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NCT00720629 · OUTCOME

Number of Participants With Grade II-IV Acute Graft-versus-Host Disease (GVHD) Score at 100 Days

Visilizumab for the Prevention of Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation · Source last updated 2014-07-18

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
100 days

What was measured

Cumulative Incidence of Grade II-IV Acute GVHD Score at 100 Days. Investigators had planned to assess whether the grade of acute GVHD was decreased by visilizumab in combination with tacrolimus/methotrexate compared to standard treatment with thymoglobulin/tacrolimus/methotrexate after transplantation from unrelated mismatched donors, from day of transplant up to one year. Study was closed during the first treatment stage and did not proceed to the second stage treatment comparison to ATG in combination with tacrolimus/methotrexate as originally planned. Overall GVHD Grade: From Filipovich AH, Weisdorf D, Pavletic S, etal: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 11:945-955 (2005). Grade I: Skin Stage 1-2, Liver Stage 0, Gut State 0; Grade II: Skin Stage 3 or, Liver Stage 1 or, Gut Stage 1; Grade II

Analysis population: All participants

Groups in this outcome

First Study Stage: Study Treatment

Visilizumab, Tacrolimus and Methotrexate. All participants.

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

Analysis denominator · Participants

GroupSource count
First Study Stage: Study Treatment8

Reported measurements

Grade II-IV Acute GVHD
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
First Study Stage: Study Treatment8Not reportedNot reportedNot reportedNot reported
Grade I-II Acute GVHD
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
First Study Stage: Study Treatment6Not reportedNot reportedNot reportedNot reported
Grade III-IV Acute GVHD
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
First Study Stage: Study Treatment2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Grade II-IV Acute GVHD
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Grade I-II Acute GVHD
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade III-IV Acute GVHD
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Cumulative Incidence of Grade II-IV Acute GVHD Score at 100 Days. Investigators had planned to assess whether the grade of acute GVHD was decreased by visilizumab in combination with tacrolimus/methotrexate compared to standard treatment with thymoglobulin/tacrolimus/methotrexate after transplantation from unrelated mismatched donors, from day of transplant up to one year. Study was closed during the first treatment stage and did not proceed to the second stage treatment comparison to ATG in combination with tacrolimus/methotrexate as originally planned. Overall GVHD Grade: From Filipovich AH, Weisdorf D, Pavletic S, etal: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 11:945-955 (2005). Grade I: Skin Stage 1-2, Liver Stage 0, Gut State 0; Grade II: Skin Stage 3 or, Liver Stage 1 or, Gut Stage 1; Grade II
groups
  1. description
    Visilizumab, Tacrolimus and Methotrexate. All participants.
    id
    OG000
    title
    First Study Stage: Study Treatment
param Type
NUMBER
population Description
All participants
reporting Status
POSTED
time Frame
100 days
title
Number of Participants With Grade II-IV Acute Graft-versus-Host Disease (GVHD) Score at 100 Days
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice