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NCT00382109 · OUTCOME

Estimated Rate of Overall Chronic Graft VS Host Disease

Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission · Source last updated 2019-08-07

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
At 2 years

What was measured

Chronic graft vs host disease is defined in APPENDIX III of study protocol.

Analysis population: 2 ineligible patients on experimental arm excluded from analysis. Definition of Chronic GVHD: APPENDIX III: DEFINING CHRONIC GRAFT VS. HOST DISEASE (FROM BMT CTN MOP SEPT. 2005) on page 97 protocol.

Groups in this outcome

Experimental

Tacro-MTX/Sirolimus GVHD Prophylaxis

Control

Tacro-MTX GVHD Prophylaxis

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

Analysis denominator · Participants

GroupSource count
Experimental74
Control70

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Experimental22Not reported1436Not reported
Control27Not reported1840Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14
        upper Limit
        36
        value
        22
      2. group Id
        OG001
        lower Limit
        18
        upper Limit
        40
        value
        27
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      70
    units
    Participants
description
Chronic graft vs host disease is defined in APPENDIX III of study protocol.
dispersion Type
95% Confidence Interval
groups
  1. description
    Tacro-MTX/Sirolimus GVHD Prophylaxis
    id
    OG000
    title
    Experimental
  2. description
    Tacro-MTX GVHD Prophylaxis
    id
    OG001
    title
    Control
param Type
NUMBER
population Description
2 ineligible patients on experimental arm excluded from analysis. Definition of Chronic GVHD: APPENDIX III: DEFINING CHRONIC GRAFT VS. HOST DISEASE (FROM BMT CTN MOP SEPT. 2005) on page 97 protocol.
reporting Status
POSTED
time Frame
At 2 years
title
Estimated Rate of Overall Chronic Graft VS Host Disease
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice