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NCT02485691 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      129
    2. group Id
      BG001
      value
      126
    3. group Id
      BG002
      value
      255
    units
    Participants
groups
  1. 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
    BG000
    title
    Cabazitaxel
  2. 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
    BG001
    title
    Abiraterone Acetate or Enzalutamide
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.3
          value
          69.7
        2. group Id
          BG001
          spread
          7.9
          value
          69.7
        3. group Id
          BG002
          spread
          8.1
          value
          69.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          255
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          255
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          255
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
population Description
Analysis was performed on Intent-to-treat (ITT) population, that included any participant who had been allocated to a randomized treatment regardless of whether the treatment kit was used, analyzed according to the treatment group allocated by randomization.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      129
    2. group Id
      BG001
      value
      126
    3. group Id
      BG002
      value
      255
    units
    Participants
groups
  1. 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
    BG000
    title
    Cabazitaxel
  2. 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
    BG001
    title
    Abiraterone Acetate or Enzalutamide
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.3
          value
          69.7
        2. group Id
          BG001
          spread
          7.9
          value
          69.7
        3. group Id
          BG002
          spread
          8.1
          value
          69.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          255
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          255
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          129
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          255
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
population Description
Analysis was performed on Intent-to-treat (ITT) population, that included any participant who had been allocated to a randomized treatment regardless of whether the treatment kit was used, analyzed according to the treatment group allocated by randomization.

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Preserved source evidence · Not medical advice