Colorectal Neoplasms
Conditions
Keywords
metastatic colorectal cancer sunitinib (Sutent) bevacizumab (Avastin) randomized study
Brief summary
This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before.
Detailed description
The study was terminated on April 26, 2010 due to lack of efficacy, as determined during the interim analysis of data in April 2010, showing that the study did not meet its primary endpoint to demonstrate a statistically significant improvement in PFS. The decision to terminate the trial was not based on any safety concerns.
Interventions
DRUGsunitinib
Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).
DRUGmFOLFOX6
FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle
DRUGbevacizumab
Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adenocarcinoma of the colon or rectum with locally advanced or metastatic disease * Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) * Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion criteria
* Previous treatment with Sutent, Avastin, or any other systemic therapy for locally advanced or metastatic colorectal cancer * Less than 6 months since completion of adjuvant chemotherapy to documentation of recurrent disease * History of cardiac disease * Brain mets
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115) | Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| One Year Survival Probability | Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year) | One year survival probability was defined as the probability of survival at one year after the first dose of study treatment. |
| Two Year Survival Probability | Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years) | Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment. |
| Percentage of Participants With Objective Response (OR) | Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115 | 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. |
| Overall Survival (OS) | Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115) | Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication 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). |
| Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115) | FACT-C used for assessment of health-related quality of life (QoL) in participants with cancer. It consists of 36 items, summarized to 5 subscales:physical well-being (PWB) (7 items), functional well-being (FWB) (7 items), social/family well-being (SWB) (7 items); all 3 subscales range from 0 to 28, emotional well-being (EWB) (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL. |
| Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks) | FACT&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects. |
| Duration of Response (DR) | Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115 | Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response. |
Countries
Denmark, Germany, Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib + mFOLFOX6 Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m\^2 and leucovorin 400 mg/m\^2 (or levo-leucovorin 200 mg/m\^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m\^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m\^2 on Days 1 and 2 of each 2 week cycle. | 96 |
| Bevacizumab + mFOLFOX6 Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m\^2 and leucovorin 400 mg/m\^2 (or levo-leucovorin 200 mg/m\^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m\^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m\^2 on Days 1 and 2 of each 2 week cycle. | 95 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 14 | 10 |
| Overall Study | Death | 1 | 4 |
| Overall Study | Global deterioration of health status | 6 | 2 |
| Overall Study | Objective progression or relapse | 47 | 41 |
| Overall Study | Other | 7 | 14 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Study terminated by sponsor | 16 | 3 |
| Overall Study | Withdrawal by Subject | 4 | 20 |
Baseline characteristics
| Characteristic | Sunitinib + mFOLFOX6 | Bevacizumab + mFOLFOX6 | Total |
|---|---|---|---|
| Age Continuous | 60.60 Years STANDARD_DEVIATION 9.26 | 59.10 Years STANDARD_DEVIATION 10.81 | 59.90 Years STANDARD_DEVIATION 10.06 |
| Sex: Female, Male Female | 35 Participants | 33 Participants | 68 Participants |
| Sex: Female, Male Male | 61 Participants | 62 Participants | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 96 / 96 | 93 / 93 |
| serious Total, serious adverse events | 36 / 96 | 30 / 93 |
Outcome results
Primary
Progression-free Survival (PFS)
Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication 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, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)
Population: The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib + mFOLFOX6 | Progression-free Survival (PFS) | 40.50 Weeks |
| Bevacizumab + mFOLFOX6 | Progression-free Survival (PFS) | 67.00 Weeks |
Comparison: P-value was calculated from a 1-sided, log-rank test stratified for Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), Baseline Lactate Dehydrogenase (LDH): greater than (\>) 1.5 vs. less than or equal to (\<=) 1.5 \* upper limit of normal range (ULN), and Prior Adjuvant Treatment (yes vs. no).p-value: 0.996395% CI: [1.272, 5.751]Log Rank
Secondary
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score
FACT-C used for assessment of health-related quality of life (QoL) in participants with cancer. It consists of 36 items, summarized to 5 subscales:physical well-being (PWB) (7 items), functional well-being (FWB) (7 items), social/family well-being (SWB) (7 items); all 3 subscales range from 0 to 28, emotional well-being (EWB) (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.
Time frame: Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115)
Population: FA set included participants randomized with study drug assignment, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. Here n signifies those participants evaluated for this measure at specific time point for each cohort respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C13 D1 (n=34, 39) | -0.24 Units on a scale | Standard Deviation 2.486 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C28 D1 (n=1, 10) | 4.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C34 D1 (n=1, 1) | 6.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C31 D1 (n=1, 4) | 2.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C16 D1 (n=25, 31) | -0.64 Units on a scale | Standard Deviation 3.369 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C34 D1 (n=1, 1) | 4.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C4 D1 (n=80, 82) | -2.65 Units on a scale | Standard Deviation 4.132 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C37 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C19 D1 (n=13, 23) | -0.79 Units on a scale | Standard Deviation 2.024 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C37 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C43 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C22 D1 (n=6, 20) | -0.67 Units on a scale | Standard Deviation 2.065 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C46 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C19 D1 (n=13, 23) | -3.46 Units on a scale | Standard Deviation 4.977 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C49 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C25 D1 (n=1, 15) | -4.00 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at EOT (n=57, 43) | 0.35 Units on a scale | Standard Deviation 4.805 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C40 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Baseline (n=93, 89) | 17.88 Units on a scale | Standard Deviation 5.818 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C28 D1 (n=1, 10) | -3.50 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C4 D1 (n=80, 81) | -0.78 Units on a scale | Standard Deviation 5.007 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C10 D1 (n=45, 62) | -3.66 Units on a scale | Standard Deviation 4.732 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C7 D1 (n=59, 74) | -0.02 Units on a scale | Standard Deviation 5.425 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C31 D1 (n=1, 4) | -4.00 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C10 D1 (n=45, 61) | -0.35 Units on a scale | Standard Deviation 4.471 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C43 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C13 D1 (n=34, 40) | -0.4 Units on a scale | Standard Deviation 5.02 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C34 D1 (n=1, 1) | -3.50 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C16 D1 (n=24, 31) | -0.7 Units on a scale | Standard Deviation 3.65 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C22 D1 (n=6, 20) | -1.67 Units on a scale | Standard Deviation 4.885 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C19 D1 (n=13, 22) | -0.3 Units on a scale | Standard Deviation 3.88 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C37 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C22 D1 (n=6, 19) | 0.7 Units on a scale | Standard Deviation 6.35 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C46 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C25 D1 (n=1, 14) | 12.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C 40 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C28 D1 (n=1, 9) | 13.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Baseline (n= 93, 90) | 23.21 Units on a scale | Standard Deviation 4.108 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C31 D1 (n=1, 3) | 6.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C43 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C34 D1 (n=1, 1) | 12.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C49 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C37 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C46 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C40 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C25 D1 (n=1, 15) | 7.00 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C43 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C49 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C46 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at EOT (n=57, 43) | -4.16 Units on a scale | Standard Deviation 4.686 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C49 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at EOT (n=57, 43) | -0.35 Units on a scale | Standard Deviation 3.501 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at EOT (n=56, 43) | 1.62 Units on a scale | Standard Deviation 5.394 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C13 D1 (n=34, 40) | -3.88 Units on a scale | Standard Deviation 4.969 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Baseline (n=93, 90) | 20.93 Units on a scale | Standard Deviation 4.733 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Baseline (n=93, 90) | 16.74 Units on a scale | Standard Deviation 4.342 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C4 D1 (n=78, 82) | -1.49 Units on a scale | Standard Deviation 4.228 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Baseline (n=93, 88) | 23.42 Units on a scale | Standard Deviation 4.679 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C7 D1 (n=60, 75) | -1.00 Units on a scale | Standard Deviation 5.193 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C4 D1 (n=80, 82) | 0.95 Units on a scale | Standard Deviation 3.505 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C10 D1 (n=45, 62) | -1.03 Units on a scale | Standard Deviation 4.859 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C28 D1 (n=1, 10) | 4.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C13 D1 (n=34, 40) | -1.33 Units on a scale | Standard Deviation 5.224 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C7 D1 (n=59, 75) | 1.65 Units on a scale | Standard Deviation 3.108 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C16 D1 (n=25, 32) | -1.32 Units on a scale | Standard Deviation 4.425 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C4 D1 (n=80, 81) | 0.03 Units on a scale | Standard Deviation 3.129 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C19 D1 (n=13, 23) | -2.13 Units on a scale | Standard Deviation 4.732 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C10 D1 (n=45, 62) | 1.40 Units on a scale | Standard Deviation 4.014 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C22 D1 (n=6, 20) | -0.92 Units on a scale | Standard Deviation 5.219 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C7 D1 (n=59, 75) | -3.39 Units on a scale | Standard Deviation 5.532 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C25 D1 (n=1, 15) | 1.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C13 D1 (n=34, 40) | 1.3 Units on a scale | Standard Deviation 4.45 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C28 D1 (n=1, 10) | -2.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C7 D1 (n=59, 73) | -0.24 Units on a scale | Standard Deviation 3.941 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C31 D1 (n=1, 4) | -2.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C16 D1 (n=25, 32) | 0.84 Units on a scale | Standard Deviation 3.934 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C34 D1 (n=1, 1) | -1.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C31 D1 (n=1, 4) | 3.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C37 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C19 D1 (n=13, 23) | 1.2 Units on a scale | Standard Deviation 2.92 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C40 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C10 D1 (n=45, 60) | -0.89 Units on a scale | Standard Deviation 3.781 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C43 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C22 D1 (n=6, 20) | 0.2 Units on a scale | Standard Deviation 3.66 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C46 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C16 D1 (n=25, 32) | -3.88 Units on a scale | Standard Deviation 4.85 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C49 D1 (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C25 D1 (n=1, 15) | 4.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at EOT (n=55, 43) | -1.06 Units on a scale | Standard Deviation 4.942 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C40 D1 (n=0, 1) | NA Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at EOT (n=55, 43) | -0.48 Units on a scale | Standard Deviation 5.679 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Baseline (n= 93, 90) | 23.29 Units on a scale | Standard Deviation 4.324 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C4 D1 (n=80, 82) | -1.24 Units on a scale | Standard Deviation 4.93 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C7 D1 (n=59, 75) | -1.94 Units on a scale | Standard Deviation 4.217 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C10 D1 (n=45, 62) | -1.85 Units on a scale | Standard Deviation 4.69 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C13 D1 (n=34, 40) | -2.24 Units on a scale | Standard Deviation 4.364 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C16 D1 (n=25, 32) | -2.83 Units on a scale | Standard Deviation 4.937 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C19 D1 (n=13, 23) | -1.49 Units on a scale | Standard Deviation 4.308 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C22 D1 (n=6, 20) | -2.08 Units on a scale | Standard Deviation 3.429 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C25 D1 (n=1, 15) | -1.90 Units on a scale | Standard Deviation 3.762 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C28 D1 (n=1, 10) | -1.6 Units on a scale | Standard Deviation 5.15 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C31 D1 (n=1, 4) | -2.8 Units on a scale | Standard Deviation 6.18 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C34 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C37 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C40 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C43 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C46 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at C49 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | PWB Change at EOT (n=57, 43) | -3.52 Units on a scale | Standard Deviation 6.222 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Baseline (n=93, 88) | 23.16 Units on a scale | Standard Deviation 4.442 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C4 D1 (n=80, 81) | 0.31 Units on a scale | Standard Deviation 3.823 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C7 D1 (n=59, 73) | 0.27 Units on a scale | Standard Deviation 3.931 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C10 D1 (n=45, 60) | 0.05 Units on a scale | Standard Deviation 3.753 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C13 D1 (n=34, 39) | -1.33 Units on a scale | Standard Deviation 4.278 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C16 D1 (n=25, 31) | -1.24 Units on a scale | Standard Deviation 4.415 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C19 D1 (n=13, 23) | -1.47 Units on a scale | Standard Deviation 4.751 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C22 D1 (n=6, 20) | -1.18 Units on a scale | Standard Deviation 3.787 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C25 D1 (n=1, 15) | -0.06 Units on a scale | Standard Deviation 4.191 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C28 D1 (n=1, 10) | -0.65 Units on a scale | Standard Deviation 4.627 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C31 D1 (n=1, 4) | 3.58 Units on a scale | Standard Deviation 3.233 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C34 D1 (n=1, 1) | 1.00 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C37 D1 (n=0, 1) | 1.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C 40 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C43 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C46 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at C49 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | SWB Change at EOT (n=57, 43) | -0.63 Units on a scale | Standard Deviation 2.902 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Baseline (n=93, 90) | 17.30 Units on a scale | Standard Deviation 3.995 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C4 D1 (n=80, 82) | 1.40 Units on a scale | Standard Deviation 4.108 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C7 D1 (n=59, 75) | 1.71 Units on a scale | Standard Deviation 4.036 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C10 D1 (n=45, 62) | 1.65 Units on a scale | Standard Deviation 4.121 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C13 D1 (n=34, 40) | 1.4 Units on a scale | Standard Deviation 4.3 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C16 D1 (n=25, 32) | 0.96 Units on a scale | Standard Deviation 4.511 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C19 D1 (n=13, 23) | 1.8 Units on a scale | Standard Deviation 4.56 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C22 D1 (n=6, 20) | 1.1 Units on a scale | Standard Deviation 3.39 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C25 D1 (n=1, 15) | -0.3 Units on a scale | Standard Deviation 5.32 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C28 D1 (n=1, 10) | 0.1 Units on a scale | Standard Deviation 3.45 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C31 D1 (n=1, 4) | 2.3 Units on a scale | Standard Deviation 4.5 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C34 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C37 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C40 D1 (n=0, 1) | 1.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C43 D1 (n=0, 1) | 1.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C46 D1 (n=0, 1) | 1.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at C49 D1 (n=0, 1) | 1.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | EWB Change at EOT (n=57, 43) | 0.77 Units on a scale | Standard Deviation 4.942 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Baseline (n=93, 89) | 17.29 Units on a scale | Standard Deviation 6.328 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C4 D1 (n=80, 81) | 1.56 Units on a scale | Standard Deviation 5.536 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C7 D1 (n=59, 74) | 1.02 Units on a scale | Standard Deviation 5.493 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C10 D1 (n=45, 61) | 0.74 Units on a scale | Standard Deviation 5.884 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C13 D1 (n=34, 40) | 0.8 Units on a scale | Standard Deviation 5.88 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C16 D1 (n=24, 31) | -0.7 Units on a scale | Standard Deviation 4.95 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C19 D1 (n=13, 22) | 0.1 Units on a scale | Standard Deviation 6.11 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C22 D1 (n=6, 19) | -0.8 Units on a scale | Standard Deviation 4.72 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C25 D1 (n=1, 14) | -1.0 Units on a scale | Standard Deviation 4.4 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C28 D1 (n=1, 9) | -0.8 Units on a scale | Standard Deviation 4.74 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C31 D1 (n=1, 3) | 1.0 Units on a scale | Standard Deviation 3.61 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C34 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C37 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C40 D1 (n=0, 1) | -3.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C43 D1 (n=0, 1) | -3.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C46 D1 (n=0, 1) | -3.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at C49 D1 (n=0, 1) | -3.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | FWB Change at EOT (n=56, 43) | 0.14 Units on a scale | Standard Deviation 6.075 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Baseline (n=93, 90) | 21.26 Units on a scale | Standard Deviation 5.064 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C4 D1 (n=78, 82) | -0.13 Units on a scale | Standard Deviation 4.485 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C7 D1 (n=60, 75) | -0.26 Units on a scale | Standard Deviation 4.726 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C10 D1 (n=45, 62) | -0.16 Units on a scale | Standard Deviation 5.474 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C13 D1 (n=34, 40) | -0.20 Units on a scale | Standard Deviation 5.105 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C16 D1 (n=25, 32) | -1.25 Units on a scale | Standard Deviation 5.086 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C19 D1 (n=13, 23) | -0.36 Units on a scale | Standard Deviation 4.754 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C22 D1 (n=6, 20) | 0.15 Units on a scale | Standard Deviation 3.815 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C25 D1 (n=1, 15) | 1.3 Units on a scale | Standard Deviation 5.55 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C28 D1 (n=1, 10) | 0.4 Units on a scale | Standard Deviation 5.46 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C31 D1 (n=1, 4) | 1.8 Units on a scale | Standard Deviation 4.35 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C34 D1 (n=1, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C37 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C40 D1 (n=0, 1) | -1.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C43 D1 (n=0, 1) | -1.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C46 D1 (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score | CCS Change at C49 D1 (n=0, 1) | 0.0 Units on a scale | — |
Comparison: Differences in PWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.p-value: 0.051595% CI: [-2.82, 0.01]t-test, 2 sided
Comparison: Differences in PWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.p-value: 0.087695% CI: [-3.11, 0.22]t-test, 2 sided
Comparison: Differences in PWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.p-value: 0.052295% CI: [-3.64, 0.02]t-test, 2 sided
Comparison: Differences in PWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.p-value: 0.133995% CI: [-3.81, 0.52]t-test, 2 sided
