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NCT01664923 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer · Source last updated 2019-01-30

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 first dose of study drug until the end of open label phase (up to maximum duration of 65 months)
Other-event reporting threshold
0%

Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Enzalutamide

Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received same treatment for up to 36 months in open label phase.

76 / 197187 / 197Not reported / Not reported
DB Phase: Bicalutamide

Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules for up to 29 months in DB phase.

60 / 198179 / 198Not reported / Not reported
Open Label Phase: Bicalutamide Crossover to Enzalutamide

Participants who received bicalutamide 50 mg in DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth in open label phase for up to 36 months.

16 / 3736 / 37Not reported / Not reported

Group identifiers: EG000: Enzalutamide · EG001: DB Phase: Bicalutamide · EG002: Open Label Phase: Bicalutamide Crossover to 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
      4
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
    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
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Lymphadenitis
  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
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
    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
      5
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    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
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Aortic valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Atrial flutter
  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
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    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
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
    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
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      37
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      37
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      37
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      37
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      37
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      37
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      37
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
    term
    Muscular weakness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
    term
    Musculoskeletal pain
Complete source fields
description
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study
event Groups
  1. description
    Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule for up to 29 months in DB phase. Participants who completed DB phase and consented to participate in open label phase, received same treatment for up to 36 months in open label phase.
    id
    EG000
    other Num Affected
    187
    other Num At Risk
    197
    serious Num Affected
    76
    serious Num At Risk
    197
    title
    Enzalutamide
  2. description
    Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules for up to 29 months in DB phase.
    id
    EG001
    other Num Affected
    179
    other Num At Risk
    198
    serious Num Affected
    60
    serious Num At Risk
    198
    title
    DB Phase: Bicalutamide
  3. description
    Participants who received bicalutamide 50 mg in DB phase and consented to participate in open label phase, received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth in open label phase for up to 36 months.
    id
    EG002
    other Num Affected
    36
    other Num At Risk
    37
    serious Num Affected
    16
    serious Num At Risk
    37
    title
    Open Label Phase: Bicalutamide Crossover to Enzalutamide
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      37
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      37
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      37
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      37
    term
    Vomiting
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
    term
    Asthenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      82
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      37
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
    term
    Pyrexia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      45
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      37
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      37
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
    term
    Muscular weakness
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
    term
    Musculoskeletal pain
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
      4
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
    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
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Lymphadenitis
  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
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Acute coronary syndrome
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
    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
      5
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    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
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Aortic valve disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Atrial flutter
  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
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    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
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      37
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      37
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (16.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      197
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      198
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      37
    term
    Cardiac failure congestive
time Frame
From first dose of study drug until the end of open label phase (up to maximum duration of 65 months)

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Preserved source evidence · Not medical advice