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NCT02677896 · ADVERSE EVENTS

Adverse events

A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) · Source last updated 2025-10-24

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
All-cause mortality: From randomization up to end of study duration (approximately 7 years) AEs: From first dose up to 30 days after last dose of study drug (maximum duration of treatment 7 years)
Other-event reporting threshold
5%

All-cause mortality: The at risk population included all randomized participants AEs: The at risk population included the Safety Analysis Set (SAF) consisting of all randomized participants who received at least one dose of study drug.

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

Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

244 / 572463 / 572190 / 574
Placebo + ADT

Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. This arm represents only double blind period.

128 / 574401 / 574197 / 576
Placebo Cross-over Enzalutamide

Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock. This arm represents only the open-label extension period.

81 / 182133 / 18227 / 182

Group identifiers: EG000: Enzalutamide + Androgen Deprivation Therapy (ADT) · EG001: Placebo + ADT · EG002: Placebo Cross-over 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 v26
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      572
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      574
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      182
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      572
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      574
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Blood loss anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      572
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      572
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Immune thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      572
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Iron deficiency anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      572
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Lymphadenopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      572
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      574
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      572
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      574
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      572
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      574
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      182
      num Events
      2
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      572
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      572
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      574
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Angina unstable
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      572
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Aortic valve incompetence

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 v26
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      572
      num Events
      86
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      574
      num Events
      39
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      182
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      572
      num Events
      72
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      574
      num Events
      34
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      182
      num Events
      13
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      572
      num Events
      72
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      574
      num Events
      35
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      182
      num Events
      10
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      572
      num Events
      65
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      574
      num Events
      35
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      182
      num Events
      19
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      572
      num Events
      79
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      574
      num Events
      36
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      182
      num Events
      7
    term
    Asthenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      147
      num At Risk
      572
      num Events
      197
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      574
      num Events
      103
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      182
      num Events
      54
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      572
      num Events
      66
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      574
      num Events
      48
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      182
      num Events
      9
    term
    Oedema peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      572
      num Events
      74
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      574
      num Events
      39
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      182
      num Events
      22
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      572
      num Events
      96
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      574
      num Events
      16
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      182
      num Events
      30
    term
    Fall
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      572
      num Events
      89
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      574
      num Events
      51
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      182
      num Events
      2
    term
    Weight increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      572
      num Events
      46
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      574
      num Events
      20
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      182
      num Events
      17
    term
    Decreased appetite
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      147
      num At Risk
      572
      num Events
      214
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      574
      num Events
      99
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      182
      num Events
      25
    term
    Arthralgia
Complete source fields
description
All-cause mortality: The at risk population included all randomized participants AEs: The at risk population included the Safety Analysis Set (SAF) consisting of all randomized participants who received at least one dose of study drug.
event Groups
  1. deaths Num Affected
    190
    deaths Num At Risk
    574
    description
    Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
    id
    EG000
    other Num Affected
    463
    other Num At Risk
    572
    serious Num Affected
    244
    serious Num At Risk
    572
    title
    Enzalutamide + Androgen Deprivation Therapy (ADT)
  2. deaths Num Affected
    197
    deaths Num At Risk
    576
    description
    Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. This arm represents only double blind period.
    id
    EG001
    other Num Affected
    401
    other Num At Risk
    574
    serious Num Affected
    128
    serious Num At Risk
    574
    title
    Placebo + ADT
  3. deaths Num Affected
    27
    deaths Num At Risk
    182
    description
    Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock. This arm represents only the open-label extension period.
    id
    EG002
    other Num Affected
    133
    other Num At Risk
    182
    serious Num Affected
    81
    serious Num At Risk
    182
    title
    Placebo Cross-over Enzalutamide
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      572
      num Events
      86
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      574
      num Events
      39
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      182
      num Events
      6
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      572
      num Events
      72
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      574
      num Events
      34
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      182
      num Events
      13
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      572
      num Events
      72
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      574
      num Events
      35
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      182
      num Events
      10
    term
    Diarrhoea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      572
      num Events
      65
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      574
      num Events
      35
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      182
      num Events
      19
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      572
      num Events
      79
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      574
      num Events
      36
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      182
      num Events
      7
    term
    Asthenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      147
      num At Risk
      572
      num Events
      197
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      574
      num Events
      103
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      182
      num Events
      54
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      572
      num Events
      66
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      574
      num Events
      48
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      182
      num Events
      9
    term
    Oedema peripheral
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      572
      num Events
      74
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      574
      num Events
      39
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      182
      num Events
      22
    term
    Nasopharyngitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      63
      num At Risk
      572
      num Events
      96
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      574
      num Events
      16
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      182
      num Events
      30
    term
    Fall
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      572
      num Events
      89
    2. group Id
      EG001
      num Affected
      45
      num At Risk
      574
      num Events
      51
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      182
      num Events
      2
    term
    Weight increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      572
      num Events
      46
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      574
      num Events
      20
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      182
      num Events
      17
    term
    Decreased appetite
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      147
      num At Risk
      572
      num Events
      214
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      574
      num Events
      99
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      182
      num Events
      25
    term
    Arthralgia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      572
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      574
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      182
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      572
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      574
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Blood loss anaemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      572
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      572
      num Events
      6
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Immune thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      572
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Iron deficiency anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      572
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Lymphadenopathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      572
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      574
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      572
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      574
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      572
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      574
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      182
      num Events
      2
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      572
      num Events
      8
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Angina pectoris
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      572
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      574
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Angina unstable
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      572
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      574
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      182
      num Events
      0
    term
    Aortic valve incompetence
time Frame
All-cause mortality: From randomization up to end of study duration (approximately 7 years) AEs: From first dose up to 30 days after last dose of study drug (maximum duration of treatment 7 years)

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