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NCT01308580 · ADVERSE EVENTS

Adverse events

Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer · Source last updated 2017-04-17

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
All AEs were collected from signature of the informed consent form up to the final visit (48 months) regardless of seriousness or relationship to investigational product.
Other-event reporting threshold
5%

Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug until 30 days after the last administration of study drug). Analysis was performed on safety population.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cabazitaxel 20 mg/m^2

Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

177 / 580450 / 580Not reported / Not reported
Cabazitaxel 25 mg/m^2

Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

257 / 595507 / 595Not reported / Not reported

Group identifiers: EG000: Cabazitaxel 20 mg/m^2 · EG001: Cabazitaxel 25 mg/m^2

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
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      595
    term
    Amoebic dysentery
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Arthritis bacterial
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      595
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      595
    term
    Cellulitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Cholecystitis infective
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Clostridial infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Clostridium bacteraemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Device related infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Erysipelas
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      595
    term
    Escherichia sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      595
    term
    Febrile infection

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
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      595
    term
    Urinary tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      595
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      108
      num At Risk
      595
    term
    Decreased appetite
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      595
    term
    Dizziness
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      595
    term
    Dysgeusia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      595
    term
    Peripheral sensory neuropathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      595
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      595
    term
    Dyspnoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      595
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      595
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      175
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      231
      num At Risk
      595
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      140
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      188
      num At Risk
      595
    term
    Nausea
Complete source fields
description
Reported AEs are TEAEs that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug until 30 days after the last administration of study drug). Analysis was performed on safety population.
event Groups
  1. description
    Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    EG000
    other Num Affected
    450
    other Num At Risk
    580
    serious Num Affected
    177
    serious Num At Risk
    580
    title
    Cabazitaxel 20 mg/m^2
  2. description
    Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    EG001
    other Num Affected
    507
    other Num At Risk
    595
    serious Num Affected
    257
    serious Num At Risk
    595
    title
    Cabazitaxel 25 mg/m^2
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      51
      num At Risk
      595
    term
    Urinary tract infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      595
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      74
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      108
      num At Risk
      595
    term
    Decreased appetite
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      595
    term
    Dizziness
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      595
    term
    Dysgeusia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      63
      num At Risk
      595
    term
    Peripheral sensory neuropathy
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      595
    term
    Cough
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      595
    term
    Dyspnoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      595
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      595
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      175
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      231
      num At Risk
      595
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      140
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      188
      num At Risk
      595
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Abdominal infection
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      595
    term
    Amoebic dysentery
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Arthritis bacterial
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      595
    term
    Bronchitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      595
    term
    Cellulitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Cholecystitis infective
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Clostridial infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Clostridium bacteraemia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Device related infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      595
    term
    Erysipelas
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      595
    term
    Escherichia sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDra 18.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      580
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      595
    term
    Febrile infection
time Frame
All AEs were collected from signature of the informed consent form up to the final visit (48 months) regardless of seriousness or relationship to investigational product.

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