NCT00069095 · ADVERSE EVENTS
Adverse events
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.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Xelox | 117 / 316 | 310 / 316 | Not reported / Not reported |
| Folfox-4 | 120 / 313 | 310 / 313 | Not reported / Not reported |
| Xelox+P | 121 / 339 | 330 / 339 | Not reported / Not reported |
| Folfox-4+P | 128 / 336 | 331 / 336 | Not reported / Not reported |
| Xelox+BV | 131 / 353 | 348 / 353 | Not reported / Not reported |
| Folfox-4+BV | 146 / 341 | 335 / 341 | Not reported / Not reported |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 25
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 26
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 8
- num At Risk
- 341
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 16
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 14
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 7
- num At Risk
- 341
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 6
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 5
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 7
- num At Risk
- 341
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 4
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 6
- num At Risk
- 341
- term
- Intestinal obstruction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 4
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 7
- num At Risk
- 341
- term
- Small intestinal obstruction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 5
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 341
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 341
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 3
- num At Risk
- 341
- term
- Gastrointestinal haemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 341
- term
- Ascites
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 4
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 341
- term
- Rectal haemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 341
- term
- Stomatitis all
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 341
- term
- Enteritis
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 207
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 186
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 208
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 197
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 210
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 218
- num At Risk
- 341
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 194
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 208
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 209
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 204
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 230
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 215
- num At Risk
- 341
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 136
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 123
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 134
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 127
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 160
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 127
- num At Risk
- 341
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 63
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 111
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 76
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 130
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 101
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 141
- num At Risk
- 341
- term
- Stomatitis All
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 73
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 78
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 77
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 99
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 68
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 101
- num At Risk
- 341
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 81
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 76
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 86
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 89
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 85
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 81
- num At Risk
- 341
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 53
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 41
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 35
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 30
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 40
- num At Risk
- 341
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 25
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 28
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 43
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 32
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 34
- num At Risk
- 341
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 11
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 20
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 7
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 19
- num At Risk
- 341
- term
- Dry mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 116
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 117
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 126
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 127
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 133
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 135
- num At Risk
- 341
- term
- Paraesthesia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 48
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 60
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 70
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 64
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 72
- num At Risk
- 341
- term
- Peripheral Sensory Neuropathy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 64
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 70
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 64
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 60
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 70
- num At Risk
- 353
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 207
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 186
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 208
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 197
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 210
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 218
- num At Risk
- 341
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 194
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 208
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 209
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 204
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 230
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 215
- num At Risk
- 341
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 136
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 123
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 134
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 127
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 160
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 127
- num At Risk
- 341
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 63
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 111
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 76
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 130
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 101
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 141
- num At Risk
- 341
- term
- Stomatitis All
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 73
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 78
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 77
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 99
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 68
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 101
- num At Risk
- 341
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 81
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 76
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 86
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 89
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 85
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 81
- num At Risk
- 341
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 30
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 53
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 41
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 35
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 30
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 40
- num At Risk
- 341
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 25
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 28
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 43
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 32
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 34
- num At Risk
- 341
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 11
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 20
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 7
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 19
- num At Risk
- 341
- term
- Dry mouth
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 116
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 117
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 126
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 127
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 133
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 135
- num At Risk
- 341
- term
- Paraesthesia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 48
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 31
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 60
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 70
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 64
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 72
- num At Risk
- 341
- term
- Peripheral Sensory Neuropathy
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 64
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 70
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 64
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 60
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 70
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 61
- num At Risk
- 341
- term
- Neuropathy Peripheral
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 27
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 25
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 7
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 26
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 8
- num At Risk
- 341
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 16
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 14
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 7
- num At Risk
- 341
- term
- Vomiting
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 7
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 6
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 5
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 7
- num At Risk
- 341
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 4
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 6
- num At Risk
- 341
- term
- Intestinal obstruction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 4
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 7
- num At Risk
- 341
- term
- Small intestinal obstruction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 5
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 341
- term
- Nausea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 0
- num At Risk
- 341
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 3
- num At Risk
- 341
- term
- Gastrointestinal haemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 341
- term
- Ascites
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 0
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 4
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 1
- num At Risk
- 341
- term
- Rectal haemorrhage
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 353
- group Id
- EG005
- num Affected
- 2
- num At Risk
- 341
- term
- Stomatitis all
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA (9.0)
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 316
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 313
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 339
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 336
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 353
- 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
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