: For change in eating related items at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-1258.79, 1308.79]
Comparison: For change in altered bowel habits at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-283.46, 450.13]
Comparison: For change in jaundice at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-175.06, 191.73]
Comparison: For change in ascites at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-733.59, 733.59]
Comparison: For change in indigestion at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-733.59, 733.59]
Comparison: For change in flatulence at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-283.46, 450.13]
Comparison: For change in side effects at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-1375.5, 1436.61]
Secondary
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
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).
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C11 D1 | 37.04 units on a scale | Standard Deviation 46.26 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C4 D1 | -7.81 units on a scale | Standard Deviation 29.63 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C4 D1 | -3.23 units on a scale | Standard Deviation 22.64 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C4 D1 | -6.99 units on a scale | Standard Deviation 25.74 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C4 D1 | -8.60 units on a scale | Standard Deviation 35.45 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C4 D1 | 7.47 units on a scale | Standard Deviation 25.19 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C4 D1 | -4.69 units on a scale | Standard Deviation 19.96 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C4 D1 | -16.67 units on a scale | Standard Deviation 29.02 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C4 D1 | 0.00 units on a scale | Standard Deviation 28.54 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C4 D1 | -11.46 units on a scale | Standard Deviation 28.85 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C4 D1 | 6.25 units on a scale | Standard Deviation 36.35 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C4 D1 | -24.44 units on a scale | Standard Deviation 37.07 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C4 D1 | 7.53 units on a scale | Standard Deviation 39.17 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C4 D1 | 1.15 units on a scale | Standard Deviation 22.68 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C5 D1 | -9.29 units on a scale | Standard Deviation 27.82 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C5 D1 | -8.57 units on a scale | Standard Deviation 23.08 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C5 D1 | -8.93 units on a scale | Standard Deviation 29.22 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C5 D1 | -3.87 units on a scale | Standard Deviation 22.96 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C5 D1 | -2.38 units on a scale | Standard Deviation 24.73 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C5 D1 | -15.48 units on a scale | Standard Deviation 33.92 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C5 D1 | 9.72 units on a scale | Standard Deviation 28.59 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C5 D1 | 0.00 units on a scale | Standard Deviation 26.06 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C5 D1 | -5.36 units on a scale | Standard Deviation 34.26 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C5 D1 | 9.52 units on a scale | Standard Deviation 27 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C5 D1 | -19.05 units on a scale | Standard Deviation 35.63 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C5 D1 | 0.00 units on a scale | Standard Deviation 42.55 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C5 D1 | -21.43 units on a scale | Standard Deviation 35.39 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C5 D1 | 0.00 units on a scale | Standard Deviation 22.65 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C6 D1 | -14.22 units on a scale | Standard Deviation 20.36 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C6 D1 | -6.32 units on a scale | Standard Deviation 25.38 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C6 D1 | -9.65 units on a scale | Standard Deviation 27.95 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C6 D1 | 2.19 units on a scale | Standard Deviation 15.92 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C6 D1 | -0.88 units on a scale | Standard Deviation 18.82 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C6 D1 | -2.63 units on a scale | Standard Deviation 27.92 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C6 D1 | 6.73 units on a scale | Standard Deviation 24.19 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C6 D1 | -4.39 units on a scale | Standard Deviation 22.8 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C6 D1 | -8.77 units on a scale | Standard Deviation 30.11 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C6 D1(n=18,2) | -1.85 units on a scale | Standard Deviation 21.3 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C6 D1 | -7.02 units on a scale | Standard Deviation 30.59 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C6 D1(n=19,2) | -3.51 units on a scale | Standard Deviation 53.16 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C6 D1 | -10.53 units on a scale | Standard Deviation 35.23 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C6 D1 | -1.75 units on a scale | Standard Deviation 28.27 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C6 D1 | 1.75 units on a scale | Standard Deviation 13.49 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C7 D1 | -4.63 units on a scale | Standard Deviation 37.76 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C7 D1 | -3.33 units on a scale | Standard Deviation 24.8 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C7 D1 | -15.00 units on a scale | Standard Deviation 30.88 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C7 D1 | -8.33 units on a scale | Standard Deviation 13.03 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C7 D1 | 1.67 units on a scale | Standard Deviation 24.15 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C7 D1 | -15.00 units on a scale | Standard Deviation 41.16 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C7 D1 | -2.22 units on a scale | Standard Deviation 25.01 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C7D1 | 1.67 units on a scale | Standard Deviation 21.44 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C7 D1 | -3.33 units on a scale | Standard Deviation 32.2 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C7 D1 | 16.67 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C7 D1 | -10.00 units on a scale | Standard Deviation 35.31 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C7 D1 | -10.00 units on a scale | Standard Deviation 58.9 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C7 D1 | -13.33 units on a scale | Standard Deviation 47.66 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C7 D1 | 3.33 units on a scale | Standard Deviation 29.19 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C7 D1 | -6.67 units on a scale | Standard Deviation 21.08 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C8 D1 | -12.50 units on a scale | Standard Deviation 33.62 |
| Axitinib + Gemcitabine | 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 | Physical Functioning Change at C8 D1 | -10.67 units on a scale | Standard Deviation 22.71 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C8 D1 | -13.33 units on a scale | Standard Deviation 23.31 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C8 D1 | -7.50 units on a scale | Standard Deviation 18.61 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C8 D1 | 0.00 units on a scale | Standard Deviation 22.22 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C8 D1 | -11.67 units on a scale | Standard Deviation 34.29 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C8 D1 | 4.44 units on a scale | Standard Deviation 25.23 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C8 D1 | 0.00 units on a scale | Standard Deviation 19.25 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C8 D1 | -8.33 units on a scale | Standard Deviation 37.06 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C8 D1 | 14.81 units on a scale | Standard Deviation 29.4 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C8 D1 | -20.00 units on a scale | Standard Deviation 47.66 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C8 D1 | -3.33 units on a scale | Standard Deviation 48.3 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C8 D1 | -3.33 units on a scale | Standard Deviation 29.19 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C8 D1 | 6.67 units on a scale | Standard Deviation 37.84 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C8 D1 | -3.33 units on a scale | Standard Deviation 18.92 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C9 D1 | -17.71 units on a scale | Standard Deviation 36.03 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C9 D1 | -6.67 units on a scale | Standard Deviation 20.16 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C9 D1 | -29.17 units on a scale | Standard Deviation 24.8 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C9 D1 | -3.13 units on a scale | Standard Deviation 13.32 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C9 D1 | -2.08 units on a scale | Standard Deviation 28.78 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C9 D1 | -6.25 units on a scale | Standard Deviation 47.09 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C9 D1 | 18.06 units on a scale | Standard Deviation 33.56 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C9 D1 | -8.33 units on a scale | Standard Deviation 17.82 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C9 D1 | 0.00 units on a scale | Standard Deviation 30.86 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C9 D1 | 19.05 units on a scale | Standard Deviation 26.23 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C9 D1 | -4.17 units on a scale | Standard Deviation 33.03 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C9 D1 | 8.33 units on a scale | Standard Deviation 63.62 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C9 D1 | -8.33 units on a scale | Standard Deviation 38.83 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C9 D1 | 12.50 units on a scale | Standard Deviation 43.42 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C9 D1 | -4.17 units on a scale | Standard Deviation 21.36 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C10 D1 | -16.67 units on a scale | Standard Deviation 21.52 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C10 D1 | -19.05 units on a scale | Standard Deviation 13.01 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C10 D1 | -23.81 units on a scale | Standard Deviation 21.21 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C10 D1 | -20.24 units on a scale | Standard Deviation 23 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C10 D1 | -9.52 units on a scale | Standard Deviation 21.21 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C10 D1 | -21.43 units on a scale | Standard Deviation 31.5 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C10 D1 | 25.40 units on a scale | Standard Deviation 24.61 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C10 D1 | 0.00 units on a scale | Standard Deviation 25.46 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C10 D1 | 11.90 units on a scale | Standard Deviation 35.63 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C10 D1 | 22.22 units on a scale | Standard Deviation 27.22 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C10 D1 | 4.76 units on a scale | Standard Deviation 23 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C10 D1 | -19.05 units on a scale | Standard Deviation 37.8 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C10 D1 | 9.52 units on a scale | Standard Deviation 31.71 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C10 D1 | -4.76 units on a scale | Standard Deviation 23 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C11 D1 | -38.89 units on a scale | Standard Deviation 53.58 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C11 D1 | -24.44 units on a scale | Standard Deviation 36.72 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C11 D1 | -38.89 units on a scale | Standard Deviation 53.58 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C11 D1 | -25.00 units on a scale | Standard Deviation 52.04 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C11 D1 | -27.78 units on a scale | Standard Deviation 63.1 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C11 D1 | -38.89 units on a scale | Standard Deviation 53.58 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C11 D1 | 27.78 units on a scale | Standard Deviation 63.1 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C11 D1 | 22.22 units on a scale | Standard Deviation 69.39 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C11 D1 | 22.22 units on a scale | Standard Deviation 69.39 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C11 D1 | 22.22 units on a scale | Standard Deviation 69.39 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C11 D1 | 44.44 units on a scale | Standard Deviation 50.92 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C11 D1 | 0.00 units on a scale | Standard Deviation 33.33 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C11 D1 | 11.11 units on a scale | Standard Deviation 19.25 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C11 D1 | -11.11 units on a scale | Standard Deviation 19.25 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C12 D1 | -11.11 units on a scale | Standard Deviation 17.35 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C12 D1 | -6.67 units on a scale | Standard Deviation 6.67 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C12 D1 | -11.11 units on a scale | Standard Deviation 19.25 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C12 D1 | -2.78 units on a scale | Standard Deviation 20.97 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C12 D1 | 0.00 units on a scale | Standard Deviation 16.67 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C12 D1 | -5.56 units on a scale | Standard Deviation 9.62 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C12 D1 | 7.41 units on a scale | Standard Deviation 12.83 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C12 D1 | 16.67 units on a scale | Standard Deviation 60.09 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C12 D1 | -5.56 units on a scale | Standard Deviation 9.62 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C12 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C12 D1 | -11.11 units on a scale | Standard Deviation 19.25 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C12 D1 | 22.22 units on a scale | Standard Deviation 19.25 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C12 D1 | -22.22 units on a scale | Standard Deviation 38.49 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C12 D1 | 22.22 units on a scale | Standard Deviation 19.25 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C12 D1 | -11.11 units on a scale | Standard Deviation 19.25 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C13 D1 | -50.00 units on a scale | Standard Deviation 35.36 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C13 D1 | -23.33 units on a scale | Standard Deviation 33 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C13 D1 | -41.67 units on a scale | Standard Deviation 35.36 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C13 D1 | -8.33 units on a scale | Standard Deviation 11.79 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C13 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C13 D1 | -8.33 units on a scale | Standard Deviation 35.36 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C13 D1 | 33.33 units on a scale | Standard Deviation 47.14 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C13 D1 | -8.33 units on a scale | Standard Deviation 35.36 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C13 D1 | 41.67 units on a scale | Standard Deviation 58.93 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C13 D1 | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C13 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C13 D1 | 33.33 units on a scale | Standard Deviation 47.14 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C13 D1 | -16.67 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C13 D1 | 16.67 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C13 D1 | -16.67 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C14 D1 | -16.67 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C14 D1 | -6.67 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C14 D1 | -33.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C14 D1 | -8.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C14 D1 | 16.67 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C14 D1 | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C14 D1 | 22.22 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C14 D1 | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Pain: Change at C14 D1 | 16.67 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C14 D1 | 33.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C14 D1 | -33.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C14 D1 | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C14 D1 | 0.00 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C14 D1 | 33.