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NCT00513474 · FLOW

Participant flow

Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant · Source last updated 2017-05-25

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

groups
  1. description
    Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
    id
    FG000
    title
    Rasburicase Group
  2. description
    Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
    id
    FG001
    title
    Control Group
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        9
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Participant Withdrew Consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        21
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        0
      type
      Received Rasburicase Per Protocol
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        12
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
    id
    FG000
    title
    Rasburicase Group
  2. description
    Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
    id
    FG001
    title
    Control Group
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        9
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Participant Withdrew Consent
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      2. group Id
        FG001
        num Subjects
        21
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        24
      2. group Id
        FG001
        num Subjects
        0
      type
      Received Rasburicase Per Protocol
    3. achievements
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        12
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice