Trial Outcomes & Findings for A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer (NCT NCT00069095)

NCT ID: NCT00069095

Last Updated: 2016-10-06

Results Overview

PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4- containing arms was investigated.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2035 participants

Primary outcome timeframe

Baseline until disease progression or death, approximately 2 years 6 months

Results posted on

2016-10-06

Participant Flow

This study was conducted in 32 countries - Australia, Austria, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Hungary, Ireland, Israel, Italy, Korea, Mexico, New Zealand, Norway, Panama, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey and USA.

A total of 2035 participants were randomized to any one of the treatment groups in the study (634 participants in the initial 2-arm part and 1401 participants in the 2x2 factorial part of the study), but only 2034 received study treatment as 1 participant was enrolled twice in the study at 2 study centers.

Participant milestones

Participant milestones
Measure
Xelox
Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4
Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Xelox+P
Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) \[volume equivalent to 7.5 mg/kg BV\] over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4+P
Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Xelox+BV
Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4+BV
Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Primary Treatment Phase
STARTED
317
317
350
351
350
349
Primary Treatment Phase
COMPLETED
22
15
36
31
48
48
Primary Treatment Phase
NOT COMPLETED
295
302
314
320
302
301
Post-study Treatment Phase
STARTED
8
13
21
17
36
29
Post-study Treatment Phase
COMPLETED
0
0
0
0
0
0
Post-study Treatment Phase
NOT COMPLETED
8
13
21
17
36
29
Follow-up Phase
STARTED
284
299
298
299
278
272
Follow-up Phase
COMPLETED
110
93
178
187
186
171
Follow-up Phase
NOT COMPLETED
174
206
120
112
92
101

Reasons for withdrawal

Reasons for withdrawal
Measure
Xelox
Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4
Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Xelox+P
Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) \[volume equivalent to 7.5 mg/kg BV\] over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4+P
Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Xelox+BV
Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4+BV
Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Primary Treatment Phase
Ongoing
0
0
5
7
7
4
Primary Treatment Phase
Admin/Other
29
38
31
45
48
42
Primary Treatment Phase
Adverse Event
99
92
71
72
109
101
Primary Treatment Phase
Death
14
8
2
5
8
8
Primary Treatment Phase
Failure to return
5
5
0
0
0
2
Primary Treatment Phase
Insufficient Therapeutic Response
131
127
175
154
101
102
Primary Treatment Phase
Refused treatment
15
26
17
31
24
27
Primary Treatment Phase
Withdrew
2
3
8
2
4
9
Primary Treatment Phase
Other Violation
0
1
1
1
0
1
Primary Treatment Phase
Violation criteria
0
2
4
3
1
5
Post-study Treatment Phase
Missing reason
1
3
12
8
18
17
Post-study Treatment Phase
Adverse Event
2
3
1
0
5
1
Post-study Treatment Phase
Eligible for surgery
2
0
0
0
0
0
Post-study Treatment Phase
Insufficient therapeutic response
1
4
5
6
7
9
Post-study Treatment Phase
Participant refusal/Admin reasons
1
0
0
0
0
1
Post-study Treatment Phase
Participant had complete response
1
1
0
0
0
0
Post-study Treatment Phase
More than 21 days delay between cycles
0
1
0
0
0
0
Post-study Treatment Phase
Investigator decision (enough treatment)
0
1
1
0
1
0
Post-study Treatment Phase
Participant withdrew consent
0
0
1
0
0
0
Post-study Treatment Phase
Participant will start new treatment
0
0
1
0
0
0
Post-study Treatment Phase
Participant wanted break from treatment
0
0
0
1
0
0
Post-study Treatment Phase
Participant completed treatment
0
0
0
1
0
0
Post-study Treatment Phase
Surgery
0
0
0
1
1
0
Post-study Treatment Phase
Death
0
0
0
0
1
0
Post-study Treatment Phase
Participant had progressive disease
0
0
0
0
1
0
Post-study Treatment Phase
Participant/Physician decision to stop
0
0
0
0
1
0
Post-study Treatment Phase
Preplanned 6 cycles after surgery
0
0
0
0
1
0
Post-study Treatment Phase
Investigator decision
0
0
0
0
0
1
Follow-up Phase
Death
174
206
120
112
92
101

Baseline Characteristics

A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Xelox
n=317 Participants
Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4
n=317 Participants
Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Xelox+P
n=350 Participants
Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) \[volume equivalent to 7.5 mg/kg BV\] over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4+P
n=351 Participants
Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Xelox+BV
n=350 Participants
Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4+BV
n=349 Participants
Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Total
n=2034 Participants
Total of all reporting groups
Age, Continuous
60.3 years
STANDARD_DEVIATION 10.76 • n=5 Participants
60.6 years
STANDARD_DEVIATION 10.94 • n=7 Participants
59.1 years
STANDARD_DEVIATION 12.14 • n=5 Participants
58.8 years
STANDARD_DEVIATION 10.87 • n=4 Participants
59.7 years
STANDARD_DEVIATION 11.28 • n=21 Participants
59.7 years
STANDARD_DEVIATION 10.74 • n=10 Participants
59.7 years
STANDARD_DEVIATION 11.14 • n=115 Participants
Sex: Female, Male
Female
123 Participants
n=5 Participants
113 Participants
n=7 Participants
145 Participants
n=5 Participants
165 Participants
n=4 Participants
137 Participants
n=21 Participants
144 Participants
n=10 Participants
827 Participants
n=115 Participants
Sex: Female, Male
Male
194 Participants
n=5 Participants
204 Participants
n=7 Participants
205 Participants
n=5 Participants
186 Participants
n=4 Participants
213 Participants
n=21 Participants
205 Participants
n=10 Participants
1207 Participants
n=115 Participants

PRIMARY outcome

Timeframe: Baseline until disease progression or death, approximately 2 years 6 months

Population: The eligible patient population (EPP) excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4- containing arms was investigated.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=937 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=967 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4
259 days
Interval 245.0 to 268.0
241 days
Interval 229.0 to 254.0

PRIMARY outcome

Timeframe: Baseline until disease progression or death, approximately 2 years 6 months

Population: The ITT population included all randomized participants who provided written informed consent.

PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=701 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=699 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
244.0 days
Interval 230.0 to 257.0
285.0 days
Interval 271.0 to 297.0

SECONDARY outcome

Timeframe: Baseline until disease progression or death, approximately 2 years 6 months

Population: The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=937 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=967 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4
304.0 days
Interval 281.0 to 319.0
261.0 days
Interval 246.0 to 276.0

SECONDARY outcome

Timeframe: Baseline until disease progression or death, approximately 2 years 6 months

Population: The ITT population included all randomized participants who provided written informed consent.

PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the bevacizumab-containing arms was compared with the placebo-containing arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=701 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=699 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
259.0 days
Interval 244.0 to 278.0
335.0 days
Interval 310.0 to 363.0

SECONDARY outcome

Timeframe: Baseline until disease progression or death, approximately 2 years 6 months

Population: The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=937 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=967 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4
268.0 days
Interval 252.0 to 290.0
234.0 days
Interval 221.0 to 251.0

SECONDARY outcome

Timeframe: Baseline until disease progression or death, approximately 2 years 6 months

Population: The ITT population included all randomized participants who provided written informed consent.

PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=701 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=699 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
241.0 days
Interval 227.0 to 254.0
316.0 days
Interval 294.0 to 338.0

SECONDARY outcome

Timeframe: Baseline until disease progression or death, approximately 2 years 6 months

Population: EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=937 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=967 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4
260.0 days
Interval 247.0 to 270.0
244.0 days
Interval 230.0 to 255.0

SECONDARY outcome

Timeframe: Baseline until disease progression or death, approximately 2 years 6 months

Population: The ITT population included all randomized participants who provided written informed consent.

PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=701 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=699 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
245.0 days
Interval 230.0 to 258.0
287.0 days
Interval 276.0 to 300.0

SECONDARY outcome

Timeframe: Baseline until disease progression or death, approximately 2 years 6 months

Population: The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=937 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=967 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4
549.0 days
Interval 528.0 to 576.0
577.0 days
Interval 535.0 to 615.0

SECONDARY outcome

Timeframe: Baseline until disease progression or death, approximately 2 years 6 months

Population: The ITT population included all randomized participants who provided written informed consent.

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=701 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=699 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
574.0 days
Interval 537.0 to 592.0
551.0 days
Interval 528.0 to 635.0

SECONDARY outcome

Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months

Population: The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=937 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=967 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4
49.4 Percentage of responders
46.4 Percentage of responders

SECONDARY outcome

Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months

Population: The ITT population included all randomized participants who provided written informed consent.

According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=701 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=699 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
49.2 Percentage of responders
46.5 Percentage of responders

SECONDARY outcome

Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months

Population: The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=937 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=967 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
38.6 Percentage of responders
37.1 Percentage of responders

SECONDARY outcome

Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months

Population: The ITT population included all randomized participants who provided written informed consent.

According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=701 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=699 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
37.5 Percentage of responders
37.5 Percentage of responders

SECONDARY outcome

Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months

Population: The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase.The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=990 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=1008 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
General Approach
191.0 days
Interval 183.0 to 202.0
179.0 days
Interval 171.0 to 187.0
Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
On-treatment Approach
190.0 days
Interval 182.0 to 200.0
176.0 days
Interval 170.0 to 185.0

SECONDARY outcome

Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months

Population: The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach included all tumor assessments or deaths that occurred during the primary study treatment phase, the post-study treatment phase, or the follow-up phase. The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=675 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=694 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
General Approach
183.0 days
Interval 176.0 to 198.0
209.0 days
Interval 199.0 to 220.0
Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
On-treatment Approach
182.0 days
Interval 175.0 to 196.0
208.0 days
Interval 198.0 to 220.0

SECONDARY outcome

Timeframe: Week 1 to Week 54

Population: The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=937 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=967 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Week 19-24
25 Participants
38 Participants
Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Week 37-42
3 Participants
1 Participants
Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Week 49-54
2 Participants
0 Participants
Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Week 1-6
67 Participants
93 Participants
Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Week 7-12
190 Participants
191 Participants
Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Week 13-18
155 Participants
110 Participants
Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Week 25-30
14 Participants
13 Participants
Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
Week 31-36
7 Participants
3 Participants

SECONDARY outcome

Timeframe: Week 1 to Week 54

Population: The ITT population included all randomized participants who provided written informed consent.

For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=701 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=699 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Week 7-12
146 Participants
138 Participants
Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Week 19-24
26 Participants
29 Participants
Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Week 25-30
7 Participants
12 Participants
Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Week 31-36
2 Participants
8 Participants
Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Week 1-6
58 Participants
48 Participants
Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Week 13-18
105 Participants
87 Participants
Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Week 37-42
1 Participants
2 Participants
Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
Week 49-54
0 Participants
1 Participants

SECONDARY outcome

Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months

Population: The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=937 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=967 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
239.0 days
Interval 225.0 to 256.0
226.0 days
Interval 211.0 to 246.0

SECONDARY outcome

Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months

Population: The ITT population included all randomized participants who provided written informed consent.

Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=701 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=699 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone
225.0 days
Interval 217.0 to 240.0
257.0 days
Interval 241.0 to 278.0

SECONDARY outcome

Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months

Population: The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=937 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=967 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4
347.0 days
Interval 196.0 to 403.0
589.0 days
Interval 270.0 to
The estimate is Not Available due to insufficient follow-up time to estimate the missing parameter.

SECONDARY outcome

Timeframe: From baseline until disease progression/recurrence, approximately 2 years 6 months

Population: The ITT population included all randomized participants who provided written informed consent.

For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.

Outcome measures

Outcome measures
Measure
FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV
n=701 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1). 2. Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks). 3. Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).
XELOX/XELOX+P/XELOX+BV
n=699 Participants
Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups - 1. Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1). 2. Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks). 3. Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks).
Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone
403.0 days
Interval 228.0 to
The estimate is Not Available due to insufficient follow-up time to estimate the missing parameter.
386.0 days
Interval 133.0 to 386.0

Adverse Events

Xelox

Serious events: 117 serious events
Other events: 310 other events
Deaths: 0 deaths

Folfox-4

Serious events: 120 serious events
Other events: 310 other events
Deaths: 0 deaths

Xelox+P

Serious events: 121 serious events
Other events: 330 other events
Deaths: 0 deaths

Folfox-4+P

Serious events: 128 serious events
Other events: 331 other events
Deaths: 0 deaths

Xelox+BV

Serious events: 131 serious events
Other events: 348 other events
Deaths: 0 deaths

Folfox-4+BV

Serious events: 146 serious events
Other events: 335 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Xelox
n=316 participants at risk
Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4
n=313 participants at risk
Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Xelox+P
n=339 participants at risk
Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) \[volume equivalent to 7.5 mg/kg BV\] over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4+P
n=336 participants at risk
Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Xelox+BV
n=353 participants at risk
Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4+BV
n=341 participants at risk
Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Infections and infestations
Rectal abscess
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Staphylococcal infection
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Dizziness
0.63%
2/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Diarrhoea
8.5%
27/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.2%
13/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.4%
25/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.1%
7/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.4%
26/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.3%
8/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Vomiting
2.2%
7/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.2%
7/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.7%
16/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.0%
14/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.1%
7/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Abdominal pain
1.3%
4/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.2%
7/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.1%
7/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.8%
6/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.4%
5/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.1%
7/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Intestinal obstruction
1.3%
4/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.9%
6/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.8%
6/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.7%
9/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.1%
4/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.8%
6/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Small intestinal obstruction
1.6%
5/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.96%
3/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.88%
3/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.1%
4/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.1%
7/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Nausea
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.9%
6/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.2%
4/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.4%
5/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Constipation
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.6%
5/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.89%
3/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.85%
3/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.88%
3/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.88%
3/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Ascites
0.95%
3/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Rectal haemorrhage
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.1%
4/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Stomatitis all
0.63%
2/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Enteritis
0.95%
3/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Intestinal perforation
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Abdominal pain upper
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Ileus
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Colitis
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Haematemesis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Large intestinal obstruction
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Mechanical ileus
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Pancreatitis
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Gastrointestinal toxicity
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Intestinal functional disorder
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Melaena
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Abdominal adhesions
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Abdominal distension
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Caecitis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Enterocolitis
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Enterovesical fistula
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Gastritis
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Gastrointestinal disorder
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Gastrointestinal hypomotility
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Gastrointestinal obstruction
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Ileus paralytic
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Intestinal haemorrhage
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Pericoronitis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Peritonitis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Anal fissure
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Anal stenosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Colonic obstruction
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Crohn's disease
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Duodenal ulcer
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Dyspepsia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Enterocolonic fistula
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Faecaloma
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Gastrointestinal necrosis
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Gastrointestinal perforation
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Haematochezia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Inguinal hernia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Intestinal ischemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Oesophagitis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Proctalgia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Rectal perforation
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Subileus
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Toxic dilatation of intestine
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Central line infection
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.3%
4/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.7%
9/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.2%
4/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Pneumonia
0.63%
2/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.6%
5/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.2%
4/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.89%
3/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.1%
4/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.88%
3/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.2%
4/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.5%
5/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Sepsis
1.3%
4/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.3%
4/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.1%
4/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.2%
4/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Urinary tract infection
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.88%
3/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.5%
5/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Septic shock
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Cellulitis
0.63%
2/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Catheter site infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Lower respiratory tract infection
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Neutropenic sepsis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Diverticulitis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Abdominal abscess
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Bacteraemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Respiratory tract infection
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Bacterial sepsis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Clostridium difficile colitis
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Postoperative wound infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Abdominal infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Abdominal wall infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Abscess
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Diarrhoea infectious
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Gastroenteritis
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Gastrointestinal infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Hepatitis B
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Pneumonia pneumococcal
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Pyelonephritis
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Urosepsis
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Viral pharyngitis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Abdominal wall abscess
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Acinetobacter bacteraemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Anal fistula infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Bacterial infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Bronchitis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Bronchopneumonia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Catheter related infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Catheter sepsis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Fungaemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Neutropenic infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Peritoneal infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Pseudomonas infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Pyonephrosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Staphylococcal sepsis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Upper respiratory tract infection
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Pyrexia
5.1%
16/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.1%
16/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.8%
6/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.8%
16/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.0%
7/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.4%
15/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Asthenia
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Chest pain
0.63%
2/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Catheter related complication
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Fatigue
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
General physical health deterioration
0.63%
2/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Oedema peripheral
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Multi-organ failure
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Performance status decreased
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Extravasation
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Non-cardiac chest pain
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Pain
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Infusion related reaction
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Sudden death
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Wound necrosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Chills
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Impaired healing
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Oedema
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Febrile neutropenia
0.95%
3/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.5%
14/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.5%
15/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.1%
14/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Neutropenia
0.63%
2/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.9%
9/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.8%
6/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.5%
5/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Anaemia
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.89%
3/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Blood disorder
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Coagulopathy
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Agranulocytosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Haemolytic anaemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Pancytopenia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
2.8%
9/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.96%
3/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.88%
3/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.5%
5/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.5%
9/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.3%
8/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.89%
3/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.1%
4/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.88%
3/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.85%
3/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Dysaesthesia pharynx
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.2%
4/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.88%
3/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Alveolitis fibrosing
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Laryngospasm
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Dehydration
1.3%
4/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.9%
9/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.9%
10/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.8%
10/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.2%
4/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Hypokalaemia'
0.63%
2/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Hyperglycaemia
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Anorexia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Hypernatraemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Hyponatraemia
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Hypomagnesaemia
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Malnutrition
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Cachexia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Hypovolaemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Deep vein thrombosis
1.9%
6/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.9%
6/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.1%
7/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.0%
7/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.8%
6/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Thrombosis
0.63%
2/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Hypertension
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Jugular vein thrombosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Hypotension
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Thrombophlebitis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Embolism
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Peripheral ischaemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Hypertensive crisis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Pelvic venous thrombosis
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Venous thrombosis limb
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Circulatory collapse
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Embolism venous
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Haematoma
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Haemorrhage
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Hypovolaemic shock
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Poor venous access
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Shock
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Shock haemorrhagic
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Subclavian vein thrombosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Venous thrombosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Atrial fibrillation
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.1%
4/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Myocardial infarction
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.96%
3/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.88%
3/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Pericardial effusion
0.63%
2/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Cardiac arrest
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Angina pectoris
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Cardiomyopathy
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Myocardial ischaemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Arrhythmia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Acute left ventricular failure
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Acute myocardial infarction
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Atrial thrombosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Bradycardia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Cardiac failure congestive
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Cardio-respiratory arrest
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Cardiogenic shock
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Cardiopulmonary failure
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Sick sinus syndrome
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Supraventricular tachycardia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Cardiac disorders
Ventricular fibrillation
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Neuropathy peripheral
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Convulsion
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Syncope
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Cerebrovascular accident
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Headache
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Transient ischaemic attack
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Cerebral infarction
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Coordination abnormal
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Dementia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Loss of consciousness
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Neuralgia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Spinal cord compression
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Cerebral haemorrhage
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Cerebral ischaemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Depressed level of consciousness
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Encephalophathy
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Hepatic encephalopathy
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Hypoaesthesia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Paraesthesia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Stent occlussion
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Fall
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Head injury
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Radius fracture
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Device migration
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Failure to anastomose
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Femoral neck fracture
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Hip fracture
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Overdose
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Skull fracture
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Tendon rupture
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Ulna fracture
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Injury, poisoning and procedural complications
Vascular graft occlussion
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Renal failure acute
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.88%
3/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.85%
3/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Renal failure
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Haematuria
0.95%
3/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Hydronephrosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Renal colic
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Urinary bladder haemmorhage
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Urinary retention
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Obstructive uropathy
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Renal impairment
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Renal tubular disorder
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Renal tubular necrosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Ureteric obstruction
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Hepatobiliary disorders
Hepatic failure
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Hepatobiliary disorders
Bile duct obstruction
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Hepatobiliary disorders
Portal vein thrombosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Hepatobiliary disorders
Cholangitis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Hepatobiliary disorders
Cholecystitis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Hepatobiliary disorders
Hepatitis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Hepatobiliary disorders
Hepatitis Cholestatic
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.63%
2/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.64%
2/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Muscle contracture
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Shoulder pain
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Arthralgia
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Flank pain
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Immune system disorders
Hypersensitivity
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.60%
2/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.57%
2/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Immune system disorders
Drug hypersensitivity
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.89%
3/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Immune system disorders
Anaphylactic reaction
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Immune system disorders
Anaphylactic shock
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.59%
2/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor haemorrhage
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to ovary
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Investigations
Blood creatinine increased
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Investigations
Transaminases increased
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Investigations
International normalized ratio increased
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.30%
1/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Investigations
Blood bilirubin abnormal
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Investigations
Endoscopic retrograde cholangiopancreatography
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Angioneurotic oedema
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Skin toxicity
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Skin ulcer
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Vascular purpura
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Psychiatric disorders
Confusional state
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Psychiatric disorders
Anxiety
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Psychiatric disorders
Depression
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.28%
1/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Ear and labyrinth disorders
Vertigo
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Eye disorders
Retinal vascular thrombosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Eye disorders
Amaurosis
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Surgical and medical procedures
Catheter placement
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Surgical and medical procedures
Colostomy closure
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Surgical and medical procedures
Ileostomy closure
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.29%
1/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Reproductive system and breast disorders
Vaginal fistula
0.00%
0/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.32%
1/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Reproductive system and breast disorders
Vaginal haemorrhage
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

Other adverse events

Other adverse events
Measure
Xelox
n=316 participants at risk
Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4
n=313 participants at risk
Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Xelox+P
n=339 participants at risk
Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) \[volume equivalent to 7.5 mg/kg BV\] over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4+P
n=336 participants at risk
Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Xelox+BV
n=353 participants at risk
Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m\^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Folfox-4+BV
n=341 participants at risk
Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m\^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m\^2 iv for 2 hours followed by fluorouracil 400 mg/m\^2 bolus injection over 2 to 4 min followed by 600 mg/m\^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
Musculoskeletal and connective tissue disorders
Myalgia
2.8%
9/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.9%
9/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.3%
18/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.2%
14/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.1%
11/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.9%
10/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Psychiatric disorders
Insomnia
10.4%
33/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
14.1%
44/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.1%
31/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
13.7%
46/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.5%
30/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.7%
40/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Diarrhoea
65.5%
207/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
59.4%
186/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
61.4%
208/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
58.6%
197/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
59.5%
210/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
63.9%
218/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Nausea
61.4%
194/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
66.5%
208/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
61.7%
209/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
60.7%
204/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
65.2%
230/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
63.0%
215/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Vomiting
43.0%
136/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
39.3%
123/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
39.5%
134/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
37.8%
127/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
45.3%
160/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
37.2%
127/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Stomatitis All
19.9%
63/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
35.5%
111/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
22.4%
76/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
38.7%
130/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
28.6%
101/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
41.3%
141/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Constipation
23.1%
73/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
24.9%
78/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
22.7%
77/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
29.5%
99/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
19.3%
68/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
29.6%
101/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Abdominal pain
25.6%
81/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
24.3%
76/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
25.4%
86/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
26.5%
89/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
24.1%
85/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
23.8%
81/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Dyspepsia
9.5%
30/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
16.9%
53/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
12.1%
41/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.4%
35/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.5%
30/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.7%
40/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Abdominal pain upper
7.9%
25/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.6%
27/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.3%
28/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
12.8%
43/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.1%
32/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.0%
34/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Gastrointestinal disorders
Dry mouth
3.2%
10/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.1%
16/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.2%
11/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.0%
20/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.0%
7/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.6%
19/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Paraesthesia
36.7%
116/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
37.4%
117/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
37.2%
126/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
37.8%
127/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
37.7%
133/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
39.6%
135/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Peripheral Sensory Neuropathy
15.2%
48/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.9%
31/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
17.7%
60/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
20.8%
70/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
18.1%
64/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
21.1%
72/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Neuropathy Peripheral
20.3%
64/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
22.4%
70/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
18.9%
64/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
17.9%
60/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
19.8%
70/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
17.9%
61/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Dysaesthesia
11.7%
37/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
12.1%
38/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
12.7%
43/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
14.9%
50/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
13.0%
46/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
12.3%
42/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Neuropathy
13.3%
42/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.5%
33/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
15.0%
51/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
15.2%
51/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
14.2%
50/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
14.1%
48/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Lethargy
10.8%
34/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
14.7%
46/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.8%
30/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.0%
20/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.2%
29/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.9%
27/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Headache
13.0%
41/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.9%
34/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.6%
36/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
14.9%
50/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
15.0%
53/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
18.2%
62/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Dysgeusia
14.6%
46/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
15.3%
48/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.5%
39/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
16.7%
56/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.9%
42/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
14.4%
49/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Hypoaesthesia
10.1%
32/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.3%
29/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.9%
20/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.2%
14/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.5%
16/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.4%
15/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Dizziness
14.2%
45/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
13.4%
42/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.8%
40/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
13.4%
45/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.9%
28/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.6%
36/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Nervous system disorders
Neurotoxicity
6.0%
19/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.8%
12/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.7%
9/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.1%
7/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.5%
9/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.4%
15/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Fatigue
41.8%
132/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
48.6%
152/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
34.8%
118/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
41.7%
140/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
37.7%
133/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
39.6%
135/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Asthenia
13.6%
43/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
13.1%
41/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
23.9%
81/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
26.8%
90/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
21.8%
77/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
28.4%
97/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Pyrexia
13.6%
43/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
24.3%
76/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
19.5%
66/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
25.0%
84/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
18.7%
66/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
24.0%
82/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Temperature Intolerance
6.6%
21/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.3%
29/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.1%
31/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.4%
18/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.8%
31/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.5%
22/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Oedema Peripheral
8.9%
28/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.5%
36/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.8%
23/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.2%
21/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.6%
27/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.4%
15/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Chills
3.2%
10/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.8%
18/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.7%
16/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.8%
23/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.4%
12/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.9%
20/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
General disorders
Chest pain
3.2%
10/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.5%
14/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.1%
14/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.5%
15/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.6%
27/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.2%
28/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Neutropenia
27.8%
88/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
55.0%
172/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
26.5%
90/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
58.9%
198/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
19.8%
70/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
54.8%
187/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Thrombocytopenia
26.9%
85/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
22.4%
70/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
18.0%
61/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
23.2%
78/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
13.6%
48/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
12.9%
44/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Anaemia
15.8%
50/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.8%
37/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
12.1%
41/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.9%
40/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.8%
31/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.1%
38/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Blood and lymphatic system disorders
Leukopenia
3.2%
10/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.7%
24/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.1%
7/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.5%
15/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.7%
6/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.3%
25/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
30.1%
95/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.6%
30/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
30.4%
103/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.7%
36/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
39.1%
138/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
13.5%
46/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Alopecia
6.0%
19/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
16.6%
52/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.3%
18/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
18.5%
62/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.7%
13/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
15.5%
53/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Rash
4.4%
14/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.2%
32/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.1%
31/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.1%
34/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.1%
25/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.7%
40/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Pruritus
3.5%
11/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.4%
20/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.7%
9/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.0%
20/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.1%
11/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.9%
20/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Dry skin
4.7%
15/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.4%
17/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.2%
21/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.5%
15/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.4%
26/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.0%
17/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Skin and subcutaneous tissue disorders
Erythema
3.5%
11/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.8%
18/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.8%
13/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.6%
12/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.1%
11/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.1%
14/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Epistaxis
7.0%
22/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
13.1%
41/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.1%
24/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
18.5%
62/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.8%
38/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
31.4%
107/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Dysaesthesia pharynx
13.0%
41/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.7%
21/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
13.3%
45/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.8%
23/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.3%
33/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.1%
14/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Cough
11.4%
36/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
12.8%
40/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.4%
32/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
14.0%
47/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.9%
28/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
12.3%
42/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
11.7%
37/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.4%
20/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.0%
34/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.7%
36/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.0%
39/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.5%
29/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Hiccups
4.4%
14/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.7%
21/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.0%
17/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.9%
13/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.7%
13/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.2%
21/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
5.4%
17/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.1%
16/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.5%
12/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.0%
27/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.4%
19/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.6%
26/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
2.8%
9/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.1%
16/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.9%
10/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.0%
20/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.2%
22/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.5%
22/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Respiratory, thoracic and mediastinal disorders
Dysphonia
1.6%
5/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.96%
3/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.8%
6/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.5%
5/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.9%
21/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.2%
28/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Anorexia
30.1%
95/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
29.7%
93/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
24.8%
84/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
25.6%
86/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
30.9%
109/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
28.2%
96/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Hypokalaemia
11.1%
35/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.2%
32/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.1%
31/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.2%
21/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.4%
26/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.2%
21/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Decreased appetite
5.1%
16/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.8%
15/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.1%
14/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.0%
10/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.5%
9/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.3%
18/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Metabolism and nutrition disorders
Dehydration
8.9%
28/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.1%
16/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.0%
17/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.3%
11/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.7%
20/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.2%
11/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Pain in extremity
13.6%
43/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.4%
20/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.3%
35/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.7%
26/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
12.2%
43/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.0%
34/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Pain in jaw
7.3%
23/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.1%
16/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.8%
13/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.8%
16/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.2%
15/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.5%
12/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Back pain
10.4%
33/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.6%
27/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.3%
28/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.3%
38/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.2%
29/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.8%
30/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Muscle spasms
5.4%
17/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.2%
10/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.7%
16/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.9%
13/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.5%
9/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.4%
15/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Musculoskeletal and connective tissue disorders
Arthralgia
4.1%
13/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.1%
16/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.5%
12/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.1%
24/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.9%
21/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.9%
20/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Psychiatric disorders
Depression
6.3%
20/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.2%
13/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.8%
23/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.2%
14/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.0%
14/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.9%
10/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Psychiatric disorders
Anxiety
4.4%
14/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.1%
16/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.0%
17/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.2%
14/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.5%
16/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.1%
7/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Nasopharyngitis
2.8%
9/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.8%
18/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.0%
27/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.7%
36/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.4%
26/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
11.4%
39/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Urinary tract infection
3.5%
11/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.4%
17/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.2%
11/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.3%
28/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.2%
22/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.6%
19/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Infections and infestations
Upper respiratory tract infection
3.8%
12/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.7%
21/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.1%
7/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.2%
14/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.1%
18/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.7%
16/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Hypertension
0.95%
3/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.2%
10/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.7%
16/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.5%
22/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
13.9%
49/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
18.5%
63/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Vascular disorders
Flushing
2.2%
7/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.0%
22/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.2%
4/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.1%
7/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.5%
9/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.3%
8/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Investigations
Weight decreased
8.5%
27/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.6%
27/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
10.3%
35/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
7.4%
25/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
12.7%
45/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
9.4%
32/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Proteinuria
0.32%
1/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.00%
0/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.9%
10/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.2%
21/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.0%
14/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.5%
22/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Renal and urinary disorders
Dysuria
1.9%
6/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.2%
7/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.8%
6/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.1%
17/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.5%
9/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.9%
10/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Eye disorders
Lacrimation increased
2.5%
8/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.4%
20/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.0%
17/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.7%
19/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
4.2%
15/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
8.8%
30/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Hepatobiliary disorders
Hyperbilirubinaemia
3.2%
10/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.3%
4/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.3%
18/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.8%
6/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
3.1%
11/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
0.88%
3/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
Immune system disorders
Hypersensitivity
1.6%
5/316 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.9%
9/313 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
1.5%
5/339 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
6.5%
22/336 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
2.8%
10/353 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
5.3%
18/341 • Approximately 2 years 6 months
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

Additional Information

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Phone: +41 61 6878333

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.
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Restriction type: OTHER