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NCT00382109 · OUTCOME

Estimated Rate of Acute Graft VS Host Disease (GVHD)

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 200 days

What was measured

Any grade acute graft vs host disease (defined in APPENDIX II study protocol).

Analysis population: 2 ineligible patients on experimental arm excluded from analysis. Definition of Acute GVHD: APPENDIX II: COG STEM CELL COMMITTEE CONSENSUS GUIDELINES FOR ESTABLISHING ORGAN STAGE AND OVERALL GRADE OF ACUTE GRAFT VERSUS HOST DISEASE (GVHD) page 90-96 protocol.

Groups in this outcome

Experiemental

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
Experiemental74
Control70

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Experiemental32Not reported2245Not reported
Control49Not reported3863Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22
        upper Limit
        45
        value
        32
      2. group Id
        OG001
        lower Limit
        38
        upper Limit
        63
        value
        49
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      70
    units
    Participants
description
Any grade acute graft vs host disease (defined in APPENDIX II study protocol).
dispersion Type
95% Confidence Interval
groups
  1. description
    Tacro-MTX/Sirolimus GVHD Prophylaxis
    id
    OG000
    title
    Experiemental
  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 Acute GVHD: APPENDIX II: COG STEM CELL COMMITTEE CONSENSUS GUIDELINES FOR ESTABLISHING ORGAN STAGE AND OVERALL GRADE OF ACUTE GRAFT VERSUS HOST DISEASE (GVHD) page 90-96 protocol.
reporting Status
POSTED
time Frame
At 200 days
title
Estimated Rate of Acute Graft VS Host Disease (GVHD)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice