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NCT01995513 · ADVERSE EVENTS

Adverse events

Safety Study of Continued Enzalutamide Treatment In Prostate Cancer Patients · Source last updated 2023-09-18

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 the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)
Other-event reporting threshold
0%

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. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.

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

Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily in the study.

163 / 509474 / 50932 / 509
Enzalutamide Crossing Over to Abiraterone + Prednisone

Participants who received (after switching from enzalutamide) abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily in the study.

4 / 1313 / 131 / 13
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg

Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.

47 / 125113 / 12514 / 126
Placebo + Abiraterone 1000 mg + Prednisone 10mg

Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.

37 / 124113 / 12410 / 125

Group identifiers: EG000: Enzalutamide 160 mg · EG001: Enzalutamide Crossing Over to Abiraterone + Prednisone · EG002: Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg · EG003: Placebo + Abiraterone 1000 mg + Prednisone 10mg

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
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Anaemia
  2. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Acute coronary syndrome
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Acute myocardial infarction
  4. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
    term
    Angina pectoris
  5. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Angina unstable
  6. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Aortic valve stenosis
  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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Atrial fibrillation
  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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Atrioventricular block complete
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Cardiac arrest
  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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
    term
    Cardiac failure
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Cardiac failure congestive
  12. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Cardio-respiratory arrest

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
      32
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      124
    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
      0
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
    term
    Bone marrow failure
  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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Haemorrhagic 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Iron deficiency anaemia
  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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Leukocytosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Lymphadenopathy
  7. assessment Type
    NON_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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Lymphopenia
  8. assessment Type
    NON_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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Pancytopenia
  9. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Pernicious anaemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
    term
    Thrombocytopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    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
      1
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Angina unstable
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. The all-cause mortality data was evaluated on all enrolled participants while the data for SAEs and other AEs were evaluated for safety population.
event Groups
  1. deaths Num Affected
    32
    deaths Num At Risk
    509
    description
    Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily in the study.
    id
    EG000
    other Num Affected
    474
    other Num At Risk
    509
    serious Num Affected
    163
    serious Num At Risk
    509
    title
    Enzalutamide 160 mg
  2. deaths Num Affected
    1
    deaths Num At Risk
    13
    description
    Participants who received (after switching from enzalutamide) abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily in the study.
    id
    EG001
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    4
    serious Num At Risk
    13
    title
    Enzalutamide Crossing Over to Abiraterone + Prednisone
  3. deaths Num Affected
    14
    deaths Num At Risk
    126
    description
    Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
    id
    EG002
    other Num Affected
    113
    other Num At Risk
    125
    serious Num Affected
    47
    serious Num At Risk
    125
    title
    Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
  4. deaths Num Affected
    10
    deaths Num At Risk
    125
    description
    Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
    id
    EG003
    other Num Affected
    113
    other Num At Risk
    124
    serious Num Affected
    37
    serious Num At Risk
    124
    title
    Placebo + Abiraterone 1000 mg + Prednisone 10mg
frequency Threshold
0
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
      32
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      124
    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
      0
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
    term
    Bone marrow failure
  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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Haemorrhagic 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Iron deficiency anaemia
  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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Leukocytosis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Lymphadenopathy
  7. assessment Type
    NON_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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Lymphopenia
  8. assessment Type
    NON_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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Pancytopenia
  9. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Pernicious anaemia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
    term
    Thrombocytopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    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
      1
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Angina unstable
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
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Anaemia
  2. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Acute coronary syndrome
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Acute myocardial infarction
  4. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
    term
    Angina pectoris
  5. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Angina unstable
  6. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Aortic valve stenosis
  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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Atrial fibrillation
  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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Atrioventricular block complete
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Cardiac arrest
  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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      124
    term
    Cardiac failure
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 16.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Cardiac failure congestive
  12. 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
      509
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      13
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      125
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      124
    term
    Cardio-respiratory arrest
time Frame
Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum duration of exposure: 99.4 months)

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Preserved source evidence · Not medical advice