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NCT03748641 · ADVERSE EVENTS

Adverse events

A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer · Source last updated 2026-07-31

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
Up to 32 months
Other-event reporting threshold
5%

The safety analysis set for Cohort 1 and Cohort 2 included all randomized participants who received at least 1 dose of study drug in Cohort 1 or Cohort 2. The safety analysis set for Cohort 3 included all participants who received at least 1 dose of study drug in Cohort 3.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg

Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.

76 / 212198 / 21255 / 212
Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg

Participants with mCRPC and positive HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.

52 / 211178 / 21159 / 211
Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg

Participants with mCRPC and negative HRR gene alteration, received niraparib 200 mg capsule in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.

66 / 123117 / 12353 / 123
Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg

Participants with mCRPC and negative HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.

45 / 123108 / 12344 / 123
Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg

Participants with mCRPC and positive HRR gene alteration, received fixed-dose combination (FDC) of niraparib 200 mg and abiraterone acetate 1000 mg combination tablet orally QD with prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 9 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive same treatment in long-term extension phase.

21 / 9583 / 959 / 95

Group identifiers: EG000: Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg · EG001: Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg · EG002: Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg · EG003: Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg · EG004: Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Lymphoid Tissue Hyperplasia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Acute Coronary Syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
    term
    Acute Myocardial Infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Angina Pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Angina Unstable
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Arrhythmia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Arrhythmia Supraventricular

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      59
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      37
      num At Risk
      95
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      95
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      95
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      95
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      95
    term
    Abdominal Distension
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
    term
    Abdominal Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      95
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      95
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      95
    term
    Dry Mouth
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      95
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
    term
    Gastritis
Complete source fields
description
The safety analysis set for Cohort 1 and Cohort 2 included all randomized participants who received at least 1 dose of study drug in Cohort 1 or Cohort 2. The safety analysis set for Cohort 3 included all participants who received at least 1 dose of study drug in Cohort 3.
event Groups
  1. deaths Num Affected
    55
    deaths Num At Risk
    212
    description
    Participants with metastatic castration-resistant prostate cancer (mCRPC) and positive homologous recombination repair (HRR) gene alteration, received niraparib 200 milligrams (mg) capsule in combination with abiraterone acetate 1000 mg tablet orally once daily (QD) and prednisone 5 mg tablet orally twice daily (BID) (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.
    id
    EG000
    other Num Affected
    198
    other Num At Risk
    212
    serious Num Affected
    76
    serious Num At Risk
    212
    title
    Cohort 1: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg
  2. deaths Num Affected
    59
    deaths Num At Risk
    211
    description
    Participants with mCRPC and positive HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.
    id
    EG001
    other Num Affected
    178
    other Num At Risk
    211
    serious Num Affected
    52
    serious Num At Risk
    211
    title
    Cohort 1: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg
  3. deaths Num Affected
    53
    deaths Num At Risk
    123
    description
    Participants with mCRPC and negative HRR gene alteration, received niraparib 200 mg capsule in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open label extension phase.
    id
    EG002
    other Num Affected
    117
    other Num At Risk
    123
    serious Num Affected
    66
    serious Num At Risk
    123
    title
    Cohort 2: Niraparib 200 mg + Abiraterone Acetate 1000 mg + Prednisone 10 mg
  4. deaths Num Affected
    44
    deaths Num At Risk
    123
    description
    Participants with mCRPC and negative HRR gene alteration, received placebo in combination with abiraterone acetate 1000 mg tablet orally QD and prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 29 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants who received placebo and abiraterone acetate plus prednisone were allowed to cross over to receive niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg in the open-label extension phase.
    id
    EG003
    other Num Affected
    108
    other Num At Risk
    123
    serious Num Affected
    45
    serious Num At Risk
    123
    title
    Cohort 2: Placebo + Abiraterone Acetate 1000 mg + Prednisone 10 mg
  5. deaths Num Affected
    9
    deaths Num At Risk
    95
    description
    Participants with mCRPC and positive HRR gene alteration, received fixed-dose combination (FDC) of niraparib 200 mg and abiraterone acetate 1000 mg combination tablet orally QD with prednisone 5 mg tablet orally BID (total dose 10 mg) in each 28 days treatment cycle starting from Cycle 1 Day 1 up to 9 months. Participants were then followed up for safety up to 5 years after last dose or until death, loss to follow-up, withdrawal of consent, or study termination. Participants were continued to receive same treatment in long-term extension phase.
    id
    EG004
    other Num Affected
    83
    other Num At Risk
    95
    serious Num Affected
    21
    serious Num At Risk
    95
    title
    Cohort 3: Niraparib 200 mg and Abiraterone Acetate 1000 mg FDC + Prednisone 10 mg
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      59
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      37
      num At Risk
      95
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      95
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
    term
    Lymphopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      95
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      11
      num At Risk
      95
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      7
      num At Risk
      95
    term
    Abdominal Distension
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
    term
    Abdominal Pain
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      25
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      23
      num At Risk
      95
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      95
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      5
      num At Risk
      95
    term
    Dry Mouth
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      6
      num At Risk
      95
    term
    Dyspepsia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
    term
    Gastritis
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      95
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Lymphoid Tissue Hyperplasia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Thrombocytopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Acute Coronary Syndrome
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      95
    term
    Acute Myocardial Infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Angina Pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Angina Unstable
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Arrhythmia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      212
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      211
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      123
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      123
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      95
    term
    Arrhythmia Supraventricular
time Frame
Up to 32 months

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Preserved source evidence · Not medical advice