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NCT01212991 · ADVERSE EVENTS

Adverse events

A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer · Source last updated 2020-03-17

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
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
Other-event reporting threshold
5%

Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.

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

Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.

384 / 871814 / 871699 / 871
Placebo

Participants received placebo, administered as four capsules, once per day by mouth.

229 / 844723 / 844550 / 844
Placebo Participants Crossover to Enzalutamide

Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.

104 / 234180 / 234166 / 234

Group identifiers: EG000: Enzalutamide · EG001: Placebo · EG002: Placebo Participants 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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      234
    term
    Anaemia
  2. assessment Type
    NON_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
      871
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      234
    term
    Disseminated intravascular coagulation
  3. assessment Type
    NON_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
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Iron deficiency anaemia
  4. assessment Type
    NON_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
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Neutropenia
  5. assessment Type
    NON_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
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Pancytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Atrial fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      234
    term
    Acute myocardial infarction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      234
    term
    Arteriosclerosis coronary artery
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Atrioventricular block
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Acute coronary syndrome
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      234
    term
    Angina pectoris
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      234
    term
    Angina unstable

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 16.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      234
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      211
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      192
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      234
    term
    Nausea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      220
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      145
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      234
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      160
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      121
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      234
    term
    Diarrhoea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      234
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      234
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      332
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      220
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      234
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      234
    term
    Asthenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      115
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      234
    term
    Oedema peripheral
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      234
    term
    Urinary tract infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      234
    term
    Nasopharyngitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      234
    term
    Upper respiratory tract infection
Complete source fields
description
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety set.
event Groups
  1. deaths Num Affected
    699
    deaths Num At Risk
    871
    description
    Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    EG000
    other Num Affected
    814
    other Num At Risk
    871
    serious Num Affected
    384
    serious Num At Risk
    871
    title
    Enzalutamide
  2. deaths Num Affected
    550
    deaths Num At Risk
    844
    description
    Participants received placebo, administered as four capsules, once per day by mouth.
    id
    EG001
    other Num Affected
    723
    other Num At Risk
    844
    serious Num Affected
    229
    serious Num At Risk
    844
    title
    Placebo
  3. deaths Num Affected
    166
    deaths Num At Risk
    234
    description
    Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
    id
    EG002
    other Num Affected
    180
    other Num At Risk
    234
    serious Num Affected
    104
    serious Num At Risk
    234
    title
    Placebo Participants Crossover to Enzalutamide
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      23
      num At Risk
      234
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      211
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      192
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      34
      num At Risk
      234
    term
    Nausea
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      220
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      145
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      38
      num At Risk
      234
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      160
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      121
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      234
    term
    Diarrhoea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      234
    term
    Vomiting
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      234
    term
    Abdominal pain
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      332
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      220
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      234
    term
    Fatigue
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      234
    term
    Asthenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      115
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      70
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      234
    term
    Oedema peripheral
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      70
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      234
    term
    Urinary tract infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      234
    term
    Nasopharyngitis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      234
    term
    Upper respiratory tract infection
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      234
    term
    Anaemia
  2. assessment Type
    NON_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
      871
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      234
    term
    Disseminated intravascular coagulation
  3. assessment Type
    NON_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
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Iron deficiency anaemia
  4. assessment Type
    NON_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
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Neutropenia
  5. assessment Type
    NON_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
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Pancytopenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Atrial fibrillation
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      234
    term
    Acute myocardial infarction
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      234
    term
    Arteriosclerosis coronary artery
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Atrioventricular block
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      234
    term
    Acute coronary syndrome
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      234
    term
    Angina pectoris
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      871
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      844
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      234
    term
    Angina unstable
time Frame
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)

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Preserved source evidence · Not medical advice