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NCT02799602 · ADVERSE EVENTS

Adverse events

Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer · Source last updated 2025-12-04

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 the last administration, including adverse event of all-cause mortality at any time during the study, up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)
Other-event reporting threshold
5%

Treatment-emergent AEs (TEAEs) were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration. Events causally related to treatment were considered as events causally related to either darolutamide / Docetaxel or Placebo / Docetaxel A total of 1305 patients were randomized for efficacy analysis, however 1302 patients only started treatment and were included to safety analyses.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Darolutamide (BAY1841788) + Docetaxel

Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started \<=12 weeks before randomization.

306 / 652636 / 652231 / 652
Placebo + Docetaxel

Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started \<=12 weeks before randomization.

276 / 650634 / 650305 / 650

Group identifiers: EG000: Darolutamide (BAY1841788) + Docetaxel · EG001: Placebo + Docetaxel

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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      652
      num Events
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      650
      num Events
      4
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      652
      num Events
      40
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      650
      num Events
      44
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      650
      num Events
      0
    term
    Granulocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      652
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      650
      num Events
      2
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      650
      num Events
      0
    term
    Lymphadenopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      650
      num Events
      1
    term
    Myelosuppression
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      652
      num Events
      17
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      650
      num Events
      17
    term
    Neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      650
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      650
      num Events
      0
    term
    Thrombocytopenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      650
      num Events
      1
    term
    Bicytopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      652
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      650
      num Events
      1
    term
    Bone marrow oedema syndrome
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      650
      num Events
      0
    term
    Immune thrombocytopenia

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 (25.1)
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      652
      num Events
      276
    2. group Id
      EG001
      num Affected
      164
      num At Risk
      650
      num Events
      227
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      652
      num Events
      108
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      650
      num Events
      103
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      652
      num Events
      40
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      650
      num Events
      47
    term
    Lacrimation increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      652
      num Events
      40
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      650
      num Events
      40
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      149
      num At Risk
      652
      num Events
      202
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      650
      num Events
      162
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      168
      num At Risk
      652
      num Events
      229
    2. group Id
      EG001
      num Affected
      157
      num At Risk
      650
      num Events
      225
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      117
      num At Risk
      652
      num Events
      150
    2. group Id
      EG001
      num Affected
      134
      num At Risk
      650
      num Events
      174
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      652
      num Events
      87
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      650
      num Events
      69
    term
    Stomatitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      652
      num Events
      63
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      650
      num Events
      69
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      652
      num Events
      89
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      650
      num Events
      83
    term
    Asthenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      222
      num At Risk
      652
      num Events
      291
    2. group Id
      EG001
      num Affected
      215
      num At Risk
      650
      num Events
      287
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      652
      num Events
      78
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      650
      num Events
      97
    term
    Malaise
Complete source fields
description
Treatment-emergent AEs (TEAEs) were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration. Events causally related to treatment were considered as events causally related to either darolutamide / Docetaxel or Placebo / Docetaxel A total of 1305 patients were randomized for efficacy analysis, however 1302 patients only started treatment and were included to safety analyses.
event Groups
  1. deaths Num Affected
    231
    deaths Num At Risk
    652
    description
    Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started \<=12 weeks before randomization.
    id
    EG000
    other Num Affected
    636
    other Num At Risk
    652
    serious Num Affected
    306
    serious Num At Risk
    652
    title
    Darolutamide (BAY1841788) + Docetaxel
  2. deaths Num Affected
    305
    deaths Num At Risk
    650
    description
    Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started \<=12 weeks before randomization.
    id
    EG001
    other Num Affected
    634
    other Num At Risk
    650
    serious Num Affected
    276
    serious Num At Risk
    650
    title
    Placebo + Docetaxel
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      652
      num Events
      276
    2. group Id
      EG001
      num Affected
      164
      num At Risk
      650
      num Events
      227
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      652
      num Events
      108
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      650
      num Events
      103
    term
    Neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      652
      num Events
      40
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      650
      num Events
      47
    term
    Lacrimation increased
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      652
      num Events
      40
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      650
      num Events
      40
    term
    Abdominal pain
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      149
      num At Risk
      652
      num Events
      202
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      650
      num Events
      162
    term
    Constipation
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      168
      num At Risk
      652
      num Events
      229
    2. group Id
      EG001
      num Affected
      157
      num At Risk
      650
      num Events
      225
    term
    Diarrhoea
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      117
      num At Risk
      652
      num Events
      150
    2. group Id
      EG001
      num Affected
      134
      num At Risk
      650
      num Events
      174
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      652
      num Events
      87
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      650
      num Events
      69
    term
    Stomatitis
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      652
      num Events
      63
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      650
      num Events
      69
    term
    Vomiting
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      652
      num Events
      89
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      650
      num Events
      83
    term
    Asthenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      222
      num At Risk
      652
      num Events
      291
    2. group Id
      EG001
      num Affected
      215
      num At Risk
      650
      num Events
      287
    term
    Fatigue
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      652
      num Events
      78
    2. group Id
      EG001
      num Affected
      67
      num At Risk
      650
      num Events
      97
    term
    Malaise
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      652
      num Events
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      650
      num Events
      4
    term
    Anaemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      652
      num Events
      40
    2. group Id
      EG001
      num Affected
      39
      num At Risk
      650
      num Events
      44
    term
    Febrile neutropenia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      650
      num Events
      0
    term
    Granulocytopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      652
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      650
      num Events
      2
    term
    Leukopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      650
      num Events
      0
    term
    Lymphadenopathy
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      650
      num Events
      1
    term
    Myelosuppression
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      652
      num Events
      17
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      650
      num Events
      17
    term
    Neutropenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      650
      num Events
      0
    term
    Pancytopenia
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      650
      num Events
      0
    term
    Thrombocytopenia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      650
      num Events
      1
    term
    Bicytopenia
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      652
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      650
      num Events
      1
    term
    Bone marrow oedema syndrome
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (25.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      652
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      650
      num Events
      0
    term
    Immune thrombocytopenia
time Frame
From start of study drug administration until 30 days after the last administration, including adverse event of all-cause mortality at any time during the study, up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)

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Preserved source evidence · Not medical advice