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NCT01308580 · FLOW

Participant flow

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.

groups
  1. description
    Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    FG000
    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
    FG001
    title
    Cabazitaxel 25 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        598
      2. group Id
        FG001
        num Subjects
        602
      type
      STARTED
    2. achievements
      1. comment
        Random assignment, was not actual treatment in some cases
        group Id
        FG000
        num Subjects
        587
      2. comment
        Random assignment, was not actual treatment in some cases
        group Id
        FG001
        num Subjects
        588
      type
      Treated
    3. achievements
      1. comment
        Completed participants included those who withdrew treatment consent but were followed for survival
        group Id
        FG000
        num Subjects
        586
      2. comment
        Completed participants included those who withdrew treatment consent but were followed for survival
        group Id
        FG001
        num Subjects
        595
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were randomized by Interactive Voice Response System (IVRS) in 1:1 ratio (Cabazitaxel 20 mg/m\^2: Cabazitaxel 25 mg/m\^2) and stratified according to Eastern Cooperative Oncology Group Performance Status (ECOG PS) score (0 or 1 versus 2), measurability of disease (measurable versus non-measurable) and region.
recruitment Details
The study was conducted at 172 centers in 22 countries. A total of 1463 participants were screened between 19 April 2011 and 18 November 2013. Out of 1463 participants, 1200 participants were enrolled in this study and 263 were not eligible to join the study.
Complete source fields
groups
  1. description
    Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
    id
    FG000
    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
    FG001
    title
    Cabazitaxel 25 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        598
      2. group Id
        FG001
        num Subjects
        602
      type
      STARTED
    2. achievements
      1. comment
        Random assignment, was not actual treatment in some cases
        group Id
        FG000
        num Subjects
        587
      2. comment
        Random assignment, was not actual treatment in some cases
        group Id
        FG001
        num Subjects
        588
      type
      Treated
    3. achievements
      1. comment
        Completed participants included those who withdrew treatment consent but were followed for survival
        group Id
        FG000
        num Subjects
        586
      2. comment
        Completed participants included those who withdrew treatment consent but were followed for survival
        group Id
        FG001
        num Subjects
        595
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Participants were randomized by Interactive Voice Response System (IVRS) in 1:1 ratio (Cabazitaxel 20 mg/m\^2: Cabazitaxel 25 mg/m\^2) and stratified according to Eastern Cooperative Oncology Group Performance Status (ECOG PS) score (0 or 1 versus 2), measurability of disease (measurable versus non-measurable) and region.
recruitment Details
The study was conducted at 172 centers in 22 countries. A total of 1463 participants were screened between 19 April 2011 and 18 November 2013. Out of 1463 participants, 1200 participants were enrolled in this study and 263 were not eligible to join the study.

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Preserved source evidence · Not medical advice