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NCT00136084 · FLOW

Participant flow

Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia · Source last updated 2012-12-05

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

groups
  1. description
    High-dose Cytarabine (HDAC)
    id
    FG000
    title
    Arm 1: (HDAC)
  2. description
    Low-dose Cytarabine (LDAC)
    id
    FG001
    title
    Arm 2:(LDAC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        5
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        11
      type
      Unacceptable toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        23
      type
      Relapse
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      No Response
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        109
      2. group Id
        FG001
        num Subjects
        114
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        72
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        42
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
238 patients were enrolled on the study. This report is based on results for 223 patients. 15 patients were excluded for the following reasons: 7 were switched to lymphoid-directed therapy shortly after enrollment, 6 were determined to be ineligible shortly after enrollment (wrong diagnosis), and 2 were not randomized.
recruitment Details
238 patients were recruited between October, 2002 and June, 2008.
Complete source fields
groups
  1. description
    High-dose Cytarabine (HDAC)
    id
    FG000
    title
    Arm 1: (HDAC)
  2. description
    Low-dose Cytarabine (LDAC)
    id
    FG001
    title
    Arm 2:(LDAC)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        5
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        8
      2. group Id
        FG001
        num Subjects
        11
      type
      Unacceptable toxicity
    3. reasons
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        23
      type
      Relapse
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        2
      type
      No Response
    6. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        109
      2. group Id
        FG001
        num Subjects
        114
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        72
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        48
      2. group Id
        FG001
        num Subjects
        42
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
238 patients were enrolled on the study. This report is based on results for 223 patients. 15 patients were excluded for the following reasons: 7 were switched to lymphoid-directed therapy shortly after enrollment, 6 were determined to be ineligible shortly after enrollment (wrong diagnosis), and 2 were not randomized.
recruitment Details
238 patients were recruited between October, 2002 and June, 2008.

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Preserved source evidence · Not medical advice