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NCT02354586 · ADVERSE EVENTS

Adverse events

A Study of Niraparib in Patients With Ovarian Cancer Who Have Received Three or Four Previous Chemotherapy Regimens · Source last updated 2022-09-15

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, Non-serious adverse events (Non-SAEs) and Serious adverse events (SAEs) were reported up to a maximum of 71.56 months
Other-event reporting threshold
0%

All-cause mortality, Non-SAEs and SAEs were reported for Safety Population which comprised of all participants who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Niraparib 300 mg

Participants received Niraparib (300 milligram \[mg\], taken as 3 capsules of 100 mg once daily \[QD\]) orally beginning on Day 1 of every cycle (28 days) until treatment discontinuation.

200 / 463461 / 463232 / 463

Group identifiers: EG000: Niraparib 300 mg

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 24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      463
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      463
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      463
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      463
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Normochromic anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      463
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      463
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Arrhythmia supraventricular
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      463
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Cardiopulmonary failure

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 24.1
    stats
    1. group Id
      EG000
      num Affected
      233
      num At Risk
      463
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Anaemia macrocytic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Aplastic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      463
    term
    Increased tendency to bruise
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      463
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      463
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      463
    term
    Lymph node pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      463
    term
    Lymphadenopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Lymphocytosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      463
    term
    Lymphopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      463
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Neutrophilia
Complete source fields
description
All-cause mortality, Non-SAEs and SAEs were reported for Safety Population which comprised of all participants who received at least 1 dose of study drug.
event Groups
  1. deaths Num Affected
    232
    deaths Num At Risk
    463
    description
    Participants received Niraparib (300 milligram \[mg\], taken as 3 capsules of 100 mg once daily \[QD\]) orally beginning on Day 1 of every cycle (28 days) until treatment discontinuation.
    id
    EG000
    other Num Affected
    461
    other Num At Risk
    463
    serious Num Affected
    200
    serious Num At Risk
    463
    title
    Niraparib 300 mg
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      233
      num At Risk
      463
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Anaemia macrocytic
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Aplastic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      463
    term
    Increased tendency to bruise
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      463
    term
    Leukocytosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      463
    term
    Leukopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      463
    term
    Lymph node pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      463
    term
    Lymphadenopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Lymphocytosis
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      463
    term
    Lymphopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      463
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Neutrophilia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      463
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      463
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      463
    term
    Lymphopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      463
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Normochromic anaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      463
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      463
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Arrhythmia supraventricular
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      463
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 24.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      463
    term
    Cardiopulmonary failure
time Frame
All-cause mortality, Non-serious adverse events (Non-SAEs) and Serious adverse events (SAEs) were reported up to a maximum of 71.56 months

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