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C14 D1 | -33.33 units on a scale | — |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at EoS | -54.17 units on a scale | Standard Deviation 29.46 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at EoS | -70.00 units on a scale | Standard Deviation 4.71 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at EoS | -33.33 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at EoS | -66.67 units on a scale | Standard Deviation 35.36 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at EoS | -66.67 units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at EoS | -83.33 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at EoS | 55.56 units on a scale | Standard Deviation 15.71 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at EoS | 33.33 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Pain: Change at EoS | 41.67 units on a scale | Standard Deviation 82.5 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at EoS | 83.33 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at EoS | 66.67 units on a scale | Standard Deviation 47.14 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at EoS | 50.00 units on a scale | Standard Deviation 70.71 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at EoS | -16.67 units on a scale | Standard Deviation 117.85 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at EoS | 33.33 units on a scale | Standard Deviation 47.14 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at EoS | -16.67 units on a scale | Standard Deviation 23.57 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C2 D1 | 3.21 units on a scale | Standard Deviation 21.34 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C3 D1 | -4.07 units on a scale | Standard Deviation 32.66 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C5 D1 | 7.14 units on a scale | Standard Deviation 33.16 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C10 D1 | 23.81 units on a scale | Standard Deviation 46 |
| Axitinib + Gemcitabine | 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 | Global QoL: Baseline | 55.60 units on a scale | Standard Deviation 27.18 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Baseline | 76.90 units on a scale | Standard Deviation 24.73 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Baseline | 62.56 units on a scale | Standard Deviation 33.21 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Baseline | 67.22 units on a scale | Standard Deviation 26.17 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Baseline | 82.82 units on a scale | Standard Deviation 23.93 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Baseline | 67.44 units on a scale | Standard Deviation 33 |
| Axitinib + Gemcitabine | 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 | Fatigue: Baseline | 43.50 units on a scale | Standard Deviation 29.78 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Baseline | 19.74 units on a scale | Standard Deviation 28.24 |
| Axitinib + Gemcitabine | 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 | Pain: Baseline | 40.00 units on a scale | Standard Deviation 33.31 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Baseline | 12.50 units on a scale | Standard Deviation 21.82 |
| Axitinib + Gemcitabine | 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 | Insomnia: Baseline | 31.28 units on a scale | Standard Deviation 31.66 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Baseline | 41.03 units on a scale | Standard Deviation 40.3 |
| Axitinib + Gemcitabine | 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 | Constipation: Baseline | 34.87 units on a scale | Standard Deviation 37.93 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Baseline | 20.00 units on a scale | Standard Deviation 27.51 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Baseline | 10.42 units on a scale | Standard Deviation 19.59 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C2 D1 | -5.10 units on a scale | Standard Deviation 21.17 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C2 D1 | -5.07 units on a scale | Standard Deviation 18.85 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C2 D1 | 0.33 units on a scale | Standard Deviation 25.93 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C2 D1 | -3.53 units on a scale | Standard Deviation 21.48 |
| Axitinib + Gemcitabine | 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 | Social Functioning: Change at C2 D1 | -4.17 units on a scale | Standard Deviation 29.5 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C2 D1 | 1.42 units on a scale | Standard Deviation 21.74 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C2 D1 | -5.88 units on a scale | Standard Deviation 26.84 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C2 D1 | -9.29 units on a scale | Standard Deviation 27.89 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C2 D1 | 9.33 units on a scale | Standard Deviation 26.97 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C2 D1 | -9.15 units on a scale | Standard Deviation 28.35 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C2 D1 | -0.65 units on a scale | Standard Deviation 35.58 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C2 D1 | -9.62 units on a scale | Standard Deviation 32.56 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C2 D1 | -1.28 units on a scale | Standard Deviation 29.49 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C2 D1 | 0.67 units on a scale | Standard Deviation 19.62 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C3 D1 | -9.17 units on a scale | Standard Deviation 30.36 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C3 D1 | -8.13 units on a scale | Standard Deviation 21.46 |
| Axitinib + Gemcitabine | 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 | Role Functioning: Change at C3 D1 | -5.56 units on a scale | Standard Deviation 27.71 |
| Axitinib + Gemcitabine | 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 | Emotional Functioning: Change at C3 D1 | -1.69 units on a scale | Standard Deviation 26.8 |
| Axitinib + Gemcitabine | 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 | Cognitive Functioning: Change at C3 D1 | -4.88 units on a scale | Standard Deviation 24.79 |
| Axitinib + Gemcitabine | 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 | Fatigue: Change at C3 D1 | 7.41 units on a scale | Standard Deviation 28.61 |
| Axitinib + Gemcitabine | 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 | Nausea and Vomiting: Change at C3 D1 | -4.37 units on a scale | Standard Deviation 29 |
| Axitinib + Gemcitabine | 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 | Pain: Change at C3 D1 | -6.75 units on a scale | Standard Deviation 33.75 |
| Axitinib + Gemcitabine | 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 | Dyspnea: Change at C3 D1 | 3.25 units on a scale | Standard Deviation 27.69 |
| Axitinib + Gemcitabine | 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 | Insomnia: Change at C3 D1 | -10.32 units on a scale | Standard Deviation 34.13 |
| Axitinib + Gemcitabine | 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 | Appetite loss: Change at C3 D1 | 11.11 units on a scale | Standard Deviation 39.42 |
| Axitinib + Gemcitabine | 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 | Constipation: Change at C3 D1 | -10.57 units on a scale | Standard Deviation 32.86 |
| Axitinib + Gemcitabine | 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 | Diarrhea: Change at C3 D1 | 7.32 units on a scale | Standard Deviation 32.07 |
| Axitinib + Gemcitabine | 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 | Financial Difficulties: Change at C3 D1 | 3.33 units on a scale | Standard Deviation 24.81 |
| Axitinib + Gemcitabine | 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 | Global QoL: Change at C4 D1 | -6.67 units on a scale | Standard Deviation 21.04 |
| Axitinib + Gemcitabine | 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 | Physical Functioning: Change at C4 D1 | -6.67 units on a scale | Standard Deviation 23.15 |
| Gemcitabine | 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 | Global QoL: Baseline | 54.32 units on a scale | Standard Deviation 21.1 |
| Gemcitabine | 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 | Emotional Functioning: Change at C7 D1 | -7.41 units on a scale | Standard Deviation 21.58 |
| Gemcitabine | 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 | Physical Functioning: Baseline | 82.22 units on a scale | Standard Deviation 14.44 |
| Gemcitabine | 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 | Emotional Functioning: Change at C10 D1 | -16.67 units on a scale | — |
| Gemcitabine | 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 | Role Functioning: Baseline | 60.26 units on a scale | Standard Deviation 35.3 |
| Gemcitabine | 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 | Cognitive Functioning: Change at C7 D1 | -5.56 units on a scale | Standard Deviation 9.62 |
| Gemcitabine | 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 | Emotional Functioning: Baseline | 66.98 units on a scale | Standard Deviation 23.96 |
| Gemcitabine | 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 | Insomnia: Change at EoS | 33.33 units on a scale | — |
| Gemcitabine | 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 | Cognitive Functioning: Baseline | 82.10 units on a scale | Standard Deviation 19.57 |
| Gemcitabine | 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 | Social Functioning: Change at C7 D1 | -25.00 units on a scale | Standard Deviation 11.79 |
| Gemcitabine | 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 | Social Functioning: Baseline | 70.51 units on a scale | Standard Deviation 29.56 |
| Gemcitabine | 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 | Cognitive Functioning: Change at C10 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Fatigue: Baseline | 42.80 units on a scale | Standard Deviation 25.73 |
| Gemcitabine | 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 | Fatigue: Change at C7 D1 | 14.81 units on a scale | Standard Deviation 42.07 |
| Gemcitabine | 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 | Nausea and Vomiting: Baseline | 13.58 units on a scale | Standard Deviation 20.17 |
| Gemcitabine | 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 | Constipation: Change at C11 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Pain: Baseline | 37.04 units on a scale | Standard Deviation 31.8 |
| Gemcitabine | 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 | Nausea and Vomiting: Change at C7D1 | 16.67 units on a scale | Standard Deviation 0 |
| Gemcitabine | 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 | Dyspnea: Baseline | 16.05 units on a scale | Standard Deviation 26.75 |
| Gemcitabine | 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 | Social Functioning: Change at C10 D1 | -50.00 units on a scale | — |
| Gemcitabine | 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 | Insomnia: Baseline | 39.51 units on a scale | Standard Deviation 39.26 |
| Gemcitabine | 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 | Pain: Change at C7 D1 | -11.11 units on a scale | Standard Deviation 41.94 |
| Gemcitabine | 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 | Appetite loss: Baseline | 33.33 units on a scale | Standard Deviation 34.59 |
| Gemcitabine | 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 | Emotional Functioning: Change at EoS | -25.00 units on a scale | — |
| Gemcitabine | 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 | Constipation: Baseline | 38.27 units on a scale | Standard Deviation 38.9 |
| Gemcitabine | 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 | Dyspnea: Change at C7 D1 | 33.33 units on a scale | Standard Deviation 33.33 |
| Gemcitabine | 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 | Diarrhea: Baseline | 16.05 units on a scale | Standard Deviation 28.3 |
| Gemcitabine | 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 | Fatigue: Change at C10 D1 | 55.56 units on a scale | — |
| Gemcitabine | 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 | Financial Difficulties: Baseline | 28.40 units on a scale | Standard Deviation 41.04 |
| Gemcitabine | 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 | Insomnia: Change at C7 D1 | 11.11 units on a scale | Standard Deviation 38.49 |
| Gemcitabine | 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 | Global QoL: Change at C2 D1 | 3.33 units on a scale | Standard Deviation 16.97 |
| Gemcitabine | 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 | Diarrhea: Change at C11 D1 | -66.67 units on a scale | — |
| Gemcitabine | 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 | Physical Functioning: Change at C2 D1 | 0.95 units on a scale | Standard Deviation 16.23 |
| Gemcitabine | 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 | Appetite loss: Change at C7 D1 | 22.22 units on a scale | Standard Deviation 50.92 |
| Gemcitabine | 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 | Emotional Functioning: Change at C2 D1 | 7.94 units on a scale | Standard Deviation 17.77 |
| Gemcitabine | 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 | Nausea and Vomiting: Change at C10 D1 | 16.67 units on a scale | — |
| Gemcitabine | 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 | Cognitive Functioning: Change at C2 D1 | 1.59 units on a scale | Standard Deviation 18.93 |
| Gemcitabine | 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 | Constipation: Change at C7 D1 | -66.67 units on a scale | Standard Deviation 57.74 |
| Gemcitabine | 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 | Social Functioning: Change at C2 D1 | -0.83 units on a scale | Standard Deviation 28.85 |
| Gemcitabine | 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 | Financial Difficulties: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Fatigue: Change at C2 D1 | -8.99 units on a scale | Standard Deviation 26.67 |
| Gemcitabine | 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 | Diarrhea: Change at C7 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Gemcitabine | 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 | Nausea and Vomiting: Change at C2 D1 | -1.59 units on a scale | Standard Deviation 12.81 |
| Gemcitabine | 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 | Pain: Change at C10 D1 | 16.67 units on a scale | — |
| Gemcitabine | 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 | Pain: Change at C2 D1 | -16.67 units on a scale | Standard Deviation 31.62 |
| Gemcitabine | 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 | Financial Difficulties: Change at C7 D1 | 0.00 units on a scale | Standard Deviation 0 |
| Gemcitabine | 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 | Dyspnea: Change at C2 D1 | -3.17 units on a scale | Standard Deviation 25.61 |
| Gemcitabine | 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 | Financial Difficulties: Change at C11 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Insomnia: Change at C2 D1 | -19.05 units on a scale | Standard Deviation 34.27 |
| Gemcitabine | 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 | Global QoL: Change at C8 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Appetite loss: Change at C2 D1 | -14.29 units on a scale | Standard Deviation 35.86 |
| Gemcitabine | 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 | Dyspnea: Change at C10 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Constipation: Change at C2 D1 | -14.29 units on a scale | Standard Deviation 29 |
| Gemcitabine | 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 | Physical Functioning Change at C8 D1 | -20.00 units on a scale | — |
| Gemcitabine | 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 | Diarrhea: Change at C2 D1 | 0.00 units on a scale | Standard Deviation 18.26 |
| Gemcitabine | 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 | Cognitive Functioning: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Financial Difficulties: Change at C2 D1 | -4.76 units on a scale | Standard Deviation 19.11 |
| Gemcitabine | 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 | Role Functioning: Change at C8 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Global QoL: Change at C3 D1 | 6.67 units on a scale | Standard Deviation 15.17 |
| Gemcitabine | 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 | Insomnia: Change at C10 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Physical Functioning: Change at C3 D1 | 3.44 units on a scale | Standard Deviation 18.73 |
| Gemcitabine | 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 | Emotional Functioning: Change at C8 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Role Functioning: Change at C3 D1 | 13.10 units on a scale | Standard Deviation 25.47 |
| Gemcitabine | 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 | Appetite loss: Change at C10 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Emotional Functioning: Change at C3 D1 | 12.22 units on a scale | Standard Deviation 19.89 |
| Gemcitabine | 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 | Cognitive Functioning: Change at C8 D1 | -16.67 units on a scale | — |
| Gemcitabine | 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 | Cognitive Functioning: Change at C3 D1 | 2.22 units on a scale | Standard Deviation 16.51 |
| Gemcitabine | 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 | Appetite loss: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Fatigue: Change at C3 D1 | -8.73 units on a scale | Standard Deviation 26.57 |
| Gemcitabine | 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 | Social Functioning: Change at C8 D1 | -16.67 units on a scale | — |
| Gemcitabine | 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 | Nausea and Vomiting: Change at C3 D1 | -2.56 units on a scale | Standard Deviation 16.45 |
| Gemcitabine | 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 | Constipation: Change at C10 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Pain: Change at C3 D1 | -23.33 units on a scale | Standard Deviation 30.08 |
| Gemcitabine | 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 | Fatigue: Change at C8 D1 | 2.22 units on a scale | — |
| Gemcitabine | 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 | Dyspnea: Change at C3 D1 | -7.14 units on a scale | Standard Deviation 19.3 |
| Gemcitabine | 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 | Social Functioning: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Insomnia: Change at C3 D1 | -11.90 units on a scale | Standard Deviation 38.36 |
| Gemcitabine | 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 | Nausea and Vomiting: Change at C8 D1 | 16.67 units on a scale | — |
| Gemcitabine | 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 | Appetite loss: Change at C3 D1 | -5.13 units on a scale | Standard Deviation 29.96 |
| Gemcitabine | 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 | Diarrhea: Change at C10 D1 | -66.67 units on a scale | — |
| Gemcitabine | 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 | Constipation: Change at C3 D1 | -13.33 units on a scale | Standard Deviation 35.19 |
| Gemcitabine | 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 | Pain: Change at C8 D1 | -16.67 units on a scale | — |
| Gemcitabine | 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 | Diarrhea: Change at C3 D1 | 4.44 units on a scale | Standard Deviation 30.52 |
| Gemcitabine | 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 | Role Functioning: Change at C2 D1 | 9.65 units on a scale | Standard Deviation 29.56 |
| Gemcitabine | 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 | Financial Difficulties: Change at C3 D1 | -2.22 units on a scale | Standard Deviation 26.63 |
| Gemcitabine | 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 | Dyspnea: Change at C8 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Global QoL: Change at C4 D1 | -1.03 units on a scale | Standard Deviation 15.27 |
| Gemcitabine | 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 | Financial Difficulties: Change at C10 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Physical Functioning: Change at C4 D1 | -1.03 units on a scale | Standard Deviation 15.36 |
| Gemcitabine | 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 | Insomnia: Change at C8 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Role Functioning: Change at C4 D1 | 9.72 units on a scale | Standard Deviation 36.56 |
| Gemcitabine | 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 | Fatigue: Change at EoS | -11.11 units on a scale | — |
| Gemcitabine | 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 | Emotional Functioning: Change at C4 D1 | 9.03 units on a scale | Standard Deviation 36.56 |
| Gemcitabine | 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 | Appetite loss: Change at C8 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Cognitive Functioning: Change at C4 D1 | 0.00 units on a scale | Standard Deviation 15.89 |
| Gemcitabine | 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 | Global QoL: Change at C11 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Social Functioning: Change at C4 D1 | -1.52 units on a scale | Standard Deviation 24.1 |
| Gemcitabine | 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 | Constipation: Change at C8 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Fatigue: Change at C4 D1 | -3.42 units on a scale | Standard Deviation 25.41 |
| Gemcitabine | 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 | Constipation: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Nausea and Vomiting: Change at C4 D1 | 6.41 units on a scale | Standard Deviation 18.68 |
| Gemcitabine | 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 | Diarrhea: Change at C8 D1 | -66.67 units on a scale | — |
| Gemcitabine | 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 | Pain: Change at C4 D1 | -11.54 units on a scale | Standard Deviation 28.37 |
| Gemcitabine | 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 | Physical Functioning: Change at C11 D1 | -40.00 units on a scale | — |
| Gemcitabine | 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 | Dyspnea: Change at C4 D1 | -5.13 units on a scale | Standard Deviation 29.96 |
| Gemcitabine | 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 | Financial Difficulties: Change at C8 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Insomnia: Change at C4 D1 | -5.13 units on a scale | Standard Deviation 32.9 |
| Gemcitabine | 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 | Nausea and Vomiting: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Appetite loss: Change at C4 D1 | -2.78 units on a scale | Standard Deviation 33.21 |
| Gemcitabine | 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 | Global QoL: Change at C9 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Constipation: Change at C4 D1 | -25.00 units on a scale | Standard Deviation 40.51 |
| Gemcitabine | 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 | Role Functioning: Change at C11 D1 | -66.67 units on a scale | — |
| Gemcitabine | 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 | Diarrhea: Change at C4 D1 | 5.56 units on a scale | Standard Deviation 34.33 |
| Gemcitabine | 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 | Physical Functioning: Change at C9 D1 | -40.00 units on a scale | — |
| Gemcitabine | 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 | Financial Difficulties: Change at C4 D1 | -8.33 units on a scale | Standard Deviation 20.72 |
| Gemcitabine | 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 | Social Functioning: Change at C3 D1 | 5.56 units on a scale | Standard Deviation 24.93 |
| Gemcitabine | 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 | Global QoL: Change at C5 D1 | 10.71 units on a scale | Standard Deviation 21.36 |
| Gemcitabine | 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 | Role Functioning: Change at C9 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Physical Functioning: Change at C5 D1 | 0.00 units on a scale | Standard Deviation 22.25 |
| Gemcitabine | 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 | Emotional Functioning: Change at C11 D1 | -8.33 units on a scale | — |
| Gemcitabine | 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 | Role Functioning: Change at C5 D1 | 7.14 units on a scale | Standard Deviation 28.64 |
| Gemcitabine | 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 | Emotional Functioning: Change at C9 D1 | -8.33 units on a scale | — |
| Gemcitabine | 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 | Emotional Functioning: Change at C5 D1 | 20.24 units on a scale | Standard Deviation 14.32 |
| Gemcitabine | 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 | Pain: Change at EoS | 16.67 units on a scale | — |
| Gemcitabine | 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 | Cognitive Functioning: Change at C5 D1 | 7.14 units on a scale | Standard Deviation 16.27 |
| Gemcitabine | 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 | Cognitive Functioning: Change at C9 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Social Functioning: Change at C5 D1 | 4.76 units on a scale | Standard Deviation 23 |
| Gemcitabine | 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 | Cognitive Functioning: Change at C11 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Fatigue: Change at C5 D1 | -15.28 units on a scale | Standard Deviation 17.76 |
| Gemcitabine | 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 | Social Functioning: Change at C9 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Nausea and Vomiting: Change at C5 D1 | -6.25 units on a scale | Standard Deviation 15.27 |
| Gemcitabine | 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 | Diarrhea: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Pain: Change at C5 D1 | -25.00 units on a scale | Standard Deviation 26.73 |
| Gemcitabine | 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 | Fatigue: Change at C9 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Dyspnea: Change at C5 D1 | -12.50 units on a scale | Standard Deviation 24.8 |
| Gemcitabine | 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 | Social Functioning: Change at C11 D1 | -66.67 units on a scale | — |
| Gemcitabine | 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 | Insomnia: Change at C5 D1 | -29.17 units on a scale | Standard Deviation 33.03 |
| Gemcitabine | 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 | Nausea and Vomiting: Change at C9 D1 | 16.67 units on a scale | — |
| Gemcitabine | 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 | Appetite loss: Change at C5 D1 | -20.83 units on a scale | Standard Deviation 43.42 |
| Gemcitabine | 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 | Fatigue: Change at C11 D1 | 22.22 units on a scale | — |
| Gemcitabine | 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 | Constipation: Change at C5 D1 | -33.33 units on a scale | Standard Deviation 38.49 |
| Gemcitabine | 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 | Diarrhea: Change at C5 D1 | -4.76 units on a scale | Standard Deviation 29.99 |
| Gemcitabine | 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 | Pain: Change at C9 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Financial Difficulties: Change at C5 D1 | 0.00 units on a scale | Standard Deviation 36.51 |
| Gemcitabine | 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 | Global QoL: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Global QoL: Change at C6 D1 | -5.56 units on a scale | Standard Deviation 12.73 |
| Gemcitabine | 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 | Dyspnea: Change at C9 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Physical Functioning: Change at C6 D1 | 6.67 units on a scale | Standard Deviation 18.86 |
| Gemcitabine | 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 | Nausea and Vomiting: Change at C11 D1 | 16.67 units on a scale | — |
| Gemcitabine | 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 | Role Functioning: Change at C6 D1 | 16.67 units on a scale | Standard Deviation 47.14 |
| Gemcitabine | 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 | Insomnia: Change at C9 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Emotional Functioning: Change at C6 D1 | 8.33 units on a scale | Standard Deviation 14.43 |
| Gemcitabine | 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 | Dyspnea: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Cognitive Functioning: Change at C6 D1 | 11.11 units on a scale | Standard Deviation 9.62 |
| Gemcitabine | 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 | Appetite loss: Change at C9 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Social Functioning: Change at C6 D1 | -16.67 units on a scale | Standard Deviation 16.67 |
| Gemcitabine | 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 | Pain: Change at C11 D1 | -16.67 units on a scale | — |
| Gemcitabine | 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 | Fatigue: Change at C6 D1 | -16.67 units on a scale | Standard Deviation 39.28 |
| Gemcitabine | 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 | Constipation: Change at C9 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Nausea and Vomiting: Change at C6 D1 | -8.33 units on a scale | Standard Deviation 11.79 |
| Gemcitabine | 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 | Physical Functioning: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Pain: Change at C6 D1 | -33.33 units on a scale | Standard Deviation 16.67 |
| Gemcitabine | 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 | Diarrhea: Change at C9 D1 | -66.67 units on a scale | — |
| Gemcitabine | 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 | Dyspnea: Change at C11 D1 | 33.33 units on a scale | — |
| Gemcitabine | 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 | Insomnia: Change at C6 D1 | -16.67 units on a scale | Standard Deviation 23.57 |
| Gemcitabine | 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 | Financial Difficulties: Change at C9 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Appetite loss: Change at C6 D1(n=19,2) | -16.67 units on a scale | Standard Deviation 70.71 |
| Gemcitabine | 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 | Dyspnea: Change at C6 D1(n=18,2) | 0.00 units on a scale | Standard Deviation 47.14 |
| Gemcitabine | 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 | Constipation: Change at C6 D1 | -33.33 units on a scale | Standard Deviation 33.33 |
| Gemcitabine | 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 | Global QoL: Change at C10 D1 | -33.33 units on a scale | — |
| Gemcitabine | 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 | Diarrhea: Change at C6 D1 | 0.00 units on a scale | Standard Deviation 33.33 |
| Gemcitabine | 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 | Insomnia: Change at C11 D1 | 0.00 units on a scale | — |
| Gemcitabine | 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 | Financial Difficulties: Change at C6 D1 | -22.22 units on a scale | Standard Deviation 38.49 |
| Gemcitabine | 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 | Physical Functioning: Change at C10 D1 | -46.67 units on a scale | — |
| Gemcitabine | 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 | Global QoL: Change at C7 D1 | -16.67 units on a scale | Standard Deviation 14.43 |
| Gemcitabine | 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 | Role Functioning: Change at EoS | 0.00 units on a scale | — |
| Gemcitabine | 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 | Physical Functioning: Change at C7 D1 | -22.22 units on a scale | Standard Deviation 36.72 |
| Gemcitabine | 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 | Role Functioning: Change at C10 D1 | -50.00 units on a scale | — |
| Gemcitabine | 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 | Role Functioning: Change at C7 D1 | 33.33 units on a scale | Standard Deviation 70.71 |
| Gemcitabine | 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 | Appetite loss: Change at C11 D1 | 0.00 units on a scale | — |
Comparison: For change in role functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-35.47, -1.83]
Comparison: For change in fatigue at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-5.86, 27.63]
Comparison: For change in global QoL at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-19.06, 2.19]
Comparison: For change in physical functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-15.4, 3.36]
Comparison: For change in role functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-23.77, 5.12]
Comparison: For change in emotional functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-15.25, 5.79]
Comparison: For change in cognitive functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-15.83, 5.61]
Comparison: For change in social functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-18.72, 12.06]
Comparison: For change in fatigue at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-1.62, 22.44]
Comparison: For change in nausea and vomiting at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-16.55, 7.96]
Comparison: For change in pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-7.57, 22.32]
Comparison: For change in dyspnea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-1.28, 26.3]
Comparison: For change in insomnia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-5.7, 25.49]
Comparison: For change in appetite loss at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-4.81, 32.07]
Comparison: For change in constipation at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-11.62, 20.96]
Comparison: For change in diarrhea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-15.1, 12.54]
Comparison: For change in financial difficulties at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-4.67, 15.53]
Comparison: For change in global QoL at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-32.34, 0.67]
Comparison: For change in physical functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-24.12, 0.96]
Comparison: For change in emotional functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-29.16, 1.32]
Comparison: For change in cognitive functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-20.97, 6.77]
Comparison: For change in social functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-28.28, 9.04]
Comparison: For change in fatigue at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-1.27, 33.54]
Comparison: For change in nausea and vomiting at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-18.78, 15.18]
Comparison: For change in pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-3.22, 36.39]
Comparison: For change in dyspnea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-5.68, 26.47]
Comparison: For change in insomnia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-20.19, 23.36]
Comparison: For change in appetite loss at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-7.62, 40.1]
Comparison: For change in constipation at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-17.49, 23.02]
Comparison: For change in diarrhea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-16.29, 22.03]
Comparison: For change in financial difficulties at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-9.81, 20.92]
Comparison: For change in global QoL at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-19.52, 7.57]
Comparison: For change in physical functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-19.75, 8.46]
Comparison: For change in role functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-39.11, 4.05]
Comparison: For change in emotional functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-26.5, 2]
Comparison: For change in cognitive functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-23.13, 9.15]
Comparison: For change in social functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-30.48, 16.31]
Comparison: For change in nausea and vomiting at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-24.11, 1.91]
Comparison: For change in pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-24.26, 14]
Comparison: For change in dyspnea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-14.18, 24.44]
Comparison: For change in insomnia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-26.25, 13.59]
Comparison: For change in appetite loss at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-15.26, 33.32]
Comparison: For change in constipation at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-25.71, 26.82]
Comparison: For change in diarrhea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-24.07, 28.01]
Comparison: For change in financial difficulties at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-5.89, 24.86]
Comparison: For change in global QoL at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-43.19, 3.17]
Comparison: For change in physical functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-27.24, 10.1]
Comparison: For change in role functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-41.1, 8.96]
Comparison: For change in emotional functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-42.72, -5.5]
Comparison: For change in cognitive functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-29.66, 10.61]
Comparison: For change in social functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-47.93, 7.46]
Comparison: For change in fatigue at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [3.23, 46.77]
Comparison: For change in nausea and vomiting at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-13.49, 25.99]
Comparison: For change in pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-7.12, 46.41]
Comparison: For change in dyspnea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [0.38, 43.66]
Comparison: For change in insomnia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-18.49, 38.73]
Comparison: For change in appetite loss at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-13.98, 55.65]
Comparison: For change in constipation at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-19.02, 42.83]
Comparison: For change in diarrhea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-16.13, 39.94]
Comparison: For change in financial difficulties at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-23.38, 23.38]
Comparison: For change in global QoL at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups95% CI: [-34.53, 17.21]
Comparison: For change in physical functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-52.01, 26.04]
Comparison: For change in role functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-71.87, 19.24]
Comparison: For change in emotional functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-26.59, 14.31]
Comparison: For change in cognitive functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-35.46, 11.48]
Comparison: For change in social functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-20.97, 49.04]
Comparison: For change in fatigue at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-15.83, 62.61]
Comparison: For change in nausea and vomiting at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-30.84, 38.73]
Comparison: For change in pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-13.08, 62.2]
Comparison: For change in dyspnea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-38.65, 34.94]
Comparison: For change in insomnia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-37.43, 56.73]
Comparison: For change in appetite loss at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-71.22, 97.54]
Comparison: For change in constipation at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-22.61, 68.22]
Comparison: For change in diarrhea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-39.1, 35.59]
Comparison: For change in financial difficulties at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [1.09, 46.86]
Comparison: For change in global QoL at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-39.03, 63.11]
Comparison: For change in physical functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-20.74, 58.52]
Comparison: For change in role functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-111.94, 15.28]
Comparison: For change in emotional functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-22.59, 20.74]
Comparison: For change in cognitive functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-24.98, 39.43]
Comparison: For change in social functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-57.71, 77.71]
Comparison: For change in fatigue at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-58.87, 24.79]
Comparison: For change in nausea and vomiting at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-43.1, 13.1]
Comparison: For change in pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-41.75, 57.3]
Comparison: For change in dyspnea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-53.79, 20.46]
Comparison: For change in insomnia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-73.14, 30.92]
Comparison: For change in appetite loss at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-115.58, 51.13]
Comparison: For change in constipation at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-18.6, 125.26]
Comparison: For change in diarrhea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-34.92, 41.58]
Comparison: For change in financial difficulties at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-34.3, 20.96]
Comparison: For change in global QoL at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-58.94, 100.6]
Comparison: For change in physical functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-44.54, 63.2]
Comparison: For change in role functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-35.3, 75.3]
Comparison: For change in emotional functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-51.66, 36.66]
Comparison: For change in cognitive functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-36.06, 69.39]
Comparison: For change in social functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-76.36, 86.36]
Comparison: For change in fatigue at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-77.63, 42.08]
Comparison: For change in nausea and vomiting at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-62.33, 28.99]
Comparison: For change in pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-79.59, 96.26]
Comparison: For change in dyspnea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-89.98, 52.94]
Comparison: For change in insomnia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-133.08, 93.08]
Comparison: For change in appetite loss at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-151.27, 77.94]
Comparison: For change in constipation at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-72.58, 65.91]
Comparison: For change in diarrhea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-16.45, 163.12]
Comparison: For change in financial difficulties at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-48.23, 41.56]
Comparison: For change in global QoL at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-74.75, 106]
Comparison: For change in physical functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-17.22, 83.89]
Comparison: For change in role functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-58.04, 66.37]
Comparison: For change in emotional functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-28.19, 38.61]
Comparison: For change in cognitive functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-40.94, 103.44]
Comparison: For change in social functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-91.02, 145.18]
Comparison: For change in fatigue at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-99.46, 68.9]
Comparison: For change in nausea and vomiting at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-69.69, 19.69]
Comparison: For change in pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-77.4, 77.4]
Comparison: For change in dyspnea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-82.89, 54.32]
Comparison: For change in insomnia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-87.02, 78.69]
Comparison: For change in appetite loss at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-184.57, 134.57]
Comparison: For change in constipation at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-105.73, 89.06]
Comparison: For change in diarrhea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-29.72, 188.06]
Comparison: For change in financial difficulties at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-57.74, 49.41]
Comparison: For change in global QoL at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-39.62, 72.95]
Comparison: For change in physical functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-6.42, 61.66]
Comparison: For change in role functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-29.28, 81.66]
Comparison: For change in emotional functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-63.74, 56.6]
Comparison: For change in cognitive functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-31.66, 79.28]
Comparison: For change in social functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-53.82, 110.96]
Comparison: For change in fatigue at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-94.53, 34.21]
Comparison: For change in nausea and vomiting at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-83.26, 49.93]
Comparison: For change in pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-97.98, 88.45]
Comparison: For change in dyspnea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-86.68, 64.46]
Comparison: For change in insomnia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-55.41, 64.93]
Comparison: For change in appetite loss at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-129.86, 110.82]
Comparison: For change in constipation at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-117.92, 79.82]
Comparison: For change in diarrhea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-6.75, 159.13]
Comparison: For change in financial difficulties at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-64.93, 55.41]
Comparison: For change in global QoL at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-271.74, 260.62]
Comparison: For change in physical functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-166.87, 197.98]
Comparison: For change in role functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-238.4, 293.96]
Comparison: For change in emotional functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-275.22, 241.89]
Comparison: For change in cognitive functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-307.94, 319.05]
Comparison: For change in social functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-238.4, 293.96]
Comparison: For change in fatigue at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-215.01, 244.64]
Comparison: For change in nausea and vomiting at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-302.38, 324.6]
Comparison: For change in pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-305.85, 383.63]
Comparison: For change in dyspnea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-355.85, 333.63]
Comparison: For change in insomnia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-322.52, 366.97]
Comparison: For change in appetite loss at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-208.53, 297.42]
Comparison: For change in constipation at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-165.61, 165.61]
Comparison: For change in diarrhea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-17.84, 173.39]
Comparison: For change in financial difficulties at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.95% CI: [-106.73, 84.5]
Comparison: For change in global QoL at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-512.66, 404.33]
Comparison: For change in physical functioning at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-143.36, 3.36]
Comparison: For change in role functioning at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-400.13, 333.46]
Comparison: For change in emotional functioning at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-591.86, 508.53]
Comparison: For change in cognitive functioning at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-66.67, -66.67]
Comparison: For change in social functioning at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-450.13, 283.46]
Comparison: For change in fatigue at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-177.86, 311.2]
Comparison: For change in nausea and vomiting at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-333.46, 400.13]
Comparison: For change in pain at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-1258.79, 1308.79]
Comparison: For change in dyspnea at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-283.46, 450.13]
Comparison: For change in insomnia at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-700.26, 766.93]
Comparison: For change in appetite loss at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-1050.39, 1150.39]
Comparison: For change in constipation at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-1850.65, 1817.32]
Comparison: For change in diarrhea at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-700.26, 766.93]
Comparison: For change in financial difficulties at EoS, mean change difference was used to compare the two treatment groups.95% CI: [-383.46, 350.13]
Secondary
Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib + Gemcitabine | Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT) | 0 participants |
Secondary
Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib + Gemcitabine | Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT) | 0 participants |
Secondary
Duration of Response (DR)
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time frame: Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks
Population: Subgroup of participants from Phase 2 ITT population, with a confirmed objective tumor response (CR or PR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib + Gemcitabine | Duration of Response (DR) | 379 Days |
| Gemcitabine | Duration of Response (DR) | 155 Days |
Secondary
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
Population: Phase 1 Pharmacokinetic (PK) evaluable population included all ITT participants who completed PK blood sampling on at least 1 day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Axitinib + Gemcitabine | Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736) | 45.08 nanogram/milliliter (ng/mL) | Standard Deviation 34.32 |
Secondary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Axitinib + Gemcitabine | Maximum Observed Plasma Concentration (Cmax) of Gemcitabine | 27280.0 ng/mL | Standard Deviation 12599.1 |
Secondary
One Year Survival Probability
One year survival probability was defined as the probability of survival at one year after the date of randomization based on the Kaplan Meier estimate.
Time frame: Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib + Gemcitabine | One Year Survival Probability | 36.81 Percent chance of survival |
| Gemcitabine | One Year Survival Probability | 23.53 Percent chance of survival |
Secondary
Percentage of Participants With Overall Response (OR)
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non-target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.
Time frame: Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib + Gemcitabine | Percentage of Participants With Overall Response (OR) | 7.2 Percentage of Participants |
| Gemcitabine | Percentage of Participants With Overall Response (OR) | 2.9 Percentage of Participants |
Comparison: Difference in percent of participants with overall response expressed as response rate, was used for calculation of 95% confidence interval (CI).p-value: 0.66195% CI: [-4, 12.7]Fisher Exact
Secondary
Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)
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
Population: Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Axitinib + Gemcitabine | Plasma Decay Half-life (t1/2) of Axitinib (AG-013736) | 2.97 hr | Standard Deviation 1.95 |
Secondary
Plasma Decay Half-life (t1/2) of Gemcitabine
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Axitinib + Gemcitabine | Plasma Decay Half-life (t1/2) of Gemcitabine | 0.310 hr | Standard Deviation 0.028 |
Secondary
Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2
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
Secondary
Progression-free Survival (PFS)
Time in days from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of randomization plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was Death).
Time frame: Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib + Gemcitabine | Progression-free Survival (PFS) | 116 Days |
| Gemcitabine | Progression-free Survival (PFS) | 113 Days |
Comparison: 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).p-value: 0.446695% CI: [0.54, 1.73]Log Rank
Secondary
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)
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
Population: Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib + Gemcitabine | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736) | 1.52 hr |