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Trial record 9 of 54 for:    colon cancer | ( Map: Mississippi, United States )

Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00609622
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : February 7, 2008
Results First Posted : October 11, 2012
Last Update Posted : October 11, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Neoplasms
Interventions Drug: sunitinib
Drug: mFOLFOX6
Drug: bevacizumab
Enrollment 191
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Hide Arm/Group Description Sunitinib 37.5 milligram (mg) capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, lecovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg per square meter (mg/m^2) and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour intravenous (IV) infusion followed by an IV bolus of 5-fluorouracil (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. Bevacizumab 5 mg/kilogram (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 a 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
Period Title: Overall Study
Started 96 95
Completed 0 0
Not Completed 96 95
Reason Not Completed
Adverse Event             14             10
Withdrawal by Subject             4             20
Death             1             4
Protocol Violation             1             1
Objective progression or relapse             47             41
Study terminated by sponsor             16             3
Other             7             14
Global deterioration of health status             6             2
Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6 Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 96 95 191
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 96 participants 95 participants 191 participants
60.60  (9.26) 59.10  (10.81) 59.90  (10.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 95 participants 191 participants
Female
35
  36.5%
33
  34.7%
68
  35.6%
Male
61
  63.5%
62
  65.3%
123
  64.4%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 96 95
Median (95% Confidence Interval)
Unit of Measure: Weeks
40.50
(39.50 to 44.20)
67.00
(41.60 to 67.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9963
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.705
Confidence Interval (2-Sided) 95%
1.272 to 5.751
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 96 95
Median (95% Confidence Interval)
Unit of Measure: Weeks
84.30 [1] 
(84.30 to NA)
NA [2] 
(NA to NA)
[1]
Upper limit of the confidence interval (C.I) was not reachable as data was not matured at the time of the analysis.
[2]
Median OS could not be determined as data was not matured at the time of the analysis.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments 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).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9289
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.618
Confidence Interval (2-Sided) 95%
0.845 to 3.096
Estimation Comments [Not Specified]
3.Secondary Outcome
Title One Year Survival Probability
Hide Description One year survival probability was defined as the probability of survival at one year after the 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed due to early study termination.
Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Two Year Survival Probability
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed due to early study termination.
Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage of Participants With Objective Response (OR)
Hide Description Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 96 95
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
41.70
(33.56 to 54.75)
37.90
(29.81 to 50.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5898
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter F-Distribution
Estimated Value 3.956
Confidence Interval (2-Sided) 95%
-10.412 to 18.324
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Duration of Response (DR)
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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed due to early study termination.
Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Treatment – Colorectal (FACT-C) Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 96 95
Mean (Standard Deviation)
Unit of Measure: Units on a scale
PWB Baseline (n= 93, 90) 23.21  (4.108) 23.29  (4.324)
PWB Change at C4 D1 (n=80, 82) -2.65  (4.132) -1.24  (4.930)
PWB Change at C7 D1 (n=59, 75) -3.39  (5.532) -1.94  (4.217)
PWB Change at C10 D1 (n=45, 62) -3.66  (4.732) -1.85  (4.690)
PWB Change at C13 D1 (n=34, 40) -3.88  (4.969) -2.24  (4.364)
PWB Change at C16 D1 (n=25, 32) -3.88  (4.850) -2.83  (4.937)
PWB Change at C19 D1 (n=13, 23) -3.46  (4.977) -1.49  (4.308)
PWB Change at C22 D1 (n=6, 20) -1.67  (4.885) -2.08  (3.429)
PWB Change at C25 D1 (n=1, 15) 7.00 [1]   (NA) -1.90  (3.762)
PWB Change at C28 D1 (n=1, 10) 4.0 [1]   (NA) -1.6  (5.15)
PWB Change at C31 D1 (n=1, 4) 3.0 [1]   (NA) -2.8  (6.18)
PWB Change at C34 D1 (n=1, 1) 6.0 [1]   (NA) 0.0 [1]   (NA)
PWB Change at C37 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
PWB Change at C40 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
PWB Change at C43 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
PWB Change at C46 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
PWB Change at C49 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
PWB Change at EOT (n=57, 43) -4.16  (4.686) -3.52  (6.222)
SWB Baseline (n=93, 88) 23.42  (4.679) 23.16  (4.442)
SWB Change at C4 D1 (n=80, 81) 0.03  (3.129) 0.31  (3.823)
SWB Change at C7 D1 (n=59, 73) -0.24  (3.941) 0.27  (3.931)
SWB Change at C10 D1 (n=45, 60) -0.89  (3.781) 0.05  (3.753)
SWB Change at C13 D1 (n=34, 39) -0.24  (2.486) -1.33  (4.278)
SWB Change at C16 D1 (n=25, 31) -0.64  (3.369) -1.24  (4.415)
SWB Change at C19 D1 (n=13, 23) -0.79  (2.024) -1.47  (4.751)
SWB Change at C22 D1 (n=6, 20) -0.67  (2.065) -1.18  (3.787)
SWB Change at C25 D1 (n=1, 15) -4.00 [1]   (NA) -0.06  (4.191)
SWB Change at C28 D1 (n=1, 10) -3.50 [1]   (NA) -0.65  (4.627)
SWB Change at C31 D1 (n=1, 4) -4.00 [1]   (NA) 3.58  (3.233)
SWB Change at C34 D1 (n=1, 1) -3.50 [1]   (NA) 1.00 [1]   (NA)
SWB Change at C37 D1 (n=0, 1) NA [2]   (NA) 1.0 [1]   (NA)
SWB Change at C 40 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
SWB Change at C43 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
SWB Change at C46 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
SWB Change at C49 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
SWB Change at EOT (n=57, 43) -0.35  (3.501) -0.63  (2.902)
EWB Baseline (n=93, 90) 16.74  (4.342) 17.30  (3.995)
EWB Change at C4 D1 (n=80, 82) 0.95  (3.505) 1.40  (4.108)
EWB Change at C7 D1 (n=59, 75) 1.65  (3.108) 1.71  (4.036)
EWB Change at C10 D1 (n=45, 62) 1.40  (4.014) 1.65  (4.121)
EWB Change at C13 D1 (n=34, 40) 1.3  (4.45) 1.4  (4.30)
EWB Change at C16 D1 (n=25, 32) 0.84  (3.934) 0.96  (4.511)
EWB Change at C19 D1 (n=13, 23) 1.2  (2.92) 1.8  (4.56)
EWB Change at C22 D1 (n=6, 20) 0.2  (3.66) 1.1  (3.39)
EWB Change at C25 D1 (n=1, 15) 4.0 [1]   (NA) -0.3  (5.32)
EWB Change at C28 D1 (n=1, 10) 4.0 [1]   (NA) 0.1  (3.45)
EWB Change at C31 D1 (n=1, 4) 2.0 [1]   (NA) 2.3  (4.50)
EWB Change at C34 D1 (n=1, 1) 4.0 [1]   (NA) 0.0 [1]   (NA)
EWB Change at C37 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
EWB Change at C40 D1 (n=0, 1) NA [2]   (NA) 1.0 [1]   (NA)
EWB Change at C43 D1 (n=0, 1) NA [2]   (NA) 1.0 [1]   (NA)
EWB Change at C46 D1 (n=0, 1) NA [2]   (NA) 1.0 [1]   (NA)
EWB Change at C49 D1 (n=0, 1) NA [2]   (NA) 1.0 [1]   (NA)
EWB Change at EOT (n=57, 43) 0.35  (4.805) 0.77  (4.942)
FWB Baseline (n=93, 89) 17.88  (5.818) 17.29  (6.328)
FWB Change at C4 D1 (n=80, 81) -0.78  (5.007) 1.56  (5.536)
FWB Change at C7 D1 (n=59, 74) -0.02  (5.425) 1.02  (5.493)
FWB Change at C10 D1 (n=45, 61) -0.35  (4.471) 0.74  (5.884)
FWB Change at C13 D1 (n=34, 40) -0.4  (5.02) 0.8  (5.88)
FWB Change at C16 D1 (n=24, 31) -0.7  (3.65) -0.7  (4.95)
FWB Change at C19 D1 (n=13, 22) -0.3  (3.88) 0.1  (6.11)
FWB Change at C22 D1 (n=6, 19) 0.7  (6.35) -0.8  (4.72)
FWB Change at C25 D1 (n=1, 14) 12.0 [1]   (NA) -1.0  (4.40)
FWB Change at C28 D1 (n=1, 9) 13.0 [1]   (NA) -0.8  (4.74)
FWB Change at C31 D1 (n=1, 3) 6.0 [1]   (NA) 1.0  (3.61)
FWB Change at C34 D1 (n=1, 1) 12.0 [1]   (NA) 0.0 [1]   (NA)
FWB Change at C37 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
FWB Change at C40 D1 (n=0, 1) NA [2]   (NA) -3.0 [1]   (NA)
FWB Change at C43 D1 (n=0, 1) NA [2]   (NA) -3.0 [1]   (NA)
FWB Change at C46 D1 (n=0, 1) NA [2]   (NA) -3.0 [1]   (NA)
FWB Change at C49 D1 (n=0, 1) NA [2]   (NA) -3.0 [1]   (NA)
FWB Change at EOT (n=56, 43) 1.62  (5.394) 0.14  (6.075)
CCS Baseline (n=93, 90) 20.93  (4.733) 21.26  (5.064)
CCS Change at C4 D1 (n=78, 82) -1.49  (4.228) -0.13  (4.485)
CCS Change at C7 D1 (n=60, 75) -1.00  (5.193) -0.26  (4.726)
CCS Change at C10 D1 (n=45, 62) -1.03  (4.859) -0.16  (5.474)
CCS Change at C13 D1 (n=34, 40) -1.33  (5.224) -0.20  (5.105)
CCS Change at C16 D1 (n=25, 32) -1.32  (4.425) -1.25  (5.086)
CCS Change at C19 D1 (n=13, 23) -2.13  (4.732) -0.36  (4.754)
CCS Change at C22 D1 (n=6, 20) -0.92  (5.219) 0.15  (3.815)
CCS Change at C25 D1 (n=1, 15) 1.0 [1]   (NA) 1.3  (5.55)
CCS Change at C28 D1 (n=1, 10) -2.0 [1]   (NA) 0.4  (5.46)
CCS Change at C31 D1 (n=1, 4) -2.0 [1]   (NA) 1.8  (4.35)
CCS Change at C34 D1 (n=1, 1) -1.0 [1]   (NA) 0.0 [1]   (NA)
CCS Change at C37 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
CCS Change at C40 D1 (n=0, 1) NA [2]   (NA) -1.0 [1]   (NA)
CCS Change at C43 D1 (n=0, 1) NA [2]   (NA) -1.0 [1]   (NA)
CCS Change at C46 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
CCS Change at C49 D1 (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
CCS Change at EOT (n=55, 43) -1.06  (4.942) -0.48  (5.679)
[1]
Standard deviation was not estimable since only one participant was evaluable.
[2]
Data was not analyzed due to early study termination.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0515
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.40
Confidence Interval (2-Sided) 95%
-2.82 to 0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0876
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.45
Confidence Interval (2-Sided) 95%
-3.11 to 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0522
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.81
Confidence Interval (2-Sided) 95%
-3.64 to 0.02
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1339
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.64
Confidence Interval (2-Sided) 95%
-3.81 to 0.52
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4233
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.05
Confidence Interval (2-Sided) 95%
-3.68 to 1.57
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2211
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.97
Confidence Interval (2-Sided) 95%
-5.18 to 1.24
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8184
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
-3.22 to 4.04
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0380
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.90
Confidence Interval (2-Sided) 95%
0.57 to 17.23
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3266
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.60
Confidence Interval (2-Sided) 95%
-6.61 to 17.81
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4667
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.75
Confidence Interval (2-Sided) 95%
-16.26 to 27.76
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in PWB between treatment arms (EOT) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5587
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-2.80 to 1.52
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6122
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-1.37 to 0.81
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4642
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.51
Confidence Interval (2-Sided) 95%
-1.87 to 0.86
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2105
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.94
Confidence Interval (2-Sided) 95%
-2.41 to 0.54
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1950
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
-0.57 to 2.76
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5779
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
-1.55 to 2.75
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6314
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
-2.15 to 3.50
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7554
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
-2.85 to 3.87
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3781
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.94
Confidence Interval (2-Sided) 95%
-13.22 to 5.34
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5715
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.85
Confidence Interval (2-Sided) 95%
-13.83 to 8.13
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1271
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -7.58
Confidence Interval (2-Sided) 95%
-19.08 to 3.93
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in SWB between treatment arms (EOT) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6785
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.27
Confidence Interval (2-Sided) 95%
-1.03 to 1.58
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4623
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-1.63 to 0.74
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9302
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-1.31 to 1.20
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7502
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-1.84 to 1.33
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9335
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-2.12 to 1.95
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9191
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-2.40 to 2.17
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6750
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.60
Confidence Interval (2-Sided) 95%
-3.46 to 2.27
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5874
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-4.20 to 2.43
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4507
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.27
Confidence Interval (2-Sided) 95%
-7.53 to 16.06
Estimation Comments [Not Specified]
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3087
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.90
Confidence Interval (2-Sided) 95%
-4.28 to 12.08
Estimation Comments [Not Specified]
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9635
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-16.26 to 15.76
Estimation Comments [Not Specified]
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in EWB between treatment arms (EOT) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6699
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-2.37 to 1.53
Estimation Comments [Not Specified]
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0055
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.34
Confidence Interval (2-Sided) 95%
-3.98 to -0.70
Estimation Comments [Not Specified]
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2793
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-2.92 to 0.85
Estimation Comments [Not Specified]
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2999
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.09
Confidence Interval (2-Sided) 95%
-3.17 to 0.99
Estimation Comments [Not Specified]
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3270
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-3.82 to 1.29
Estimation Comments [Not Specified]
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9779
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-2.39 to 2.45
Estimation Comments [Not Specified]
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8344
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-4.25 to 3.45
Estimation Comments [Not Specified]
Show Statistical Analysis 43 Hide Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5494
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.46
Confidence Interval (2-Sided) 95%
-3.50 to 6.41
Estimation Comments [Not Specified]
Show Statistical Analysis 44 Hide Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0136
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 13.00
Confidence Interval (2-Sided) 95%
3.15 to 22.85
Estimation Comments [Not Specified]
Show Statistical Analysis 45 Hide Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0247
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 13.78
Confidence Interval (2-Sided) 95%
2.26 to 25.29
Estimation Comments [Not Specified]
Show Statistical Analysis 46 Hide Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3527
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.00
Confidence Interval (2-Sided) 95%
-12.91 to 22.91
Estimation Comments [Not Specified]
Show Statistical Analysis 47 Hide Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 48 Hide Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in FWB between treatment arms (EOT) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1309
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.76
Confidence Interval (2-Sided) 95%
-4.05 to 0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 49 Hide Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0510
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.36
Confidence Interval (2-Sided) 95%
-2.72 to 0.01
Estimation Comments [Not Specified]
Show Statistical Analysis 50 Hide Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3858
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.74
Confidence Interval (2-Sided) 95%
-2.44 to 0.95
Estimation Comments [Not Specified]
Show Statistical Analysis 51 Hide Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3943
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-2.90 to 1.15
Estimation Comments [Not Specified]
Show Statistical Analysis 52 Hide Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3499
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.13
Confidence Interval (2-Sided) 95%
-3.53 to 1.27
Estimation Comments [Not Specified]
Show Statistical Analysis 53 Hide Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9567
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.07
Confidence Interval (2-Sided) 95%
-2.64 to 2.50
Estimation Comments [Not Specified]
Show Statistical Analysis 54 Hide Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2901
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.77
Confidence Interval (2-Sided) 95%
-5.12 to 1.58
Estimation Comments [Not Specified]
Show Statistical Analysis 55 Hide Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5857
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.07
Confidence Interval (2-Sided) 95%
-5.05 to 2.92
Estimation Comments [Not Specified]
Show Statistical Analysis 56 Hide Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9635
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-12.56 to 12.02
Estimation Comments [Not Specified]
Show Statistical Analysis 57 Hide Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6850
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.40
Confidence Interval (2-Sided) 95%
-15.36 to 10.56
Estimation Comments [Not Specified]
Show Statistical Analysis 58 Hide Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4968
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.75
Confidence Interval (2-Sided) 95%
-19.23 to 11.73
Estimation Comments [Not Specified]
Show Statistical Analysis 59 Hide Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 60 Hide Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in CCS between treatment arms (EOT) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5891
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-2.71 to 1.55
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Treatment – Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 96 95
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (Neurotoxicity) (n=90, 93) 44.04  (4.853) 44.41  (4.808)
Change at C4 D1 (Neurotoxicity) (n=75, 80) -4.73  (6.270) -4.10  (5.514)
Change at C7 D1 (Neurotoxicity) (n=60, 74) -6.20  (7.504) -5.76  (5.560)
Change at C10 D1 (Neurotoxicity) (n=45, 61) -10.21  (8.800) -7.45  (7.231)
Change at C13 D1 (Neurotoxicity) (n=34, 40) -13.96  (9.494) -12.73  (9.420)
Change at C16 D1 (Neurotoxicity) (n=24, 31) -15.58  (8.356) -14.55  (10.977)
Change at C19 D1 (Neurotoxicity) (n=13, 23) -12.4  (8.58) -16.6  (9.71)
Change at C22 D1 (Neurotoxicity) (n=5, 20) -5.60  (6.914) -13.87  (8.122)
Change at C25 D1 (Neurotoxicity) (n=1, 14) -13.0 [1]   (NA) -16.9  (9.09)
Change at C28 D1 (Neurotoxicity) (n=1, 10) -13.0 [1]   (NA) -14.0  (8.03)
Change at C31 D1 (Neurotoxicity) (n=1, 4) -12.0 [1]   (NA) -13.8  (4.11)
Change at C34 D1 (Neurotoxicity) (n=1, 1) -12.0 [1]   (NA) -9.0 [1]   (NA)
Change at C37 D1 (Neurotoxicity) (n=0, 1) NA [2]   (NA) -9.0 [1]   (NA)
Change at C40 D1 (Neurotoxicity) (n=0, 1) NA [2]   (NA) -10.0 [1]   (NA)
Change at C43 D1 (Neurotoxicity) (n=0, 1) NA [2]   (NA) -10.0 [1]   (NA)
Change at C46 D1 (Neurotoxicity) (n=0, 1) NA [2]   (NA) -8.0 [1]   (NA)
Change at C49 D1 (Neurotoxicity) (n=0, 1) NA [2]   (NA) -8.0 [1]   (NA)
Change at EOT (Neurotoxicity) (n=56, 43) -10.71  (9.561) -9.97  (8.632)
Baseline (Item 13) (n=90, 93) 3.8  (0.55) 3.9  (0.42)
Change at C4 D1 (Item 13) (n=75, 79) -0.2  (0.52) -0.2  (0.65)
Change at C7 D1 (Item 13) (n=60, 74) -0.3  (0.68) -0.2  (0.56)
Change at C10 D1 (Item 13) (n=45, 61) -0.4  (0.87) -0.2  (0.79)
Change at C13 D1 (Item 13) (n=34, 40) -0.4  (0.86) -0.2  (0.68)
Change at C16 D1 (Item 13) (n=24, 31) -0.6  (1.03) -0.6  (0.89)
Change at C19 D1 (Item 13) (n=13, 23) -0.3  (0.48) -0.7  (1.19)
Change at C22 D1 (Item 13) (n=5, 20) -0.4  (0.55) -0.4  (0.88)
Change at C25 D1 (Item 13) (n=1, 14) 0.0 [1]   (NA) -0.6  (0.94)
Change at C28 D1 (Item 13) (n=1, 10) -1.0 [1]   (NA) -0.6  (1.07)
Change at C31 D1 (Item 13) (n=1, 4) 0.0 [1]   (NA) -1.3  (0.96)
Change at C34 D1 (Item 13) (n=1, 1) -1.0 [1]   (NA) -1.0 [1]   (NA)
Change at C37 D1 (Item 13) (n=0, 1) NA [2]   (NA) -1.0 [1]   (NA)
Change at C40 D1 (Item 13) (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
Change at C43 D1 (Item 13) (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
Change at C46 D1 (Item 13) (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
Change at C49 D1 (Item 13) (n=0, 1) NA [2]   (NA) 0.0 [1]   (NA)
Change at EOT (Item 13) (n=56, 43) -0.4  (0.85) -0.3  (0.78)
[1]
Standard deviation was not estimable as only one participant was evaluable.
[2]
Data was not analyzed due to early study termination.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5081
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-2.50 to 1.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6977
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.44
Confidence Interval (2-Sided) 95%
-2.67 to 1.79
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0797
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.76
Confidence Interval (2-Sided) 95%
-5.85 to 0.33
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5808
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.22
Confidence Interval (2-Sided) 95%
-5.62 to 3.17
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7046
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.03
Confidence Interval (2-Sided) 95%
-6.44 to 4.38
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2052
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.18
Confidence Interval (2-Sided) 95%
-2.40 to 10.76
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0483
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.27
Confidence Interval (2-Sided) 95%
0.07 to 16.46
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6832
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.93
Confidence Interval (2-Sided) 95%
-16.41 to 24.26
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9081
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.00
Confidence Interval (2-Sided) 95%
-18.05 to 20.05
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7289
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.75
Confidence Interval (2-Sided) 95%
-12.88 to 16.38
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in neurotoxicity between treatment arms (EOT) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6921
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.74
Confidence Interval (2-Sided) 95%
-4.43 to 2.95
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (C4 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9788
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.19 to 0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (C7 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2747
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.33 to 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (C10 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2776
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.50 to 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (C13 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1403
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.27
Confidence Interval (2-Sided) 95%
-0.62 to 0.09
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (C16 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9151
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.55 to 0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (C19 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3277
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-0.36 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (C22 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.00
Confidence Interval (2-Sided) 95%
-0.86 to 0.86
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (C25 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5661
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
-1.53 to 2.67
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (C28 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7309
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-2.95 to 2.15
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (C31 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3273
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
-2.16 to 4.66
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (C34 of D1) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 0
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Sunitinib + mFOLFOX6, Bevacizumab + mFOLFOX6
Comments Differences in item 13 between treatment arms (EOT) was analyzed from a two-sample t-test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7108
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.39 to 0.27
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Same event may appear as both AE and SAE. But distinct events are presented. Event may be serious in 1 subject and nonserious in another, or 1 subject may have both serious, nonserious event. At risk population=participants with metastatic colorectal cancer, with at least 1 dose of study medication; Sunitinib+mFOLFOX6=96, Bevacizumab+mFOLFOX6=93.
 
Arm/Group Title Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Affected / at Risk (%) Affected / at Risk (%)
Total   36/96 (37.50%)   30/93 (32.26%) 
Blood and lymphatic system disorders     
Febrile neutropenia * 1  5/96 (5.21%)  0/93 (0.00%) 
Neutropenia * 1  1/96 (1.04%)  0/93 (0.00%) 
Pancytopenia * 1  2/96 (2.08%)  0/93 (0.00%) 
Thrombocytopenia * 1  1/96 (1.04%)  0/93 (0.00%) 
Cardiac disorders     
Cardiac failure congestive * 1  0/96 (0.00%)  1/93 (1.08%) 
Coronary artery disease * 1  0/96 (0.00%)  1/93 (1.08%) 
Left ventricular dysfunction * 1  1/96 (1.04%)  0/93 (0.00%) 
Prinzmetal angina * 1  1/96 (1.04%)  0/93 (0.00%) 
Eye disorders     
Ocular icterus * 1  0/96 (0.00%)  1/93 (1.08%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/96 (1.04%)  0/93 (0.00%) 
Anal haemorrhage * 1  0/96 (0.00%)  1/93 (1.08%) 
Constipation * 1  0/96 (0.00%)  1/93 (1.08%) 
Diarrhoea * 1  0/96 (0.00%)  2/93 (2.15%) 
Enterocutaneous fistula * 1  1/96 (1.04%)  0/93 (0.00%) 
Gastric perforation * 1  0/96 (0.00%)  1/93 (1.08%) 
Gastritis * 1  1/96 (1.04%)  0/93 (0.00%) 
Intestinal obstruction * 1  3/96 (3.13%)  0/93 (0.00%) 
Intestinal perforation * 1  0/96 (0.00%)  1/93 (1.08%) 
Lower gastrointestinal haemorrhage * 1  0/96 (0.00%)  1/93 (1.08%) 
Melaena * 1  0/96 (0.00%)  1/93 (1.08%) 
Nausea * 1  0/96 (0.00%)  1/93 (1.08%) 
Rectal ulcer * 1  0/96 (0.00%)  1/93 (1.08%) 
Small intestinal obstruction * 1  1/96 (1.04%)  2/93 (2.15%) 
Vomiting * 1  2/96 (2.08%)  1/93 (1.08%) 
General disorders     
Adverse drug reaction * 1  1/96 (1.04%)  0/93 (0.00%) 
Chest pain * 1  0/96 (0.00%)  2/93 (2.15%) 
Device dislocation * 1  0/96 (0.00%)  1/93 (1.08%) 
Disease progression * 1  4/96 (4.17%)  3/93 (3.23%) 
Medical device complication * 1  0/96 (0.00%)  1/93 (1.08%) 
Pain * 1  1/96 (1.04%)  1/93 (1.08%) 
Pyrexia * 1  1/96 (1.04%)  2/93 (2.15%) 
Hepatobiliary disorders     
Cholangitis * 1  0/96 (0.00%)  1/93 (1.08%) 
Cholestasis * 1  1/96 (1.04%)  0/93 (0.00%) 
Hepatitis * 1  0/96 (0.00%)  1/93 (1.08%) 
Immune system disorders     
Anaphylactic reaction * 1  1/96 (1.04%)  0/93 (0.00%) 
Drug hypersensitivity * 1  1/96 (1.04%)  0/93 (0.00%) 
Infections and infestations     
Abdominal infection * 1  1/96 (1.04%)  0/93 (0.00%) 
Abdominal wall infection * 1  1/96 (1.04%)  0/93 (0.00%) 
Abscess * 1  1/96 (1.04%)  0/93 (0.00%) 
Bacteraemia * 1  2/96 (2.08%)  0/93 (0.00%) 
Bronchitis * 1  0/96 (0.00%)  1/93 (1.08%) 
Clostridium difficile colitis * 1  1/96 (1.04%)  0/93 (0.00%) 
Cystitis * 1  1/96 (1.04%)  0/93 (0.00%) 
Haemophilus bacteraemia * 1  0/96 (0.00%)  1/93 (1.08%) 
Herpes zoster * 1  1/96 (1.04%)  0/93 (0.00%) 
Infection * 1  1/96 (1.04%)  0/93 (0.00%) 
Lung infection * 1  1/96 (1.04%)  0/93 (0.00%) 
Pneumonia * 1  2/96 (2.08%)  2/93 (2.15%) 
Post procedural infection * 1  1/96 (1.04%)  0/93 (0.00%) 
Septic shock * 1  0/96 (0.00%)  1/93 (1.08%) 
Injury, poisoning and procedural complications     
Wound dehiscence * 1  1/96 (1.04%)  0/93 (0.00%) 
Investigations     
Platelet count decreased * 1  1/96 (1.04%)  0/93 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  5/96 (5.21%)  2/93 (2.15%) 
Diabetic ketoacidosis * 1  0/96 (0.00%)  1/93 (1.08%) 
Musculoskeletal and connective tissue disorders     
Costochondritis * 1  0/96 (0.00%)  1/93 (1.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer * 1  0/96 (0.00%)  1/93 (1.08%) 
Nervous system disorders     
Depressed level of consciousness * 1  1/96 (1.04%)  0/93 (0.00%) 
Dizziness * 1  0/96 (0.00%)  1/93 (1.08%) 
Syncope * 1  0/96 (0.00%)  1/93 (1.08%) 
Renal and urinary disorders     
Calculus ureteric * 1  1/96 (1.04%)  0/93 (0.00%) 
Renal failure acute * 1  1/96 (1.04%)  0/93 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease * 1  0/96 (0.00%)  1/93 (1.08%) 
Dyspnoea * 1  2/96 (2.08%)  2/93 (2.15%) 
Epistaxis * 1  1/96 (1.04%)  0/93 (0.00%) 
Lung infiltration * 1  1/96 (1.04%)  0/93 (0.00%) 
Pleuritic pain * 1  1/96 (1.04%)  0/93 (0.00%) 
Pulmonary embolism * 1  0/96 (0.00%)  2/93 (2.15%) 
Pulmonary hypertension * 1  1/96 (1.04%)  0/93 (0.00%) 
Respiratory distress * 1  1/96 (1.04%)  0/93 (0.00%) 
Respiratory failure * 1  0/96 (0.00%)  1/93 (1.08%) 
Skin and subcutaneous tissue disorders     
Angioedema * 1  1/96 (1.04%)  0/93 (0.00%) 
Surgical and medical procedures     
Hepatectomy * 1  0/96 (0.00%)  1/93 (1.08%) 
Vascular disorders     
Deep vein thrombosis * 1  0/96 (0.00%)  3/93 (3.23%) 
Haemorrhage * 1  1/96 (1.04%)  0/93 (0.00%) 
Jugular vein thrombosis * 1  0/96 (0.00%)  2/93 (2.15%) 
Subclavian vein thrombosis * 1  0/96 (0.00%)  1/93 (1.08%) 
Thrombosis * 1  0/96 (0.00%)  1/93 (1.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib + mFOLFOX6 Bevacizumab + mFOLFOX6
Affected / at Risk (%) Affected / at Risk (%)
Total   96/96 (100.00%)   93/93 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  27/96 (28.13%)  26/93 (27.96%) 
Leukopenia * 1  21/96 (21.88%)  11/93 (11.83%) 
Neutropenia * 1  67/96 (69.79%)  33/93 (35.48%) 
Thrombocytopenia * 1  50/96 (52.08%)  19/93 (20.43%) 
Eye disorders     
Lacrimation increased * 1  5/96 (5.21%)  5/93 (5.38%) 
Vision blurred * 1  6/96 (6.25%)  3/93 (3.23%) 
Gastrointestinal disorders     
Abdominal distension * 1  6/96 (6.25%)  5/93 (5.38%) 
Abdominal pain * 1  20/96 (20.83%)  21/93 (22.58%) 
Abdominal pain lower * 1  1/96 (1.04%)  5/93 (5.38%) 
Abdominal pain upper * 1  6/96 (6.25%)  7/93 (7.53%) 
Cheilitis * 1  4/96 (4.17%)  5/93 (5.38%) 
Constipation * 1  22/96 (22.92%)  30/93 (32.26%) 
Diarrhoea * 1  66/96 (68.75%)  49/93 (52.69%) 
Dry mouth * 1  11/96 (11.46%)  5/93 (5.38%) 
Dyspepsia * 1  17/96 (17.71%)  7/93 (7.53%) 
Dysphagia * 1  4/96 (4.17%)  7/93 (7.53%) 
Flatulence * 1  5/96 (5.21%)  7/93 (7.53%) 
Gastrooesophageal reflux disease * 1  11/96 (11.46%)  7/93 (7.53%) 
Haemorrhoids * 1  0/96 (0.00%)  5/93 (5.38%) 
Nausea * 1  62/96 (64.58%)  57/93 (61.29%) 
Oral pain * 1  6/96 (6.25%)  5/93 (5.38%) 
Proctalgia * 1  5/96 (5.21%)  2/93 (2.15%) 
Rectal haemorrhage * 1  3/96 (3.13%)  5/93 (5.38%) 
Stomatitis * 1  31/96 (32.29%)  26/93 (27.96%) 
Vomiting * 1  33/96 (34.38%)  33/93 (35.48%) 
General disorders     
Asthenia * 1  8/96 (8.33%)  11/93 (11.83%) 
Chest pain * 1  2/96 (2.08%)  10/93 (10.75%) 
Chills * 1  2/96 (2.08%)  6/93 (6.45%) 
Fatigue * 1  65/96 (67.71%)  62/93 (66.67%) 
Mucosal inflammation * 1  12/96 (12.50%)  21/93 (22.58%) 
Oedema peripheral * 1  11/96 (11.46%)  5/93 (5.38%) 
Pain * 1  7/96 (7.29%)  9/93 (9.68%) 
Pyrexia * 1  21/96 (21.88%)  22/93 (23.66%) 
Immune system disorders     
Hypersensitivity * 1  2/96 (2.08%)  5/93 (5.38%) 
Infections and infestations     
Nasopharyngitis * 1  4/96 (4.17%)  9/93 (9.68%) 
Rhinitis * 1  0/96 (0.00%)  7/93 (7.53%) 
Upper respiratory tract infection * 1  4/96 (4.17%)  6/93 (6.45%) 
Urinary tract infection * 1  10/96 (10.42%)  3/93 (3.23%) 
Injury, poisoning and procedural complications     
Contusion * 1  5/96 (5.21%)  1/93 (1.08%) 
Investigations     
Blood alkaline phosphatase increased * 1  5/96 (5.21%)  5/93 (5.38%) 
Blood potassium decreased * 1  5/96 (5.21%)  1/93 (1.08%) 
Haemoglobin decreased * 1  6/96 (6.25%)  2/93 (2.15%) 
Neutrophil count decreased * 1  19/96 (19.79%)  8/93 (8.60%) 
Platelet count decreased * 1  17/96 (17.71%)  0/93 (0.00%) 
Weight decreased * 1  19/96 (19.79%)  16/93 (17.20%) 
White blood cell count decreased * 1  13/96 (13.54%)  5/93 (5.38%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  32/96 (33.33%)  36/93 (38.71%) 
Dehydration * 1  11/96 (11.46%)  6/93 (6.45%) 
Hyperglycaemia * 1  3/96 (3.13%)  6/93 (6.45%) 
Hypocalcaemia * 1  5/96 (5.21%)  2/93 (2.15%) 
Hypokalaemia * 1  18/96 (18.75%)  10/93 (10.75%) 
Hypomagnesaemia * 1  5/96 (5.21%)  2/93 (2.15%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  5/96 (5.21%)  7/93 (7.53%) 
Back pain * 1  13/96 (13.54%)  8/93 (8.60%) 
Bone pain * 1  4/96 (4.17%)  7/93 (7.53%) 
Musculoskeletal pain * 1  6/96 (6.25%)  6/93 (6.45%) 
Myalgia * 1  4/96 (4.17%)  8/93 (8.60%) 
Pain in extremity * 1  8/96 (8.33%)  10/93 (10.75%) 
Nervous system disorders     
Dizziness * 1  14/96 (14.58%)  16/93 (17.20%) 
Dysgeusia * 1  31/96 (32.29%)  21/93 (22.58%) 
Headache * 1  14/96 (14.58%)  22/93 (23.66%) 
Hyperaesthesia * 1  7/96 (7.29%)  8/93 (8.60%) 
Hypoaesthesia * 1  5/96 (5.21%)  5/93 (5.38%) 
Neuropathy peripheral * 1  39/96 (40.63%)  37/93 (39.78%) 
Paraesthesia * 1  6/96 (6.25%)  14/93 (15.05%) 
Peripheral sensory neuropathy * 1  29/96 (30.21%)  33/93 (35.48%) 
Polyneuropathy * 1  0/96 (0.00%)  5/93 (5.38%) 
Psychiatric disorders     
Anxiety * 1  5/96 (5.21%)  13/93 (13.98%) 
Depression * 1  6/96 (6.25%)  11/93 (11.83%) 
Insomnia * 1  16/96 (16.67%)  20/93 (21.51%) 
Renal and urinary disorders     
Proteinuria * 1  3/96 (3.13%)  5/93 (5.38%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  15/96 (15.63%)  16/93 (17.20%) 
Dysphonia * 1  2/96 (2.08%)  11/93 (11.83%) 
Dyspnoea * 1  16/96 (16.67%)  14/93 (15.05%) 
Dyspnoea exertional * 1  6/96 (6.25%)  4/93 (4.30%) 
Epistaxis * 1  22/96 (22.92%)  30/93 (32.26%) 
Hiccups * 1  10/96 (10.42%)  7/93 (7.53%) 
Oropharyngeal pain * 1  7/96 (7.29%)  8/93 (8.60%) 
Rhinorrhoea * 1  3/96 (3.13%)  5/93 (5.38%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  17/96 (17.71%)  24/93 (25.81%) 
Dry skin * 1  9/96 (9.38%)  5/93 (5.38%) 
Hyperhidrosis * 1  3/96 (3.13%)  5/93 (5.38%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  26/96 (27.08%)  15/93 (16.13%) 
Pruritus * 1  7/96 (7.29%)  9/93 (9.68%) 
Rash * 1  20/96 (20.83%)  16/93 (17.20%) 
Skin discolouration * 1  9/96 (9.38%)  5/93 (5.38%) 
Skin hyperpigmentation * 1  2/96 (2.08%)  8/93 (8.60%) 
Yellow skin * 1  9/96 (9.38%)  0/93 (0.00%) 
Vascular disorders     
Hypertension * 1  19/96 (19.79%)  21/93 (22.58%) 
Hypotension * 1  2/96 (2.08%)  6/93 (6.45%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA v13.1
Due to early study termination, not all data was analyzable.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00609622     History of Changes
Other Study ID Numbers: A6181104
First Submitted: January 25, 2008
First Posted: February 7, 2008
Results First Submitted: July 6, 2012
Results First Posted: October 11, 2012
Last Update Posted: October 11, 2012