Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01288911 · ADVERSE EVENTS

Adverse events

A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer · Source last updated 2024-12-06

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 initiation of study drug up to 30 days after the last dose of study drug or the 30-day safety follow-up visit, whichever occurred last. Median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm in the double-blind period. In the open-label period, the median duration of treatment was 21.6 months in participants who previously received enzalutamide and 20.9 months in participants who previously received bicalutamide.
Other-event reporting threshold
5%

The total number of deaths (all causes) includes deaths reported after the time frame above.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Double-blind Period: Enzalutamide

Participants received enzalutamide 160 mg orally once daily in the double-blind period until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

49 / 141123 / 14111 / 141
Double-blind Period: Bicalutamide

Participants received bicalutamide 50 mg orally once daily in the double-blind period until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

43 / 180149 / 1807 / 180
Open-label Period: Enzalutamide/Enzalutamide

Participants received enzalutamide in the double-blind period and received enzalutamide in the open-label period as well.

18 / 4242 / 420 / 42
Open-label Period: Bicalutamide/Enzalutamide

Participants received bicalutamide in the double-blind period and switched over to enzalutamide in the open-label period.

4 / 99 / 91 / 9

Group identifiers: EG000: Double-blind Period: Enzalutamide · EG001: Double-blind Period: Bicalutamide · EG002: Open-label Period: Enzalutamide/Enzalutamide · EG003: Open-label Period: Bicalutamide/Enzalutamide

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 16.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      141
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      180
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      180
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Aortic valve stenosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Arteriosclerosis coronary artery
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      141
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      180
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Atrioventricular block
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Atrioventricular block complete
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      141
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      180
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      42
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Cardiac failure congestive

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 16.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      141
      num Events
      10
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      180
      num Events
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      42
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Angina pectoris
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      141
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      180
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Palpitations
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Glaucoma
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Ocular hyperaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      141
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      180
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      42
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      141
      num Events
      21
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      180
      num Events
      25
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      42
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      141
      num Events
      18
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      180
      num Events
      18
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      42
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      2
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      141
      num Events
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      180
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      2
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      180
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      141
      num Events
      22
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      180
      num Events
      36
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      42
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Nausea
Complete source fields
description
The total number of deaths (all causes) includes deaths reported after the time frame above.
event Groups
  1. deaths Num Affected
    11
    deaths Num At Risk
    141
    description
    Participants received enzalutamide 160 mg orally once daily in the double-blind period until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
    id
    EG000
    other Num Affected
    123
    other Num At Risk
    141
    serious Num Affected
    49
    serious Num At Risk
    141
    title
    Double-blind Period: Enzalutamide
  2. deaths Num Affected
    7
    deaths Num At Risk
    180
    description
    Participants received bicalutamide 50 mg orally once daily in the double-blind period until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
    id
    EG001
    other Num Affected
    149
    other Num At Risk
    180
    serious Num Affected
    43
    serious Num At Risk
    180
    title
    Double-blind Period: Bicalutamide
  3. deaths Num Affected
    0
    deaths Num At Risk
    42
    description
    Participants received enzalutamide in the double-blind period and received enzalutamide in the open-label period as well.
    id
    EG002
    other Num Affected
    42
    other Num At Risk
    42
    serious Num Affected
    18
    serious Num At Risk
    42
    title
    Open-label Period: Enzalutamide/Enzalutamide
  4. deaths Num Affected
    1
    deaths Num At Risk
    9
    description
    Participants received bicalutamide in the double-blind period and switched over to enzalutamide in the open-label period.
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    4
    serious Num At Risk
    9
    title
    Open-label Period: Bicalutamide/Enzalutamide
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      141
      num Events
      10
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      180
      num Events
      7
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      42
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Angina pectoris
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      141
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      180
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Palpitations
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Glaucoma
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Ocular hyperaemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      141
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      180
      num Events
      7
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      42
      num Events
      4
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      141
      num Events
      21
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      180
      num Events
      25
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      42
      num Events
      7
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      141
      num Events
      18
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      180
      num Events
      18
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      42
      num Events
      6
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      2
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      141
      num Events
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      180
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      9
      num Events
      2
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      180
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Haemorrhoids
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      141
      num Events
      22
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      180
      num Events
      36
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      42
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      141
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      180
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      180
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Pancytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      141
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Acute myocardial infarction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Angina pectoris
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Aortic valve stenosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Arteriosclerosis coronary artery
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      141
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      180
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      42
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Atrioventricular block
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Atrioventricular block complete
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      141
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      180
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      42
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    Bradycardia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      141
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      180
      num Events
      3
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      42
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Cardiac failure congestive
time Frame
From initiation of study drug up to 30 days after the last dose of study drug or the 30-day safety follow-up visit, whichever occurred last. Median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm in the double-blind period. In the open-label period, the median duration of treatment was 21.6 months in participants who previously received enzalutamide and 20.9 months in participants who previously received bicalutamide.

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

Preserved source evidence · Not medical advice