Trial Outcomes & Findings for A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer (NCT NCT02141295)
NCT ID: NCT02141295
Last Updated: 2020-03-25
Results Overview
Efficacy of vanucizumab was evaluated in terms of PFS as Investigator-Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). PFS was defined as the time between randomization and the date of first documented disease progression or death from any cause on study, whichever occurred first. Death on study was defined as death from any cause within 30 days of the last study treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
197 participants
Primary outcome timeframe
Baseline, every 8 weeks, up to approximately 29 months
Results posted on
2020-03-25
Participant Flow
Participants with previously untreated metastatic colorectal cancer (mCRC) as defined by RECIST v1.1 were enrolled globally from 7 countries.
Participant milestones
| Measure |
Safety Run-In
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Vanucizumab + mFOLFOX-6
In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
94
|
95
|
|
Overall Study
COMPLETED
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
94
|
95
|
Reasons for withdrawal
| Measure |
Safety Run-In
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Vanucizumab + mFOLFOX-6
In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
18
|
11
|
|
Overall Study
Physician Decision
|
2
|
19
|
14
|
|
Overall Study
Study terminated by sponsor
|
0
|
6
|
6
|
|
Overall Study
Non-compliance
|
0
|
1
|
0
|
|
Overall Study
Progressive disease
|
3
|
32
|
50
|
|
Overall Study
Reason not specified
|
0
|
9
|
10
|
|
Overall Study
Withdrawal by Subject
|
0
|
9
|
4
|
Baseline Characteristics
A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Safety Run-In
n=8 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Vanucizumab + mFOLFOX-6
n=94 Participants
In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
n=95 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 0.2 • n=4 Participants
|
|
Age, Customized
Adults (18-64 years)
|
4 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Age, Customized
From 65-84 years
|
4 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, every 8 weeks, up to approximately 29 monthsPopulation: This analysis was based on the ITT population, which consisted of all participants who were randomized (Part II only) and received any amount of the study treatment (5 FU/folinic acid, oxaliplatin, bevacizumab, or vanucizumab) in the bevacizumab + mFOLFOX-6 and vanucizumab + mFOLFOX-6 arms. Participants in the safety-run in were not included.
Efficacy of vanucizumab was evaluated in terms of PFS as Investigator-Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). PFS was defined as the time between randomization and the date of first documented disease progression or death from any cause on study, whichever occurred first. Death on study was defined as death from any cause within 30 days of the last study treatment.
Outcome measures
| Measure |
Safety Run-In
n=94 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=95 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Progression-free Survival (PFS), Time to Event
|
338.0 days
Interval 312.0 to 381.0
|
309.0 days
Interval 284.0 to 352.0
|
—
|
SECONDARY outcome
Timeframe: Baseline (within 28 days prior to Day 1), then every 8 weeks until progressive disease (PD), start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)Efficacy of vanucizumab was evaluated in terms of Percentage of Participants With ORR as Investigator-Assessed Using RECIST v. 1.1. Best Overall Confirmed Response.
Outcome measures
| Measure |
Safety Run-In
n=8 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=94 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
n=95 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Percentage of Participants With Objective Response (ORR) as Assessed Using RECIST v. 1.1
|
62.5 Percentage of Participants
Interval 34.3 to 90.6
|
43.6 Percentage of Participants
Interval 33.59 to 53.64
|
51.6 Percentage of Participants
Interval 41.53 to 61.63
|
SECONDARY outcome
Timeframe: Baseline (within 28 days prior to Day 1), then every 8 weeks until PD, start of other anticancer therapy, withdrawal of consent, or death (up to approximately 29 months)Population: This analysis was based on the ITT population, which consisted of all participants in the bevacizumab + mFOLFOX-6 and vanucizumab + mFOLFOX-6 arms. Participants in the safety-run in were not included.
Efficacy of vanucizumab was evaluated in terms of duration of objective response as assessed using RECIST v. 1.1. This was computed using the PFS definition with death on study (deaths that occurred outside the 30 days window from the last study treatment are excluded).
Outcome measures
| Measure |
Safety Run-In
n=94 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=95 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Duration of Objective Response, as Assessed Using RECIST v. 1.1
|
342 days
Interval 274.0 to 510.0
|
304 days
Interval 220.0 to 366.0
|
—
|
SECONDARY outcome
Timeframe: Baseline until death from any cause (maximum up to approximately 3.5 years)Population: This analysis was based on the ITT population, which consisted of all participants in the bevacizumab + mFOLFOX-6 and vanucizumab + mFOLFOX-6 arms. Participants in the safety-run in were not included.
Efficacy of vanucizumab was evaluated in terms of OS as the time from randomization until death from any cause. 99999 = data not estimable due to the low number of deaths.
Outcome measures
| Measure |
Safety Run-In
n=94 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=95 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Overall Survival (OS)
|
746.0 days
Interval 687.0 to
Value is not estimable due to an insufficient number of participants with the event prior to study termination.
|
NA days
Interval 723.0 to
Value is not estimable due to an insufficient number of participants with the event prior to study termination.
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 29 monthsPopulation: n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
Safety is evaluated in terms of percentage of participants with at least one serious adverse event and percentage of participants with at least one adverse event.
Outcome measures
| Measure |
Safety Run-In
n=8 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=93 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
n=95 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs)
Serious Adverse events
|
37.5 Percentage of Participants
|
49.5 Percentage of Participants
|
43.2 Percentage of Participants
|
|
Percentage of Participants With Adverse Events (AEs)
Adverse events
|
100 Percentage of Participants
|
100.0 Percentage of Participants
|
100.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: End of study (EoS, within 28 to 42 days after last dose, latest at 29 months)Population: Endpoint includes only arms in which the participants received vanucizumab. n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
Safety is evaluated in terms of number of participants with Human Anti-human Antibodies (HAHAs) Against Vanucizumab.
Outcome measures
| Measure |
Safety Run-In
n=8 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=93 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Number of Participants With Human Anti-human Antibodies (HAHAs) Against Vanucizumab
|
2 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 8 of parts 1 and 2Population: This endpoint was only reported for arms in which the participants received vanucizumab.
PK profile of vanucizumab was evaluated in terms of AUC
Outcome measures
| Measure |
Safety Run-In
n=7 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=77 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve (AUC) of Vanucizumab
Cycle 1
|
73600 hr*ug/ml
Geometric Coefficient of Variation 20.7
|
63500 hr*ug/ml
Geometric Coefficient of Variation 27.2
|
—
|
|
Area Under the Plasma Concentration-Time Curve (AUC) of Vanucizumab
Cycle 8
|
112000 hr*ug/ml
Geometric Coefficient of Variation 11.2
|
82100 hr*ug/ml
Geometric Coefficient of Variation 31.6
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 8 of parts 1 and 2Population: This endpoint was only reported for arms in which the participants received vanucizumab.
PK profile of vanucizumab was evaluated in terms of Cmax
Outcome measures
| Measure |
Safety Run-In
n=8 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=93 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Vanucizumab
Cycle 1
|
463 ug/ml
Geometric Coefficient of Variation 18.5
|
500 ug/ml
Geometric Coefficient of Variation 26.3
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of Vanucizumab
Cycle 8
|
685 ug/ml
Geometric Coefficient of Variation 17.6
|
794 ug/ml
Geometric Coefficient of Variation 38.2
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 8 of parts 1 and 2Population: Data were collected and analyzed for the reported arms only.
PK profile of vanucizumab was evaluated in terms of Clast
Outcome measures
| Measure |
Safety Run-In
n=93 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Minimum Observed Plasma Concentration (Clast) of Vanucizumab
Cycle 1
|
103 ug/ml
Geometric Coefficient of Variation 67.2
|
—
|
—
|
|
Minimum Observed Plasma Concentration (Clast) of Vanucizumab
Cycle 8
|
361 ug/ml
Geometric Coefficient of Variation 39.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycles 1 and 8 of parts 1 and 2Population: This endpoint was only reported for arms in which the participants received vanucizumab.
PK profile of vanucizumab was evaluated in terms of Tmax
Outcome measures
| Measure |
Safety Run-In
n=8 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=93 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Time to Reach Cmax (Tmax) of Vanucizumab
Cycle 1
|
2.79 hr
Interval 1.5 to 7.67
|
2.05 hr
Interval 1.0 to 26.1
|
—
|
|
Time to Reach Cmax (Tmax) of Vanucizumab
Cycle 8
|
4.04 hr
Interval 0.5 to 5.25
|
1.58 hr
Interval 0.5 to 4.77
|
—
|
SECONDARY outcome
Timeframe: Cycle 8Population: This endpoint was only reported for arms in which the participants received vanucizumab.
PK profile of vanucizumab was evaluated in terms of t1/2, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.
Outcome measures
| Measure |
Safety Run-In
n=3 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=37 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Plasma Terminal Half-Life (t1/2) of Vanucizumab
|
202 hr
Geometric Coefficient of Variation 12.4
|
157 hr
Geometric Coefficient of Variation 30.3
|
—
|
SECONDARY outcome
Timeframe: Cycle 8Population: This endpoint was only reported for arms in which the participants received vanucizumab.
PK profile of vanucizumab was evaluated in terms of CLss, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.
Outcome measures
| Measure |
Safety Run-In
n=3 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=37 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Plasma Clearance at Steady State (CLss) of Vanucizumab
|
15.3 ml/hr
Geometric Coefficient of Variation 26.7
|
18.0 ml/hr
Geometric Coefficient of Variation 29.0
|
—
|
SECONDARY outcome
Timeframe: Cycle 8Population: This endpoint was only reported for arms in which the participants received vanucizumab.
PK profile of vanucizumab was evaluated in terms of Vss, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.
Outcome measures
| Measure |
Safety Run-In
n=3 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=37 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of Vanucizumab
|
4400 ml
Geometric Coefficient of Variation 25.1
|
4140 ml
Geometric Coefficient of Variation 29.7
|
—
|
SECONDARY outcome
Timeframe: Cycle 8Population: This endpoint was only reported for arms in which the participants received vanucizumab.
PK profile of vanucizumab was evaluated in terms of Cmax Ratio, values are reported for cycle 8 of both part 1 (safety run-in) and part 2 of the study.
Outcome measures
| Measure |
Safety Run-In
n=5 Participants
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Bevacizumab + mFOLFOX-6
n=64 Participants
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Cmax Accumulation Ratio (AR) of Vanucizumab
|
1.51 Ratio
Geometric Coefficient of Variation 27.2
|
1.63 Ratio
Geometric Coefficient of Variation 36.2
|
—
|
Adverse Events
Safety Run-In
Serious events: 3 serious events
Other events: 8 other events
Deaths: 3 deaths
Vanucizumab + mFOLFOX-6
Serious events: 46 serious events
Other events: 91 other events
Deaths: 24 deaths
Bevacizumab + mFOLFOX-6
Serious events: 41 serious events
Other events: 94 other events
Deaths: 27 deaths
Serious adverse events
| Measure |
Safety Run-In
n=8 participants at risk
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Vanucizumab + mFOLFOX-6
n=93 participants at risk
In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
n=95 participants at risk
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.1%
2/95 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Cardiac disorders
Cardiac failure
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.3%
5/95 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/95 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.2%
2/93 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/95 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.1%
2/95 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/93 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/95 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/93 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.1%
2/95 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/93 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/93 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Asthenia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Complication associated with device
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
General physical health deterioration
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.3%
4/93 • Number of events 4 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.2%
4/95 • Number of events 8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/95 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Septic shock
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.1%
2/95 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Splenic abscess
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.2%
2/93 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.2%
4/95 • Number of events 4 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor obstruction
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Seizure
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.1%
2/95 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Product Issues
Device dislocation
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Product Issues
Device occlusion
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.2%
2/93 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Vascular disorders
Aortic thrombosis
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.2%
2/93 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Vascular disorders
Vasospasm
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Renal and urinary disorders
Obstructive nephropathy
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
Other adverse events
| Measure |
Safety Run-In
n=8 participants at risk
8 eligible participants received 2000 milligrams (mg) vanucizumab + mFOLFOX-6 every two weeks for up to 8 cycles in order to confirm the dose and schedule for the randomized part.
|
Vanucizumab + mFOLFOX-6
n=93 participants at risk
In the induction therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received vanucizumab at a dose of 2000 mg as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
Bevacizumab + mFOLFOX-6
n=95 participants at risk
In the induction therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; oxaliplatin at a dose of 85 mg/m\^2 as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks for up to 8 cycles (approximately 4 months). Subsequently, in the maintenance therapy participants received bevacizumab at a dose of 5 milligram per kilogram (mg/kg) as IV infusion; folinic acid at a dose of 400 mg/m\^2 as IV infusion; and 5-FU at a dose of 400 mg/m\^2 as starting IV bolus followed by 2400 mg/m\^2 as IV infusion every 2 weeks until disease progression, unacceptable toxicities, consent withdrawal or Investigator's decision for a maximum of 24 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
37.5%
3/8 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
6.5%
6/93 • Number of events 7 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
12.6%
12/95 • Number of events 19 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
4/8 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
43.0%
40/93 • Number of events 52 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
45.3%
43/95 • Number of events 63 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
37.5%
3/8 • Number of events 4 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.3%
4/93 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
8.4%
8/95 • Number of events 9 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Eye disorders
Cataract
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Eye disorders
Eyelid oedema
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Eye disorders
Lacrimation increased
|
25.0%
2/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.3%
4/93 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
6.3%
6/95 • Number of events 7 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
2/8 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
29.0%
27/93 • Number of events 33 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
23.2%
22/95 • Number of events 22 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
7.5%
7/93 • Number of events 8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/95 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
6.5%
6/93 • Number of events 9 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
14.7%
14/95 • Number of events 15 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Constipation
|
37.5%
3/8 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
28.0%
26/93 • Number of events 36 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
32.6%
31/95 • Number of events 52 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
75.0%
6/8 • Number of events 8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
60.2%
56/93 • Number of events 107 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
60.0%
57/95 • Number of events 133 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.3%
4/93 • Number of events 4 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.3%
5/95 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
11.8%
11/93 • Number of events 15 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
8.4%
8/95 • Number of events 12 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.4%
5/93 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/95 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
55.9%
52/93 • Number of events 93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
57.9%
55/95 • Number of events 98 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Odynophagia
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
6.5%
6/93 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Proctalgia
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Stomatitis
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
16.1%
15/93 • Number of events 25 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
11.6%
11/95 • Number of events 15 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
33.3%
31/93 • Number of events 40 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
30.5%
29/95 • Number of events 46 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Asthenia
|
37.5%
3/8 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
44.1%
41/93 • Number of events 89 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
44.2%
42/95 • Number of events 129 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Chest discomfort
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Chest pain
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.4%
5/93 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/95 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
28.0%
26/93 • Number of events 33 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
24.2%
23/95 • Number of events 28 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Mass
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Mucosal inflammation
|
50.0%
4/8 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
24.7%
23/93 • Number of events 42 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
32.6%
31/95 • Number of events 68 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Oedema peripheral
|
37.5%
3/8 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
11.8%
11/93 • Number of events 15 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/95 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
18.3%
17/93 • Number of events 24 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
18.9%
18/95 • Number of events 22 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
General disorders
Temperature intolerance
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
11.8%
11/93 • Number of events 15 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
10.5%
10/95 • Number of events 16 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Ear infection
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Furuncle
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Gingivitis
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
2/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
8.6%
8/93 • Number of events 9 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
9.5%
9/95 • Number of events 12 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Oral candidiasis
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.4%
5/93 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Periodontitis
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Rhinitis
|
12.5%
1/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.2%
2/93 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
14.7%
14/95 • Number of events 15 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
2/8 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
11.8%
11/93 • Number of events 12 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
10.5%
10/95 • Number of events 14 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
20.4%
19/93 • Number of events 26 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
13.7%
13/95 • Number of events 18 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/93 • Number of events 4 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.3%
5/95 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/93 • Number of events 7 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
7.4%
7/95 • Number of events 7 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Investigations
Lipase increased
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.2%
2/93 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
9.5%
9/95 • Number of events 9 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
10.8%
10/93 • Number of events 25 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.2%
4/95 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Investigations
Weight decreased
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
12.9%
12/93 • Number of events 13 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
13.7%
13/95 • Number of events 13 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Investigations
Weight increased
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
31.2%
29/93 • Number of events 45 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
34.7%
33/95 • Number of events 67 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
9.7%
9/93 • Number of events 13 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
7.4%
7/95 • Number of events 7 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
6.3%
6/95 • Number of events 10 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
9.7%
9/93 • Number of events 10 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
10.5%
10/95 • Number of events 11 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • Number of events 4 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.3%
4/93 • Number of events 4 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
8.4%
8/95 • Number of events 10 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
8.6%
8/93 • Number of events 9 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
16.8%
16/95 • Number of events 20 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/93 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.3%
5/95 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
9.7%
9/93 • Number of events 12 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
7.4%
7/95 • Number of events 9 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
8.6%
8/93 • Number of events 11 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
8.4%
8/95 • Number of events 12 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremitiy
|
25.0%
2/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
3.2%
3/93 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
6.3%
6/95 • Number of events 8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
6.5%
6/93 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.1%
2/95 • Number of events 4 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Aphonia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.4%
5/93 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.1%
2/95 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
11.8%
11/93 • Number of events 16 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
12.6%
12/95 • Number of events 17 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Dysaesthesia
|
12.5%
1/8 • Number of events 3 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
16.1%
15/93 • Number of events 32 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
23.2%
22/95 • Number of events 79 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Dysgeusia
|
62.5%
5/8 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
17.2%
16/93 • Number of events 16 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
23.2%
22/95 • Number of events 26 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
16.1%
15/93 • Number of events 16 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
20.0%
19/95 • Number of events 30 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
1/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Neuropathy peripheral
|
37.5%
3/8 • Number of events 8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
19.4%
18/93 • Number of events 31 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
29.5%
28/95 • Number of events 66 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
8.6%
8/93 • Number of events 14 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
2.1%
2/95 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Paraesthesia
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
16.1%
15/93 • Number of events 17 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
17.9%
17/95 • Number of events 24 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
2/8 • Number of events 4 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
35.5%
33/93 • Number of events 83 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
29.5%
28/95 • Number of events 72 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
9.7%
9/93 • Number of events 9 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
8.4%
8/95 • Number of events 8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
6.5%
6/93 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
1.1%
1/95 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
11.8%
11/93 • Number of events 11 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
12.6%
12/95 • Number of events 13 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.4%
5/93 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
6.3%
6/95 • Number of events 8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
1/8 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
12.9%
12/93 • Number of events 15 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
10.5%
10/95 • Number of events 17 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Renal and urinary disorders
Urinary tract pain
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
10.8%
10/93 • Number of events 12 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
10.5%
10/95 • Number of events 13 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.5%
1/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
14.0%
13/93 • Number of events 13 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
9.5%
9/95 • Number of events 12 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
10.8%
10/93 • Number of events 12 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
10.5%
10/95 • Number of events 12 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
2/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
21.5%
20/93 • Number of events 27 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
29.5%
28/95 • Number of events 36 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.3%
4/93 • Number of events 4 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
7.4%
7/95 • Number of events 7 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.3%
4/93 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.3%
5/95 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.4%
5/93 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
14.7%
14/95 • Number of events 14 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
25.0%
2/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
9.7%
9/93 • Number of events 14 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
16.8%
16/95 • Number of events 23 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.4%
5/93 • Number of events 8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
8.4%
8/95 • Number of events 10 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
25.0%
2/8 • Number of events 2 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.4%
5/93 • Number of events 7 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.2%
4/95 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Vascular disorders
Embolism venous
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/95 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Vascular disorders
Hypertension
|
62.5%
5/8 • Number of events 9 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
45.2%
42/93 • Number of events 75 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
28.4%
27/95 • Number of events 50 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Vascular disorders
Hypotension
|
12.5%
1/8 • Number of events 1 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
0.00%
0/93 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
6.3%
6/95 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
5.4%
5/93 • Number of events 6 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
4.2%
4/95 • Number of events 5 • Up to 28 days after the last dose of study drug (maximum treatment time = approximately 29 months).
n for the vanucizumab + mFOLFOX-6 arm changed from 94 to 93 due to the withdrawal of a participant that was randomized to this arm, but received only chemotherapy before leaving the study. This participant is included in the ITT population but not in the safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER