NCT02470585 · 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 and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Placebo + Carboplatin + Paclitaxel -> Placebo | 143 / 375 | 369 / 375 | 228 / 375 |
| Veliparib + Carboplatin + Paclitaxel -> Placebo | 130 / 383 | 375 / 383 | 234 / 383 |
| Veliparib + Carboplatin + Paclitaxel -> Veliparib | 146 / 382 | 376 / 382 | 209 / 382 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 375
- num Events
- 4
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 383
- num Events
- 14
- group Id
- EG002
- num Affected
- 14
- num At Risk
- 382
- num Events
- 18
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 375
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 383
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 382
- num Events
- 1
- term
- APLASTIC ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 375
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 383
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 382
- num Events
- 1
- term
- BONE MARROW FAILURE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 375
- num Events
- 10
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 383
- num Events
- 20
- group Id
- EG002
- num Affected
- 15
- num At Risk
- 382
- num Events
- 17
- term
- FEBRILE NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 375
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 383
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 382
- num Events
- 0
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 375
- num Events
- 9
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 383
- num Events
- 22
- group Id
- EG002
- num Affected
- 12
- num At Risk
- 382
- num Events
- 16
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 375
- num Events
- 3
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 383
- num Events
- 12
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 382
- num Events
- 20
- term
- THROMBOCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 375
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 383
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 382
- num Events
- 0
- term
- ACUTE CORONARY SYNDROME
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 375
- num Events
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 383
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 382
- num Events
- 1
- term
- ATRIAL FIBRILLATION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 375
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 383
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 382
- num Events
- 1
- term
- MYOCARDIAL INFARCTION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 375
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 383
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 382
- num Events
- 0
- term
- PALPITATIONS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 375
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 383
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 382
- num Events
- 0
- term
- STRESS CARDIOMYOPATHY
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 191
- num At Risk
- 375
- num Events
- 514
- group Id
- EG001
- num Affected
- 232
- num At Risk
- 383
- num Events
- 603
- group Id
- EG002
- num Affected
- 226
- num At Risk
- 382
- num Events
- 672
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 89
- num At Risk
- 375
- num Events
- 223
- group Id
- EG001
- num Affected
- 87
- num At Risk
- 383
- num Events
- 261
- group Id
- EG002
- num Affected
- 114
- num At Risk
- 382
- num Events
- 333
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 375
- num Events
- 28
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 383
- num Events
- 20
- group Id
- EG002
- num Affected
- 26
- num At Risk
- 382
- num Events
- 57
- term
- LYMPHOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 247
- num At Risk
- 375
- num Events
- 673
- group Id
- EG001
- num Affected
- 266
- num At Risk
- 383
- num Events
- 881
- group Id
- EG002
- num Affected
- 273
- num At Risk
- 382
- num Events
- 848
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 119
- num At Risk
- 375
- num Events
- 266
- group Id
- EG001
- num Affected
- 216
- num At Risk
- 383
- num Events
- 630
- group Id
- EG002
- num Affected
- 209
- num At Risk
- 382
- num Events
- 735
- term
- THROMBOCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 375
- num Events
- 33
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 383
- num Events
- 22
- group Id
- EG002
- num Affected
- 27
- num At Risk
- 382
- num Events
- 27
- term
- VISION BLURRED
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 45
- num At Risk
- 375
- num Events
- 55
- group Id
- EG001
- num Affected
- 48
- num At Risk
- 383
- num Events
- 54
- group Id
- EG002
- num Affected
- 34
- num At Risk
- 382
- num Events
- 39
- term
- ABDOMINAL DISTENSION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 114
- num At Risk
- 375
- num Events
- 163
- group Id
- EG001
- num Affected
- 105
- num At Risk
- 383
- num Events
- 143
- group Id
- EG002
- num Affected
- 118
- num At Risk
- 382
- num Events
- 162
- term
- ABDOMINAL PAIN
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 375
- num Events
- 38
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 383
- num Events
- 24
- group Id
- EG002
- num Affected
- 29
- num At Risk
- 382
- num Events
- 37
- term
- ABDOMINAL PAIN UPPER
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 157
- num At Risk
- 375
- num Events
- 203
- group Id
- EG001
- num Affected
- 177
- num At Risk
- 383
- num Events
- 241
- group Id
- EG002
- num Affected
- 165
- num At Risk
- 382
- num Events
- 228
- term
- CONSTIPATION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 149
- num At Risk
- 375
- num Events
- 248
- group Id
- EG001
- num Affected
- 137
- num At Risk
- 383
- num Events
- 228
- group Id
- EG002
- num Affected
- 164
- num At Risk
- 382
- num Events
- 255
- term
- DIARRHOEA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 375
- num Events
- 20
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 383
- num Events
- 12
- group Id
- EG002
- num Affected
- 22
- num At Risk
- 382
- num Events
- 23
- term
- DRY MOUTH
Complete source fields
- event Groups
- deaths Num Affected
- 228
- deaths Num At Risk
- 375
- description
- Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
- id
- EG000
- other Num Affected
- 369
- other Num At Risk
- 375
- serious Num Affected
- 143
- serious Num At Risk
- 375
- title
- Placebo + Carboplatin + Paclitaxel -> Placebo
- deaths Num Affected
- 234
- deaths Num At Risk
- 383
- description
- Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
- id
- EG001
- other Num Affected
- 375
- other Num At Risk
- 383
- serious Num Affected
- 130
- serious Num At Risk
- 383
- title
- Veliparib + Carboplatin + Paclitaxel -> Placebo
- deaths Num Affected
- 209
- deaths Num At Risk
- 382
- description
- Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent\\ veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
- id
- EG002
- other Num Affected
- 376
- other Num At Risk
- 382
- serious Num Affected
- 146
- serious Num At Risk
- 382
- title
- Veliparib + Carboplatin + Paclitaxel -> Veliparib
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 191
- num At Risk
- 375
- num Events
- 514
- group Id
- EG001
- num Affected
- 232
- num At Risk
- 383
- num Events
- 603
- group Id
- EG002
- num Affected
- 226
- num At Risk
- 382
- num Events
- 672
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 89
- num At Risk
- 375
- num Events
- 223
- group Id
- EG001
- num Affected
- 87
- num At Risk
- 383
- num Events
- 261
- group Id
- EG002
- num Affected
- 114
- num At Risk
- 382
- num Events
- 333
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 375
- num Events
- 28
- group Id
- EG001
- num Affected
- 15
- num At Risk
- 383
- num Events
- 20
- group Id
- EG002
- num Affected
- 26
- num At Risk
- 382
- num Events
- 57
- term
- LYMPHOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 247
- num At Risk
- 375
- num Events
- 673
- group Id
- EG001
- num Affected
- 266
- num At Risk
- 383
- num Events
- 881
- group Id
- EG002
- num Affected
- 273
- num At Risk
- 382
- num Events
- 848
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 119
- num At Risk
- 375
- num Events
- 266
- group Id
- EG001
- num Affected
- 216
- num At Risk
- 383
- num Events
- 630
- group Id
- EG002
- num Affected
- 209
- num At Risk
- 382
- num Events
- 735
- term
- THROMBOCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 375
- num Events
- 33
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 383
- num Events
- 22
- group Id
- EG002
- num Affected
- 27
- num At Risk
- 382
- num Events
- 27
- term
- VISION BLURRED
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 45
- num At Risk
- 375
- num Events
- 55
- group Id
- EG001
- num Affected
- 48
- num At Risk
- 383
- num Events
- 54
- group Id
- EG002
- num Affected
- 34
- num At Risk
- 382
- num Events
- 39
- term
- ABDOMINAL DISTENSION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 114
- num At Risk
- 375
- num Events
- 163
- group Id
- EG001
- num Affected
- 105
- num At Risk
- 383
- num Events
- 143
- group Id
- EG002
- num Affected
- 118
- num At Risk
- 382
- num Events
- 162
- term
- ABDOMINAL PAIN
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 375
- num Events
- 38
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 383
- num Events
- 24
- group Id
- EG002
- num Affected
- 29
- num At Risk
- 382
- num Events
- 37
- term
- ABDOMINAL PAIN UPPER
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 157
- num At Risk
- 375
- num Events
- 203
- group Id
- EG001
- num Affected
- 177
- num At Risk
- 383
- num Events
- 241
- group Id
- EG002
- num Affected
- 165
- num At Risk
- 382
- num Events
- 228
- term
- CONSTIPATION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 149
- num At Risk
- 375
- num Events
- 248
- group Id
- EG001
- num Affected
- 137
- num At Risk
- 383
- num Events
- 228
- group Id
- EG002
- num Affected
- 164
- num At Risk
- 382
- num Events
- 255
- term
- DIARRHOEA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 19
- num At Risk
- 375
- num Events
- 20
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 383
- num Events
- 12
- group Id
- EG002
- num Affected
- 22
- num At Risk
- 382
- num Events
- 23
- term
- DRY MOUTH
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 375
- num Events
- 4
- group Id
- EG001
- num Affected
- 13
- num At Risk
- 383
- num Events
- 14
- group Id
- EG002
- num Affected
- 14
- num At Risk
- 382
- num Events
- 18
- term
- ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 375
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 383
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 382
- num Events
- 1
- term
- APLASTIC ANAEMIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 375
- num Events
- 0
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 383
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 382
- num Events
- 1
- term
- BONE MARROW FAILURE
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 9
- num At Risk
- 375
- num Events
- 10
- group Id
- EG001
- num Affected
- 19
- num At Risk
- 383
- num Events
- 20
- group Id
- EG002
- num Affected
- 15
- num At Risk
- 382
- num Events
- 17
- term
- FEBRILE NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 375
- num Events
- 0
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 383
- num Events
- 1
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 382
- num Events
- 0
- term
- LEUKOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 375
- num Events
- 9
- group Id
- EG001
- num Affected
- 16
- num At Risk
- 383
- num Events
- 22
- group Id
- EG002
- num Affected
- 12
- num At Risk
- 382
- num Events
- 16
- term
- NEUTROPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 375
- num Events
- 3
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 383
- num Events
- 12
- group Id
- EG002
- num Affected
- 10
- num At Risk
- 382
- num Events
- 20
- term
- THROMBOCYTOPENIA
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 375
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 383
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 382
- num Events
- 0
- term
- ACUTE CORONARY SYNDROME
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 375
- num Events
- 3
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 383
- num Events
- 2
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 382
- num Events
- 1
- term
- ATRIAL FIBRILLATION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 375
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 383
- num Events
- 0
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 382
- num Events
- 1
- term
- MYOCARDIAL INFARCTION
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 375
- num Events
- 0
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 383
- num Events
- 2
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 382
- num Events
- 0
- term
- PALPITATIONS
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 26.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 375
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 383
- num Events
- 0
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 382
- num Events
- 0
- term
- STRESS CARDIOMYOPATHY
- time Frame
- All-cause mortality and adverse events were collected from the time informed consent was signed through the end of the study. Median time on follow-up was 81.7 months for the Placebo + Carboplatin + Paclitaxel -> Placebo group, 81.2 months for the Veliparib + Carboplatin + Paclitaxel -> Placebo group, and 81.1 months for the Veliparib + Carboplatin + Paclitaxel -> Veliparib group.
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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