Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02516241 · ADVERSE EVENTS

Adverse events

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer · Source last updated 2026-07-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
From first administration of study treatment up to 90 days after last dose of study medication or date of initiation of the first subsequent therapy, whichever occurs first, approximately 5 years. All-cause mortality, from screening up to data cut-off date (27JAN2020, approximately 5 years).
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Combination Therapy

MEDI4736 (Durvalumab) + Tremelimumab

179 / 340306 / 340255 / 342
Monotherapy

MEDI4736 (Durvalumab)

139 / 345312 / 345263 / 346
Standard of Care

Standard of Care Chemotherapy Treatment

125 / 313299 / 313270 / 344

Group identifiers: EG000: Combination Therapy · EG001: Monotherapy · EG002: Standard of Care

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 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      340
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      345
      num Events
      9
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      313
      num Events
      9
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      313
      num Events
      1
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      340
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      313
      num Events
      4
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      313
      num Events
      4
    term
    Haematotoxicity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      313
      num Events
      3
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      313
      num Events
      1
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      313
      num Events
      1
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      313
      num Events
      6
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      313
      num Events
      0
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      345
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      313
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      313
      num Events
      1
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      340
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      313
      num Events
      2
    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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      340
      num Events
      53
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      345
      num Events
      63
    3. group Id
      EG002
      num Affected
      163
      num At Risk
      313
      num Events
      222
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      340
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      1
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      313
      num Events
      50
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      3
    3. group Id
      EG002
      num Affected
      89
      num At Risk
      313
      num Events
      187
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      340
      num Events
      1
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      345
      num Events
      10
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      313
      num Events
      64
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      340
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      1
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      313
      num Events
      22
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      340
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      345
      num Events
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      313
      num Events
      1
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      340
      num Events
      34
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      345
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      313
      num Events
      0
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      340
      num Events
      47
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      345
      num Events
      50
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      313
      num Events
      31
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      340
      num Events
      24
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      345
      num Events
      4
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      313
      num Events
      9
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      340
      num Events
      88
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      345
      num Events
      73
    3. group Id
      EG002
      num Affected
      89
      num At Risk
      313
      num Events
      113
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      340
      num Events
      146
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      345
      num Events
      96
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      313
      num Events
      78
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      340
      num Events
      25
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      345
      num Events
      18
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      313
      num Events
      4
    term
    Dry mouth
Complete source fields
event Groups
  1. deaths Num Affected
    255
    deaths Num At Risk
    342
    description
    MEDI4736 (Durvalumab) + Tremelimumab
    id
    EG000
    other Num Affected
    306
    other Num At Risk
    340
    serious Num Affected
    179
    serious Num At Risk
    340
    title
    Combination Therapy
  2. deaths Num Affected
    263
    deaths Num At Risk
    346
    description
    MEDI4736 (Durvalumab)
    id
    EG001
    other Num Affected
    312
    other Num At Risk
    345
    serious Num Affected
    139
    serious Num At Risk
    345
    title
    Monotherapy
  3. deaths Num Affected
    270
    deaths Num At Risk
    344
    description
    Standard of Care Chemotherapy Treatment
    id
    EG002
    other Num Affected
    299
    other Num At Risk
    313
    serious Num Affected
    125
    serious Num At Risk
    313
    title
    Standard of Care
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      51
      num At Risk
      340
      num Events
      53
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      345
      num Events
      63
    3. group Id
      EG002
      num Affected
      163
      num At Risk
      313
      num Events
      222
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      340
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      1
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      313
      num Events
      50
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      3
    3. group Id
      EG002
      num Affected
      89
      num At Risk
      313
      num Events
      187
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      340
      num Events
      1
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      345
      num Events
      10
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      313
      num Events
      64
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      340
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      1
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      313
      num Events
      22
    term
    Tinnitus
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      340
      num Events
      22
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      345
      num Events
      10
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      313
      num Events
      1
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      340
      num Events
      34
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      345
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      313
      num Events
      0
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      340
      num Events
      47
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      345
      num Events
      50
    3. group Id
      EG002
      num Affected
      27
      num At Risk
      313
      num Events
      31
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      340
      num Events
      24
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      345
      num Events
      4
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      313
      num Events
      9
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      340
      num Events
      88
    2. group Id
      EG001
      num Affected
      66
      num At Risk
      345
      num Events
      73
    3. group Id
      EG002
      num Affected
      89
      num At Risk
      313
      num Events
      113
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      340
      num Events
      146
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      345
      num Events
      96
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      313
      num Events
      78
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      340
      num Events
      25
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      345
      num Events
      18
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      313
      num Events
      4
    term
    Dry mouth
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      340
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      345
      num Events
      9
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      313
      num Events
      9
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      313
      num Events
      1
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      340
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      313
      num Events
      4
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      313
      num Events
      4
    term
    Haematotoxicity
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      313
      num Events
      3
    term
    Leukopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      313
      num Events
      1
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      313
      num Events
      1
    term
    Pancytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      345
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      313
      num Events
      6
    term
    Thrombocytopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      313
      num Events
      0
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      345
      num Events
      4
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      313
      num Events
      0
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      340
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      313
      num Events
      1
    term
    Angina pectoris
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      340
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      345
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      313
      num Events
      2
    term
    Atrial fibrillation
time Frame
From first administration of study treatment up to 90 days after last dose of study medication or date of initiation of the first subsequent therapy, whichever occurs first, approximately 5 years. All-cause mortality, from screening up to data cut-off date (27JAN2020, approximately 5 years).

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice