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NCT02485691 · ADVERSE EVENTS

Adverse events

Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent · Source last updated 2022-05-27

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

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

Collection time frame
Adverse event (AE) data was collected from Baseline up to 30 days after the last treatment administration (up to 197 weeks), deaths were collected from baseline up to end of study (up to 197 weeks).
Other-event reporting threshold
5%

Reported AEs were TEAEs i.e., AEs that developed/worsened during the 'on-treatment period' (time from first dose of study drug until 30 days after last administration of study drug) assessed for safety population (i.e., all participants who received at least one dose of study drugs and analyzed according to treatment they actually received). All-Cause Mortality data collected during the study was assessed for all randomized participants. Disease progression related death were not reported as AE.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cabazitaxel

Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).

49 / 126114 / 12696 / 129
Enzalutamide or Abiraterone

Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).

50 / 124104 / 124103 / 126

Group identifiers: EG000: Cabazitaxel · EG001: Enzalutamide or Abiraterone

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      126
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      126
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      124
      num Events
      0
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      1
    term
    Hyperfibrinolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      126
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      124
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      126
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      124
      num Events
      0
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      1
    term
    Acute Coronary Syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      1
    term
    Angina Pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      126
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      124
      num Events
      0
    term
    Atrial Fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      126
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      124
      num Events
      0
    term
    Atrial Flutter
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      124
      num Events
      2
    term
    Atrioventricular Block Complete
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      124
      num Events
      2
    term
    Cardiac Failure

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 23.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      126
      num Events
      75
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      124
      num Events
      24
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      126
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      3
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      126
      num Events
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      3
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      126
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      124
      num Events
      3
    term
    Abdominal Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      126
      num Events
      27
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      124
      num Events
      18
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      126
      num Events
      88
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      124
      num Events
      8
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      126
      num Events
      49
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      124
      num Events
      31
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      126
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      124
      num Events
      3
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      126
      num Events
      21
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      124
      num Events
      18
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      126
      num Events
      69
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      124
      num Events
      37
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      126
      num Events
      65
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      124
      num Events
      27
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      126
      num Events
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      124
      num Events
      12
    term
    Oedema Peripheral
Complete source fields
description
Reported AEs were TEAEs i.e., AEs that developed/worsened during the 'on-treatment period' (time from first dose of study drug until 30 days after last administration of study drug) assessed for safety population (i.e., all participants who received at least one dose of study drugs and analyzed according to treatment they actually received). All-Cause Mortality data collected during the study was assessed for all randomized participants. Disease progression related death were not reported as AE.
event Groups
  1. deaths Num Affected
    96
    deaths Num At Risk
    129
    description
    Participants received Cabazitaxel 25 mg/m\^2 IV infusion for over 1 hour on Day 1 of each 3 week treatment cycle in combination with Prednisone 10 mg orally once daily and primary prophylactic G-CSF as per investigator decision, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 22 weeks).
    id
    EG000
    other Num Affected
    114
    other Num At Risk
    126
    serious Num Affected
    49
    serious Num At Risk
    126
    title
    Cabazitaxel
  2. deaths Num Affected
    103
    deaths Num At Risk
    126
    description
    Participants received either abiraterone acetate 1000 mg orally once daily from Day 1 to Day 21 of each 3 week treatment cycle in combination with prednisone 5 mg orally twice daily; or enzalutamide 160 mg orally once daily continuously from Day 1 to Day 21 of each 3 week treatment cycle, until radiographic disease progression, unacceptable toxicity, or participant's refusal of further study treatment (median duration = 12.5 weeks).
    id
    EG001
    other Num Affected
    104
    other Num At Risk
    124
    serious Num Affected
    50
    serious Num At Risk
    124
    title
    Enzalutamide or Abiraterone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      126
      num Events
      75
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      124
      num Events
      24
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      126
      num Events
      12
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      3
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      126
      num Events
      35
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      3
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      126
      num Events
      12
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      124
      num Events
      3
    term
    Abdominal Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      126
      num Events
      27
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      124
      num Events
      18
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      126
      num Events
      88
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      124
      num Events
      8
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      126
      num Events
      49
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      124
      num Events
      31
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      126
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      124
      num Events
      3
    term
    Stomatitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      126
      num Events
      21
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      124
      num Events
      18
    term
    Vomiting
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      126
      num Events
      69
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      124
      num Events
      37
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      126
      num Events
      65
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      124
      num Events
      27
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      126
      num Events
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      124
      num Events
      12
    term
    Oedema Peripheral
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      126
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      126
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      124
      num Events
      0
    term
    Febrile Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      1
    term
    Hyperfibrinolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      126
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      124
      num Events
      0
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      126
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      124
      num Events
      0
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      1
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      1
    term
    Acute Coronary Syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      124
      num Events
      1
    term
    Angina Pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      126
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      124
      num Events
      0
    term
    Atrial Fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      126
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      124
      num Events
      0
    term
    Atrial Flutter
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      124
      num Events
      2
    term
    Atrioventricular Block Complete
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDra 23.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      126
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      124
      num Events
      2
    term
    Cardiac Failure
time Frame
Adverse event (AE) data was collected from Baseline up to 30 days after the last treatment administration (up to 197 weeks), deaths were collected from baseline up to end of study (up to 197 weeks).

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