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NCT00069095 · ADVERSE EVENTS

Adverse events

A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer · Source last updated 2016-10-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Approximately 2 years 6 months
Other-event reporting threshold
5%

Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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.

117 / 316310 / 316Not reported / Not reported
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.

120 / 313310 / 313Not reported / Not reported
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.

121 / 339330 / 339Not reported / Not reported
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.

128 / 336331 / 336Not reported / Not reported
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.

131 / 353348 / 353Not reported / Not reported
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.

146 / 341335 / 341Not reported / Not reported

Group identifiers: EG000: Xelox · EG001: Folfox-4 · EG002: Xelox+P · EG003: Folfox-4+P · EG004: Xelox+BV · EG005: Folfox-4+BV

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      26
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      341
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      341
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      341
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      341
    term
    Intestinal obstruction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      341
    term
    Small intestinal obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      341
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      341
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      341
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      341
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      341
    term
    Rectal haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      341
    term
    Stomatitis all
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      341
    term
    Enteritis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      207
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      186
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      208
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      197
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      210
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      218
      num At Risk
      341
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      208
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      209
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      204
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      230
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      215
      num At Risk
      341
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      136
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      123
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      134
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      127
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      160
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      127
      num At Risk
      341
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      76
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      130
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      101
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      141
      num At Risk
      341
    term
    Stomatitis All
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      77
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      99
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      68
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      101
      num At Risk
      341
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      86
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      89
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      85
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      81
      num At Risk
      341
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      35
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      30
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      40
      num At Risk
      341
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      43
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      32
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      34
      num At Risk
      341
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      341
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      116
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      117
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      126
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      127
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      133
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      135
      num At Risk
      341
    term
    Paraesthesia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      70
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      64
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      72
      num At Risk
      341
    term
    Peripheral Sensory Neuropathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      60
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      70
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      61
      num At Risk
      341
    term
    Neuropathy Peripheral
Complete source fields
description
Serious adverse events (SAEs) and non-serious adverse events were reported for members of the safety population, which included all participants were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.
event Groups
  1. description
    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.
    id
    EG000
    other Num Affected
    310
    other Num At Risk
    316
    serious Num Affected
    117
    serious Num At Risk
    316
    title
    Xelox
  2. description
    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.
    id
    EG001
    other Num Affected
    310
    other Num At Risk
    313
    serious Num Affected
    120
    serious Num At Risk
    313
    title
    Folfox-4
  3. description
    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.
    id
    EG002
    other Num Affected
    330
    other Num At Risk
    339
    serious Num Affected
    121
    serious Num At Risk
    339
    title
    Xelox+P
  4. description
    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.
    id
    EG003
    other Num Affected
    331
    other Num At Risk
    336
    serious Num Affected
    128
    serious Num At Risk
    336
    title
    Folfox-4+P
  5. description
    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.
    id
    EG004
    other Num Affected
    348
    other Num At Risk
    353
    serious Num Affected
    131
    serious Num At Risk
    353
    title
    Xelox+BV
  6. description
    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.
    id
    EG005
    other Num Affected
    335
    other Num At Risk
    341
    serious Num Affected
    146
    serious Num At Risk
    341
    title
    Folfox-4+BV
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      207
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      186
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      208
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      197
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      210
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      218
      num At Risk
      341
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      194
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      208
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      209
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      204
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      230
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      215
      num At Risk
      341
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      136
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      123
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      134
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      127
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      160
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      127
      num At Risk
      341
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      76
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      130
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      101
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      141
      num At Risk
      341
    term
    Stomatitis All
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      73
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      77
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      99
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      68
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      101
      num At Risk
      341
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      81
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      76
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      86
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      89
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      85
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      81
      num At Risk
      341
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      35
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      30
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      40
      num At Risk
      341
    term
    Dyspepsia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      43
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      32
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      34
      num At Risk
      341
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      20
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      19
      num At Risk
      341
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      116
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      117
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      126
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      127
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      133
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      135
      num At Risk
      341
    term
    Paraesthesia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      60
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      70
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      64
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      72
      num At Risk
      341
    term
    Peripheral Sensory Neuropathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      60
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      70
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      61
      num At Risk
      341
    term
    Neuropathy Peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      26
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      8
      num At Risk
      341
    term
    Diarrhoea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      14
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      341
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      341
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      6
      num At Risk
      341
    term
    Intestinal obstruction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      7
      num At Risk
      341
    term
    Small intestinal obstruction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      341
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      341
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      3
      num At Risk
      341
    term
    Gastrointestinal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      341
    term
    Ascites
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      341
    term
    Rectal haemorrhage
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      341
    term
    Stomatitis all
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (9.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      316
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      339
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      336
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      353
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      341
    term
    Enteritis
time Frame
Approximately 2 years 6 months

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Preserved source evidence · Not medical advice