Trial Outcomes & Findings for Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer (NCT NCT00609622)

Last Updated: 2012-10-11

Results Overview

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").

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

191 participants

Primary outcome timeframe

Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)

Results posted on

2012-10-11

Participant Flow

Participant milestones

Participant milestones
Measure	Sunitinib + mFOLFOX6 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 + mFOLFOX6 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.
Overall Study STARTED	96	95
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	96	95

Reasons for withdrawal

Reasons for withdrawal
Measure	Sunitinib + mFOLFOX6 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 + mFOLFOX6 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.
Overall Study Adverse Event	14	10
Overall Study Withdrawal by Subject	4	20
Overall Study Death	1	4
Overall Study Protocol Violation	1	1
Overall Study Objective progression or relapse	47	41
Overall Study Study terminated by sponsor	16	3
Overall Study Other	7	14
Overall Study Global deterioration of health status	6	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib + mFOLFOX6 n=96 Participants 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 + mFOLFOX6 n=95 Participants 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 n=191 Participants Total of all reporting groups
Age Continuous	60.60 Years STANDARD_DEVIATION 9.26 • n=93 Participants	59.10 Years STANDARD_DEVIATION 10.81 • n=4 Participants	59.90 Years STANDARD_DEVIATION 10.06 • n=27 Participants
Sex: Female, Male Female	35 Participants n=93 Participants	33 Participants n=4 Participants	68 Participants n=27 Participants
Sex: Female, Male Male	61 Participants n=93 Participants	62 Participants n=4 Participants	123 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115)

Population: The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.

Outcome measures

Outcome measures
Measure	Sunitinib + mFOLFOX6 n=96 Participants 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 + mFOLFOX6 n=95 Participants 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.
Progression-free Survival (PFS)	40.50 Weeks Interval 39.5 to 44.2	67.00 Weeks Interval 41.6 to 67.0

SECONDARY outcome

Timeframe: Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to Week 115)

Population: The FA set included all participants who were randomized, with study drug assignment designated according to initial randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.

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).

Outcome measures

Outcome measures
Measure	Sunitinib + mFOLFOX6 n=96 Participants 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 + mFOLFOX6 n=95 Participants 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 Survival (OS)	84.30 Weeks Interval 84.3 to Upper limit of the confidence interval (C.I) was not reachable as data was not matured at the time of the analysis.	NA Weeks Median OS could not be determined as data was not matured at the time of the analysis.

SECONDARY outcome

Timeframe: Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 1 year)

Population: Data was not analyzed due to early study termination.

One year survival probability was defined as the probability of survival at one year after the first dose of study treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to every 2 months until death (up to 2 years)

Population: Data was not analyzed due to early study termination.

Two year survival probability was defined as the probability of survival at two years after the first dose of study treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30 percent decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.

Outcome measures

Outcome measures
Measure	Sunitinib + mFOLFOX6 n=96 Participants 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 + mFOLFOX6 n=95 Participants 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.
Percentage of Participants With Objective Response (OR)	41.70 Percentage of participants Interval 33.56 to 54.75	37.90 Percentage of participants Interval 29.81 to 50.87

SECONDARY outcome

Timeframe: Baseline until disease progression or discontinuation of the study, at every 8-week intervals for 18 months, and then every 12 weeks thereafter up to Week 115

Population: Data was not analyzed due to early study termination.

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline [Day (D) 1 of Cycle (C) 1] then every 3 cycles thereafter and at the end of treatment (EOT) or withdrawal visit (up to Week 115)

Population: FA set included participants randomized with study drug assignment, regardless of whether participants received study drug, or received a different drug from that to which they were randomized. Here "n" signifies those participants evaluated for this measure at specific time point for each cohort respectively.

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.

Outcome measures

Outcome measures
Measure	Sunitinib + mFOLFOX6 n=96 Participants 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 + mFOLFOX6 n=95 Participants 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.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C31 D1 (n=1, 4)	-4.00 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	3.58 Units on a scale Standard Deviation 3.233
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C43 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C16 D1 (n=25, 32)	0.84 Units on a scale Standard Deviation 3.934	0.96 Units on a scale Standard Deviation 4.511
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C34 D1 (n=1, 1)	4.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C4 D1 (n=80, 82)	0.95 Units on a scale Standard Deviation 3.505	1.40 Units on a scale Standard Deviation 4.108
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C7 D1 (n=59, 75)	1.65 Units on a scale Standard Deviation 3.108	1.71 Units on a scale Standard Deviation 4.036
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C10 D1 (n=45, 62)	1.40 Units on a scale Standard Deviation 4.014	1.65 Units on a scale Standard Deviation 4.121
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C13 D1 (n=34, 40)	1.3 Units on a scale Standard Deviation 4.45	1.4 Units on a scale Standard Deviation 4.30
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C19 D1 (n=13, 23)	1.2 Units on a scale Standard Deviation 2.92	1.8 Units on a scale Standard Deviation 4.56
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C22 D1 (n=6, 20)	0.2 Units on a scale Standard Deviation 3.66	1.1 Units on a scale Standard Deviation 3.39
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C25 D1 (n=1, 15)	4.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-0.3 Units on a scale Standard Deviation 5.32
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C28 D1 (n=1, 10)	4.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.1 Units on a scale Standard Deviation 3.45
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C31 D1 (n=1, 4)	2.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	2.3 Units on a scale Standard Deviation 4.50
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C37 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Baseline (n= 93, 90)	23.21 Units on a scale Standard Deviation 4.108	23.29 Units on a scale Standard Deviation 4.324
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C4 D1 (n=80, 82)	-2.65 Units on a scale Standard Deviation 4.132	-1.24 Units on a scale Standard Deviation 4.930
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C7 D1 (n=59, 75)	-3.39 Units on a scale Standard Deviation 5.532	-1.94 Units on a scale Standard Deviation 4.217
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C10 D1 (n=45, 62)	-3.66 Units on a scale Standard Deviation 4.732	-1.85 Units on a scale Standard Deviation 4.690
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C13 D1 (n=34, 40)	-3.88 Units on a scale Standard Deviation 4.969	-2.24 Units on a scale Standard Deviation 4.364
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C16 D1 (n=25, 32)	-3.88 Units on a scale Standard Deviation 4.850	-2.83 Units on a scale Standard Deviation 4.937
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C19 D1 (n=13, 23)	-3.46 Units on a scale Standard Deviation 4.977	-1.49 Units on a scale Standard Deviation 4.308
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C22 D1 (n=6, 20)	-1.67 Units on a scale Standard Deviation 4.885	-2.08 Units on a scale Standard Deviation 3.429
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C25 D1 (n=1, 15)	7.00 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-1.90 Units on a scale Standard Deviation 3.762
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C28 D1 (n=1, 10)	4.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-1.6 Units on a scale Standard Deviation 5.15
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C31 D1 (n=1, 4)	3.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-2.8 Units on a scale Standard Deviation 6.18
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C34 D1 (n=1, 1)	6.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C37 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C40 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C43 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C46 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at C49 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score PWB Change at EOT (n=57, 43)	-4.16 Units on a scale Standard Deviation 4.686	-3.52 Units on a scale Standard Deviation 6.222
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Baseline (n=93, 88)	23.42 Units on a scale Standard Deviation 4.679	23.16 Units on a scale Standard Deviation 4.442
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C4 D1 (n=80, 81)	0.03 Units on a scale Standard Deviation 3.129	0.31 Units on a scale Standard Deviation 3.823
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C7 D1 (n=59, 73)	-0.24 Units on a scale Standard Deviation 3.941	0.27 Units on a scale Standard Deviation 3.931
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C10 D1 (n=45, 60)	-0.89 Units on a scale Standard Deviation 3.781	0.05 Units on a scale Standard Deviation 3.753
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C13 D1 (n=34, 39)	-0.24 Units on a scale Standard Deviation 2.486	-1.33 Units on a scale Standard Deviation 4.278
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C16 D1 (n=25, 31)	-0.64 Units on a scale Standard Deviation 3.369	-1.24 Units on a scale Standard Deviation 4.415
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C19 D1 (n=13, 23)	-0.79 Units on a scale Standard Deviation 2.024	-1.47 Units on a scale Standard Deviation 4.751
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C22 D1 (n=6, 20)	-0.67 Units on a scale Standard Deviation 2.065	-1.18 Units on a scale Standard Deviation 3.787
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C25 D1 (n=1, 15)	-4.00 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-0.06 Units on a scale Standard Deviation 4.191
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C28 D1 (n=1, 10)	-3.50 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-0.65 Units on a scale Standard Deviation 4.627
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C34 D1 (n=1, 1)	-3.50 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	1.00 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C37 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C 40 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C46 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at C49 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score SWB Change at EOT (n=57, 43)	-0.35 Units on a scale Standard Deviation 3.501	-0.63 Units on a scale Standard Deviation 2.902
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Baseline (n=93, 90)	16.74 Units on a scale Standard Deviation 4.342	17.30 Units on a scale Standard Deviation 3.995
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C40 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C43 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C13 D1 (n=34, 40)	-0.4 Units on a scale Standard Deviation 5.02	0.8 Units on a scale Standard Deviation 5.88
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C46 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at C49 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score EWB Change at EOT (n=57, 43)	0.35 Units on a scale Standard Deviation 4.805	0.77 Units on a scale Standard Deviation 4.942
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Baseline (n=93, 89)	17.88 Units on a scale Standard Deviation 5.818	17.29 Units on a scale Standard Deviation 6.328
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C4 D1 (n=80, 81)	-0.78 Units on a scale Standard Deviation 5.007	1.56 Units on a scale Standard Deviation 5.536
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C7 D1 (n=59, 74)	-0.02 Units on a scale Standard Deviation 5.425	1.02 Units on a scale Standard Deviation 5.493
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C10 D1 (n=45, 61)	-0.35 Units on a scale Standard Deviation 4.471	0.74 Units on a scale Standard Deviation 5.884
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C16 D1 (n=24, 31)	-0.7 Units on a scale Standard Deviation 3.65	-0.7 Units on a scale Standard Deviation 4.95
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C19 D1 (n=13, 22)	-0.3 Units on a scale Standard Deviation 3.88	0.1 Units on a scale Standard Deviation 6.11
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C22 D1 (n=6, 19)	0.7 Units on a scale Standard Deviation 6.35	-0.8 Units on a scale Standard Deviation 4.72
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C25 D1 (n=1, 14)	12.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-1.0 Units on a scale Standard Deviation 4.40
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C28 D1 (n=1, 9)	13.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	-0.8 Units on a scale Standard Deviation 4.74
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C31 D1 (n=1, 3)	6.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	1.0 Units on a scale Standard Deviation 3.61
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C34 D1 (n=1, 1)	12.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C37 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C40 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-3.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C43 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-3.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C46 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-3.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at C49 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-3.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score FWB Change at EOT (n=56, 43)	1.62 Units on a scale Standard Deviation 5.394	0.14 Units on a scale Standard Deviation 6.075
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Baseline (n=93, 90)	20.93 Units on a scale Standard Deviation 4.733	21.26 Units on a scale Standard Deviation 5.064
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C4 D1 (n=78, 82)	-1.49 Units on a scale Standard Deviation 4.228	-0.13 Units on a scale Standard Deviation 4.485
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C7 D1 (n=60, 75)	-1.00 Units on a scale Standard Deviation 5.193	-0.26 Units on a scale Standard Deviation 4.726
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C10 D1 (n=45, 62)	-1.03 Units on a scale Standard Deviation 4.859	-0.16 Units on a scale Standard Deviation 5.474
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C13 D1 (n=34, 40)	-1.33 Units on a scale Standard Deviation 5.224	-0.20 Units on a scale Standard Deviation 5.105
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C16 D1 (n=25, 32)	-1.32 Units on a scale Standard Deviation 4.425	-1.25 Units on a scale Standard Deviation 5.086
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C19 D1 (n=13, 23)	-2.13 Units on a scale Standard Deviation 4.732	-0.36 Units on a scale Standard Deviation 4.754
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C22 D1 (n=6, 20)	-0.92 Units on a scale Standard Deviation 5.219	0.15 Units on a scale Standard Deviation 3.815
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C25 D1 (n=1, 15)	1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	1.3 Units on a scale Standard Deviation 5.55
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C28 D1 (n=1, 10)	-2.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.4 Units on a scale Standard Deviation 5.46
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C31 D1 (n=1, 4)	-2.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	1.8 Units on a scale Standard Deviation 4.35
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C34 D1 (n=1, 1)	-1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C37 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C40 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C43 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C46 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at C49 D1 (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable since only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Colorectal (FACT-C) Score CCS Change at EOT (n=55, 43)	-1.06 Units on a scale Standard Deviation 4.942	-0.48 Units on a scale Standard Deviation 5.679

SECONDARY outcome

Timeframe: Baseline (D1 of C1) then every 3 cycles thereafter and at the EOT or withdrawal visit (up to 115 weeks)

FACT\&GOG-Ntx has a 13-item, treatment-specific subscale for patients with neurotoxicity. It is the sum of the PWB (7 items), FWB (7 items), SWB (7 items) and EWB (6 items) subscales plus a 13 item neurotoxicity subscale. Subscale score ranges from 0 to 28 for PWB, FWB, SWB, 0 to 24 for EWB and 0 to 52 for neurotoxicity subscale. Total possible score range is 0 to 160. Higher scores indicates better QoL, fewer disease symptoms, and/or fewer side effects of treatment and lower scores indicate worse QoL and a greater impact of disease symptoms and/or side effects.

Outcome measures

Outcome measures
Measure	Sunitinib + mFOLFOX6 n=96 Participants 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 + mFOLFOX6 n=95 Participants 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.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C49 D1 (Item 13) (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at EOT (Item 13) (n=56, 43)	-0.4 Units on a scale Standard Deviation 0.85	-0.3 Units on a scale Standard Deviation 0.78
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Baseline (Neurotoxicity) (n=90, 93)	44.04 Units on a scale Standard Deviation 4.853	44.41 Units on a scale Standard Deviation 4.808
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C4 D1 (Neurotoxicity) (n=75, 80)	-4.73 Units on a scale Standard Deviation 6.270	-4.10 Units on a scale Standard Deviation 5.514
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C7 D1 (Neurotoxicity) (n=60, 74)	-6.20 Units on a scale Standard Deviation 7.504	-5.76 Units on a scale Standard Deviation 5.560
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C10 D1 (Neurotoxicity) (n=45, 61)	-10.21 Units on a scale Standard Deviation 8.800	-7.45 Units on a scale Standard Deviation 7.231
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C13 D1 (Neurotoxicity) (n=34, 40)	-13.96 Units on a scale Standard Deviation 9.494	-12.73 Units on a scale Standard Deviation 9.420
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C16 D1 (Neurotoxicity) (n=24, 31)	-15.58 Units on a scale Standard Deviation 8.356	-14.55 Units on a scale Standard Deviation 10.977
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C19 D1 (Neurotoxicity) (n=13, 23)	-12.4 Units on a scale Standard Deviation 8.58	-16.6 Units on a scale Standard Deviation 9.71
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C22 D1 (Neurotoxicity) (n=5, 20)	-5.60 Units on a scale Standard Deviation 6.914	-13.87 Units on a scale Standard Deviation 8.122
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C25 D1 (Neurotoxicity) (n=1, 14)	-13.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.	-16.9 Units on a scale Standard Deviation 9.09
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C28 D1 (Neurotoxicity) (n=1, 10)	-13.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.	-14.0 Units on a scale Standard Deviation 8.03
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C31 D1 (Neurotoxicity) (n=1, 4)	-12.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.	-13.8 Units on a scale Standard Deviation 4.11
