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NCT01308567 · FLOW

Participant flow

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer · Source last updated 2019-06-05

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

groups
  1. description
    Docetaxel (TXT) 75 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal.
    id
    FG000
    title
    Docetaxel 75 mg/m^2
  2. description
    Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    id
    FG001
    title
    Cabazitaxel 20 mg/m^2
  3. description
    Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    id
    FG002
    title
    Cabazitaxel 25 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. comment
        Randomized
        group Id
        FG000
        num Subjects
        391
      2. comment
        Randomized
        group Id
        FG001
        num Subjects
        389
      3. comment
        Randomized
        group Id
        FG002
        num Subjects
        388
      type
      STARTED
    2. achievements
      1. comment
        For 1 participant, actual treatment received was Cabazitaxel 25 mg/m\^2.
        group Id
        FG000
        num Subjects
        388
      2. comment
        For 15 participants, actual treatment received was Cabazitaxel 25 mg/m\^2.
        group Id
        FG001
        num Subjects
        382
      3. comment
        For 2 participants, actual treatment received was Cabazitaxel 20 mg/m\^2.
        group Id
        FG002
        num Subjects
        377
      type
      Treated
    3. achievements
      1. comment
        Completed participants included those who withdrew treatment consent but were followed for survival.
        group Id
        FG000
        num Subjects
        389
      2. comment
        Completed participants included those who withdrew treatment consent but were followed for survival.
        group Id
        FG001
        num Subjects
        385
      3. comment
        Completed participants included those who withdrew treatment consent but were followed for survival.
        group Id
        FG002
        num Subjects
        384
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 1168 participants randomized in this study. Of these, 21 participants randomized but not treated. These participants were included in intent-to-treat (ITT) population, not in safety population. "Study cut-off date" for outcome measures was up to "primary completion date" (PCD) only. After PCD, only adverse event (AE) data was updated.
recruitment Details
The study was conducted at 159 centers in 25 countries. A total of 1510 participants were screened between 17 May 2011 and 09 September 2015 of whom 1168 participants were randomized and 342 were considered as screen failures.
Complete source fields
groups
  1. description
    Docetaxel (TXT) 75 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal.
    id
    FG000
    title
    Docetaxel 75 mg/m^2
  2. description
    Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    id
    FG001
    title
    Cabazitaxel 20 mg/m^2
  3. description
    Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
    id
    FG002
    title
    Cabazitaxel 25 mg/m^2
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. comment
        Randomized
        group Id
        FG000
        num Subjects
        391
      2. comment
        Randomized
        group Id
        FG001
        num Subjects
        389
      3. comment
        Randomized
        group Id
        FG002
        num Subjects
        388
      type
      STARTED
    2. achievements
      1. comment
        For 1 participant, actual treatment received was Cabazitaxel 25 mg/m\^2.
        group Id
        FG000
        num Subjects
        388
      2. comment
        For 15 participants, actual treatment received was Cabazitaxel 25 mg/m\^2.
        group Id
        FG001
        num Subjects
        382
      3. comment
        For 2 participants, actual treatment received was Cabazitaxel 20 mg/m\^2.
        group Id
        FG002
        num Subjects
        377
      type
      Treated
    3. achievements
      1. comment
        Completed participants included those who withdrew treatment consent but were followed for survival.
        group Id
        FG000
        num Subjects
        389
      2. comment
        Completed participants included those who withdrew treatment consent but were followed for survival.
        group Id
        FG001
        num Subjects
        385
      3. comment
        Completed participants included those who withdrew treatment consent but were followed for survival.
        group Id
        FG002
        num Subjects
        384
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
A total of 1168 participants randomized in this study. Of these, 21 participants randomized but not treated. These participants were included in intent-to-treat (ITT) population, not in safety population. "Study cut-off date" for outcome measures was up to "primary completion date" (PCD) only. After PCD, only adverse event (AE) data was updated.
recruitment Details
The study was conducted at 159 centers in 25 countries. A total of 1510 participants were screened between 17 May 2011 and 09 September 2015 of whom 1168 participants were randomized and 342 were considered as screen failures.

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Preserved source evidence · Not medical advice