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NCT02657889 · ADVERSE EVENTS

Adverse events

Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer · Source last updated 2022-12-01

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, serious adverse events (SAE) and non-serious adverse events (non-SAEs) were collected up to a maximum of 22 months in Phase 1 and up to a maximum of 54 months in Phase 2 of the study
Other-event reporting threshold
5%

All-cause mortality, SAE and non-SAE were collected in Safety analysis set which comprised of all participants who received any amount of study treatment in Phase 1 or Phase 2.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: Niraparib 200 mg + Pembrolizumab

Participants received Niraparib 200 milligrams (mg) orally once daily from Days 1 to 21 and Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.

6 / 77 / 75 / 7
Phase 1: Niraparib 300 mg + Pembrolizumab

Participants received Niraparib 300 mg orally once daily from Days 1 to 21 and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.

4 / 77 / 75 / 7
Phase 2 OC: Niraparib 200 mg + Pembrolizumab

Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.

22 / 5352 / 5330 / 53
Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab

Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.

24 / 5554 / 5542 / 55

Group identifiers: EG000: Phase 1: Niraparib 200 mg + Pembrolizumab · EG001: Phase 1: Niraparib 300 mg + Pembrolizumab · EG002: Phase 2 OC: Niraparib 200 mg + Pembrolizumab · EG003: Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab

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 (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      55
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Cardiac tamponade
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Adrenal insufficiency
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Abdominal distension

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 (20.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      55
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      55
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      55
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Diastolic dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      55
    term
    Hyperthyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      55
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Lacrimation increased
Complete source fields
description
All-cause mortality, SAE and non-SAE were collected in Safety analysis set which comprised of all participants who received any amount of study treatment in Phase 1 or Phase 2.
event Groups
  1. deaths Num Affected
    5
    deaths Num At Risk
    7
    description
    Participants received Niraparib 200 milligrams (mg) orally once daily from Days 1 to 21 and Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    6
    serious Num At Risk
    7
    title
    Phase 1: Niraparib 200 mg + Pembrolizumab
  2. deaths Num Affected
    5
    deaths Num At Risk
    7
    description
    Participants received Niraparib 300 mg orally once daily from Days 1 to 21 and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
    id
    EG001
    other Num Affected
    7
    other Num At Risk
    7
    serious Num Affected
    4
    serious Num At Risk
    7
    title
    Phase 1: Niraparib 300 mg + Pembrolizumab
  3. deaths Num Affected
    30
    deaths Num At Risk
    53
    description
    Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
    id
    EG002
    other Num Affected
    52
    other Num At Risk
    53
    serious Num Affected
    22
    serious Num At Risk
    53
    title
    Phase 2 OC: Niraparib 200 mg + Pembrolizumab
  4. deaths Num Affected
    42
    deaths Num At Risk
    55
    description
    Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
    id
    EG003
    other Num Affected
    54
    other Num At Risk
    55
    serious Num Affected
    24
    serious Num At Risk
    55
    title
    Phase 2 TNBC: Niraparib 200 mg + Pembrolizumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      24
      num At Risk
      55
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Leukocytosis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      55
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      14
      num At Risk
      55
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Diastolic dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Tachycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      55
    term
    Hyperthyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      55
    term
    Hypothyroidism
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Cataract
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Dry eye
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Lacrimation increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (20.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      55
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Cardiac tamponade
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Pericardial effusion
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Tachycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      55
    term
    Adrenal insufficiency
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 20.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      7
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      53
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      55
    term
    Abdominal distension
time Frame
All-cause mortality, serious adverse events (SAE) and non-serious adverse events (non-SAEs) were collected up to a maximum of 22 months in Phase 1 and up to a maximum of 54 months in Phase 2 of the study

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Preserved source evidence · Not medical advice