Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02489318 · ADVERSE EVENTS

Adverse events

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC · Source last updated 2026-08-31

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 57 months
Other-event reporting threshold
2%

Safety Analysis set included all participants who received at least 1 dose of randomized study drug. Crossover participants were counted twice (in Placebo + ADT arm and in Placebo + ADT to Apalutamide + ADT arm) for safety analysis. For crossover participants, adverse events after initiation of crossover treatment were summarized separately in Placebo + ADT to Apalutamide + ADT arm. However, adverse events occurred before crossover treatment were summarized in Placebo + ADT arm.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo + Androgen Deprivation Therapy (ADT)

Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.

115 / 527485 / 52735 / 527
Placebo + ADT to Apalutamide + ADT

After interim analysis and unblinding, participants receiving placebo +ADT crossed over to receive 240 mg apalutamide orally qd along with ADT in open-label extension phase.

29 / 208153 / 20810 / 208
Apalutamide + ADT

Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.

153 / 524494 / 52431 / 524

Group identifiers: EG000: Placebo + Androgen Deprivation Therapy (ADT) · EG001: Placebo + ADT to Apalutamide + ADT · EG002: Apalutamide + ADT

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Coagulopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Febrile Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      524
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Acute Coronary Syndrome
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      524
    term
    Acute Myocardial Infarction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      524
    term
    Angina Pectoris
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      524
    term
    Angina Unstable
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Aortic Valve Disease Mixed
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Arteriosclerosis Coronary Artery
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      524
    term
    Atrial Fibrillation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Atrioventricular Block Complete

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 23.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      524
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      524
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      524
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      524
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      524
    term
    Hypothyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      524
    term
    Abdominal Pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      524
    term
    Abdominal Pain Upper
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      524
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      56
      num At Risk
      524
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      524
    term
    Dyspepsia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      524
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      524
    term
    Toothache
Complete source fields
description
Safety Analysis set included all participants who received at least 1 dose of randomized study drug. Crossover participants were counted twice (in Placebo + ADT arm and in Placebo + ADT to Apalutamide + ADT arm) for safety analysis. For crossover participants, adverse events after initiation of crossover treatment were summarized separately in Placebo + ADT to Apalutamide + ADT arm. However, adverse events occurred before crossover treatment were summarized in Placebo + ADT arm.
event Groups
  1. deaths Num Affected
    35
    deaths Num At Risk
    527
    description
    Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    id
    EG000
    other Num Affected
    485
    other Num At Risk
    527
    serious Num Affected
    115
    serious Num At Risk
    527
    title
    Placebo + Androgen Deprivation Therapy (ADT)
  2. deaths Num Affected
    10
    deaths Num At Risk
    208
    description
    After interim analysis and unblinding, participants receiving placebo +ADT crossed over to receive 240 mg apalutamide orally qd along with ADT in open-label extension phase.
    id
    EG001
    other Num Affected
    153
    other Num At Risk
    208
    serious Num Affected
    29
    serious Num At Risk
    208
    title
    Placebo + ADT to Apalutamide + ADT
  3. deaths Num Affected
    31
    deaths Num At Risk
    524
    description
    Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
    id
    EG002
    other Num Affected
    494
    other Num At Risk
    524
    serious Num Affected
    153
    serious Num At Risk
    524
    title
    Apalutamide + ADT
frequency Threshold
2
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      524
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      29
      num At Risk
      524
    term
    Leukopenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      16
      num At Risk
      524
    term
    Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      524
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      524
    term
    Hypothyroidism
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      524
    term
    Abdominal Pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      524
    term
    Abdominal Pain Upper
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      58
      num At Risk
      524
    term
    Constipation
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      56
      num At Risk
      524
    term
    Diarrhoea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      524
    term
    Dyspepsia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      524
    term
    Nausea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      524
    term
    Toothache
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Coagulopathy
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Febrile Neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      524
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Acute Coronary Syndrome
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      524
    term
    Acute Myocardial Infarction
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      524
    term
    Angina Pectoris
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      524
    term
    Angina Unstable
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Aortic Valve Disease Mixed
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Arteriosclerosis Coronary Artery
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      524
    term
    Atrial Fibrillation
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA Version 23.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      527
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      208
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      524
    term
    Atrioventricular Block Complete
time Frame
Up to 57 months

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

Preserved source evidence · Not medical advice