NCT03504397 · 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
- All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
- Other-event reporting threshold
- 5%
Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Zolbetuximab | 133 / 279 | 276 / 279 | 197 / 283 |
| 5-fluorouracil | 262 / 557 | 550 / 557 | 414 / 565 |
| Folinic Acid / Leucovorin | 262 / 557 | 550 / 557 | 414 / 565 |
| Oxaliplatin | 262 / 557 | 550 / 557 | 414 / 565 |
| Placebo | 129 / 278 | 274 / 278 | 217 / 282 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 279
- num Events
- 6
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 557
- num Events
- 10
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 557
- num Events
- 10
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 557
- num Events
- 10
- group Id
- EG004
- num Affected
- 4
- num At Risk
- 278
- num Events
- 4
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 279
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 278
- num Events
- 0
- term
- Disseminated intravascular coagulation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 279
- num Events
- 8
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 279
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Microangiopathic haemolytic anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 279
- num Events
- 6
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 278
- num Events
- 3
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 279
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 278
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 279
- num Events
- 2
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Acute myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 279
- num Events
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 557
- num Events
- 3
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 557
- num Events
- 3
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 557
- num Events
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 278
- num Events
- 0
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 279
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Cardiac arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 279
- num Events
- 1
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 278
- num Events
- 2
- term
- Cardiac failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 279
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Cardio-respiratory arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 279
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Myocardial infarction
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 105
- num At Risk
- 279
- num Events
- 309
- group Id
- EG001
- num Affected
- 211
- num At Risk
- 557
- num Events
- 616
- group Id
- EG002
- num Affected
- 211
- num At Risk
- 557
- num Events
- 616
- group Id
- EG003
- num Affected
- 211
- num At Risk
- 557
- num Events
- 616
- group Id
- EG004
- num Affected
- 106
- num At Risk
- 278
- num Events
- 307
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 279
- num Events
- 34
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 557
- num Events
- 57
- group Id
- EG002
- num Affected
- 30
- num At Risk
- 557
- num Events
- 57
- group Id
- EG003
- num Affected
- 30
- num At Risk
- 557
- num Events
- 57
- group Id
- EG004
- num Affected
- 13
- num At Risk
- 278
- num Events
- 23
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 101
- num At Risk
- 279
- num Events
- 340
- group Id
- EG001
- num Affected
- 195
- num At Risk
- 557
- num Events
- 674
- group Id
- EG002
- num Affected
- 195
- num At Risk
- 557
- num Events
- 674
- group Id
- EG003
- num Affected
- 195
- num At Risk
- 557
- num Events
- 674
- group Id
- EG004
- num Affected
- 94
- num At Risk
- 278
- num Events
- 334
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 279
- num Events
- 67
- group Id
- EG001
- num Affected
- 74
- num At Risk
- 557
- num Events
- 180
- group Id
- EG002
- num Affected
- 74
- num At Risk
- 557
- num Events
- 180
- group Id
- EG003
- num Affected
- 74
- num At Risk
- 557
- num Events
- 180
- group Id
- EG004
- num Affected
- 45
- num At Risk
- 278
- num Events
- 113
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 279
- num Events
- 23
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 557
- num Events
- 50
- group Id
- EG002
- num Affected
- 39
- num At Risk
- 557
- num Events
- 50
- group Id
- EG003
- num Affected
- 39
- num At Risk
- 557
- num Events
- 50
- group Id
- EG004
- num Affected
- 23
- num At Risk
- 278
- num Events
- 27
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 68
- num At Risk
- 279
- num Events
- 137
- group Id
- EG001
- num Affected
- 154
- num At Risk
- 557
- num Events
- 274
- group Id
- EG002
- num Affected
- 154
- num At Risk
- 557
- num Events
- 274
- group Id
- EG003
- num Affected
- 154
- num At Risk
- 557
- num Events
- 274
- group Id
- EG004
- num Affected
- 86
- num At Risk
- 278
- num Events
- 137
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 47
- num At Risk
- 279
- num Events
- 76
- group Id
- EG001
- num Affected
- 80
- num At Risk
- 557
- num Events
- 124
- group Id
- EG002
- num Affected
- 80
- num At Risk
- 557
- num Events
- 124
- group Id
- EG003
- num Affected
- 80
- num At Risk
- 557
- num Events
- 124
- group Id
- EG004
- num Affected
- 33
- num At Risk
- 278
- num Events
- 48
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 101
- num At Risk
- 279
- num Events
- 154
- group Id
- EG001
- num Affected
- 212
- num At Risk
- 557
- num Events
- 334
- group Id
- EG002
- num Affected
- 212
- num At Risk
- 557
- num Events
- 334
- group Id
- EG003
- num Affected
- 212
- num At Risk
- 557
- num Events
- 334
- group Id
- EG004
- num Affected
- 111
- num At Risk
- 278
- num Events
- 180
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 112
- num At Risk
- 279
- num Events
- 202
- group Id
- EG001
- num Affected
- 237
- num At Risk
- 557
- num Events
- 477
- group Id
- EG002
- num Affected
- 237
- num At Risk
- 557
- num Events
- 477
- group Id
- EG003
- num Affected
- 237
- num At Risk
- 557
- num Events
- 477
- group Id
- EG004
- num Affected
- 125
- num At Risk
- 278
- num Events
- 275
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 28
- num At Risk
- 279
- num Events
- 35
- group Id
- EG001
- num Affected
- 48
- num At Risk
- 557
- num Events
- 60
- group Id
- EG002
- num Affected
- 48
- num At Risk
- 557
- num Events
- 60
- group Id
- EG003
- num Affected
- 48
- num At Risk
- 557
- num Events
- 60
- group Id
- EG004
- num Affected
- 20
- num At Risk
- 278
- num Events
- 25
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 279
- num Events
- 28
- group Id
- EG001
- num Affected
- 43
- num At Risk
- 557
- num Events
- 62
- group Id
- EG002
- num Affected
- 43
- num At Risk
- 557
- num Events
- 62
- group Id
- EG003
- num Affected
- 43
- num At Risk
- 557
- num Events
- 62
- group Id
- EG004
- num Affected
- 21
- num At Risk
- 278
- num Events
- 34
- term
- Dysphagia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 279
- num Events
- 16
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 557
- num Events
- 32
- group Id
- EG002
- num Affected
- 30
- num At Risk
- 557
- num Events
- 32
- group Id
- EG003
- num Affected
- 30
- num At Risk
- 557
- num Events
- 32
- group Id
- EG004
- num Affected
- 16
- num At Risk
- 278
- num Events
- 16
- term
- Gastrooesophageal reflux disease
Complete source fields
- description
- Serious adverse events: SAF defined as all participants who received at least one dose of the study drug. Participants may have been repeated in the arm groups. ACM was analyzed for all randomized population.
- event Groups
- deaths Num Affected
- 197
- deaths Num At Risk
- 283
- description
- Participants received an IV infusion (as a minimum of 2-hourinfusion) ofzolbetuximab at a loading dose of 800mg/m\^2 on C1D1followed by subsequent doses of 600 mg/m\^2every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria .Each cycle wasapproximately 42 days.
- id
- EG000
- other Num Affected
- 276
- other Num At Risk
- 279
- serious Num Affected
- 133
- serious Num At Risk
- 279
- title
- Zolbetuximab
- deaths Num Affected
- 414
- deaths Num At Risk
- 565
- description
- Participants received up to 12 treatments of5-fluorouracil over 4 or more cycles administered by IV bolus 400 mg/m\^2 over5 to 15 minutes followed by 2400mg/m\^2 over46-48 hours continuous IV infusion every 2weeks for 4 cycles. Participants could continue to receive 5-fluorouracil on Days 1,15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
- id
- EG001
- other Num Affected
- 550
- other Num At Risk
- 557
- serious Num Affected
- 262
- serious Num At Risk
- 557
- title
- 5-fluorouracil
- deaths Num Affected
- 414
- deaths Num At Risk
- 565
- description
- Participants received up to 12 treatments of folinic acid administered 400mg/m\^2 IV infusion over 2 hours 4 or more cycles on Days 1, 15 and29 of each cycle. Participants could continue to receive folinic acid on Days 1,15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
- id
- EG002
- other Num Affected
- 550
- other Num At Risk
- 557
- serious Num Affected
- 262
- serious Num At Risk
- 557
- title
- Folinic Acid / Leucovorin
- deaths Num Affected
- 414
- deaths Num At Risk
- 565
- description
- Participants received up to 12 treatments of oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours) on Days 1,15 and 29 of each cycle.. A maximum of 12 doses of oxaliplatin was permitted. Each cycle was approximately 42days.
- id
- EG003
- other Num Affected
- 550
- other Num At Risk
- 557
- serious Num Affected
- 262
- serious Num At Risk
- 557
- title
- Oxaliplatin
- deaths Num Affected
- 217
- deaths Num At Risk
- 282
- description
- Participants received anIV infusion (as a minimum of 2-hourinfusion) of placebo matched to zolbetuximab on C1D1followed by subsequent doses every 3 weeks starting from C1D22until participant met study treatment discontinuation criteria. Each cycle was approximately 42 days.
- id
- EG004
- other Num Affected
- 274
- other Num At Risk
- 278
- serious Num Affected
- 129
- serious Num At Risk
- 278
- title
- Placebo
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 105
- num At Risk
- 279
- num Events
- 309
- group Id
- EG001
- num Affected
- 211
- num At Risk
- 557
- num Events
- 616
- group Id
- EG002
- num Affected
- 211
- num At Risk
- 557
- num Events
- 616
- group Id
- EG003
- num Affected
- 211
- num At Risk
- 557
- num Events
- 616
- group Id
- EG004
- num Affected
- 106
- num At Risk
- 278
- num Events
- 307
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 279
- num Events
- 34
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 557
- num Events
- 57
- group Id
- EG002
- num Affected
- 30
- num At Risk
- 557
- num Events
- 57
- group Id
- EG003
- num Affected
- 30
- num At Risk
- 557
- num Events
- 57
- group Id
- EG004
- num Affected
- 13
- num At Risk
- 278
- num Events
- 23
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 101
- num At Risk
- 279
- num Events
- 340
- group Id
- EG001
- num Affected
- 195
- num At Risk
- 557
- num Events
- 674
- group Id
- EG002
- num Affected
- 195
- num At Risk
- 557
- num Events
- 674
- group Id
- EG003
- num Affected
- 195
- num At Risk
- 557
- num Events
- 674
- group Id
- EG004
- num Affected
- 94
- num At Risk
- 278
- num Events
- 334
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 279
- num Events
- 67
- group Id
- EG001
- num Affected
- 74
- num At Risk
- 557
- num Events
- 180
- group Id
- EG002
- num Affected
- 74
- num At Risk
- 557
- num Events
- 180
- group Id
- EG003
- num Affected
- 74
- num At Risk
- 557
- num Events
- 180
- group Id
- EG004
- num Affected
- 45
- num At Risk
- 278
- num Events
- 113
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 279
- num Events
- 23
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 557
- num Events
- 50
- group Id
- EG002
- num Affected
- 39
- num At Risk
- 557
- num Events
- 50
- group Id
- EG003
- num Affected
- 39
- num At Risk
- 557
- num Events
- 50
- group Id
- EG004
- num Affected
- 23
- num At Risk
- 278
- num Events
- 27
- term
- Abdominal distension
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 68
- num At Risk
- 279
- num Events
- 137
- group Id
- EG001
- num Affected
- 154
- num At Risk
- 557
- num Events
- 274
- group Id
- EG002
- num Affected
- 154
- num At Risk
- 557
- num Events
- 274
- group Id
- EG003
- num Affected
- 154
- num At Risk
- 557
- num Events
- 274
- group Id
- EG004
- num Affected
- 86
- num At Risk
- 278
- num Events
- 137
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 47
- num At Risk
- 279
- num Events
- 76
- group Id
- EG001
- num Affected
- 80
- num At Risk
- 557
- num Events
- 124
- group Id
- EG002
- num Affected
- 80
- num At Risk
- 557
- num Events
- 124
- group Id
- EG003
- num Affected
- 80
- num At Risk
- 557
- num Events
- 124
- group Id
- EG004
- num Affected
- 33
- num At Risk
- 278
- num Events
- 48
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 101
- num At Risk
- 279
- num Events
- 154
- group Id
- EG001
- num Affected
- 212
- num At Risk
- 557
- num Events
- 334
- group Id
- EG002
- num Affected
- 212
- num At Risk
- 557
- num Events
- 334
- group Id
- EG003
- num Affected
- 212
- num At Risk
- 557
- num Events
- 334
- group Id
- EG004
- num Affected
- 111
- num At Risk
- 278
- num Events
- 180
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 112
- num At Risk
- 279
- num Events
- 202
- group Id
- EG001
- num Affected
- 237
- num At Risk
- 557
- num Events
- 477
- group Id
- EG002
- num Affected
- 237
- num At Risk
- 557
- num Events
- 477
- group Id
- EG003
- num Affected
- 237
- num At Risk
- 557
- num Events
- 477
- group Id
- EG004
- num Affected
- 125
- num At Risk
- 278
- num Events
- 275
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 28
- num At Risk
- 279
- num Events
- 35
- group Id
- EG001
- num Affected
- 48
- num At Risk
- 557
- num Events
- 60
- group Id
- EG002
- num Affected
- 48
- num At Risk
- 557
- num Events
- 60
- group Id
- EG003
- num Affected
- 48
- num At Risk
- 557
- num Events
- 60
- group Id
- EG004
- num Affected
- 20
- num At Risk
- 278
- num Events
- 25
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 22
- num At Risk
- 279
- num Events
- 28
- group Id
- EG001
- num Affected
- 43
- num At Risk
- 557
- num Events
- 62
- group Id
- EG002
- num Affected
- 43
- num At Risk
- 557
- num Events
- 62
- group Id
- EG003
- num Affected
- 43
- num At Risk
- 557
- num Events
- 62
- group Id
- EG004
- num Affected
- 21
- num At Risk
- 278
- num Events
- 34
- term
- Dysphagia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 14
- num At Risk
- 279
- num Events
- 16
- group Id
- EG001
- num Affected
- 30
- num At Risk
- 557
- num Events
- 32
- group Id
- EG002
- num Affected
- 30
- num At Risk
- 557
- num Events
- 32
- group Id
- EG003
- num Affected
- 30
- num At Risk
- 557
- num Events
- 32
- group Id
- EG004
- num Affected
- 16
- num At Risk
- 278
- num Events
- 16
- term
- Gastrooesophageal reflux disease
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 279
- num Events
- 6
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 557
- num Events
- 10
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 557
- num Events
- 10
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 557
- num Events
- 10
- group Id
- EG004
- num Affected
- 4
- num At Risk
- 278
- num Events
- 4
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 279
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 278
- num Events
- 0
- term
- Disseminated intravascular coagulation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 279
- num Events
- 8
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 279
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Microangiopathic haemolytic anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 279
- num Events
- 6
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG002
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG003
- num Affected
- 9
- num At Risk
- 557
- num Events
- 9
- group Id
- EG004
- num Affected
- 3
- num At Risk
- 278
- num Events
- 3
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 279
- num Events
- 1
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 278
- num Events
- 0
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 279
- num Events
- 2
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Acute myocardial infarction
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 279
- num Events
- 3
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 557
- num Events
- 3
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 557
- num Events
- 3
- group Id
- EG003
- num Affected
- 2
- num At Risk
- 557
- num Events
- 3
- group Id
- EG004
- num Affected
- 0
- num At Risk
- 278
- num Events
- 0
- term
- Atrial fibrillation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 279
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Cardiac arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 279
- num Events
- 1
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG002
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG003
- num Affected
- 3
- num At Risk
- 557
- num Events
- 3
- group Id
- EG004
- num Affected
- 2
- num At Risk
- 278
- num Events
- 2
- term
- Cardiac failure
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 279
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Cardio-respiratory arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 279
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG003
- num Affected
- 1
- num At Risk
- 557
- num Events
- 1
- group Id
- EG004
- num Affected
- 1
- num At Risk
- 278
- num Events
- 1
- term
- Myocardial infarction
- time Frame
- All- cause mortality (ACM): From randomization up to 62 months and 18 days Adverse events: From first dose until 62 months and 18 days
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