Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01715285 · ADVERSE EVENTS

Adverse events

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC) · Source last updated 2025-02-04

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
From Day 1 up to 30 days post last dose (that is, for DB period: up to 23 months and OLE period: up to 15.6 months), deaths were collected from baseline up to end of study (up to 66 months).
Other-event reporting threshold
5%

Safety analysis set included all participants randomized into the study and who received any part of study drug. Only 72 deaths out of all cause mortalities contributed to discontinuation.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Abiraterone Acetate+Prednisone+ADT

Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.

192 / 597533 / 597275 / 597
Placebo + ADT

Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.

151 / 602515 / 602339 / 602
DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate

Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate plus Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.

4 / 7235 / 724 / 72

Group identifiers: EG000: Abiraterone Acetate+Prednisone+ADT · EG001: Placebo + ADT · EG002: DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Lymphadenitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Lymphadenopathy
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Acute Coronary Syndrome
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Acute Myocardial Infarction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Angina Pectoris
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Atrial Fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Atrial Flutter
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Cardiac Failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Cardiac Failure Acute

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 18.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      72
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Abdominal Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Diarrhoea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Nausea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Vomiting
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Asthenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Fatigue
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    term
    Oedema Peripheral
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      72
    term
    Influenza
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Nasopharyngitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    term
    Upper Respiratory Tract Infection
Complete source fields
description
Safety analysis set included all participants randomized into the study and who received any part of study drug. Only 72 deaths out of all cause mortalities contributed to discontinuation.
event Groups
  1. deaths Num Affected
    275
    deaths Num At Risk
    597
    description
    Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
    id
    EG000
    other Num Affected
    533
    other Num At Risk
    597
    serious Num Affected
    192
    serious Num At Risk
    597
    title
    Abiraterone Acetate+Prednisone+ADT
  2. deaths Num Affected
    339
    deaths Num At Risk
    602
    description
    Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
    id
    EG001
    other Num Affected
    515
    other Num At Risk
    602
    serious Num Affected
    151
    serious Num At Risk
    602
    title
    Placebo + ADT
  3. deaths Num Affected
    4
    deaths Num At Risk
    72
    description
    Participants who were originally randomized to the Placebo group were permitted to crossover to Abiraterone Acetate plus Prednisone treatment in open-label extension phase to receive abiraterone acetate tablet at a total dose of 1000 mg plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
    id
    EG002
    other Num Affected
    35
    other Num At Risk
    72
    serious Num Affected
    4
    serious Num At Risk
    72
    title
    DB Period Placebo to Open-label Extension (OLE) Abiraterone Acetate
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      72
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Abdominal Pain
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      68
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Diarrhoea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Nausea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Vomiting
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Asthenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      90
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Fatigue
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    term
    Oedema Peripheral
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      72
    term
    Influenza
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Nasopharyngitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      72
    term
    Upper Respiratory Tract Infection
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      72
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Lymphadenitis
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Lymphadenopathy
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Neutropenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Thrombocytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Acute Coronary Syndrome
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Acute Myocardial Infarction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Angina Pectoris
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Atrial Fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Atrial Flutter
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Cardiac Failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 18.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      597
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      602
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      72
    term
    Cardiac Failure Acute
time Frame
From Day 1 up to 30 days post last dose (that is, for DB period: up to 23 months and OLE period: up to 15.6 months), deaths were collected from baseline up to end of study (up to 66 months).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice