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NCT00054327 · OUTCOME

Toxicity as Measured by CTC v2.0

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer · Source last updated 2013-07-24

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
at 100 days post transplant

What was measured

Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities.

Groups in this outcome

Regimen A

Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.

Regimen B-1

Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..

Regimen B-2

Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.

Regimen B-3

Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.

Regimen C

Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.

Regimen D

Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Regimen A11
Regimen B-14
Regimen B-23
Regimen B-34
Regimen C10
Regimen D2

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Regimen A0Not reportedNot reportedNot reportedNot reported
Regimen B-10Not reportedNot reportedNot reportedNot reported
Regimen B-21Not reportedNot reportedNot reportedNot reported
Regimen B-32Not reportedNot reportedNot reportedNot reported
Regimen C2Not reportedNot reportedNot reportedNot reported
Regimen D0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      2
    units
    Participants
description
Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities.
groups
  1. description
    Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
    id
    OG000
    title
    Regimen A
  2. description
    Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
    id
    OG001
    title
    Regimen B-1
  3. description
    Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
    id
    OG002
    title
    Regimen B-2
  4. description
    Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
    id
    OG003
    title
    Regimen B-3
  5. description
    Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
    id
    OG004
    title
    Regimen C
  6. description
    Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
    id
    OG005
    title
    Regimen D
param Type
NUMBER
reporting Status
POSTED
time Frame
at 100 days post transplant
title
Toxicity as Measured by CTC v2.0
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice