Skip to content
← Full study record

NCT02470585 · ADVERSE EVENTS

Adverse events

Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2024-10-26

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%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo + Carboplatin + Paclitaxel -> Placebo

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.

143 / 375369 / 375228 / 375
Veliparib + Carboplatin + Paclitaxel -> Placebo

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.

130 / 383375 / 383234 / 383
Veliparib + Carboplatin + Paclitaxel -> Veliparib

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.

146 / 382376 / 382209 / 382

Group identifiers: EG000: Placebo + Carboplatin + Paclitaxel -> Placebo · EG001: Veliparib + Carboplatin + Paclitaxel -> Placebo · EG002: Veliparib + Carboplatin + Paclitaxel -> Veliparib

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      375
      num Events
      4
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      383
      num Events
      14
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      382
      num Events
      18
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      375
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      383
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      382
      num Events
      1
    term
    APLASTIC ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      375
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      383
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      382
      num Events
      1
    term
    BONE MARROW FAILURE
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      375
      num Events
      10
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      383
      num Events
      20
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      382
      num Events
      17
    term
    FEBRILE NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      375
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      383
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      382
      num Events
      0
    term
    LEUKOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      375
      num Events
      9
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      383
      num Events
      22
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      382
      num Events
      16
    term
    NEUTROPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      375
      num Events
      3
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      383
      num Events
      12
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      382
      num Events
      20
    term
    THROMBOCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      375
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      383
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      382
      num Events
      0
    term
    ACUTE CORONARY SYNDROME
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      375
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      383
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      382
      num Events
      1
    term
    ATRIAL FIBRILLATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      375
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      383
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      382
      num Events
      1
    term
    MYOCARDIAL INFARCTION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      375
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      383
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      382
      num Events
      0
    term
    PALPITATIONS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      375
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      383
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      382
      num Events
      0
    term
    STRESS CARDIOMYOPATHY

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
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      191
      num At Risk
      375
      num Events
      514
    2. group Id
      EG001
      num Affected
      232
      num At Risk
      383
      num Events
      603
    3. group Id
      EG002
      num Affected
      226
      num At Risk
      382
      num Events
      672
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      375
      num Events
      223
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      383
      num Events
      261
    3. group Id
      EG002
      num Affected
      114
      num At Risk
      382
      num Events
      333
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      375
      num Events
      28
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      383
      num Events
      20
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      382
      num Events
      57
    term
    LYMPHOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      247
      num At Risk
      375
      num Events
      673
    2. group Id
      EG001
      num Affected
      266
      num At Risk
      383
      num Events
      881
    3. group Id
      EG002
      num Affected
      273
      num At Risk
      382
      num Events
      848
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      375
      num Events
      266
    2. group Id
      EG001
      num Affected
      216
      num At Risk
      383
      num Events
      630
    3. group Id
      EG002
      num Affected
      209
      num At Risk
      382
      num Events
      735
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      375
      num Events
      33
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      383
      num Events
      22
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      382
      num Events
      27
    term
    VISION BLURRED
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      375
      num Events
      55
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      383
      num Events
      54
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      382
      num Events
      39
    term
    ABDOMINAL DISTENSION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      375
      num Events
      163
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      383
      num Events
      143
    3. group Id
      EG002
      num Affected
      118
      num At Risk
      382
      num Events
      162
    term
    ABDOMINAL PAIN
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      375
      num Events
      38
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      383
      num Events
      24
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      382
      num Events
      37
    term
    ABDOMINAL PAIN UPPER
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      157
      num At Risk
      375
      num Events
      203
    2. group Id
      EG001
      num Affected
      177
      num At Risk
      383
      num Events
      241
    3. group Id
      EG002
      num Affected
      165
      num At Risk
      382
      num Events
      228
    term
    CONSTIPATION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      149
      num At Risk
      375
      num Events
      248
    2. group Id
      EG001
      num Affected
      137
      num At Risk
      383
      num Events
      228
    3. group Id
      EG002
      num Affected
      164
      num At Risk
      382
      num Events
      255
    term
    DIARRHOEA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      375
      num Events
      20
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      383
      num Events
      12
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      382
      num Events
      23
    term
    DRY MOUTH
Complete source fields
event Groups
  1. 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
  2. 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
  3. 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
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      191
      num At Risk
      375
      num Events
      514
    2. group Id
      EG001
      num Affected
      232
      num At Risk
      383
      num Events
      603
    3. group Id
      EG002
      num Affected
      226
      num At Risk
      382
      num Events
      672
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      375
      num Events
      223
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      383
      num Events
      261
    3. group Id
      EG002
      num Affected
      114
      num At Risk
      382
      num Events
      333
    term
    LEUKOPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      375
      num Events
      28
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      383
      num Events
      20
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      382
      num Events
      57
    term
    LYMPHOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      247
      num At Risk
      375
      num Events
      673
    2. group Id
      EG001
      num Affected
      266
      num At Risk
      383
      num Events
      881
    3. group Id
      EG002
      num Affected
      273
      num At Risk
      382
      num Events
      848
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      375
      num Events
      266
    2. group Id
      EG001
      num Affected
      216
      num At Risk
      383
      num Events
      630
    3. group Id
      EG002
      num Affected
      209
      num At Risk
      382
      num Events
      735
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      375
      num Events
      33
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      383
      num Events
      22
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      382
      num Events
      27
    term
    VISION BLURRED
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      375
      num Events
      55
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      383
      num Events
      54
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      382
      num Events
      39
    term
    ABDOMINAL DISTENSION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      375
      num Events
      163
    2. group Id
      EG001
      num Affected
      105
      num At Risk
      383
      num Events
      143
    3. group Id
      EG002
      num Affected
      118
      num At Risk
      382
      num Events
      162
    term
    ABDOMINAL PAIN
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      375
      num Events
      38
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      383
      num Events
      24
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      382
      num Events
      37
    term
    ABDOMINAL PAIN UPPER
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      157
      num At Risk
      375
      num Events
      203
    2. group Id
      EG001
      num Affected
      177
      num At Risk
      383
      num Events
      241
    3. group Id
      EG002
      num Affected
      165
      num At Risk
      382
      num Events
      228
    term
    CONSTIPATION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      149
      num At Risk
      375
      num Events
      248
    2. group Id
      EG001
      num Affected
      137
      num At Risk
      383
      num Events
      228
    3. group Id
      EG002
      num Affected
      164
      num At Risk
      382
      num Events
      255
    term
    DIARRHOEA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      375
      num Events
      20
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      383
      num Events
      12
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      382
      num Events
      23
    term
    DRY MOUTH
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      375
      num Events
      4
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      383
      num Events
      14
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      382
      num Events
      18
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      375
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      383
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      382
      num Events
      1
    term
    APLASTIC ANAEMIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      375
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      383
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      382
      num Events
      1
    term
    BONE MARROW FAILURE
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      375
      num Events
      10
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      383
      num Events
      20
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      382
      num Events
      17
    term
    FEBRILE NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      375
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      383
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      382
      num Events
      0
    term
    LEUKOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      375
      num Events
      9
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      383
      num Events
      22
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      382
      num Events
      16
    term
    NEUTROPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      375
      num Events
      3
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      383
      num Events
      12
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      382
      num Events
      20
    term
    THROMBOCYTOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      375
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      383
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      382
      num Events
      0
    term
    ACUTE CORONARY SYNDROME
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      375
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      383
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      382
      num Events
      1
    term
    ATRIAL FIBRILLATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      375
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      383
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      382
      num Events
      1
    term
    MYOCARDIAL INFARCTION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      375
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      383
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      382
      num Events
      0
    term
    PALPITATIONS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      375
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      383
      num Events
      0
    3. 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