Carcinoma, Pancreatic Ductal
Conditions
Keywords
Randomized Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For Advanced Pancreatic Cancer.
Brief summary
The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.
Detailed description
This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enrollment on this study has been discontinued.
Interventions
DRUGAG-013736
oral administration, starting dose 5 mg twice daily \[BID\] every day until unacceptable toxicity or tumor progression.
DRUGGemcitabine
intravenous administration at 1,000 mg/m\^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
DRUGplacebo
placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection. * Adequate renal, hepatic and bone marrow function. * Performance status 0 or 1.
Exclusion criteria
* Prior treatment with any systemic chemotherapy for metastatic disease. * Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors. * Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent. * Inability to take oral medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Baseline until death or at least 1 year after the randomization of last participant | Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Objective Response (OR) | Baseline, every 8 weeks until tumor progression or death | Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent. |
| Duration of Response (DR) | Baseline until death or at least 1 year after the randomization of last participant | Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. |
| Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score. |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues. |
| Progression Free Survival (PFS) | Baseline until disease progression or at least 1 year after the randomization of last participant | Time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was Death). |
| Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. |
| Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. |
| Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736) | Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months | 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. |
| Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal | BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference. |
Countries
Argentina, Australia, Austria, Belgium, Canada, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Axitinib + Gemcitabine Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. | 314 |
| Placebo + Gemcitabine Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m\^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks. | 316 |
| Total | 630 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 32 | 33 |
| Overall Study | Death | 11 | 12 |
| Overall Study | Global deterioration of health status | 12 | 14 |
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Objective progression or relapse | 84 | 87 |
| Overall Study | Other | 4 | 5 |
| Overall Study | Protocol Violation | 2 | 2 |
| Overall Study | Randomized but not treated | 9 | 8 |
| Overall Study | Withdrawal by Subject | 14 | 11 |
Baseline characteristics
| Characteristic | Axitinib + Gemcitabine | Placebo + Gemcitabine | Total |
|---|---|---|---|
| Age, Customized Greater than or equal to 65 years | 111 Participants | 137 Participants | 248 Participants |
| Age, Customized Less than 65 years | 203 Participants | 179 Participants | 382 Participants |
| Sex: Female, Male Female | 123 Participants | 128 Participants | 251 Participants |
| Sex: Female, Male Male | 191 Participants | 188 Participants | 379 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 276 / 304 | 276 / 309 |
| serious Total, serious adverse events | 108 / 304 | 102 / 309 |
Outcome results
Primary
Overall Survival (OS)
Time in weeks from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time frame: Baseline until death or at least 1 year after the randomization of last participant
Population: Intent-to-treat (ITT) population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib + Gemcitabine | Overall Survival (OS) | 36.9 Weeks |
| Placebo + Gemcitabine | Overall Survival (OS) | 35.8 Weeks |
Comparison: Differences in OS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).p-value: 0.543695% CI: [0.786, 1.309]Log Rank
Secondary
Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score
BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question is answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure can be scored by item, with lower scores being indicative of less pain or pain interference.
Time frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Baseline (n=242, 243) | 2.2 Units on a scale | Standard Deviation 2.78 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C2 D1 (n=189, 194) | 0.1 Units on a scale | Standard Deviation 2.84 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C8 D1 (n=12, 13) | 1.1 Units on a scale | Standard Deviation 1.93 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C3 D1 (n=133, 143) | -0.2 Units on a scale | Standard Deviation 3.41 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C4 D1 (n=97, 108) | 0.3 Units on a scale | Standard Deviation 3.32 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C9 D1 (n=6, 6) | -1.5 Units on a scale | Standard Deviation 1.76 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C5 D1 (n=66, 62) | 0.1 Units on a scale | Standard Deviation 3.49 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C3 D1 (n=138, 151) | -1.5 Units on a scale | Standard Deviation 3.09 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C6 D1 (n=41, 41) | 0.5 Units on a scale | Standard Deviation 2.86 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C10 D1 (n=2, 3) | -2.0 Units on a scale | Standard Deviation 2.83 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C7 D1 (n=25, 25) | 1.1 Units on a scale | Standard Deviation 2.67 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C8 D1 (n=12, 12) | 0.7 Units on a scale | Standard Deviation 2.46 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C9 D1 (n=6, 6) | -1.0 Units on a scale | Standard Deviation 3.52 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at follow-up (n=47, 46) | 0.5 Units on a scale | Standard Deviation 3.08 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C10 D1 (n=2, 3) | -2.0 Units on a scale | Standard Deviation 2.83 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at followup (n=48, 45) | 0.4 Units on a scale | Standard Deviation 2.7 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C10 D1 (n=2, 3) | -2.0 Units on a scale | Standard Deviation 2.83 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at follow-up (n=47, 45) | 0.9 Units on a scale | Standard Deviation 4.13 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at follow-up (n=48, 46) | 0.4 Units on a scale | Standard Deviation 2.64 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Baseline (n=240, 240) | 3.5 Units on a scale | Standard Deviation 3.34 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Baseline (n=246, 248) | 2.9 Units on a scale | Standard Deviation 2.16 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C2 D1 (n=187, 191) | -0.4 Units on a scale | Standard Deviation 3.24 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Treatment (Tx): Baseline (n=226, 221) | 7.8 Units on a scale | Standard Deviation 12.09 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C3 D1 (n=133, 139) | -0.6 Units on a scale | Standard Deviation 3.33 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 Hours (hrs): Baseline (n=246, 248) | 1.8 Units on a scale | Standard Deviation 1.92 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C4 D1 (n=96, 107) | -0.2 Units on a scale | Standard Deviation 3.15 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C2 D1 (n=164, 165) | 0.6 Units on a scale | Standard Deviation 13.96 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C5 D1 (n=65, 61) | -0.7 Units on a scale | Standard Deviation 3.86 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C2 D1 (n=195, 198) | -0.5 Units on a scale | Standard Deviation 2.02 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C6 D1 (n=39, 41) | 0.2 Units on a scale | Standard Deviation 3.62 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C3 D1 (n=122, 124) | -2.1 Units on a scale | Standard Deviation 13.1 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C7 D1 (n=25, 24) | 0.5 Units on a scale | Standard Deviation 2.76 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C4 D1 (n=99, 113) | -1.0 Units on a scale | Standard Deviation 3.41 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C8 D1 (n=12, 12) | -0.3 Units on a scale | Standard Deviation 3.7 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C4 D1 (n=88, 92) | -1.7 Units on a scale | Standard Deviation 13.51 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C9 D1 (n=6, 6) | -1.5 Units on a scale | Standard Deviation 3.51 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C3 D1 (n=140, 149) | -0.8 Units on a scale | Standard Deviation 2.48 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C10 D1 (n=2, 3) | -0.5 Units on a scale | Standard Deviation 0.71 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C5 D1 (n=59, 51) | -2.9 Units on a scale | Standard Deviation 16.35 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C2 D1 (n=193, 197) | -0.2 Units on a scale | Standard Deviation 2.21 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C6 D1 (n=34, 33) | -1.6 Units on a scale | Standard Deviation 11.9 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at follow-up (n=46, 43) | 1.0 Units on a scale | Standard Deviation 4.54 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C7 D1 (n=21, 18) | 1.0 Units on a scale | Standard Deviation 2.78 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Baseline (n=244, 242) | 2.3 Units on a scale | Standard Deviation 2.93 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C4 D1 (n=99, 113) | -0.7 Units on a scale | Standard Deviation 2.44 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C2 D1 (n=190, 193) | -0.3 Units on a scale | Standard Deviation 2.82 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C8 D1 (n=10, 8) | -5.0 Units on a scale | Standard Deviation 21.2 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C3 D1 (n=136, 142) | -0.4 Units on a scale | Standard Deviation 3.81 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C3 D1 (n=138, 150) | -0.6 Units on a scale | Standard Deviation 2.01 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C4 D1 (n=98, 108) | -0.2 Units on a scale | Standard Deviation 3.36 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C9 D1 (n=5, 5) | -14.0 Units on a scale | Standard Deviation 28.99 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C5 D1 (n=66, 62) | -0.6 Units on a scale | Standard Deviation 3.11 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C5 D1 (n=69, 63) | -0.7 Units on a scale | Standard Deviation 2.48 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C6 D1 (n=40, 41) | -0.3 Units on a scale | Standard Deviation 4.01 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C10 D1 (n=1, 2) | 6.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C7 D1 (n=25, 25) | 0.8 Units on a scale | Standard Deviation 3.32 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C5 D1 (n=69, 64) | -1.1 Units on a scale | Standard Deviation 3.43 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C8 D1 (n=12, 12) | 0.6 Units on a scale | Standard Deviation 2.61 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C11 D1 (n=0, 1) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C9 D1 (n=6, 6) | -1.2 Units on a scale | Standard Deviation 2.93 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C6 D1 (n=40, 43) | -0.5 Units on a scale | Standard Deviation 2.07 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C10 D1 (n=2, 3) | 1.0 Units on a scale | Standard Deviation 1.41 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C12 D1 (n=0, 0) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C4 D1 (n=99, 112) | -0.3 Units on a scale | Standard Deviation 2.15 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C13 D1 (n=0, 0) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C7 D1 (n=25, 26) | -0.3 Units on a scale | Standard Deviation 1.46 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at follow-up (n=47, 45) | 0.7 Units on a scale | Standard Deviation 3.94 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at follow-up (n=43, 36) | 0.2 Units on a scale | Standard Deviation 3.82 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Baseline (n=244, 242) | 3.3 Units on a scale | Standard Deviation 3.16 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Baseline (n=247, 250) | 3.8 Units on a scale | Standard Deviation 2.84 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C2 D1 (n=191, 193) | -1.1 Units on a scale | Standard Deviation 3.36 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Baseline (n=243, 243) | 3.2 Units on a scale | Standard Deviation 3.11 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C3 D1 (n=136, 142) | -1.6 Units on a scale | Standard Deviation 3.52 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C8 D1 (n=12, 13) | 1.0 Units on a scale | Standard Deviation 2 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C4 D1 (n=98, 107) | -1.2 Units on a scale | Standard Deviation 3.29 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C2 D1 (n=190, 193) | -0.6 Units on a scale | Standard Deviation 2.96 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C5 D1 (n=66, 62) | -1.3 Units on a scale | Standard Deviation 4.06 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C5 D1 (n=69, 63) | -0.3 Units on a scale | Standard Deviation 2.41 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C6 D1(n=39, 41) | -1.5 Units on a scale | Standard Deviation 3.22 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C3 D1 (n=135, 143) | -1.1 Units on a scale | Standard Deviation 3.47 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C7 D1 (n=25, 25) | -0.2 Units on a scale | Standard Deviation 3.61 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C9 D1 (n=6, 6) | -1.7 Units on a scale | Standard Deviation 1.51 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C8 D1 (n=12, 12) | 0.6 Units on a scale | Standard Deviation 2.71 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C4 D1 (n=97, 109) | -0.4 Units on a scale | Standard Deviation 3.1 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C9 D1 (n=6, 6) | -2.3 Units on a scale | Standard Deviation 3.2 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C6 D1 (n=41, 43) | -0.9 Units on a scale | Standard Deviation 2.98 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C10 D1 (n=2, 3) | 1.0 Units on a scale | Standard Deviation 1.41 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C5 D1 (n=66, 62) | -0.8 Units on a scale | Standard Deviation 3.64 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C10 D1 (n=2, 3) | -2.0 Units on a scale | Standard Deviation 2.83 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C6 D1 (n=40, 41) | -0.6 Units on a scale | Standard Deviation 3.82 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C6 D1 (n=40, 43) | -0.2 Units on a scale | Standard Deviation 2.07 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at follow-up (n=47, 44) | 0.5 Units on a scale | Standard Deviation 3.65 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C7 D1 (n=25, 25) | -0.5 Units on a scale | Standard Deviation 2.87 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Baseline (n=242, 240) | 3.5 Units on a scale | Standard Deviation 3.34 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C2 D1 (n=191, 191) | -0.6 Units on a scale | Standard Deviation 2.99 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C8 D1 (n=12, 12) | 0.1 Units on a scale | Standard Deviation 2.07 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C3 D1 (n=134, 142) | -0.7 Units on a scale | Standard Deviation 3.64 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C4 D1 (n=98, 107) | -0.6 Units on a scale | Standard Deviation 3.58 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C9 D1 (n=6, 6) | -2.2 Units on a scale | Standard Deviation 2.71 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C5 D1 (n=66, 62) | -0.6 Units on a scale | Standard Deviation 4.03 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C6 D1 (n=40, 41) | -0.4 Units on a scale | Standard Deviation 3.87 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C10 D1 (n=2, 3) | -2.5 Units on a scale | Standard Deviation 3.54 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C7 D1 (n=25, 25) | 0.4 Units on a scale | Standard Deviation 3.53 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C7 D1 (n=25, 26) | 0.4 Units on a scale | Standard Deviation 1.47 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C8 D1 (n=12, 12) | 0.8 Units on a scale | Standard Deviation 2.98 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C9 D1 (n=6, 6) | -0.5 Units on a scale | Standard Deviation 5.01 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C10 D1 (n=2, 3) | 0.5 Units on a scale | Standard Deviation 0.71 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C7 D1 (n=25, 26) | -0.8 Units on a scale | Standard Deviation 2.27 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at followup (n=48, 45) | 0.6 Units on a scale | Standard Deviation 2.7 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at follow-up (n=47, 43) | 0.2 Units on a scale | Standard Deviation 3.68 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at follow-up (n=47, 44) | 1.0 Units on a scale | Standard Deviation 4.32 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pain Intensity(PI): Baseline (n=248, 251) | 2.7 Units on a scale | Standard Deviation 1.98 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C8 D1 (n=12, 13) | 1.3 Units on a scale | Standard Deviation 2.34 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C2 D1 (n=196, 202) | -0.4 Units on a scale | Standard Deviation 1.97 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Baseline (n=243, 241) | 3.0 Units on a scale | Standard Deviation 2.92 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C3 D1 (n=140, 151) | -0.9 Units on a scale | Standard Deviation 2.15 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Baseline (n=248, 249) | 2.1 Units on a scale | Standard Deviation 2.13 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C4 D1 (n=99, 114) | -0.6 Units on a scale | Standard Deviation 2.19 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C2 D1 (n=191, 191) | -0.6 Units on a scale | Standard Deviation 2.74 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C5 D1 (n=69, 64) | -0.6 Units on a scale | Standard Deviation 2.46 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C2 D1 (n=192, 200) | -0.7 Units on a scale | Standard Deviation 3.04 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C6 D1 (n=41, 43) | -0.5 Units on a scale | Standard Deviation 1.92 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C3 D1 (n=135, 141) | -1.0 Units on a scale | Standard Deviation 3.39 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C7 D1 (n=25, 27) | -0.1 Units on a scale | Standard Deviation 1.48 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C2 D1 (n=196, 200) | -0.4 Units on a scale | Standard Deviation 2.23 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C8 D1 (n=12, 13) | 1.0 Units on a scale | Standard Deviation 2.01 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C4 D1 (n=98, 106) | -0.3 Units on a scale | Standard Deviation 3.22 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C9 D1 (n=6, 6) | -1.3 Units on a scale | Standard Deviation 1.51 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C9 D1 (n=6, 6) | -0.3 Units on a scale | Standard Deviation 1.37 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C10 D1 (n=2, 3) | -1.9 Units on a scale | Standard Deviation 2.69 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C5 D1 (n=66, 61) | -0.7 Units on a scale | Standard Deviation 3.66 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C3 D1 (n=140, 150) | -0.8 Units on a scale | Standard Deviation 2.31 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C6 D1 (n=40, 41) | -0.6 Units on a scale | Standard Deviation 3.23 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C8 D1 (n=12, 13) | 0.8 Units on a scale | Standard Deviation 2.56 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI:Change follow-up (n=48, 47) | 0.5 Units on a scale | Standard Deviation 2.34 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C7 D1 (n=25, 25) | 0.0 Units on a scale | Standard Deviation 2.54 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pain Interference(Pf):Baseline(n=244,243) | 3.0 Units on a scale | Standard Deviation 2.64 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C4 D1 (n=99, 113) | -0.6 Units on a scale | Standard Deviation 2.26 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C2 D1 (n=191, 194) | -0.5 Units on a scale | Standard Deviation 2.44 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C8 D1 (n=12, 12) | 0.6 Units on a scale | Standard Deviation 1.31 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C3 D1 (n=136,143) | -0.8 Units on a scale | Standard Deviation 2.99 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C10 D1 (n=2, 3) | -1.5 Units on a scale | Standard Deviation 2.12 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C4 D1 (n=98,109) | -0.4 Units on a scale | Standard Deviation 2.62 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C9 D1 (n=6, 6) | -1.3 Units on a scale | Standard Deviation 1.97 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C5 D1 (n=66, 62) | -0.6 Units on a scale | Standard Deviation 3.18 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C5 D1 (n=68, 63) | -0.5 Units on a scale | Standard Deviation 2.76 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C6 D1 (n=41, 41) | -0.4 Units on a scale | Standard Deviation 2.92 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C10 D1 (n=2, 3) | -1.0 Units on a scale | Standard Deviation 1.41 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C7 D1 (n=25, 25) | 0.3 Units on a scale | Standard Deviation 2.32 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C9 D1(n=6, 6) | -1.8 Units on a scale | Standard Deviation 1.94 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C8 D1 (n=12, 12) | 0.4 Units on a scale | Standard Deviation 1.84 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C9 D1 (n=6, 6) | -1.4 Units on a scale | Standard Deviation 2.69 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C6 D1 (n=40, 43) | -0.5 Units on a scale | Standard Deviation 1.96 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C10 D1 (n=2, 3) | -0.5 Units on a scale | Standard Deviation 0.71 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C13 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at follow-up (n=47, 44) | 0.9 Units on a scale | Standard Deviation 3.65 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at follow-up (n=47, 45) | 0.7 Units on a scale | Standard Deviation 3.55 |
| Axitinib + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C7 D1 (n=25, 26) | 0.1 Units on a scale | Standard Deviation 1.66 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at follow-up (n=47, 45) | 0.3 Units on a scale | Standard Deviation 3.4 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C10 D1 (n=2, 3) | -0.3 Units on a scale | Standard Deviation 2.31 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Baseline (n=247, 250) | 3.7 Units on a scale | Standard Deviation 2.96 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C2 D1 (n=192, 200) | -0.9 Units on a scale | Standard Deviation 2.84 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C3 D1 (n=138, 151) | -0.9 Units on a scale | Standard Deviation 2.83 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C4 D1 (n=99, 113) | -0.9 Units on a scale | Standard Deviation 3.09 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C5 D1 (n=69, 64) | -1.2 Units on a scale | Standard Deviation 3.08 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C6 D1 (n=41, 43) | -1.0 Units on a scale | Standard Deviation 3.17 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C7 D1 (n=25, 26) | -0.9 Units on a scale | Standard Deviation 3.5 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C8 D1 (n=12, 13) | -1.5 Units on a scale | Standard Deviation 3.2 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C13 D1 (n=1, 1) | -4.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at follow-up (n=47, 46) | 0.0 Units on a scale | Standard Deviation 3.21 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 Hours (hrs): Baseline (n=246, 248) | 1.7 Units on a scale | Standard Deviation 1.93 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C2 D1 (n=193, 197) | -0.3 Units on a scale | Standard Deviation 1.92 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C3 D1 (n=138, 150) | -0.3 Units on a scale | Standard Deviation 1.88 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C4 D1 (n=99, 112) | -0.0 Units on a scale | Standard Deviation 1.96 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C5 D1 (n=69, 63) | -0.2 Units on a scale | Standard Deviation 2.04 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C6 D1 (n=40, 43) | -0.1 Units on a scale | Standard Deviation 1.64 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C7 D1 (n=25, 26) | -0.0 Units on a scale | Standard Deviation 2.46 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C8 D1 (n=12, 13) | -0.2 Units on a scale | Standard Deviation 1.41 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C9 D1 (n=6, 6) | 0.2 Units on a scale | Standard Deviation 1.6 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C10 D1 (n=2, 3) | 0.3 Units on a scale | Standard Deviation 0.58 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C11 D1 (n=1, 1) | 4.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at C13 D1 (n=1, 1) | -1.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain in Last 24 hrs: Change at followup (n=48, 45) | 0.8 Units on a scale | Standard Deviation 2.58 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Baseline (n=246, 248) | 2.8 Units on a scale | Standard Deviation 2.27 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C2 D1 (n=195, 198) | -0.5 Units on a scale | Standard Deviation 2.29 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C3 D1 (n=140, 149) | -0.5 Units on a scale | Standard Deviation 2.1 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C4 D1 (n=99, 113) | -0.6 Units on a scale | Standard Deviation 2.03 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C5 D1 (n=69, 63) | -0.6 Units on a scale | Standard Deviation 2.29 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C6 D1 (n=40, 43) | -0.9 Units on a scale | Standard Deviation 2.12 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C7 D1 (n=25, 26) | -0.5 Units on a scale | Standard Deviation 2.97 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C8 D1 (n=12, 13) | -1.4 Units on a scale | Standard Deviation 1.94 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C9 D1 (n=6, 6) | -1.7 Units on a scale | Standard Deviation 1.86 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C10 D1 (n=2, 3) | -1.0 Units on a scale | Standard Deviation 2.65 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C11 D1 (n=1, 1) | -3.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at C13 D1 (n=1, 1) | -2.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain on the Average: Change at followup (n=48, 45) | 0.4 Units on a scale | Standard Deviation 2.74 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Baseline (n=248, 249) | 2.1 Units on a scale | Standard Deviation 2.36 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C2 D1 (n=196, 200) | -0.5 Units on a scale | Standard Deviation 2.37 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C3 D1 (n=140, 150) | -0.6 Units on a scale | Standard Deviation 2.06 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C4 D1 (n=99, 113) | -0.5 Units on a scale | Standard Deviation 2.45 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C5 D1 (n=68, 63) | -0.3 Units on a scale | Standard Deviation 2.65 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C6 D1 (n=40, 43) | -0.5 Units on a scale | Standard Deviation 2.14 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C7 D1 (n=25, 26) | -0.2 Units on a scale | Standard Deviation 3.26 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C8 D1 (n=12, 13) | -0.6 Units on a scale | Standard Deviation 1.56 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C9 D1 (n=6, 6) | -0.3 Units on a scale | Standard Deviation 0.52 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C10 D1 (n=2, 3) | 0.7 Units on a scale | Standard Deviation 1.15 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C11 D1 (n=1, 1) | 5.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at C13 D1 (n=1, 1) | -5.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Pain Right Now: Change at follow-up (n=48, 46) | -0.0 Units on a scale | Standard Deviation 2.67 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Treatment (Tx): Baseline (n=226, 221) | 6.9 Units on a scale | Standard Deviation 9.71 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C2 D1 (n=164, 165) | 0.4 Units on a scale | Standard Deviation 11.48 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C3 D1 (n=122, 124) | 0.1 Units on a scale | Standard Deviation 9.16 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C4 D1 (n=88, 92) | -0.9 Units on a scale | Standard Deviation 17.56 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C5 D1 (n=59, 51) | 1.8 Units on a scale | Standard Deviation 11.62 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C6 D1 (n=34, 33) | 0.5 Units on a scale | Standard Deviation 4.28 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C7 D1 (n=21, 18) | -3.2 Units on a scale | Standard Deviation 19.65 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C8 D1 (n=10, 8) | -11.6 Units on a scale | Standard Deviation 28.16 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C9 D1 (n=5, 5) | -16.6 Units on a scale | Standard Deviation 35.44 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C10 D1 (n=1, 2) | 0.0 Units on a scale | Standard Deviation 1.41 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C11 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C12 D1 (n=0, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at C13 D1 (n=0, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relief Pain Tx: Change at follow-up (n=43, 36) | -0.4 Units on a scale | Standard Deviation 5.08 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Baseline (n=243, 243) | 3.0 Units on a scale | Standard Deviation 3.01 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C2 D1 (n=190, 193) | -0.7 Units on a scale | Standard Deviation 2.55 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C3 D1 (n=135, 143) | -0.7 Units on a scale | Standard Deviation 2.61 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C4 D1 (n=97, 109) | -0.8 Units on a scale | Standard Deviation 2.53 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C5 D1 (n=66, 62) | -0.5 Units on a scale | Standard Deviation 2.51 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C6 D1 (n=40, 41) | -0.7 Units on a scale | Standard Deviation 2.62 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C7 D1 (n=25, 25) | -0.4 Units on a scale | Standard Deviation 2.84 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C8 D1 (n=12, 12) | -0.8 Units on a scale | Standard Deviation 2.7 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C9 D1 (n=6, 6) | 0.3 Units on a scale | Standard Deviation 3.72 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C10 D1 (n=2, 3) | 3.0 Units on a scale | Standard Deviation 5.29 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C11 D1 (n=1, 1) | 1.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at C13 D1 (n=1, 1) | -1.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | General Activity: Change at follow-up (n=47, 44) | 0.0 Units on a scale | Standard Deviation 3.63 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Baseline (n=243, 241) | 2.8 Units on a scale | Standard Deviation 2.77 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C2 D1 (n=191, 191) | -0.2 Units on a scale | Standard Deviation 2.46 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C3 D1 (n=135, 141) | -0.5 Units on a scale | Standard Deviation 2.51 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C4 D1 (n=98, 106) | -0.9 Units on a scale | Standard Deviation 2.81 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C5 D1 (n=66, 61) | -0.9 Units on a scale | Standard Deviation 2.59 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C6 D1 (n=40, 41) | -0.8 Units on a scale | Standard Deviation 2.93 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C7 D1 (n=25, 25) | -0.2 Units on a scale | Standard Deviation 3.18 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C8 D1 (n=12, 12) | -1.1 Units on a scale | Standard Deviation 3.12 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C9 D1 (n=6, 6) | -0.8 Units on a scale | Standard Deviation 3.31 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C10 D1 (n=2, 3) | 3.3 Units on a scale | Standard Deviation 1.53 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C11 D1 (n=1, 1) | 5.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at C13 D1 (n=1, 1) | -3.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Mood: Change at follow-up (n=47, 44) | 0.2 Units on a scale | Standard Deviation 3.62 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Baseline (n=242, 243) | 2.3 Units on a scale | Standard Deviation 2.81 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C2 D1 (n=189, 194) | -0.1 Units on a scale | Standard Deviation 2.61 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C3 D1 (n=133, 143) | -0.3 Units on a scale | Standard Deviation 2.52 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C4 D1 (n=97, 108) | -0.4 Units on a scale | Standard Deviation 2.64 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C5 D1 (n=66, 62) | -0.3 Units on a scale | Standard Deviation 2.37 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C6 D1 (n=41, 41) | -0.2 Units on a scale | Standard Deviation 2.24 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C7 D1 (n=25, 25) | -0.1 Units on a scale | Standard Deviation 2.42 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C8 D1 (n=12, 12) | -1.3 Units on a scale | Standard Deviation 2.42 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C9 D1 (n=6, 6) | 0.2 Units on a scale | Standard Deviation 4.62 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C10 D1 (n=2, 3) | 1.3 Units on a scale | Standard Deviation 5.51 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at C13 D1 (n=1, 1) | -2.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Walking Ability: Change at follow-up (n=47, 45) | 0.7 Units on a scale | Standard Deviation 3.27 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Baseline (n=240, 240) | 3.2 Units on a scale | Standard Deviation 3.23 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C2 D1 (n=187, 191) | -0.1 Units on a scale | Standard Deviation 3.16 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C3 D1 (n=133, 139) | -0.4 Units on a scale | Standard Deviation 2.67 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C4 D1 (n=96, 107) | -0.7 Units on a scale | Standard Deviation 2.9 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C5 D1 (n=65, 61) | -0.6 Units on a scale | Standard Deviation 2.71 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C6 D1 (n=39, 41) | -0.2 Units on a scale | Standard Deviation 3.12 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C7 D1 (n=25, 24) | -0.4 Units on a scale | Standard Deviation 2.52 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C8 D1 (n=12, 12) | -0.1 Units on a scale | Standard Deviation 3.37 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C9 D1 (n=6, 6) | 3.5 Units on a scale | Standard Deviation 4.32 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C10 D1 (n=2, 3) | 1.3 Units on a scale | Standard Deviation 3.51 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C11 D1 (n=1, 1) | 2.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at C13 D1 (n=1, 1) | -2.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Normal Work: Change at follow-up (n=46, 43) | 0.3 Units on a scale | Standard Deviation 3.9 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Baseline (n=244, 242) | 1.9 Units on a scale | Standard Deviation 2.44 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C2 D1 (n=190, 193) | 0.0 Units on a scale | Standard Deviation 2.18 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C3 D1 (n=136, 142) | -0.0 Units on a scale | Standard Deviation 2.16 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C4 D1 (n=98, 108) | -0.1 Units on a scale | Standard Deviation 2.52 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C5 D1 (n=66, 62) | -0.1 Units on a scale | Standard Deviation 2.27 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C6 D1 (n=40, 41) | -0.1 Units on a scale | Standard Deviation 2.76 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C7 D1 (n=25, 25) | -0.7 Units on a scale | Standard Deviation 2.44 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C8 D1 (n=12, 12) | -0.9 Units on a scale | Standard Deviation 2.35 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C9 D1 (n=6, 6) | 0.8 Units on a scale | Standard Deviation 4.88 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C10 D1 (n=2, 3) | 2.7 Units on a scale | Standard Deviation 2.52 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C11 D1 (n=1, 1) | 2.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at C13 D1 (n=1, 1) | -2.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Relations: Change at follow-up (n=47, 45) | 0.8 Units on a scale | Standard Deviation 3.56 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Baseline (n=244, 242) | 3.2 Units on a scale | Standard Deviation 3.17 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C2 D1 (n=191, 193) | -0.9 Units on a scale | Standard Deviation 2.73 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C3 D1 (n=136, 142) | -1.1 Units on a scale | Standard Deviation 2.89 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C4 D1 (n=98, 107) | -1.2 Units on a scale | Standard Deviation 3.02 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C5 D1 (n=66, 62) | -0.8 Units on a scale | Standard Deviation 3.37 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C6 D1(n=39, 41) | -0.8 Units on a scale | Standard Deviation 3.62 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C7 D1 (n=25, 25) | -0.6 Units on a scale | Standard Deviation 2.81 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C8 D1 (n=12, 12) | -1.2 Units on a scale | Standard Deviation 3.51 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C9 D1 (n=6, 6) | 0.3 Units on a scale | Standard Deviation 2.07 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C10 D1 (n=2, 3) | 0.7 Units on a scale | Standard Deviation 3.51 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C11 D1 (n=1, 1) | 4.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at C13 D1 (n=1, 1) | -5.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Sleep: Change at follow-up (n=47, 44) | -0.3 Units on a scale | Standard Deviation 3.54 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Baseline (n=242, 240) | 3.4 Units on a scale | Standard Deviation 3.17 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C2 D1 (n=191, 191) | -0.5 Units on a scale | Standard Deviation 2.89 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C3 D1 (n=134, 142) | -0.7 Units on a scale | Standard Deviation 2.77 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C4 D1 (n=98, 107) | -0.9 Units on a scale | Standard Deviation 2.7 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C5 D1 (n=66, 62) | -0.8 Units on a scale | Standard Deviation 3.07 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C6 D1 (n=40, 41) | -1.0 Units on a scale | Standard Deviation 3.17 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C7 D1 (n=25, 25) | -0.9 Units on a scale | Standard Deviation 2.28 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C8 D1 (n=12, 12) | -0.8 Units on a scale | Standard Deviation 2.53 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C9 D1 (n=6, 6) | 0.2 Units on a scale | Standard Deviation 2.86 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C10 D1 (n=2, 3) | 2.3 Units on a scale | Standard Deviation 5.51 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C11 D1 (n=1, 1) | -1.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at C13 D1 (n=1, 1) | -4.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Enjoyment of Life: Change at follow-up (n=47, 43) | -0.2 Units on a scale | Standard Deviation 3.99 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pain Intensity(PI): Baseline (n=248, 251) | 2.6 Units on a scale | Standard Deviation 2.12 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C2 D1 (n=196, 202) | -0.5 Units on a scale | Standard Deviation 1.97 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C3 D1 (n=140, 151) | -0.6 Units on a scale | Standard Deviation 1.88 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C4 D1 (n=99, 114) | -0.5 Units on a scale | Standard Deviation 1.99 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C5 D1 (n=69, 64) | -0.6 Units on a scale | Standard Deviation 2.19 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C6 D1 (n=41, 43) | -0.6 Units on a scale | Standard Deviation 1.89 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C7 D1 (n=25, 27) | -0.4 Units on a scale | Standard Deviation 2.78 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C8 D1 (n=12, 13) | -0.9 Units on a scale | Standard Deviation 1.76 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C9 D1 (n=6, 6) | -0.8 Units on a scale | Standard Deviation 1.11 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C10 D1 (n=2, 3) | -0.1 Units on a scale | Standard Deviation 1.44 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C11 D1 (n=1, 1) | 1.5 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI: Change at C13 D1 (n=1, 1) | -3.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined PI:Change follow-up (n=48, 47) | 0.2 Units on a scale | Standard Deviation 2.56 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pain Interference(Pf):Baseline(n=244,243) | 2.8 Units on a scale | Standard Deviation 2.52 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C2 D1 (n=191, 194) | -0.4 Units on a scale | Standard Deviation 1.97 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C3 D1 (n=136,143) | -0.5 Units on a scale | Standard Deviation 2.01 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C4 D1 (n=98,109) | -0.7 Units on a scale | Standard Deviation 2.12 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C5 D1 (n=66, 62) | -0.6 Units on a scale | Standard Deviation 2.07 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C6 D1 (n=41, 41) | -0.6 Units on a scale | Standard Deviation 2.38 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C7 D1 (n=25, 25) | -0.5 Units on a scale | Standard Deviation 2.1 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C8 D1 (n=12, 12) | -0.9 Units on a scale | Standard Deviation 2.15 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C9 D1 (n=6, 6) | 0.7 Units on a scale | Standard Deviation 2.86 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C10 D1 (n=2, 3) | 2.1 Units on a scale | Standard Deviation 2.9 |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C11 D1 (n=1, 1) | 1.9 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Combined Pf: Change at C13 D1 (n=1, 1) | -2.7 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline Brief Pain Inventory-short Form (BPI-sf) Score | Worst Pain: Change at C9 D1(n=6, 6) | -1.3 Units on a scale | Standard Deviation 1.51 |
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score
EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.
Time frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning:Change at followup (n=67, 70) | -17.713 Units on a scale | Standard Deviation 23.8263 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C8 D1 (n=17, 20) | -9.8 Units on a scale | Standard Deviation 26.39 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C9 D1 (n=9, 9) | -22.2 Units on a scale | Standard Deviation 43.29 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at follow-up (n=66, 72) | -20.0 Units on a scale | Standard Deviation 31.52 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C10 D1 (n=3, 4) | -33.3 Units on a scale | Standard Deviation 33.3 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C4 D1 (n=134, 133) | -5.671 Units on a scale | Standard Deviation 18.8623 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at follow-up (n=65, 71) | -12.6 Units on a scale | Standard Deviation 25.01 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Emotional functioning (EF): Baseline (n=294, 287) | 70.8 Units on a scale | Standard Deviation 22.01 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at follow-up (n=66, 72) | 3.3 Units on a scale | Standard Deviation 37.01 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Baseline (n=289, 286) | 68.9 Units on a scale | Standard Deviation 27.98 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Baseline (n=295, 295) | 16.1 Units on a scale | Standard Deviation 22.3 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C8 D1 (n=15, 21) | -4.000 Units on a scale | Standard Deviation 16.8759 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C2 D1 (n=238, 240) | 5.5 Units on a scale | Standard Deviation 23.58 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C2 D1 (n=232, 230) | 1.3 Units on a scale | Standard Deviation 24.73 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C3 D1 (n=175, 186) | 5.7 Units on a scale | Standard Deviation 26.84 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C2 D1 (n=233, 229) | 5.0 Units on a scale | Standard Deviation 21.48 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C4 D1 (n=135, 135) | 7.7 Units on a scale | Standard Deviation 26.99 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C3 D1 (n=169, 178) | -1.3 Units on a scale | Standard Deviation 29.38 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C5 D1 (n=98, 82) | 4.4 Units on a scale | Standard Deviation 26.05 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C2 D1 (n=239, 242) | -2.2 Units on a scale | Standard Deviation 30.95 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C6 D1 (n=60, 59) | 9.4 Units on a scale | Standard Deviation 26.09 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C4 D1 (n=132, 134) | 0.1 Units on a scale | Standard Deviation 25.51 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C7 D1 (n=37, 37) | 6.3 Units on a scale | Standard Deviation 24.63 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C3 D1 (n=170, 180) | 3.7 Units on a scale | Standard Deviation 20.19 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C8 D1 (n=16, 21) | 4.2 Units on a scale | Standard Deviation 20.62 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C5 D1 (n=95, 80) | 2.1 Units on a scale | Standard Deviation 27.31 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C9 D1 (n=9, 9) | 11.1 Units on a scale | Standard Deviation 47.14 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Baseline (n=295, 289) | 77.445 Units on a scale | Standard Deviation 20.3052 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C10 D1 (n=3, 4) | -11.1 Units on a scale | Standard Deviation 50.92 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C6 D1 (n=58, 56) | -4.9 Units on a scale | Standard Deviation 28.79 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C4 D1 (n=134, 131) | 3.0 Units on a scale | Standard Deviation 22.54 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C7 D1 (n=37, 35) | -5.4 Units on a scale | Standard Deviation 20.05 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C3 D1 (n=177, 185) | -4.6 Units on a scale | Standard Deviation 32.65 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at follow-up (n=68, 73) | 13.2 Units on a scale | Standard Deviation 28.3 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C8 D1 (n=17, 19) | 4.9 Units on a scale | Standard Deviation 29.91 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Baseline (n=297, 295) | 36.8 Units on a scale | Standard Deviation 31.95 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C5 D1 (n=96, 80) | 4.3 Units on a scale | Standard Deviation 21.09 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C2 D1 (n=240, 241) | -13.6 Units on a scale | Standard Deviation 33.55 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C9 D1 (n=9, 9) | -0.0 Units on a scale | Standard Deviation 32.29 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C3 D1 (n=178, 185) | -13.5 Units on a scale | Standard Deviation 33.33 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C9 D1 (n=9, 9) | 0.033 Units on a scale | Standard Deviation 15.2534 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C4 D1 (n=134, 134) | -12.7 Units on a scale | Standard Deviation 38.52 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C10 D1 (n=3, 4) | 5.6 Units on a scale | Standard Deviation 9.64 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C5 D1 (n=99, 82) | -14.5 Units on a scale | Standard Deviation 33.05 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C6 D1 (n=60, 56) | 4.0 Units on a scale | Standard Deviation 19.31 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C6 D1 (n=60, 59) | -8.3 Units on a scale | Standard Deviation 30.46 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C7 D1 (n=37, 37) | -11.7 Units on a scale | Standard Deviation 36.19 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C4 D1 (n=135, 136) | -4.3 Units on a scale | Standard Deviation 32.13 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C8 D1 (n=17, 21) | 5.9 Units on a scale | Standard Deviation 35.82 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C9 D1 (n=9, 9) | -14.8 Units on a scale | Standard Deviation 24.23 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C7 D1 (n=37, 34) | 0.0 Units on a scale | Standard Deviation 18.84 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C10 D1 (n=3, 4) | 11.1 Units on a scale | Standard Deviation 19.23 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C5 D1 (n=96, 82) | -2.498 Units on a scale | Standard Deviation 21.8687 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at follow-up (n=64, 70) | -13.3 Units on a scale | Standard Deviation 33.75 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C8 D1 (n=17, 19) | -2.9 Units on a scale | Standard Deviation 22.05 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at follow-up (n=68, 73) | 1.5 Units on a scale | Standard Deviation 36.63 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Baseline (n=293, 289) | 41.0 Units on a scale | Standard Deviation 23.87 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Baseline (n=297, 295) | 39.6 Units on a scale | Standard Deviation 35.49 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C5 D1 (n=99, 81) | -0.5 Units on a scale | Standard Deviation 34.95 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C2 D1 (n=240, 240) | -2.1 Units on a scale | Standard Deviation 34.24 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C2 D1 (n=227, 228) | 2.8 Units on a scale | Standard Deviation 21.15 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C3 D1 (n=178, 186) | -1.3 Units on a scale | Standard Deviation 31.57 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C9 D1 (n=9, 9) | 3.7 Units on a scale | Standard Deviation 16.72 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C4 D1 (n=135, 135) | 0.0 Units on a scale | Standard Deviation 35.27 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C3 D1 (n=170, 181) | 3.4 Units on a scale | Standard Deviation 21.94 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C5 D1 (n=99, 82) | 1.7 Units on a scale | Standard Deviation 35.76 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C10 D1 (n=3, 4) | 6.667 Units on a scale | Standard Deviation 17.5754 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C6 D1 (n=60, 59) | 2.8 Units on a scale | Standard Deviation 33.22 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C4 D1 (n=132, 132) | 5.6 Units on a scale | Standard Deviation 23.97 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C7 D1 (n=38, 37) | 0.9 Units on a scale | Standard Deviation 35.92 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C10 D1 (n=3, 4) | 13.9 Units on a scale | Standard Deviation 12.73 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C8 D1 (n=17, 20) | 7.8 Units on a scale | Standard Deviation 25.07 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C5 D1 (n=97, 80) | -0.0 Units on a scale | Standard Deviation 24.39 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C9 D1 (n=9, 9) | -14.8 Units on a scale | Standard Deviation 29.41 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C6 D1 (n=60, 58) | -4.4 Units on a scale | Standard Deviation 29.25 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C10 D1 (n=3, 4) | -22.2 Units on a scale | Standard Deviation 19.23 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C6 D1 (n=60, 57) | 5.0 Units on a scale | Standard Deviation 21.31 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C7 D1 (n=38, 36) | 1.8 Units on a scale | Standard Deviation 20.61 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C3 D1 (n=173, 179) | -5.897 Units on a scale | Standard Deviation 19.3522 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at follow-up (n=67, 73) | 7.0 Units on a scale | Standard Deviation 39.17 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C8 D1 (n=17, 20) | 7.2 Units on a scale | Standard Deviation 22.89 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Baseline (n=293, 289) | 30.7 Units on a scale | Standard Deviation 32.13 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C2 D1 (n=234, 235) | -4.8 Units on a scale | Standard Deviation 32.18 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C9 D1 (n=9, 9) | -6.2 Units on a scale | Standard Deviation 21.63 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C3 D1 (n =173, 181) | -7.3 Units on a scale | Standard Deviation 32.12 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C7 D1 (n=38, 37) | -3.1 Units on a scale | Standard Deviation 25.07 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C4 D1 (n=134, 135) | -6.5 Units on a scale | Standard Deviation 35.99 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C10 D1 (n=3, 4) | -11.1 Units on a scale | Standard Deviation 19.28 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C5 D1 (n=97, 80) | -11.0 Units on a scale | Standard Deviation 33.59 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C6 D1 (n=60, 58) | -5.6 Units on a scale | Standard Deviation 37.42 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C7 D1 (n=38, 36) | -2.6 Units on a scale | Standard Deviation 31.37 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C11 D1 (n=1, 1) | 0.000 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C8 D1 (n=17, 20) | 0.0 Units on a scale | Standard Deviation 28.87 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C9 D1 (n=9, 9) | -18.5 Units on a scale | Standard Deviation 33.79 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at follow-up (n=65, 71) | -7.3 Units on a scale | Standard Deviation 23.51 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C10 D1 (n=3, 4) | -11.1 Units on a scale | Standard Deviation 19.23 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C8 D1 (n=16, 21) | -6.2 Units on a scale | Standard Deviation 20.05 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at follow-up (n=63, 71) | 13.1 Units on a scale | Standard Deviation 25.93 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Cognitive Functioning (CF): Baseline (n=293, 288) | 78.7 Units on a scale | Standard Deviation 22.26 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at follow-up (n=66, 71) | 5.1 Units on a scale | Standard Deviation 42.27 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Baseline (n=295, 294) | 12.9 Units on a scale | Standard Deviation 19.19 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Baseline (n=294, 290) | 14.3 Units on a scale | Standard Deviation 21.68 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C6 D1 (n=59, 58) | -5.193 Units on a scale | Standard Deviation 19.6995 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C2 D1 (n=235, 235) | 1.7 Units on a scale | Standard Deviation 25.73 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C2 D1 (n=238, 239) | 3.7 Units on a scale | Standard Deviation 20.69 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C3 D1 (n=173, 182) | 9.4 Units on a scale | Standard Deviation 28.66 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C2 D1 (n=234, 234) | -1.1 Units on a scale | Standard Deviation 19.86 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C4 D1 (n=134, 136) | 7.7 Units on a scale | Standard Deviation 28 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C3 D1 (n=176, 185) | 1.9 Units on a scale | Standard Deviation 20.38 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C5 D1 (n=96, 81) | 11.8 Units on a scale | Standard Deviation 27.35 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C9 D1 (n=9, 9) | 1.9 Units on a scale | Standard Deviation 28.21 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C6 D1 (n=60, 58) | 20.0 Units on a scale | Standard Deviation 33.72 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C4 D1 (n=133, 135) | 3.5 Units on a scale | Standard Deviation 20.82 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C7 D1 (n=38, 36) | 14.9 Units on a scale | Standard Deviation 32.6 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C8 D1 (n=17, 20) | 25.5 Units on a scale | Standard Deviation 38.24 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C3 D1 (n=172, 179) | -2.1 Units on a scale | Standard Deviation 20.43 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C9 D1 (n=9, 9) | 37.0 Units on a scale | Standard Deviation 45.47 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C5 D1 (n=98, 81) | 4.6 Units on a scale | Standard Deviation 22.16 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C10 D1 (n=3, 4) | 22.2 Units on a scale | Standard Deviation 50.91 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C12 D1 (n=1, 0) | 0.000 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C6 D1 (n=60, 59) | 6.9 Units on a scale | Standard Deviation 22.61 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C4 D1 (n=134, 134) | -4.2 Units on a scale | Standard Deviation 19.98 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C7 D1 (n=38, 37) | 1.3 Units on a scale | Standard Deviation 19.52 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at follow-up (n=66, 71) | 2.5 Units on a scale | Standard Deviation 29.41 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C10 D1 (n=3, 4) | 5.6 Units on a scale | Standard Deviation 9.64 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Financial difficulties (FD): Baseline (n=292, 285) | 24.7 Units on a scale | Standard Deviation 30.41 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C8 D1 (n=17, 21) | -4.9 Units on a scale | Standard Deviation 18.41 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD:Change at C2 D1 (n=233, 228) | -3.1 Units on a scale | Standard Deviation 22.95 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C5 D1 (n=97, 80) | -1.4 Units on a scale | Standard Deviation 20.21 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C3 D1 (n=171, 176) | -7.2 Units on a scale | Standard Deviation 26.94 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C9 D1 (n=9, 9) | -13.0 Units on a scale | Standard Deviation 32.02 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C4 D1 (n=133, 133) | -5.5 Units on a scale | Standard Deviation 26.33 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C2 D1 (n=233, 233) | -2.713 Units on a scale | Standard Deviation 16.7682 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C5 D1 (n=96, 80) | -4.9 Units on a scale | Standard Deviation 21.62 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C10 D1 (n=3, 4) | -11.1 Units on a scale | Standard Deviation 19.23 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C6 D1 (n=60, 56) | -3.9 Units on a scale | Standard Deviation 24.61 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C6 D1 (n=60, 56) | -3.1 Units on a scale | Standard Deviation 19.27 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C7 D1 (n=37, 34) | -2.7 Units on a scale | Standard Deviation 24.06 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C8 D1 (n=17, 17) | 2.0 Units on a scale | Standard Deviation 14.28 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C9 D1 (n=9, 9) | 7.4 Units on a scale | Standard Deviation 22.23 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C10 D1 (n=3, 4) | 0.0 Units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C7 D1 (n=38, 34) | -4.4 Units on a scale | Standard Deviation 18.45 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C13 D1 (n=1, 0) | 0.000 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at followup (n=68, 73) | 9.8 Units on a scale | Standard Deviation 25.63 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at follow-up (n=65, 70) | 6.7 Units on a scale | Standard Deviation 29.59 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C8 D1 (n=17, 17) | -8.8 Units on a scale | Standard Deviation 22.15 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/Quality of Life (QoL): Baseline (n=292, 288) | 54.2 Units on a scale | Standard Deviation 22.34 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Baseline (n=291, 291) | 40.7 Units on a scale | Standard Deviation 30.16 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C2 D1 (n=234, 233) | 2.2 Units on a scale | Standard Deviation 23.36 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C3 D1 (n=168, 180) | -0.3 Units on a scale | Standard Deviation 25.42 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C2 D1 (n=231, 234) | -10.1 Units on a scale | Standard Deviation 29.47 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C4 D1(n=132, 132) | 0.1 Units on a scale | Standard Deviation 23.79 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C9 D1 (n=9, 9) | -0.0 Units on a scale | Standard Deviation 25.03 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C5 D1 (n=96, 81) | 1.5 Units on a scale | Standard Deviation 22.63 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C3 D1 (n=169, 181) | -13.6 Units on a scale | Standard Deviation 29.81 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C6 D1 (n=60, 57) | 0.8 Units on a scale | Standard Deviation 21.41 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C7 D1 (n=38, 37) | -1.924 Units on a scale | Standard Deviation 14.2726 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C7 D1 (n=38, 35) | 2.6 Units on a scale | Standard Deviation 23.01 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C4 D1 (n=131, 135) | -12.2 Units on a scale | Standard Deviation 32.48 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C8 D1 (n=17, 19) | -1.0 Units on a scale | Standard Deviation 23.73 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C10 D1 (n=3, 4) | -5.6 Units on a scale | Standard Deviation 9.64 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C9 D1 (n=9, 9) | 7.4 Units on a scale | Standard Deviation 16.89 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C5 D1 (n=97, 80) | -10.5 Units on a scale | Standard Deviation 32.75 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL: Change at C10 D1 (n=3, 4) | 22.3 Units on a scale | Standard Deviation 19.28 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C6 D1 (n=59, 58) | -11.9 Units on a scale | Standard Deviation 27.51 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C7 D1 (n=38, 35) | -14.0 Units on a scale | Standard Deviation 27.81 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at follow-up (n=65, 71) | -9.1 Units on a scale | Standard Deviation 26.06 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Baseline (n=297, 295) | 66.3 Units on a scale | Standard Deviation 30.09 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at follow-up (n=65, 71) | -6.7 Units on a scale | Standard Deviation 24.5 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C7 D1 (n=38, 36) | 2.8 Units on a scale | Standard Deviation 23.05 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Baseline (n=295, 289) | 78.546 Units on a scale | Standard Deviation 18.9192 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C2 D1 (n=233, 233) | -3.261 Units on a scale | Standard Deviation 15.0742 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C3 D1 (n=173, 179) | -1.565 Units on a scale | Standard Deviation 16.2738 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C4 D1 (n=134, 133) | -1.453 Units on a scale | Standard Deviation 17.1209 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C5 D1 (n=96, 82) | -0.076 Units on a scale | Standard Deviation 16.9709 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C6 D1 (n=59, 58) | -1.719 Units on a scale | Standard Deviation 15.526 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C7 D1 (n=38, 37) | 0.011 Units on a scale | Standard Deviation 18.9261 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C8 D1 (n=15, 21) | 0.014 Units on a scale | Standard Deviation 13.8428 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C9 D1 (n=9, 9) | -12.578 Units on a scale | Standard Deviation 20.949 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C10 D1 (n=3, 4) | -1.675 Units on a scale | Standard Deviation 22.0563 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C11 D1 (n=1, 1) | -6.600 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Physical functioning:Change at followup (n=67, 70) | -11.523 Units on a scale | Standard Deviation 21.0513 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Baseline (n=297, 295) | 68.1 Units on a scale | Standard Deviation 30.72 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C2 D1 (n=239, 242) | -2.8 Units on a scale | Standard Deviation 25.75 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C3 D1 (n=177, 185) | 1.5 Units on a scale | Standard Deviation 26.9 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C4 D1 (n=135, 136) | 1.2 Units on a scale | Standard Deviation 27.18 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C5 D1 (n=99, 81) | -2.7 Units on a scale | Standard Deviation 29.63 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C6 D1 (n=60, 58) | -2.3 Units on a scale | Standard Deviation 24.27 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C7 D1 (n=38, 37) | -1.3 Units on a scale | Standard Deviation 26.75 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C8 D1 (n=16, 21) | 0.0 Units on a scale | Standard Deviation 31.63 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C9 D1 (n=9, 9) | -20.4 Units on a scale | Standard Deviation 33.11 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C10 D1 (n=3, 4) | -4.2 Units on a scale | Standard Deviation 28.46 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C11 D1 (n=1, 1) | -50.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Role functioning: Change at follow-up (n=66, 72) | -14.1 Units on a scale | Standard Deviation 32.34 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Emotional functioning (EF): Baseline (n=294, 287) | 71.7 Units on a scale | Standard Deviation 22.47 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C2 D1 (n=233, 229) | 5.0 Units on a scale | Standard Deviation 18.92 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C3 D1 (n=170, 180) | 3.4 Units on a scale | Standard Deviation 18.95 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C4 D1 (n=134, 131) | 5.2 Units on a scale | Standard Deviation 21.12 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C5 D1 (n=96, 80) | 5.9 Units on a scale | Standard Deviation 17.24 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C6 D1 (n=60, 56) | 6.7 Units on a scale | Standard Deviation 17.43 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C7 D1 (n=37, 34) | 3.2 Units on a scale | Standard Deviation 16.28 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C8 D1 (n=17, 19) | 5.3 Units on a scale | Standard Deviation 14.74 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C9 D1 (n=9, 9) | -4.6 Units on a scale | Standard Deviation 15.07 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C10 D1 (n=3, 4) | 2.1 Units on a scale | Standard Deviation 18.5 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C11 D1 (n=1, 1) | -16.6 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | EF: Change at follow-up (n=65, 71) | -2.7 Units on a scale | Standard Deviation 23.14 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Cognitive Functioning (CF): Baseline (n=293, 288) | 80.9 Units on a scale | Standard Deviation 21.5 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C2 D1 (n=234, 234) | -0.3 Units on a scale | Standard Deviation 17.74 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C3 D1 (n=172, 179) | -0.9 Units on a scale | Standard Deviation 18.67 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C4 D1 (n=134, 134) | 2.0 Units on a scale | Standard Deviation 18.62 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C5 D1 (n=97, 80) | 1.7 Units on a scale | Standard Deviation 18.86 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C6 D1 (n=60, 56) | -4.5 Units on a scale | Standard Deviation 19.97 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C7 D1 (n=38, 34) | 0.5 Units on a scale | Standard Deviation 14.5 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C8 D1 (n=17, 17) | -2.9 Units on a scale | Standard Deviation 23.74 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C9 D1 (n=9, 9) | -1.8 Units on a scale | Standard Deviation 24.22 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C10 D1 (n=3, 4) | 8.3 Units on a scale | Standard Deviation 28.88 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | CF: Change at follow-up (n=65, 71) | -7.5 Units on a scale | Standard Deviation 25.47 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Baseline (n=289, 286) | 69.7 Units on a scale | Standard Deviation 28.83 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C2 D1 (n=232, 230) | 0.9 Units on a scale | Standard Deviation 26.35 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C3 D1 (n=169, 178) | 3.2 Units on a scale | Standard Deviation 27.31 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C4 D1 (n=132, 134) | 0.6 Units on a scale | Standard Deviation 26.83 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C5 D1 (n=95, 80) | 0.8 Units on a scale | Standard Deviation 27.93 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C6 D1 (n=58, 56) | 1.5 Units on a scale | Standard Deviation 29.52 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C7 D1 (n=37, 35) | 2.4 Units on a scale | Standard Deviation 29.47 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C8 D1 (n=17, 19) | -1.7 Units on a scale | Standard Deviation 27.72 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C9 D1 (n=9, 9) | -1.8 Units on a scale | Standard Deviation 28.2 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C10 D1 (n=3, 4) | 12.5 Units on a scale | Standard Deviation 43.83 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C11 D1 (n=1, 1) | 33.4 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Social functioning: Change at follow-up (n=64, 70) | -2.6 Units on a scale | Standard Deviation 33.88 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Baseline (n=293, 289) | 40.1 Units on a scale | Standard Deviation 25.12 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C2 D1 (n=227, 228) | 2.1 Units on a scale | Standard Deviation 20.12 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C3 D1 (n=170, 181) | -0.9 Units on a scale | Standard Deviation 21.76 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C4 D1 (n=132, 132) | -1.1 Units on a scale | Standard Deviation 22.77 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C5 D1 (n=97, 80) | 1.1 Units on a scale | Standard Deviation 21.92 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C6 D1 (n=60, 57) | 0.0 Units on a scale | Standard Deviation 21.22 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C7 D1 (n=38, 36) | 2.2 Units on a scale | Standard Deviation 19.12 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C8 D1 (n=17, 20) | 4.4 Units on a scale | Standard Deviation 22.05 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C9 D1 (n=9, 9) | 14.8 Units on a scale | Standard Deviation 24.21 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C10 D1 (n=3, 4) | -5.5 Units on a scale | Standard Deviation 27.98 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C11 D1 (n=1, 1) | 11.1 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Fatigue: Change at follow-up (n=63, 71) | 12.1 Units on a scale | Standard Deviation 25.95 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Baseline (n=295, 294) | 13.1 Units on a scale | Standard Deviation 19.75 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C2 D1 (n=238, 239) | 2.9 Units on a scale | Standard Deviation 22.93 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C3 D1 (n=176, 185) | -0.4 Units on a scale | Standard Deviation 19.54 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C4 D1 (n=133, 135) | 0.4 Units on a scale | Standard Deviation 19.68 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C5 D1 (n=98, 81) | 1.0 Units on a scale | Standard Deviation 18.88 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C6 D1 (n=60, 59) | 2.8 Units on a scale | Standard Deviation 20.33 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C7 D1 (n=38, 37) | 2.7 Units on a scale | Standard Deviation 20.24 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C8 D1 (n=17, 21) | 0.8 Units on a scale | Standard Deviation 22.66 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C9 D1 (n=9, 9) | -5.6 Units on a scale | Standard Deviation 18.64 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C10 D1 (n=3, 4) | 8.3 Units on a scale | Standard Deviation 9.58 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Nausea and vomiting: Change at followup (n=68, 73) | 7.5 Units on a scale | Standard Deviation 22.4 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Baseline (n=291, 291) | 36.9 Units on a scale | Standard Deviation 29.57 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C2 D1 (n=231, 234) | -7.9 Units on a scale | Standard Deviation 25.28 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C3 D1 (n=169, 181) | -11.2 Units on a scale | Standard Deviation 26.63 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C4 D1 (n=131, 135) | -7.8 Units on a scale | Standard Deviation 27.14 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C5 D1 (n=97, 80) | -6.9 Units on a scale | Standard Deviation 26.21 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C6 D1 (n=59, 58) | -7.5 Units on a scale | Standard Deviation 29.48 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C7 D1 (n=38, 35) | -9.5 Units on a scale | Standard Deviation 24.67 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C8 D1 (n=17, 20) | -6.7 Units on a scale | Standard Deviation 29.32 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C9 D1 (n=9, 9) | -5.6 Units on a scale | Standard Deviation 39.08 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C10 D1 (n=3, 4) | -4.2 Units on a scale | Standard Deviation 45.88 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C11 D1 (n=1, 1) | -33.3 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Pain: Change at follow-up (n=66, 72) | 3.5 Units on a scale | Standard Deviation 31.14 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Baseline (n=295, 295) | 14.8 Units on a scale | Standard Deviation 23.55 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C2 D1 (n=238, 240) | 2.1 Units on a scale | Standard Deviation 20.91 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C3 D1 (n=175, 186) | 3.9 Units on a scale | Standard Deviation 24.67 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C4 D1 (n=135, 135) | 4.4 Units on a scale | Standard Deviation 21.08 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C5 D1 (n=98, 82) | 2.8 Units on a scale | Standard Deviation 18.29 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C6 D1 (n=60, 59) | -0.0 Units on a scale | Standard Deviation 16.37 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C7 D1 (n=37, 37) | 5.4 Units on a scale | Standard Deviation 20.05 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C8 D1 (n=16, 21) | 12.7 Units on a scale | Standard Deviation 24.66 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C9 D1 (n=9, 9) | 14.8 Units on a scale | Standard Deviation 29.39 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C10 D1 (n=3, 4) | 0.0 Units on a scale | Standard Deviation 27.19 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Dyspnoea: Change at follow-up (n=68, 73) | 8.7 Units on a scale | Standard Deviation 24.23 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Baseline (n=297, 295) | 32.2 Units on a scale | Standard Deviation 32.17 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C2 D1 (n=240, 241) | -7.3 Units on a scale | Standard Deviation 33.16 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C3 D1 (n=178, 185) | -8.7 Units on a scale | Standard Deviation 33.3 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C4 D1 (n=134, 134) | -11.2 Units on a scale | Standard Deviation 27.41 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C5 D1 (n=99, 82) | -7.3 Units on a scale | Standard Deviation 28.7 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C6 D1 (n=60, 59) | -2.3 Units on a scale | Standard Deviation 30.86 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C7 D1 (n=37, 37) | -2.7 Units on a scale | Standard Deviation 19.84 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C8 D1 (n=17, 21) | -3.2 Units on a scale | Standard Deviation 20.82 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C9 D1 (n=9, 9) | -0.0 Units on a scale | Standard Deviation 23.56 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C10 D1 (n=3, 4) | -0.0 Units on a scale | Standard Deviation 27.23 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C11 D1 (n=1, 1) | 33.3 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Insomnia: Change at follow-up (n=68, 73) | 1.4 Units on a scale | Standard Deviation 28.02 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Baseline (n=297, 295) | 37.5 Units on a scale | Standard Deviation 33.36 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C2 D1 (n=240, 240) | -2.6 Units on a scale | Standard Deviation 27.91 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C3 D1 (n=178, 186) | -5.9 Units on a scale | Standard Deviation 31.5 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C4 D1 (n=135, 135) | -6.7 Units on a scale | Standard Deviation 29.88 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C5 D1 (n=99, 82) | -4.5 Units on a scale | Standard Deviation 30.44 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C6 D1 (n=60, 59) | -4.5 Units on a scale | Standard Deviation 29.34 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C7 D1 (n=38, 37) | -7.2 Units on a scale | Standard Deviation 27.37 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C8 D1 (n=17, 20) | -1.7 Units on a scale | Standard Deviation 29.57 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C9 D1 (n=9, 9) | -7.4 Units on a scale | Standard Deviation 36.44 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C10 D1 (n=3, 4) | 0.0 Units on a scale | Standard Deviation 38.48 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C11 D1 (n=1, 1) | 33.3 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Loss of appetite: Change at follow-up (n=67, 73) | 7.8 Units on a scale | Standard Deviation 36.24 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Baseline (n=293, 289) | 29.6 Units on a scale | Standard Deviation 32.66 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C2 D1 (n=234, 235) | -2.8 Units on a scale | Standard Deviation 33.21 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C3 D1 (n =173, 181) | -6.1 Units on a scale | Standard Deviation 36.43 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C4 D1 (n=134, 135) | -10.6 Units on a scale | Standard Deviation 36.8 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C5 D1 (n=97, 80) | -8.7 Units on a scale | Standard Deviation 29.88 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C6 D1 (n=60, 58) | -9.8 Units on a scale | Standard Deviation 32.45 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C7 D1 (n=38, 36) | -13.0 Units on a scale | Standard Deviation 32.15 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C8 D1 (n=17, 20) | -16.7 Units on a scale | Standard Deviation 39.74 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C9 D1 (n=9, 9) | -29.6 Units on a scale | Standard Deviation 35.14 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C10 D1 (n=3, 4) | -50.0 Units on a scale | Standard Deviation 43.04 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C11 D1 (n=1, 1) | -66.7 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Constipation: Change at follow-up (n=66, 71) | -6.1 Units on a scale | Standard Deviation 35.77 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Baseline (n=294, 290) | 13.7 Units on a scale | Standard Deviation 24.19 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C2 D1 (n=235, 235) | 0.3 Units on a scale | Standard Deviation 21.78 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C3 D1 (n=173, 182) | 0.2 Units on a scale | Standard Deviation 23.1 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C4 D1 (n=134, 136) | -1.5 Units on a scale | Standard Deviation 22.53 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C5 D1 (n=96, 81) | 1.2 Units on a scale | Standard Deviation 27.1 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C6 D1 (n=60, 58) | 1.7 Units on a scale | Standard Deviation 28.22 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C8 D1 (n=17, 20) | 1.7 Units on a scale | Standard Deviation 27.52 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C9 D1 (n=9, 9) | 22.2 Units on a scale | Standard Deviation 33.35 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C10 D1 (n=3, 4) | 16.7 Units on a scale | Standard Deviation 19.23 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Diarrhoea: Change at follow-up (n=66, 71) | 2.8 Units on a scale | Standard Deviation 25.03 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | Financial difficulties (FD): Baseline (n=292, 285) | 23.0 Units on a scale | Standard Deviation 30.83 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD:Change at C2 D1 (n=233, 228) | -4.5 Units on a scale | Standard Deviation 23.29 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C3 D1 (n=171, 176) | -3.4 Units on a scale | Standard Deviation 23.39 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C4 D1 (n=133, 133) | -3.3 Units on a scale | Standard Deviation 23.52 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C5 D1 (n=96, 80) | 1.3 Units on a scale | Standard Deviation 25.68 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C6 D1 (n=60, 56) | -1.8 Units on a scale | Standard Deviation 28.02 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C7 D1 (n=37, 34) | -3.9 Units on a scale | Standard Deviation 32.6 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C8 D1 (n=17, 17) | 2.0 Units on a scale | Standard Deviation 34.31 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C9 D1 (n=9, 9) | 3.7 Units on a scale | Standard Deviation 45.49 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C10 D1 (n=3, 4) | 25.0 Units on a scale | Standard Deviation 41.94 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C11 D1 (n=1, 1) | 66.7 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | FD: Change at follow-up (n=65, 70) | -0.5 Units on a scale | Standard Deviation 21.61 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/Quality of Life (QoL): Baseline (n=292, 288) | 57.1 Units on a scale | Standard Deviation 23.14 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C2 D1 (n=234, 233) | 1.9 Units on a scale | Standard Deviation 22.39 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C3 D1 (n=168, 180) | 5.7 Units on a scale | Standard Deviation 21.45 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C4 D1(n=132, 132) | 2.8 Units on a scale | Standard Deviation 21.54 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C5 D1 (n=96, 81) | 2.7 Units on a scale | Standard Deviation 18.35 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C6 D1 (n=60, 57) | 3.2 Units on a scale | Standard Deviation 23.4 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C7 D1 (n=38, 35) | 2.1 Units on a scale | Standard Deviation 22.35 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C8 D1 (n=17, 19) | 1.3 Units on a scale | Standard Deviation 23.76 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL:Change at C9 D1 (n=9, 9) | -8.3 Units on a scale | Standard Deviation 20.39 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL: Change at C10 D1 (n=3, 4) | -0.0 Units on a scale | Standard Deviation 32.59 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire Core-30 (EORTC QLQ- C30) Score | GHS/QoL: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
Secondary
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score
QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100; higher scores= greater degree of symptoms or treatment side effects and emotional issues.
Time frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Baseline (n=250, 256) | 38.7 Units on a scale | Standard Deviation 32.98 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C2 D1 (n=197, 207) | -8.6 Units on a scale | Standard Deviation 33.32 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C9 D1 (n=4, 6) | 25.0 Units on a scale | Standard Deviation 31.93 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C3 D1 (n=144, 158) | -8.3 Units on a scale | Standard Deviation 33.34 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at follow-up (n=47, 46) | -3.5 Units on a scale | Standard Deviation 29.59 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C4 D1 (n=101, 114) | -5.0 Units on a scale | Standard Deviation 36.64 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C10 D1 (n=0, 3) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C5 D1 (n=71, 65) | -8.5 Units on a scale | Standard Deviation 34.15 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C6 D1 (n=42, 45) | -3.2 Units on a scale | Standard Deviation 31.08 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C11 D1 (n=0, 1) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C7 D1 (n=26, 26) | -14.1 Units on a scale | Standard Deviation 32.91 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C8 D1 (n=11, 11) | -7.6 Units on a scale | Standard Deviation 27.76 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C8 D1 (n=11, 14) | -18.2 Units on a scale | Standard Deviation 43.12 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C12 D1 (n=0, 0) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C9 D1 (n=6, 6) | -11.1 Units on a scale | Standard Deviation 34.42 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at follow-up (n=47, 48) | 2.8 Units on a scale | Standard Deviation 23.38 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C10 D1 (n=2, 3) | -16.7 Units on a scale | Standard Deviation 23.55 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C13 D1 (n=0, 0) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Baseline (n=245, 254) | 10.2 Units on a scale | Standard Deviation 17.21 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at follow-up (n=36, 41) | -3.2 Units on a scale | Standard Deviation 41.18 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Baseline (n=250, 255) | 34.3 Units on a scale | Standard Deviation 30.78 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at follow-up (n=48, 48) | 5.6 Units on a scale | Standard Deviation 35.96 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Health care(HC)satisfaction: Baseline (n=241, 247) | 78.0 Units on a scale | Standard Deviation 26.66 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Baseline (n=252, 257) | 29.4 Units on a scale | Standard Deviation 30.38 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C5 D1 (n=67, 64) | -15.8 Units on a scale | Standard Deviation 28.06 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C2 D1 (n=198, 208) | -0.3 Units on a scale | Standard Deviation 26.87 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C2 D1 (n=182, 194) | 0.1 Units on a scale | Standard Deviation 27.73 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C3 D1 (n=144, 159) | 0.2 Units on a scale | Standard Deviation 30.16 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C2 D1 (n=195, 206) | 2.8 Units on a scale | Standard Deviation 29.15 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C4 D1 (n=101, 115) | -4.0 Units on a scale | Standard Deviation 24.63 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C3 D1 (n=135, 149) | 0.2 Units on a scale | Standard Deviation 31.54 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C5 D1 (n=71, 65) | 0.5 Units on a scale | Standard Deviation 29.01 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C2 D1 (n=193, 205) | 0.3 Units on a scale | Standard Deviation 18.24 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C6 D1 (n=41, 45) | 1.6 Units on a scale | Standard Deviation 31.58 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C4 D1 (n=97, 108) | -4.3 Units on a scale | Standard Deviation 34.88 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C7 D1 (n=26, 26) | -3.8 Units on a scale | Standard Deviation 19.6 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C3 D1 (n=144, 159) | -1.2 Units on a scale | Standard Deviation 31.58 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C8 D1 (n=11, 14) | 0.0 Units on a scale | Standard Deviation 21.06 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C5 D1 (n=66, 59) | 1.0 Units on a scale | Standard Deviation 29.66 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C9 D1 (n=6, 6) | -5.6 Units on a scale | Standard Deviation 25.07 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C9 D1 (n=6, 6) | -29.2 Units on a scale | Standard Deviation 31.06 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C10 D1 (n=2, 3) | -16.7 Units on a scale | Standard Deviation 23.55 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C6 D1 (n=40, 39) | -6.7 Units on a scale | Standard Deviation 26.91 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C4 D1 (n=100, 114) | 0.5 Units on a scale | Standard Deviation 30.57 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C7 D1 (n=27, 20) | -4.3 Units on a scale | Standard Deviation 22.44 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C3 D1 (n=142, 157) | -1.4 Units on a scale | Standard Deviation 16.78 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at follow-up (n=48, 48) | 7.6 Units on a scale | Standard Deviation 30.94 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C8 D1 (n=12, 11) | -16.7 Units on a scale | Standard Deviation 52.23 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Baseline (n=249, 256) | 37.9 Units on a scale | Standard Deviation 32.34 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C5 D1 (n=69, 65) | 1.4 Units on a scale | Standard Deviation 32.8 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C2 D1 (n=197, 206) | 1.2 Units on a scale | Standard Deviation 29.81 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C9 D1 (n=6, 6) | 16.7 Units on a scale | Standard Deviation 47.14 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C3 D1 (n=146, 159) | 3.2 Units on a scale | Standard Deviation 33.07 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C2 D1 (n=191, 197) | -10.9 Units on a scale | Standard Deviation 24.38 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C4 D1 (n=101, 115) | -1.3 Units on a scale | Standard Deviation 33.65 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C10 D1 (n=2, 3) | -33.3 Units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C5 D1 (n=70, 65) | -1.0 Units on a scale | Standard Deviation 32.6 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C6 D1 (n=40, 45) | 3.3 Units on a scale | Standard Deviation 30.23 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C6 D1 (n=41, 45) | -1.6 Units on a scale | Standard Deviation 26.83 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C11 D1 (n=1, 1) | -33.3 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C7 D1 (n=25, 26) | -1.3 Units on a scale | Standard Deviation 26.31 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C4 D1 (n=99, 112) | -2.5 Units on a scale | Standard Deviation 18.34 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C8 D1 (n=10, 14) | -10.0 Units on a scale | Standard Deviation 35.34 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C12 D1 (n=1, 0) | -33.3 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C9 D1 (n=5, 6) | 0.0 Units on a scale | Standard Deviation 0 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C7 D1 (n=25, 26) | -6.0 Units on a scale | Standard Deviation 30.76 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C10 D1 (n=1, 3) | 33.3 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C13 D1(n=1, 0) | -33.3 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C11 D1 (n=0, 1) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C10 D1 (n=2, 3) | -20.9 Units on a scale | Standard Deviation 29.49 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C12 D1 (n=0, 0) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at follow-up (n=46, 45) | -0.7 Units on a scale | Standard Deviation 29.39 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C13 D1 (n=0, 0) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C8 D1 (n=11, 14) | 4.5 Units on a scale | Standard Deviation 42.87 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at follow-up (n=48, 46) | -0.7 Units on a scale | Standard Deviation 35.41 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Baseline (n=249, 251) | 28.5 Units on a scale | Standard Deviation 28.46 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Baseline (n=251, 253) | 33.1 Units on a scale | Standard Deviation 27.62 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C5 D1 (n=68, 64) | 1.0 Units on a scale | Standard Deviation 17.49 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C2 D1 (n=197, 205) | 4.2 Units on a scale | Standard Deviation 24.26 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C2 D1 (n=189, 200) | 4.9 Units on a scale | Standard Deviation 23.11 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C3 D1 (n=145, 157) | 4.6 Units on a scale | Standard Deviation 25.87 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C9 D1 (n=6, 6) | -13.9 Units on a scale | Standard Deviation 46.44 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C4 D1 (n=101, 112) | 1.2 Units on a scale | Standard Deviation 26.37 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C3 D1 (n=142, 149) | 4.9 Units on a scale | Standard Deviation 22.26 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C5 D1 (n=70, 64) | 0.5 Units on a scale | Standard Deviation 28.37 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C6 D1 (n=41, 43) | -15.9 Units on a scale | Standard Deviation 25.47 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C6 D1 (n=40, 44) | -2.1 Units on a scale | Standard Deviation 24.8 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C4 D1 (n=97, 111) | 6.7 Units on a scale | Standard Deviation 26.2 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C7 D1 (n=24, 26) | -0.7 Units on a scale | Standard Deviation 24.31 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C10 D1 (n=2, 3) | -33.3 Units on a scale | Standard Deviation 47.09 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C8 D1 (n=10, 14) | 15.0 Units on a scale | Standard Deviation 34.64 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C5 D1 (n=70, 62) | 4.8 Units on a scale | Standard Deviation 26.33 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C9 D1 (n=5, 6) | 16.7 Units on a scale | Standard Deviation 31.16 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C6 D1 (n=40, 41) | 0.4 Units on a scale | Standard Deviation 15.34 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C10 D1 (n=1, 3) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C6 D1 (n=40, 42) | 8.3 Units on a scale | Standard Deviation 28.24 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C11 D1 (n=0, 1) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C12 D1 (n=0, 0) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C7 D1 (n=25, 24) | 12.0 Units on a scale | Standard Deviation 27.43 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C13 D1 (n=0, 0) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at follow-up (n=48, 47) | 8.0 Units on a scale | Standard Deviation 31.69 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C8 D1 (n=11, 12) | 21.2 Units on a scale | Standard Deviation 42.23 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Baseline (n=209, 226) | 24.9 Units on a scale | Standard Deviation 21.21 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C2 D1 (n=159, 181) | 11.2 Units on a scale | Standard Deviation 23.11 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C9 D1 (n=6, 6) | 33.3 Units on a scale | Standard Deviation 52.69 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C3 D1 (n=113, 137) | 13.0 Units on a scale | Standard Deviation 24.67 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C7 D1 (n=25, 24) | -0.7 Units on a scale | Standard Deviation 16.3 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C4 D1 (n=80, 102) | 10.1 Units on a scale | Standard Deviation 20.64 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C10 D1 (n=2, 3) | -8.3 Units on a scale | Standard Deviation 11.74 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C5 D1 (n=54, 59) | 7.4 Units on a scale | Standard Deviation 25.55 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C6 D1 (n=29, 40) | 8.1 Units on a scale | Standard Deviation 26.72 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C7 D1 (n=17, 22) | 15.0 Units on a scale | Standard Deviation 20.77 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C4 D1 (n=99, 111) | -13.2 Units on a scale | Standard Deviation 28.7 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C8 D1 (n=8, 11) | 9.7 Units on a scale | Standard Deviation 19.19 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C9 D1 (n=3, 6) | 14.8 Units on a scale | Standard Deviation 23.15 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at follow-up (n=47, 47) | 6.0 Units on a scale | Standard Deviation 38.14 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C10 D1 (n=0, 3) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C11 D1 (n=0, 1) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C8 D1 (n=11, 12) | -4.5 Units on a scale | Standard Deviation 13.1 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C12 D1 (n=0, 0) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at follow-up (n=47, 45) | 13.1 Units on a scale | Standard Deviation 30.67 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C13 D1 (n=0, 0) | NA Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Baseline (n=217, 232) | 56.8 Units on a scale | Standard Deviation 36.9 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at follow-up (n=42, 42) | 18.8 Units on a scale | Standard Deviation 24.37 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Baseline (n=250, 255) | 20.3 Units on a scale | Standard Deviation 22.92 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of Future Health (FH): Baseline (n=252, 250)) | 59.3 Units on a scale | Standard Deviation 31.33 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C2 D1 (n=192, 201) | -3.5 Units on a scale | Standard Deviation 31.82 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C2 D1 (n=193, 204) | 3.0 Units on a scale | Standard Deviation 24.19 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C3 D1 (n=145, 155) | -0.9 Units on a scale | Standard Deviation 34.02 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C2 D1 (n=157, 181) | -0.5 Units on a scale | Standard Deviation 37.81 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C4 D1 (n=103, 113) | -4.5 Units on a scale | Standard Deviation 32.7 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C3 D1 (n=143, 156) | 6.2 Units on a scale | Standard Deviation 26.37 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C5 D1 (n=71, 64) | -0.5 Units on a scale | Standard Deviation 31.12 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C9 D1 (n=6, 5) | -11.1 Units on a scale | Standard Deviation 13.6 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C6 D1 (n=42, 44) | -4.8 Units on a scale | Standard Deviation 30.86 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C4 D1 (n=98, 114) | 6.6 Units on a scale | Standard Deviation 25.52 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C7 D1 (n=27, 25) | -6.2 Units on a scale | Standard Deviation 22.72 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C3 D1 (n=118, 139) | -4.9 Units on a scale | Standard Deviation 37.7 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C8 D1 (n=12, 12) | 2.8 Units on a scale | Standard Deviation 30.02 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C5 D1 (n=68, 63) | 8.3 Units on a scale | Standard Deviation 33.15 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C9 D1 (n=6, 6) | 16.7 Units on a scale | Standard Deviation 27.9 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C7 D1 (n=25, 25) | -15.3 Units on a scale | Standard Deviation 28.02 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C10 D1 (n=2, 3) | -16.7 Units on a scale | Standard Deviation 23.62 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C6 D1 (n=40, 43) | 9.6 Units on a scale | Standard Deviation 30.63 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C4 D1 (n=85, 100) | -4.1 Units on a scale | Standard Deviation 38.4 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C7 D1 (n=25, 25) | 6.0 Units on a scale | Standard Deviation 25.4 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C10 D1 (n=2, 2) | -16.7 Units on a scale | Standard Deviation 23.55 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH:Change at follow-up (n=48, 45) | 5.6 Units on a scale | Standard Deviation 28.63 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C8 D1 (n=11, 13) | 1.5 Units on a scale | Standard Deviation 29.29 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Baseline (n=250, 249) | 34.3 Units on a scale | Standard Deviation 33.59 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C5 D1 (n=55, 58) | -1.5 Units on a scale | Standard Deviation 34.3 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C2 D1 (n=192, 198) | 6.1 Units on a scale | Standard Deviation 38.19 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C9 D1 (n=6, 6) | 13.9 Units on a scale | Standard Deviation 32.35 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability:Change at C3 D1 (n=142, 153) | 3.5 Units on a scale | Standard Deviation 39.65 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability:Change at C4 D1 (n=101, 112) | 5.6 Units on a scale | Standard Deviation 36.55 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C10 D1 (n=2, 3) | -8.3 Units on a scale | Standard Deviation 35.36 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability:Change at C5 D1 (n=70, 62) | 0.9 Units on a scale | Standard Deviation 34.05 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C6 D1 (n=30, 38) | 12.2 Units on a scale | Standard Deviation 29.67 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability:Change at C6 D1 (n=42, 42) | 4.8 Units on a scale | Standard Deviation 34.99 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C11 D1 (n=1, 1) | 16.7 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C7 D1 (n=26, 24) | 2.6 Units on a scale | Standard Deviation 28.18 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C8 D1 (n=11, 11) | 6.1 Units on a scale | Standard Deviation 32.74 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C12 D1 (n=1, 0) | 16.7 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C9 D1 (n=5, 6) | 0.0 Units on a scale | Standard Deviation 23.55 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C7 D1 (n=19, 21) | 4.4 Units on a scale | Standard Deviation 35.06 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C10 D1 (n=1, 3) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C3 D1 (n=141, 153) | -16.3 Units on a scale | Standard Deviation 25.51 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C12 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at followup (n=47, 48) | 6.0 Units on a scale | Standard Deviation 29.36 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C13 D1 (n=1, 0) | 0.0 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C8 D1 (n=8, 10) | 12.5 Units on a scale | Standard Deviation 24.82 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at followup (n=48, 45) | 21.5 Units on a scale | Standard Deviation 35.4 |
| Axitinib + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Baseline (n=246, 250) | 41.6 Units on a scale | Standard Deviation 27.16 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at followup (n=48, 45) | 5.2 Units on a scale | Standard Deviation 38.25 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Baseline (n=246, 250) | 40.0 Units on a scale | Standard Deviation 25.54 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C2 D1 (n=191, 197) | -10.1 Units on a scale | Standard Deviation 22.93 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C3 D1 (n=141, 153) | -11.2 Units on a scale | Standard Deviation 24.92 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C4 D1 (n=99, 111) | -11.4 Units on a scale | Standard Deviation 26.16 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C5 D1 (n=67, 64) | -13.0 Units on a scale | Standard Deviation 23.85 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C6 D1 (n=41, 43) | -13.0 Units on a scale | Standard Deviation 24.62 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C7 D1 (n=25, 25) | -15.0 Units on a scale | Standard Deviation 25.69 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C8 D1 (n=11, 11) | -9.8 Units on a scale | Standard Deviation 30.01 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C9 D1 (n=6, 6) | 0.0 Units on a scale | Standard Deviation 15.81 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C10 D1 (n=2, 3) | 5.6 Units on a scale | Standard Deviation 26.79 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Pancreatic Pain: Change at follow-up (n=47, 46) | -3.6 Units on a scale | Standard Deviation 28.8 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Baseline (n=245, 254) | 10.8 Units on a scale | Standard Deviation 17.59 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C2 D1 (n=193, 205) | -2.0 Units on a scale | Standard Deviation 17.67 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C3 D1 (n=142, 157) | -2.5 Units on a scale | Standard Deviation 18.6 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C4 D1 (n=99, 112) | -2.4 Units on a scale | Standard Deviation 18.15 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C5 D1 (n=68, 64) | -2.6 Units on a scale | Standard Deviation 16.6 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C6 D1 (n=40, 41) | -3.2 Units on a scale | Standard Deviation 17.57 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C7 D1 (n=25, 24) | -4.9 Units on a scale | Standard Deviation 18.7 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C8 D1 (n=11, 12) | -4.2 Units on a scale | Standard Deviation 12.57 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C9 D1 (n=6, 5) | -13.3 Units on a scale | Standard Deviation 13.94 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C10 D1 (n=2, 2) | -8.4 Units on a scale | Standard Deviation 11.81 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Hepatic: Change at follow-up (n=47, 48) | -1.4 Units on a scale | Standard Deviation 23.27 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Baseline (n=250, 255) | 33.9 Units on a scale | Standard Deviation 31.05 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C2 D1 (n=195, 206) | 0.6 Units on a scale | Standard Deviation 26.72 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C3 D1 (n=144, 159) | -4.3 Units on a scale | Standard Deviation 32.97 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C4 D1 (n=100, 114) | -4.5 Units on a scale | Standard Deviation 30.9 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C5 D1 (n=69, 65) | -3.6 Units on a scale | Standard Deviation 36.14 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C6 D1 (n=40, 45) | 0.4 Units on a scale | Standard Deviation 35.97 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C7 D1 (n=25, 26) | -1.3 Units on a scale | Standard Deviation 24.91 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C8 D1 (n=11, 14) | 17.9 Units on a scale | Standard Deviation 23.07 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C9 D1 (n=6, 6) | 22.2 Units on a scale | Standard Deviation 25.1 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C10 D1 (n=2, 3) | 11.1 Units on a scale | Standard Deviation 19.23 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C11 D1 (n=1, 1) | 66.7 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Digestive Symptom: Change at follow-up (n=47, 47) | 2.8 Units on a scale | Standard Deviation 35.83 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Baseline (n=217, 232) | 55.5 Units on a scale | Standard Deviation 38.04 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C2 D1 (n=157, 181) | -4.0 Units on a scale | Standard Deviation 33.17 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C3 D1 (n=118, 139) | -3.0 Units on a scale | Standard Deviation 32.25 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C4 D1 (n=85, 100) | 3.0 Units on a scale | Standard Deviation 29.9 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C5 D1 (n=55, 58) | -5.2 Units on a scale | Standard Deviation 29.32 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C6 D1 (n=30, 38) | -11.4 Units on a scale | Standard Deviation 33.58 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C7 D1 (n=19, 21) | -7.1 Units on a scale | Standard Deviation 31.88 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C8 D1 (n=8, 10) | -15.0 Units on a scale | Standard Deviation 26.59 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C9 D1 (n=4, 6) | 0.0 Units on a scale | Standard Deviation 23.55 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C10 D1 (n=0, 3) | 11.1 Units on a scale | Standard Deviation 19.28 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C11 D1 (n=0, 1) | 33.3 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C12 D1 (n=0, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at C13 D1 (n=0, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Sexuality: Change at follow-up (n=36, 41) | -23.2 Units on a scale | Standard Deviation 42.31 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Health care(HC)satisfaction: Baseline (n=241, 247) | 78.3 Units on a scale | Standard Deviation 23.94 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C2 D1 (n=182, 194) | 1.8 Units on a scale | Standard Deviation 24.13 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C3 D1 (n=135, 149) | 5.4 Units on a scale | Standard Deviation 24.98 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C4 D1 (n=97, 108) | -0.2 Units on a scale | Standard Deviation 26.52 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C5 D1 (n=66, 59) | 0.8 Units on a scale | Standard Deviation 28.77 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C6 D1 (n=40, 39) | -0.4 Units on a scale | Standard Deviation 27.96 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C7 D1 (n=27, 20) | 6.7 Units on a scale | Standard Deviation 33.06 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C8 D1 (n=12, 11) | 7.6 Units on a scale | Standard Deviation 20.22 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C9 D1 (n=6, 6) | -5.6 Units on a scale | Standard Deviation 17.23 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C10 D1 (n=2, 3) | 5.6 Units on a scale | Standard Deviation 9.64 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at C13 D1(n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | HC satisfaction: Change at follow-up (n=46, 45) | -2.2 Units on a scale | Standard Deviation 31.5 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Baseline (n=249, 251) | 28.8 Units on a scale | Standard Deviation 28.67 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C2 D1 (n=189, 200) | -0.2 Units on a scale | Standard Deviation 26.78 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C3 D1 (n=142, 149) | 2.1 Units on a scale | Standard Deviation 26.16 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C4 D1 (n=97, 111) | 0.9 Units on a scale | Standard Deviation 26.48 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C5 D1 (n=70, 62) | -0.3 Units on a scale | Standard Deviation 25.87 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C6 D1 (n=40, 42) | -0.8 Units on a scale | Standard Deviation 33.92 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C7 D1 (n=25, 24) | -5.6 Units on a scale | Standard Deviation 33.22 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C8 D1 (n=11, 12) | 11.1 Units on a scale | Standard Deviation 32.04 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C9 D1 (n=6, 6) | 8.3 Units on a scale | Standard Deviation 46.87 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C10 D1 (n=2, 3) | 5.6 Units on a scale | Standard Deviation 78.77 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C11 D1 (n=1, 1) | -50.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Body Image: Change at follow-up (n=47, 45) | 11.5 Units on a scale | Standard Deviation 24.56 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Baseline (n=250, 255) | 21.2 Units on a scale | Standard Deviation 25.72 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C2 D1 (n=193, 204) | 1.5 Units on a scale | Standard Deviation 22.21 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C3 D1 (n=143, 156) | 2.5 Units on a scale | Standard Deviation 24.67 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C4 D1 (n=98, 114) | 4.8 Units on a scale | Standard Deviation 22.14 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C5 D1 (n=68, 63) | 1.3 Units on a scale | Standard Deviation 24.56 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C6 D1 (n=40, 43) | 2.3 Units on a scale | Standard Deviation 28.07 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C7 D1 (n=25, 25) | 1.3 Units on a scale | Standard Deviation 30.77 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C8 D1 (n=11, 13) | 7.7 Units on a scale | Standard Deviation 38.86 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C9 D1 (n=6, 6) | -5.6 Units on a scale | Standard Deviation 51.27 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C10 D1 (n=2, 3) | -16.7 Units on a scale | Standard Deviation 72.62 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C11 D1 (n=1, 1) | -100.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Altered Bowel Habit: Change at followup (n=47, 48) | 5.9 Units on a scale | Standard Deviation 21.33 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Baseline (n=250, 256) | 32.9 Units on a scale | Standard Deviation 30.61 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C2 D1 (n=197, 207) | -3.4 Units on a scale | Standard Deviation 29.65 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C3 D1 (n=144, 158) | -5.1 Units on a scale | Standard Deviation 28.7 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C4 D1 (n=101, 114) | -0.3 Units on a scale | Standard Deviation 26.05 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C5 D1 (n=71, 65) | -0.5 Units on a scale | Standard Deviation 29.17 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C6 D1 (n=42, 45) | -2.2 Units on a scale | Standard Deviation 32.1 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C7 D1 (n=26, 26) | -12.8 Units on a scale | Standard Deviation 23.25 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C8 D1 (n=11, 14) | -11.9 Units on a scale | Standard Deviation 28.05 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C9 D1 (n=6, 6) | -16.7 Units on a scale | Standard Deviation 34.95 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C10 D1 (n=2, 3) | 22.2 Units on a scale | Standard Deviation 38.51 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C11 D1 (n=1, 1) | 33.3 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Ascites: Change at follow-up (n=48, 48) | -2.1 Units on a scale | Standard Deviation 26.11 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Baseline (n=252, 257) | 24.0 Units on a scale | Standard Deviation 28.55 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C2 D1 (n=198, 208) | -2.4 Units on a scale | Standard Deviation 24.29 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C3 D1 (n=144, 159) | -5.2 Units on a scale | Standard Deviation 25.59 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C4 D1 (n=101, 115) | -4.1 Units on a scale | Standard Deviation 25.8 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C5 D1 (n=71, 65) | -4.6 Units on a scale | Standard Deviation 22.72 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C6 D1 (n=41, 45) | -1.5 Units on a scale | Standard Deviation 24.57 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C7 D1 (n=26, 26) | -1.3 Units on a scale | Standard Deviation 17.59 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C8 D1 (n=11, 14) | 2.4 Units on a scale | Standard Deviation 20.53 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C9 D1 (n=6, 6) | 11.1 Units on a scale | Standard Deviation 27.23 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C10 D1 (n=2, 3) | 22.2 Units on a scale | Standard Deviation 19.23 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Indigestion: Change at follow-up (n=48, 48) | 1.4 Units on a scale | Standard Deviation 30.73 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Baseline (n=249, 256) | 34.0 Units on a scale | Standard Deviation 31.31 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C2 D1 (n=197, 206) | 2.6 Units on a scale | Standard Deviation 31.82 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C3 D1 (n=146, 159) | 0.2 Units on a scale | Standard Deviation 34.48 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C4 D1 (n=101, 115) | 2.3 Units on a scale | Standard Deviation 32.07 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C5 D1 (n=70, 65) | 1.0 Units on a scale | Standard Deviation 31.17 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C6 D1 (n=41, 45) | -1.5 Units on a scale | Standard Deviation 29.27 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C7 D1 (n=25, 26) | -3.8 Units on a scale | Standard Deviation 23.71 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C8 D1 (n=10, 14) | 2.4 Units on a scale | Standard Deviation 27.62 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C9 D1 (n=5, 6) | 5.6 Units on a scale | Standard Deviation 13.59 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C10 D1 (n=1, 3) | -11.1 Units on a scale | Standard Deviation 19.23 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C11 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C12 D1 (n=0, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at C13 D1 (n=0, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Flatulence: Change at follow-up (n=48, 46) | 2.2 Units on a scale | Standard Deviation 34 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Baseline (n=251, 253) | 33.6 Units on a scale | Standard Deviation 26.84 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C2 D1 (n=197, 205) | 0.6 Units on a scale | Standard Deviation 21.63 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C3 D1 (n=145, 157) | -3.3 Units on a scale | Standard Deviation 21.13 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C4 D1 (n=101, 112) | -6.2 Units on a scale | Standard Deviation 24.82 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C5 D1 (n=70, 64) | -8.3 Units on a scale | Standard Deviation 24.48 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C6 D1 (n=40, 44) | -5.3 Units on a scale | Standard Deviation 24.84 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C7 D1 (n=24, 26) | -5.1 Units on a scale | Standard Deviation 25.27 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C8 D1 (n=10, 14) | -4.7 Units on a scale | Standard Deviation 21.12 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C9 D1 (n=5, 6) | 2.8 Units on a scale | Standard Deviation 19.47 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C10 D1 (n=1, 3) | 0.0 Units on a scale | Standard Deviation 28.87 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C11 D1 (n=0, 1) | -16.6 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C12 D1 (n=0, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at C13 D1 (n=0, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Cachexia: Change at follow-up (n=48, 47) | 6.4 Units on a scale | Standard Deviation 30.79 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Baseline (n=209, 226) | 27.4 Units on a scale | Standard Deviation 23.08 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C2 D1 (n=159, 181) | 5.8 Units on a scale | Standard Deviation 22.06 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C3 D1 (n=113, 137) | 4.7 Units on a scale | Standard Deviation 22.18 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C4 D1 (n=80, 102) | 4.9 Units on a scale | Standard Deviation 22.48 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C5 D1 (n=54, 59) | 3.6 Units on a scale | Standard Deviation 23.84 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C6 D1 (n=29, 40) | -1.4 Units on a scale | Standard Deviation 25.32 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C7 D1 (n=17, 22) | -1.0 Units on a scale | Standard Deviation 19.38 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C8 D1 (n=8, 11) | -3.0 Units on a scale | Standard Deviation 22.83 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C9 D1 (n=3, 6) | -1.9 Units on a scale | Standard Deviation 27.6 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C10 D1 (n=0, 3) | 0.0 Units on a scale | Standard Deviation 40.12 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C11 D1 (n=0, 1) | -33.4 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C12 D1 (n=0, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at C13 D1 (n=0, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Side Effects: Change at follow-up (n=42, 42) | 13.2 Units on a scale | Standard Deviation 27.8 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of Future Health (FH): Baseline (n=252, 250)) | 61.1 Units on a scale | Standard Deviation 33.07 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C2 D1 (n=192, 201) | -9.6 Units on a scale | Standard Deviation 28.8 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C3 D1 (n=145, 155) | -11.6 Units on a scale | Standard Deviation 30.07 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C4 D1 (n=103, 113) | -15.9 Units on a scale | Standard Deviation 30.9 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C5 D1 (n=71, 64) | -10.9 Units on a scale | Standard Deviation 29.74 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C6 D1 (n=42, 44) | -14.4 Units on a scale | Standard Deviation 32.47 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C7 D1 (n=27, 25) | -13.3 Units on a scale | Standard Deviation 33.34 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C8 D1 (n=12, 12) | 5.6 Units on a scale | Standard Deviation 27.84 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C9 D1 (n=6, 6) | 16.7 Units on a scale | Standard Deviation 34.96 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C10 D1 (n=2, 3) | 11.1 Units on a scale | Standard Deviation 50.96 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C11 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Fear of FH:Change at follow-up (n=48, 45) | -4.4 Units on a scale | Standard Deviation 38.67 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Baseline (n=250, 249) | 38.0 Units on a scale | Standard Deviation 34.4 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C2 D1 (n=192, 198) | -0.3 Units on a scale | Standard Deviation 34.58 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability:Change at C3 D1 (n=142, 153) | 0.4 Units on a scale | Standard Deviation 36.68 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability:Change at C4 D1 (n=101, 112) | 0.3 Units on a scale | Standard Deviation 37.04 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability:Change at C5 D1 (n=70, 62) | -3.8 Units on a scale | Standard Deviation 39.17 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability:Change at C6 D1 (n=42, 42) | 0.8 Units on a scale | Standard Deviation 46.27 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C7 D1 (n=26, 24) | -7.0 Units on a scale | Standard Deviation 36.76 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C8 D1 (n=11, 11) | 3.0 Units on a scale | Standard Deviation 43.36 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C9 D1 (n=5, 6) | 0.0 Units on a scale | Standard Deviation 55.78 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C10 D1 (n=1, 3) | -11.1 Units on a scale | Standard Deviation 69.43 |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C11 D1 (n=1, 1) | -66.7 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Pancreatic 26 (EORTC QLQ- PAN26) Score | Future Plan ability: Change at C13 D1 (n=1, 0) | NA Units on a scale | — |
Secondary
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C5 D1 (n=94, 80) | 0.010 Units on a scale | Standard Deviation 0.2889 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C9 D1 (n=9, 9) | 0.049 Units on a scale | Standard Deviation 0.1878 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C2 D1 (n=231, 240) | 0.050 Units on a scale | Standard Deviation 0.2699 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C10 D1 (n=3, 4) | 0.181 Units on a scale | Standard Deviation 0.2206 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C6 D1 (n=57, 57) | 0.001 Units on a scale | Standard Deviation 0.2489 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C11 D1 (n=1, 1) | 0.000 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C4 D1 (n=128, 131) | 0.010 Units on a scale | Standard Deviation 0.273 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C12 D1 (n=1, 0) | 0.000 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C7 D1 (n=37, 36) | 0.049 Units on a scale | Standard Deviation 0.1891 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C13 D1 (n=1, 1) | 0.000 Units on a scale | — |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C3 D1 (n=171, 178) | 0.053 Units on a scale | Standard Deviation 0.2528 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at follow-up (n=65, 73) | -0.148 Units on a scale | Standard Deviation 0.3637 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C8 D1 (n=17, 20) | -0.021 Units on a scale | Standard Deviation 0.2366 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Baseline (n=289, 290) | 0.665 Units on a scale | Standard Deviation 0.2709 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C8 D1 (n=17, 20) | 0.071 Units on a scale | Standard Deviation 0.2188 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C2 D1 (n=231, 240) | 0.020 Units on a scale | Standard Deviation 0.2033 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C3 D1 (n=171, 178) | 0.028 Units on a scale | Standard Deviation 0.2362 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C4 D1 (n=128, 131) | 0.050 Units on a scale | Standard Deviation 0.2209 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C5 D1 (n=94, 80) | 0.044 Units on a scale | Standard Deviation 0.2092 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C6 D1 (n=57, 57) | 0.058 Units on a scale | Standard Deviation 0.2294 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C7 D1 (n=37, 36) | 0.075 Units on a scale | Standard Deviation 0.1838 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Baseline (n=289, 290) | 0.690 Units on a scale | Standard Deviation 0.2479 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C9 D1 (n=9, 9) | 0.121 Units on a scale | Standard Deviation 0.3006 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C10 D1 (n=3, 4) | 0.208 Units on a scale | Standard Deviation 0.3034 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C11 D1 (n=1, 1) | 0.058 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C12 D1 (n=1, 0) | NA Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at C13 D1 (n=1, 1) | 0.470 Units on a scale | — |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) Health State Profile | Change at follow-up (n=65, 73) | -0.080 Units on a scale | Standard Deviation 0.3243 |
Secondary
Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Day 1 (D1) of each cycle (C2-C13) up to 28 days after the last dose (follow-up) or early withdrawal
Population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Baseline (n= 277, 281) | 60.6 Millimeter (mm) | Standard Deviation 23.67 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 2 Day 1 (n= 223, 226) | 1.0 Millimeter (mm) | Standard Deviation 19.64 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 3 Day 1 (n= 161, 171) | 2.6 Millimeter (mm) | Standard Deviation 22.3 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 4 Day 1 (n=122, 128) | 0.5 Millimeter (mm) | Standard Deviation 22.38 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 5 Day 1 (n= 90, 79) | -0.3 Millimeter (mm) | Standard Deviation 22.83 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 6 Day 1 (n= 56, 56) | 1.0 Millimeter (mm) | Standard Deviation 24.63 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 7 Day 1 (n= 36, 35) | 2.6 Millimeter (mm) | Standard Deviation 25.82 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 8 Day 1 (n= 16, 19) | 3.8 Millimeter (mm) | Standard Deviation 23.21 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 9 Day 1 (n= 9, 9) | 22.2 Millimeter (mm) | Standard Deviation 24.93 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 10 Day 1 (n= 3, 4) | 20.0 Millimeter (mm) | Standard Deviation 26.46 |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 11 Day 1 (n= 1, 1) | 0.0 Millimeter (mm) | — |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 12 Day 1 (n= 1, 0) | 0.0 Millimeter (mm) | — |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 13 Day 1 (n= 1, 1) | 0.0 Millimeter (mm) | — |
| Axitinib + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at follow-up (n= 62, 68) | -6.3 Millimeter (mm) | Standard Deviation 24.07 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 11 Day 1 (n= 1, 1) | 30.0 Millimeter (mm) | — |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Baseline (n= 277, 281) | 62.6 Millimeter (mm) | Standard Deviation 23.09 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 8 Day 1 (n= 16, 19) | 9.6 Millimeter (mm) | Standard Deviation 28.55 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 2 Day 1 (n= 223, 226) | -0.4 Millimeter (mm) | Standard Deviation 20.42 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 13 Day 1 (n= 1, 1) | 36.0 Millimeter (mm) | — |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 3 Day 1 (n= 161, 171) | 1.1 Millimeter (mm) | Standard Deviation 20.25 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 9 Day 1 (n= 9, 9) | 7.7 Millimeter (mm) | Standard Deviation 20 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 4 Day 1 (n=122, 128) | 3.2 Millimeter (mm) | Standard Deviation 19.81 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 12 Day 1 (n= 1, 0) | NA Millimeter (mm) | — |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 5 Day 1 (n= 90, 79) | 1.9 Millimeter (mm) | Standard Deviation 19.4 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 10 Day 1 (n= 3, 4) | 6.3 Millimeter (mm) | Standard Deviation 24.62 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 6 Day 1 (n= 56, 56) | 3.7 Millimeter (mm) | Standard Deviation 21.84 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at follow-up (n= 62, 68) | -4.8 Millimeter (mm) | Standard Deviation 22.79 |
| Placebo + Gemcitabine | Change From Baseline in Euro QoL Questionnaire- 5 Dimension (EQ-5D) VAS Score | Change at Cycle 7 Day 1 (n= 36, 35) | 4.1 Millimeter (mm) | Standard Deviation 22.52 |
Secondary
Duration of Response (DR)
Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.
Time frame: Baseline until death or at least 1 year after the randomization of last participant
Population: DR was calculated for the subgroup of participants from the ITT population, with a confirmed objective tumor response (CR or PR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib + Gemcitabine | Duration of Response (DR) | 33.1 Weeks |
| Placebo + Gemcitabine | Duration of Response (DR) | NA Weeks |
Secondary
Percentage of Participants With Objective 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 response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Time frame: Baseline, every 8 weeks until tumor progression or death
Population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib + Gemcitabine | Percentage of Participants With Objective Response (OR) | 4.9 Percentage of participants |
| Placebo + Gemcitabine | Percentage of Participants With Objective Response (OR) | 1.6 Percentage of participants |
Comparison: Differences in OR between treatment arms was analyzed by 1-sided Cochran-Mantel-Haenszel (CMH) test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).p-value: 0.03895% CI: [1, 10.1]Cochran-Mantel-Haenszel
Secondary
Population Pharmacokinetic (PK) Analysis for Axitinib (AG-013736)
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: Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 23 months
Secondary
Progression Free Survival (PFS)
Time in weeks from randomization to the first documentation of objective tumor progression or death due to any cause. PFS was calculated as = (first event date minus randomization date plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \[PD\]), or from adverse event (AE) data (where the outcome was Death).
Time frame: Baseline until disease progression or at least 1 year after the randomization of last participant
Population: ITT population included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib + Gemcitabine | Progression Free Survival (PFS) | 19.1 Weeks |
| Placebo + Gemcitabine | Progression Free Survival (PFS) | 18.9 Weeks |
Comparison: Differences in PFS between treatment arms was analyzed by 1-sided log rank test, stratified for extent of disease (locally advanced cancer versus metastatic cancer).p-value: 0.520395% CI: [0.779, 1.298]Log Rank