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C34 D1 (Neurotoxicity) (n=1, 1)	-12.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.	-9.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C37 D1 (Neurotoxicity) (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-9.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C40 D1 (Neurotoxicity) (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-10.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C43 D1 (Neurotoxicity) (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-10.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C46 D1 (Neurotoxicity) (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-8.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C49 D1 (Neurotoxicity) (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-8.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at EOT (Neurotoxicity) (n=56, 43)	-10.71 Units on a scale Standard Deviation 9.561	-9.97 Units on a scale Standard Deviation 8.632
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Baseline (Item 13) (n=90, 93)	3.8 Units on a scale Standard Deviation 0.55	3.9 Units on a scale Standard Deviation 0.42
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C4 D1 (Item 13) (n=75, 79)	-0.2 Units on a scale Standard Deviation 0.52	-0.2 Units on a scale Standard Deviation 0.65
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C7 D1 (Item 13) (n=60, 74)	-0.3 Units on a scale Standard Deviation 0.68	-0.2 Units on a scale Standard Deviation 0.56
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C10 D1 (Item 13) (n=45, 61)	-0.4 Units on a scale Standard Deviation 0.87	-0.2 Units on a scale Standard Deviation 0.79
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C13 D1 (Item 13) (n=34, 40)	-0.4 Units on a scale Standard Deviation 0.86	-0.2 Units on a scale Standard Deviation 0.68
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C16 D1 (Item 13) (n=24, 31)	-0.6 Units on a scale Standard Deviation 1.03	-0.6 Units on a scale Standard Deviation 0.89
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C19 D1 (Item 13) (n=13, 23)	-0.3 Units on a scale Standard Deviation 0.48	-0.7 Units on a scale Standard Deviation 1.19
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C22 D1 (Item 13) (n=5, 20)	-0.4 Units on a scale Standard Deviation 0.55	-0.4 Units on a scale Standard Deviation 0.88
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C25 D1 (Item 13) (n=1, 14)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.	-0.6 Units on a scale Standard Deviation 0.94
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C28 D1 (Item 13) (n=1, 10)	-1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.	-0.6 Units on a scale Standard Deviation 1.07
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C31 D1 (Item 13) (n=1, 4)	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.	-1.3 Units on a scale Standard Deviation 0.96
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C34 D1 (Item 13) (n=1, 1)	-1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.	-1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C37 D1 (Item 13) (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	-1.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C40 D1 (Item 13) (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C43 D1 (Item 13) (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.
Change From Baseline in Functional Assessment of Cancer Treatment - Gynecologic Oncology Group Oxaliplatin-Specific Neurotoxicity (FACT&GOG-Ntx) Score Change at C46 D1 (Item 13) (n=0, 1)	NA Units on a scale Standard Deviation NA Data was not analyzed due to early study termination.	0.0 Units on a scale Standard Deviation NA Standard deviation was not estimable as only one participant was evaluable.

Adverse Events

Sunitinib + mFOLFOX6

Serious events: 36 serious events

Other events: 96 other events

Deaths: 0 deaths

Bevacizumab + mFOLFOX6

Serious events: 30 serious events

Other events: 93 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Sunitinib + mFOLFOX6 n=96 participants at risk 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 + mFOLFOX6 n=93 participants at risk 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.
Blood and lymphatic system disorders Febrile neutropenia	5.2% 5/96 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.	0.00% 0/93 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.
Blood and lymphatic system disorders Neutropenia	1.0% 1/96 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.	0.00% 0/93 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.
Blood and lymphatic system disorders Pancytopenia	2.1% 2/96 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.	0.00% 0/93 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.
Blood and lymphatic system disorders Thrombocytopenia	1.0% 1/96 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.	0.00% 0/93 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.
Cardiac disorders Cardiac failure congestive	0.00% 0/96 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.	1.1% 1/93 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.
Cardiac disorders Coronary artery disease	0.00% 0/96 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.	1.1% 1/93 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.
Cardiac disorders Left ventricular dysfunction	1.0% 1/96 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.	0.00% 0/93 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.
Cardiac disorders Prinzmetal angina	1.0% 1/96 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.	0.00% 0/93 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.
Eye disorders Ocular icterus	0.00% 0/96 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.	1.1% 1/93 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.
Gastrointestinal disorders Abdominal pain	1.0% 1/96 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.	0.00% 0/93 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.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/96 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.	1.1% 1/93 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.
Gastrointestinal disorders Constipation	0.00% 0/96 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.	1.1% 1/93 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.
Gastrointestinal disorders Diarrhoea	0.00% 0/96 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.	2.2% 2/93 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.
Gastrointestinal disorders Enterocutaneous fistula	1.0% 1/96 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.	0.00% 0/93 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.
Gastrointestinal disorders Gastric perforation	0.00% 0/96 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.	1.1% 1/93 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.
Gastrointestinal disorders Gastritis	1.0% 1/96 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.	0.00% 0/93 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.
Gastrointestinal disorders Intestinal obstruction	3.1% 3/96 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.	0.00% 0/93 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.
Gastrointestinal disorders Intestinal perforation	0.00% 0/96 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.	1.1% 1/93 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.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/96 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.	1.1% 1/93 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.
Gastrointestinal disorders Melaena	0.00% 0/96 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.	1.1% 1/93 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.
Gastrointestinal disorders Nausea	0.00% 0/96 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.	1.1% 1/93 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.
Gastrointestinal disorders Rectal ulcer	0.00% 0/96 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.	1.1% 1/93 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.
Gastrointestinal disorders Small intestinal obstruction	1.0% 1/96 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.	2.2% 2/93 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.
Gastrointestinal disorders Vomiting	2.1% 2/96 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.	1.1% 1/93 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.
General disorders Adverse drug reaction	1.0% 1/96 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.	0.00% 0/93 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.
General disorders Chest pain	0.00% 0/96 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.	2.2% 2/93 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.
General disorders Device dislocation	0.00% 0/96 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.	1.1% 1/93 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.
General disorders Disease progression	4.2% 4/96 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.	3.2% 3/93 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.
General disorders Medical device complication	0.00% 0/96 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.	1.1% 1/93 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.
General disorders Pain	1.0% 1/96 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.	1.1% 1/93 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.
General disorders Pyrexia	1.0% 1/96 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.	2.2% 2/93 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.
Hepatobiliary disorders Cholangitis	0.00% 0/96 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.	1.1% 1/93 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.
Hepatobiliary disorders Cholestasis	1.0% 1/96 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.	0.00% 0/93 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.
Hepatobiliary disorders Hepatitis	0.00% 0/96 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.	1.1% 1/93 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.
Immune system disorders Anaphylactic reaction	1.0% 1/96 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.	0.00% 0/93 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.
Immune system disorders Drug hypersensitivity	1.0% 1/96 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.	0.00% 0/93 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.
Infections and infestations Abdominal infection	1.0% 1/96 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.	0.00% 0/93 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.
Infections and infestations Abdominal wall infection	1.0% 1/96 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.	0.00% 0/93 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.
Infections and infestations Abscess	1.0% 1/96 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.	0.00% 0/93 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.
Infections and infestations Bacteraemia	2.1% 2/96 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.	0.00% 0/93 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.

Other adverse events
Measure	Sunitinib + mFOLFOX6 n=96 participants at risk 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 + mFOLFOX6 n=93 participants at risk 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.
Blood and lymphatic system disorders Anaemia	28.1% 27/96 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.	28.0% 26/93 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.
Blood and lymphatic system disorders Leukopenia	21.9% 21/96 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.	11.8% 11/93 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.
Blood and lymphatic system disorders Neutropenia	69.8% 67/96 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.	35.5% 33/93 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.
Blood and lymphatic system disorders Thrombocytopenia	52.1% 50/96 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.	20.4% 19/93 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.
Eye disorders Lacrimation increased	5.2% 5/96 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.	5.4% 5/93 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.
Eye disorders Vision blurred	6.2% 6/96 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.	3.2% 3/93 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.
Gastrointestinal disorders Abdominal distension	6.2% 6/96 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.	5.4% 5/93 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.
Gastrointestinal disorders Abdominal pain	20.8% 20/96 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.	22.6% 21/93 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.
Gastrointestinal disorders Abdominal pain lower	1.0% 1/96 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.	5.4% 5/93 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.
Gastrointestinal disorders Abdominal pain upper	6.2% 6/96 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.	7.5% 7/93 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.
Gastrointestinal disorders Cheilitis	4.2% 4/96 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.	5.4% 5/93 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.
Gastrointestinal disorders Constipation	22.9% 22/96 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.	32.3% 30/93 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.
Gastrointestinal disorders Diarrhoea	68.8% 66/96 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.	52.7% 49/93 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.
Gastrointestinal disorders Dry mouth	11.5% 11/96 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.	5.4% 5/93 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.
Gastrointestinal disorders Dyspepsia	17.7% 17/96 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.	7.5% 7/93 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.
Gastrointestinal disorders Dysphagia	4.2% 4/96 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.	7.5% 7/93 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.
Gastrointestinal disorders Flatulence	5.2% 5/96 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.	7.5% 7/93 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.
Gastrointestinal disorders Gastrooesophageal reflux disease	11.5% 11/96 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.	7.5% 7/93 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.
Gastrointestinal disorders Haemorrhoids	0.00% 0/96 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.	5.4% 5/93 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.
Gastrointestinal disorders Nausea	64.6% 62/96 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.	61.3% 57/93 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.
Gastrointestinal disorders Oral pain	6.2% 6/96 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.	5.4% 5/93 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.
Gastrointestinal disorders Proctalgia	5.2% 5/96 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.	2.2% 2/93 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.
Gastrointestinal disorders Rectal haemorrhage	3.1% 3/96 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.	5.4% 5/93 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.
Gastrointestinal disorders Stomatitis	32.3% 31/96 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.	28.0% 26/93 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.
Gastrointestinal disorders Vomiting	34.4% 33/96 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.	35.5% 33/93 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.
General disorders Asthenia	8.3% 8/96 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.	11.8% 11/93 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.
General disorders Chest pain	2.1% 2/96 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.	10.8% 10/93 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.
General disorders Chills	2.1% 2/96 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.	6.5% 6/93 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.
General disorders Fatigue	67.7% 65/96 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.	66.7% 62/93 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.
General disorders Mucosal inflammation	12.5% 12/96 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.	22.6% 21/93 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.
General disorders Oedema peripheral	11.5% 11/96 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.	5.4% 5/93 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.
General disorders Pain	7.3% 7/96 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.	9.7% 9/93 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.
General disorders Pyrexia	21.9% 21/96 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.	23.7% 22/93 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.
Immune system disorders Hypersensitivity	2.1% 2/96 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.	5.4% 5/93 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.
Infections and infestations Nasopharyngitis	4.2% 4/96 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.	9.7% 9/93 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.
Infections and infestations Rhinitis	0.00% 0/96 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.	7.5% 7/93 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.
Infections and infestations Upper respiratory tract infection	4.2% 4/96 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.	6.5% 6/93 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.
Infections and infestations Urinary tract infection	10.4% 10/96 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.	3.2% 3/93 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.
Injury, poisoning and procedural complications Contusion	5.2% 5/96 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.	1.1% 1/93 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.
Investigations Blood alkaline phosphatase increased	5.2% 5/96 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.	5.4% 5/93 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.