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NCT00022633 · FLOW

Participant flow

S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract · Source last updated 2016-08-11

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

groups
  1. description
    Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
    id
    FG000
    title
    Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
  2. description
    Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
    id
    FG001
    title
    Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Refusal unrelated to adverse event
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        2
      type
      Progression/relapse
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Other - not protocol specified
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        51
      2. group Id
        FG001
        num Subjects
        10
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        5
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The purpose of the subset of patients who aged 60 years or younger was to serve as a younger reference group for the pharmacokinetic parameter estimation. Therefore, this younger cohort is not included in analyses of adverse event, efficacy, and feasibility assessment of patient-reported outcome measures.
Complete source fields
groups
  1. description
    Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
    id
    FG000
    title
    Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
  2. description
    Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
    id
    FG001
    title
    Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        11
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Refusal unrelated to adverse event
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        2
      type
      Progression/relapse
    4. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      type
      Other - not protocol specified
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Ineligible
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        55
      2. group Id
        FG001
        num Subjects
        10
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        51
      2. group Id
        FG001
        num Subjects
        10
      type
      Eligible
    3. achievements
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        5
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        32
      2. group Id
        FG001
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The purpose of the subset of patients who aged 60 years or younger was to serve as a younger reference group for the pharmacokinetic parameter estimation. Therefore, this younger cohort is not included in analyses of adverse event, efficacy, and feasibility assessment of patient-reported outcome measures.

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Preserved source evidence · Not medical advice