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NCT02003924 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer · Source last updated 2026-01-27

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 up to 30 days after last dose of study drug or till death, whichever occurred first (up to a maximum duration of 69.8 months)
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. Data reported in this section was collected and analyzed only for participants who were treated with at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Enzalutamide 160 mg

Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.

372 / 930762 / 930285 / 930
Placebo

Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.

100 / 465299 / 465173 / 465
Placebo Patients Crossover to Enzalutamide 160 mg

Participants who received placebo in double-blind phase and who agreed to proceed to open-label phase, received 4 capsules of Enzalutamide 40 mg each (total dose of 160 mg per day), orally once daily (up to a maximum of 18.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.

12 / 8745 / 874 / 87

Group identifiers: EG000: Enzalutamide 160 mg · EG001: Placebo · EG002: Placebo Patients Crossover to Enzalutamide 160 mg

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
      10
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Anaemia macrocytic
  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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Haemolytic 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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Acute coronary syndrome
  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
      930
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    term
    Acute myocardial infarction
  7. 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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Angina pectoris
  8. 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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Angina unstable
  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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Aortic valve incompetence
  10. 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
      930
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Aortic valve stenosis
  11. 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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Arrhythmia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Atrial fibrillation

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
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      87
    term
    Asthenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      348
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      87
    term
    Fatigue
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Diarrhoea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      125
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Nausea
  6. 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
      930
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    term
    Urinary tract infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      164
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      87
    term
    Fall
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      87
    term
    Weight decreased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Decreased appetite
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Arthralgia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      87
    term
    Back pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      87
    term
    Dizziness
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. Data reported in this section was collected and analyzed only for participants who were treated with at least 1 dose of study drug.
event Groups
  1. deaths Num Affected
    285
    deaths Num At Risk
    930
    description
    Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
    id
    EG000
    other Num Affected
    762
    other Num At Risk
    930
    serious Num Affected
    372
    serious Num At Risk
    930
    title
    Enzalutamide 160 mg
  2. deaths Num Affected
    173
    deaths Num At Risk
    465
    description
    Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    id
    EG001
    other Num Affected
    299
    other Num At Risk
    465
    serious Num Affected
    100
    serious Num At Risk
    465
    title
    Placebo
  3. deaths Num Affected
    4
    deaths Num At Risk
    87
    description
    Participants who received placebo in double-blind phase and who agreed to proceed to open-label phase, received 4 capsules of Enzalutamide 40 mg each (total dose of 160 mg per day), orally once daily (up to a maximum of 18.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
    id
    EG002
    other Num Affected
    45
    other Num At Risk
    87
    serious Num Affected
    12
    serious Num At Risk
    87
    title
    Placebo Patients Crossover to Enzalutamide 160 mg
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      94
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      87
    term
    Asthenia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      348
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      87
    term
    Fatigue
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      121
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    term
    Constipation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Diarrhoea
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      125
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Nausea
  6. 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
      930
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    term
    Urinary tract infection
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      164
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      87
    term
    Fall
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      80
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      87
    term
    Weight decreased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      108
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Decreased appetite
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      87
    term
    Arthralgia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      87
    term
    Back pain
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      87
    term
    Dizziness
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
      10
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Anaemia macrocytic
  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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Haemolytic 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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Thrombocytopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Acute coronary syndrome
  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
      930
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      87
    term
    Acute myocardial infarction
  7. 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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Angina pectoris
  8. 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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Angina unstable
  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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Aortic valve incompetence
  10. 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
      930
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Aortic valve stenosis
  11. 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
      930
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Arrhythmia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      930
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      465
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      87
    term
    Atrial fibrillation
time Frame
Baseline up to 30 days after last dose of study drug or till death, whichever occurred first (up to a maximum duration of 69.8 months)

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Preserved source evidence · Not medical advice