Comparison: Differences in PWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.p-value: 0.423395% CI: [-3.68, 1.57]t-test, 2 sided
Comparison: Differences in PWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.p-value: 0.221195% CI: [-5.18, 1.24]t-test, 2 sided
Comparison: Differences in PWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.p-value: 0.818495% CI: [-3.22, 4.04]t-test, 2 sided
Comparison: Differences in PWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.p-value: 0.03895% CI: [0.57, 17.23]t-test, 2 sided
Comparison: Differences in PWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.p-value: 0.326695% CI: [-6.61, 17.81]t-test, 2 sided
Comparison: Differences in PWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.p-value: 0.466795% CI: [-16.26, 27.76]t-test, 2 sided
Comparison: Differences in PWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.p-value: <0.000195% CI: [0, 0]t-test, 2 sided
Comparison: Differences in PWB between treatment arms (EOT) was analyzed from a two-sample t-test.p-value: 0.558795% CI: [-2.8, 1.52]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.p-value: 0.612295% CI: [-1.37, 0.81]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.p-value: 0.464295% CI: [-1.87, 0.86]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.p-value: 0.210595% CI: [-2.41, 0.54]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.p-value: 0.19595% CI: [-0.57, 2.76]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.p-value: 0.577995% CI: [-1.55, 2.75]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.p-value: 0.631495% CI: [-2.15, 3.5]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.p-value: 0.755495% CI: [-2.85, 3.87]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.p-value: 0.378195% CI: [-13.22, 5.34]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.p-value: 0.571595% CI: [-13.83, 8.13]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.p-value: 0.127195% CI: [-19.08, 3.93]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.p-value: <0.000195% CI: [0, 0]t-test, 2 sided
Comparison: Differences in SWB between treatment arms (EOT) was analyzed from a two-sample t-test.p-value: 0.678595% CI: [-1.03, 1.58]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.p-value: 0.462395% CI: [-1.63, 0.74]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.p-value: 0.930295% CI: [-1.31, 1.2]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.p-value: 0.750295% CI: [-1.84, 1.33]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.p-value: 0.933595% CI: [-2.12, 1.95]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.p-value: 0.919195% CI: [-2.4, 2.17]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.p-value: 0.67595% CI: [-3.46, 2.27]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.p-value: 0.587495% CI: [-4.2, 2.43]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.p-value: 0.450795% CI: [-7.53, 16.06]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.p-value: 0.308795% CI: [-4.28, 12.08]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.p-value: 0.963595% CI: [-16.26, 15.76]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.p-value: <0.000195% CI: [0, 0]t-test, 2 sided
Comparison: Differences in EWB between treatment arms (EOT) was analyzed from a two-sample t-test.p-value: 0.669995% CI: [-2.37, 1.53]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.p-value: 0.005595% CI: [-3.98, -0.7]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.p-value: 0.279395% CI: [-2.92, 0.85]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.p-value: 0.299995% CI: [-3.17, 0.99]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.p-value: 0.32795% CI: [-3.82, 1.29]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.p-value: 0.977995% CI: [-2.39, 2.45]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.p-value: 0.834495% CI: [-4.25, 3.45]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.p-value: 0.549495% CI: [-3.5, 6.41]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.p-value: 0.013695% CI: [3.15, 22.85]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.p-value: 0.024795% CI: [2.26, 25.29]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.p-value: 0.352795% CI: [-12.91, 22.91]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.p-value: <0.000195% CI: [0, 0]t-test, 2 sided
Comparison: Differences in FWB between treatment arms (EOT) was analyzed from a two-sample t-test.p-value: 0.130995% CI: [-4.05, 0.53]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (C4 of D1) was analyzed from a two-sample t-test.p-value: 0.05195% CI: [-2.72, 0.01]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (C7 of D1) was analyzed from a two-sample t-test.p-value: 0.385895% CI: [-2.44, 0.95]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (C10 of D1) was analyzed from a two-sample t-test.p-value: 0.394395% CI: [-2.9, 1.15]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (C13 of D1) was analyzed from a two-sample t-test.p-value: 0.349995% CI: [-3.53, 1.27]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (C16 of D1) was analyzed from a two-sample t-test.p-value: 0.956795% CI: [-2.64, 2.5]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (C19 of D1) was analyzed from a two-sample t-test.p-value: 0.290195% CI: [-5.12, 1.58]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (C22 of D1) was analyzed from a two-sample t-test.p-value: 0.585795% CI: [-5.05, 2.92]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (C25 of D1) was analyzed from a two-sample t-test.p-value: 0.963595% CI: [-12.56, 12.02]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (C28 of D1) was analyzed from a two-sample t-test.p-value: 0.68595% CI: [-15.36, 10.56]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (C31 of D1) was analyzed from a two-sample t-test.p-value: 0.496895% CI: [-19.23, 11.73]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (C34 of D1) was analyzed from a two-sample t-test.p-value: <0.000195% CI: [0, 0]t-test, 2 sided
Comparison: Differences in CCS between treatment arms (EOT) was analyzed from a two-sample t-test.p-value: 0.589195% CI: [-2.71, 1.55]t-test, 2 sided
Secondary
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score
FACT&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects.
Time frame: Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)
Population: The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Baseline (Item 13) (n=90, 93) | 3.8 Units on a scale | Standard Deviation 0.55 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C16 D1 (Neurotoxicity) (n=24, 31) | -15.58 Units on a scale | Standard Deviation 8.356 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C4 D1 (Item 13) (n=75, 79) | -0.2 Units on a scale | Standard Deviation 0.52 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C31 D1 (Neurotoxicity) (n=1, 4) | -12.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C7 D1 (Item 13) (n=60, 74) | -0.3 Units on a scale | Standard Deviation 0.68 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C10 D1 (Neurotoxicity) (n=45, 61) | -10.21 Units on a scale | Standard Deviation 8.8 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C10 D1 (Item 13) (n=45, 61) | -0.4 Units on a scale | Standard Deviation 0.87 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C34 D1 (Neurotoxicity) (n=1, 1) | -12.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C13 D1 (Item 13) (n=34, 40) | -0.4 Units on a scale | Standard Deviation 0.86 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C19 D1 (Neurotoxicity) (n=13, 23) | -12.4 Units on a scale | Standard Deviation 8.58 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C16 D1 (Item 13) (n=24, 31) | -0.6 Units on a scale | Standard Deviation 1.03 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C37 D1 (Neurotoxicity) (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C19 D1 (Item 13) (n=13, 23) | -0.3 Units on a scale | Standard Deviation 0.48 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C7 D1 (Neurotoxicity) (n=60, 74) | -6.20 Units on a scale | Standard Deviation 7.504 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C22 D1 (Item 13) (n=5, 20) | -0.4 Units on a scale | Standard Deviation 0.55 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C40 D1 (Neurotoxicity) (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C25 D1 (Item 13) (n=1, 14) | 0.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C22 D1 (Neurotoxicity) (n=5, 20) | -5.60 Units on a scale | Standard Deviation 6.914 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C28 D1 (Item 13) (n=1, 10) | -1.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C43 D1 (Neurotoxicity) (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C31 D1 (Item 13) (n=1, 4) | 0.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C13 D1 (Neurotoxicity) (n=34, 40) | -13.96 Units on a scale | Standard Deviation 9.494 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C34 D1 (Item 13) (n=1, 1) | -1.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C46 D1 (Neurotoxicity) (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C37 D1 (Item 13) (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C25 D1 (Neurotoxicity) (n=1, 14) | -13.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C40 D1 (Item 13) (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C49 D1 (Neurotoxicity) (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C43 D1 (Item 13) (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C4 D1 (Neurotoxicity) (n=75, 80) | -4.73 Units on a scale | Standard Deviation 6.27 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C46 D1 (Item 13) (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at EOT (Neurotoxicity) (n=56, 43) | -10.71 Units on a scale | Standard Deviation 9.561 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C49 D1 (Item 13) (n=0, 1) | NA Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C28 D1 (Neurotoxicity) (n=1, 10) | -13.0 Units on a scale | — |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at EOT (Item 13) (n=56, 43) | -0.4 Units on a scale | Standard Deviation 0.85 |
| Sunitinib + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Baseline (Neurotoxicity) (n=90, 93) | 44.04 Units on a scale | Standard Deviation 4.853 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at EOT (Item 13) (n=56, 43) | -0.3 Units on a scale | Standard Deviation 0.78 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Baseline (Neurotoxicity) (n=90, 93) | 44.41 Units on a scale | Standard Deviation 4.808 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C4 D1 (Neurotoxicity) (n=75, 80) | -4.10 Units on a scale | Standard Deviation 5.514 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C7 D1 (Neurotoxicity) (n=60, 74) | -5.76 Units on a scale | Standard Deviation 5.56 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C10 D1 (Neurotoxicity) (n=45, 61) | -7.45 Units on a scale | Standard Deviation 7.231 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C13 D1 (Neurotoxicity) (n=34, 40) | -12.73 Units on a scale | Standard Deviation 9.42 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C16 D1 (Neurotoxicity) (n=24, 31) | -14.55 Units on a scale | Standard Deviation 10.977 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C19 D1 (Neurotoxicity) (n=13, 23) | -16.6 Units on a scale | Standard Deviation 9.71 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C22 D1 (Neurotoxicity) (n=5, 20) | -13.87 Units on a scale | Standard Deviation 8.122 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C25 D1 (Neurotoxicity) (n=1, 14) | -16.9 Units on a scale | Standard Deviation 9.09 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C28 D1 (Neurotoxicity) (n=1, 10) | -14.0 Units on a scale | Standard Deviation 8.03 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C31 D1 (Neurotoxicity) (n=1, 4) | -13.8 Units on a scale | Standard Deviation 4.11 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C34 D1 (Neurotoxicity) (n=1, 1) | -9.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C37 D1 (Neurotoxicity) (n=0, 1) | -9.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C40 D1 (Neurotoxicity) (n=0, 1) | -10.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C43 D1 (Neurotoxicity) (n=0, 1) | -10.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C46 D1 (Neurotoxicity) (n=0, 1) | -8.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C49 D1 (Neurotoxicity) (n=0, 1) | -8.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at EOT (Neurotoxicity) (n=56, 43) | -9.97 Units on a scale | Standard Deviation 8.632 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Baseline (Item 13) (n=90, 93) | 3.9 Units on a scale | Standard Deviation 0.42 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C4 D1 (Item 13) (n=75, 79) | -0.2 Units on a scale | Standard Deviation 0.65 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C7 D1 (Item 13) (n=60, 74) | -0.2 Units on a scale | Standard Deviation 0.56 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C10 D1 (Item 13) (n=45, 61) | -0.2 Units on a scale | Standard Deviation 0.79 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C13 D1 (Item 13) (n=34, 40) | -0.2 Units on a scale | Standard Deviation 0.68 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C16 D1 (Item 13) (n=24, 31) | -0.6 Units on a scale | Standard Deviation 0.89 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C19 D1 (Item 13) (n=13, 23) | -0.7 Units on a scale | Standard Deviation 1.19 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C22 D1 (Item 13) (n=5, 20) | -0.4 Units on a scale | Standard Deviation 0.88 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C25 D1 (Item 13) (n=1, 14) | -0.6 Units on a scale | Standard Deviation 0.94 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C28 D1 (Item 13) (n=1, 10) | -0.6 Units on a scale | Standard Deviation 1.07 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C31 D1 (Item 13) (n=1, 4) | -1.3 Units on a scale | Standard Deviation 0.96 |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C34 D1 (Item 13) (n=1, 1) | -1.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C37 D1 (Item 13) (n=0, 1) | -1.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C40 D1 (Item 13) (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C43 D1 (Item 13) (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C46 D1 (Item 13) (n=0, 1) | 0.0 Units on a scale | — |
| Bevacizumab + mFOLFOX6 | Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score | Change at C49 D1 (Item 13) (n=0, 1) | 0.0 Units on a scale | — |
Comparison: Differences in neurotoxicity between treatment arms (C4 of D1) was analyzed from a two-sample t-test.p-value: 0.508195% CI: [-2.5, 1.24]t-test, 2 sided
Comparison: Differences in neurotoxicity between treatment arms (C7 of D1) was analyzed from a two-sample t-test.p-value: 0.697795% CI: [-2.67, 1.79]t-test, 2 sided
Comparison: Differences in neurotoxicity between treatment arms (C10 of D1) was analyzed from a two-sample t-test.p-value: 0.079795% CI: [-5.85, 0.33]t-test, 2 sided
Comparison: Differences in neurotoxicity between treatment arms (C13 of D1) was analyzed from a two-sample t-test.p-value: 0.580895% CI: [-5.62, 3.17]t-test, 2 sided
Comparison: Differences in neurotoxicity between treatment arms (C16 of D1) was analyzed from a two-sample t-test.p-value: 0.704695% CI: [-6.44, 4.38]t-test, 2 sided
Comparison: Differences in neurotoxicity between treatment arms (C19 of D1) was analyzed from a two-sample t-test.p-value: 0.205295% CI: [-2.4, 10.76]t-test, 2 sided
Comparison: Differences in neurotoxicity between treatment arms (C22 of D1) was analyzed from a two-sample t-test.p-value: 0.048395% CI: [0.07, 16.46]t-test, 2 sided
Comparison: Differences in neurotoxicity between treatment arms (C25 of D1) was analyzed from a two-sample t-test.p-value: 0.683295% CI: [-16.41, 24.26]t-test, 2 sided
Comparison: Differences in neurotoxicity between treatment arms (C28 of D1) was analyzed from a two-sample t-test.p-value: 0.908195% CI: [-18.05, 20.05]t-test, 2 sided
Comparison: Differences in neurotoxicity between treatment arms (C31 of D1) was analyzed from a two-sample t-test.p-value: 0.728995% CI: [-12.88, 16.38]t-test, 2 sided
Comparison: Differences in neurotoxicity between treatment arms (C34 of D1) was analyzed from a two-sample t-test.p-value: <0.000195% CI: [0, 0]t-test, 2 sided
Comparison: Differences in neurotoxicity between treatment arms (EOT) was analyzed from a two-sample t-test.p-value: 0.692195% CI: [-4.43, 2.95]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (C4 of D1) was analyzed from a two-sample t-test.p-value: 0.978895% CI: [-0.19, 0.19]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (C7 of D1) was analyzed from a two-sample t-test.p-value: 0.274795% CI: [-0.33, 0.09]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (C10 of D1) was analyzed from a two-sample t-test.p-value: 0.277695% CI: [-0.5, 0.14]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (C13 of D1) was analyzed from a two-sample t-test.p-value: 0.140395% CI: [-0.62, 0.09]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (C16 of D1) was analyzed from a two-sample t-test.p-value: 0.915195% CI: [-0.55, 0.5]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (C19 of D1) was analyzed from a two-sample t-test.p-value: 0.327795% CI: [-0.36, 1.05]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (C22 of D1) was analyzed from a two-sample t-test.p-value: 195% CI: [-0.86, 0.86]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (C25 of D1) was analyzed from a two-sample t-test.p-value: 0.566195% CI: [-1.53, 2.67]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (C28 of D1) was analyzed from a two-sample t-test.p-value: 0.730995% CI: [-2.95, 2.15]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (C31 of D1) was analyzed from a two-sample t-test.p-value: 0.327395% CI: [-2.16, 4.66]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (C34 of D1) was analyzed from a two-sample t-test.p-value: <0.000195% CI: [0, 0]t-test, 2 sided
Comparison: Differences in item 13 between treatment arms (EOT) was analyzed from a two-sample t-test.p-value: 0.710895% CI: [-0.39, 0.27]t-test, 2 sided
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 cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time frame: Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115
Population: Data was not analyzed due to early study termination.
Secondary
One Year Survival Probability
One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.
Time frame: Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year)
Population: Data was not analyzed due to early study termination.
Secondary
Overall Survival (OS)
Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication 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, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115)
Population: The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib + mFOLFOX6 | Overall Survival (OS) | 84.30 Weeks |
| Bevacizumab + mFOLFOX6 | Overall Survival (OS) | NA Weeks |
Comparison: P-value was calculated from a 1-sided, log-rank test stratified for ECOG Performance Status (0 vs. 1), Baseline LDH: \>1.5 vs. \<=1.5 \* ULN, and Prior Adjuvant Treatment (yes vs. no).p-value: 0.928995% CI: [0.845, 3.096]Log Rank
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 until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115
Population: The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib + mFOLFOX6 | Percentage of Participants With Objective Response (OR) | 41.70 Percentage of participants |
| Bevacizumab + mFOLFOX6 | Percentage of Participants With Objective Response (OR) | 37.90 Percentage of participants |
p-value: 0.589895% CI: [-10.412, 18.324]Chi-squared
Secondary
Two Year Survival Probability
Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.
Time frame: Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years)
Population: Data was not analyzed due to early study termination.