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NCT02200614 · ADVERSE EVENTS

Adverse events

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer · Source last updated 2022-06-28

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 start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)
Other-event reporting threshold
2%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Darolutamide (DB)

Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg (double blind \[DB\]).

251 / 954673 / 954155 / 954
Darolutamide (DB+OL)

Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).

367 / 954742 / 954224 / 954
Placebo (DB)

Participants received matching placebo 2 tablets twice daily with food (double blind \[DB\]).

121 / 554354 / 554137 / 554
Placebo+Darolutamide (CO)

Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).

43 / 170110 / 17016 / 170

Group identifiers: EG000: Darolutamide (DB) · EG001: Darolutamide (DB+OL) · EG002: Placebo (DB) · EG003: Placebo+Darolutamide (CO)

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 (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      954
      num Events
      4
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      954
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      170
      num Events
      1
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      954
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      954
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      554
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      954
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      954
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      954
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      954
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      954
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      954
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      554
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      954
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      954
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      954
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      954
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      170
      num Events
      1
    term
    Immune thrombocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      954
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      954
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Acute myocardial infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      954
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      954
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      554
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      170
      num Events
      1
    term
    Angina pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      954
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      954
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      554
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Angina unstable
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      954
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      954
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      554
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Aortic valve stenosis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      954
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      954
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      170
      num Events
      1
    term
    Arrhythmia

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 (24.0)
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      954
      num Events
      76
    2. group Id
      EG001
      num Affected
      93
      num At Risk
      954
      num Events
      136
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      554
      num Events
      33
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      170
      num Events
      7
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      954
      num Events
      17
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      954
      num Events
      27
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      554
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      170
      num Events
      2
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      954
      num Events
      20
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      954
      num Events
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      554
      num Events
      8
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      170
      num Events
      4
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      954
      num Events
      11
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      954
      num Events
      16
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      554
      num Events
      6
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      170
      num Events
      4
    term
    Cataract
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      954
      num Events
      27
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      954
      num Events
      39
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      554
      num Events
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      170
      num Events
      2
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      954
      num Events
      16
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      954
      num Events
      19
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      554
      num Events
      15
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      170
      num Events
      3
    term
    Abdominal pain upper
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      954
      num Events
      70
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      954
      num Events
      94
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      554
      num Events
      41
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      170
      num Events
      11
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      954
      num Events
      87
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      954
      num Events
      114
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      554
      num Events
      37
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      170
      num Events
      16
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      954
      num Events
      59
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      954
      num Events
      76
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      554
      num Events
      37
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      170
      num Events
      6
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      954
      num Events
      19
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      954
      num Events
      24
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      554
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      170
      num Events
      3
    term
    Vomiting
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      954
      num Events
      42
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      954
      num Events
      53
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      554
      num Events
      23
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      170
      num Events
      8
    term
    Asthenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      126
      num At Risk
      954
      num Events
      164
    2. group Id
      EG001
      num Affected
      142
      num At Risk
      954
      num Events
      198
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      554
      num Events
      60
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      170
      num Events
      9
    term
    Fatigue
Complete source fields
event Groups
  1. deaths Num Affected
    155
    deaths Num At Risk
    954
    description
    Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg (double blind \[DB\]).
    id
    EG000
    other Num Affected
    673
    other Num At Risk
    954
    serious Num Affected
    251
    serious Num At Risk
    954
    title
    Darolutamide (DB)
  2. deaths Num Affected
    224
    deaths Num At Risk
    954
    description
    Participants received Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equal to a total daily dose of 1200 mg. Participants in the darolutamide treatment arm were ongoing with open-label darolutamide treatment (darolutamide double-blind \[DB\] + open-label \[OL\]).
    id
    EG001
    other Num Affected
    742
    other Num At Risk
    954
    serious Num Affected
    367
    serious Num At Risk
    954
    title
    Darolutamide (DB+OL)
  3. deaths Num Affected
    137
    deaths Num At Risk
    554
    description
    Participants received matching placebo 2 tablets twice daily with food (double blind \[DB\]).
    id
    EG002
    other Num Affected
    354
    other Num At Risk
    554
    serious Num Affected
    121
    serious Num At Risk
    554
    title
    Placebo (DB)
  4. deaths Num Affected
    16
    deaths Num At Risk
    170
    description
    Participants received matching placebo 2 tablets twice daily with food. Participants from the placebo arm crossed over to receive open-label darolutamide treatment (placebo-darolutamide cross-over \[CO\]).
    id
    EG003
    other Num Affected
    110
    other Num At Risk
    170
    serious Num Affected
    43
    serious Num At Risk
    170
    title
    Placebo+Darolutamide (CO)
frequency Threshold
2
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      954
      num Events
      76
    2. group Id
      EG001
      num Affected
      93
      num At Risk
      954
      num Events
      136
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      554
      num Events
      33
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      170
      num Events
      7
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      954
      num Events
      17
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      954
      num Events
      27
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      554
      num Events
      4
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      170
      num Events
      2
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      954
      num Events
      20
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      954
      num Events
      30
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      554
      num Events
      8
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      170
      num Events
      4
    term
    Atrial fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      954
      num Events
      11
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      954
      num Events
      16
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      554
      num Events
      6
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      170
      num Events
      4
    term
    Cataract
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      954
      num Events
      27
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      954
      num Events
      39
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      554
      num Events
      14
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      170
      num Events
      2
    term
    Abdominal pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      954
      num Events
      16
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      954
      num Events
      19
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      554
      num Events
      15
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      170
      num Events
      3
    term
    Abdominal pain upper
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      65
      num At Risk
      954
      num Events
      70
    2. group Id
      EG001
      num Affected
      84
      num At Risk
      954
      num Events
      94
    3. group Id
      EG002
      num Affected
      36
      num At Risk
      554
      num Events
      41
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      170
      num Events
      11
    term
    Constipation
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      954
      num Events
      87
    2. group Id
      EG001
      num Affected
      87
      num At Risk
      954
      num Events
      114
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      554
      num Events
      37
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      170
      num Events
      16
    term
    Diarrhoea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      954
      num Events
      59
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      954
      num Events
      76
    3. group Id
      EG002
      num Affected
      32
      num At Risk
      554
      num Events
      37
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      170
      num Events
      6
    term
    Nausea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      954
      num Events
      19
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      954
      num Events
      24
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      554
      num Events
      12
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      170
      num Events
      3
    term
    Vomiting
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      954
      num Events
      42
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      954
      num Events
      53
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      554
      num Events
      23
    4. group Id
      EG003
      num Affected
      7
      num At Risk
      170
      num Events
      8
    term
    Asthenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      126
      num At Risk
      954
      num Events
      164
    2. group Id
      EG001
      num Affected
      142
      num At Risk
      954
      num Events
      198
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      554
      num Events
      60
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      170
      num Events
      9
    term
    Fatigue
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      954
      num Events
      4
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      954
      num Events
      9
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      170
      num Events
      1
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      954
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      954
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      554
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      954
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      954
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      954
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      954
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      954
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      954
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      554
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Neutropenia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      954
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      954
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Autoimmune haemolytic anaemia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      954
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      954
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      170
      num Events
      1
    term
    Immune thrombocytopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      954
      num Events
      5
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      954
      num Events
      6
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Acute myocardial infarction
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      954
      num Events
      5
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      954
      num Events
      5
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      554
      num Events
      2
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      170
      num Events
      1
    term
    Angina pectoris
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      954
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      954
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      554
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Angina unstable
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      954
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      954
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      554
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      170
      num Events
      0
    term
    Aortic valve stenosis
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      954
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      954
      num Events
      3
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      554
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      170
      num Events
      1
    term
    Arrhythmia
time Frame
From start of study drug administration until 30 days after last treatment (last cut-off date 14 JUN 2021)

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

Preserved source evidence · Not medical advice