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NCT01251575 · OUTCOME

Number of Patients With Grade II-IV Acute Graft Versus Host Disease (GVHD)

Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant · Source last updated 2019-12-09

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
100 days post-transplant

What was measured

Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death

Groups in this outcome

Class I Mismatch

Patients 1) mismatched at antigen level for any single class I locus (HLA-A, -B, -C) +/- an additional class mismatch at the allele level, or 2) mismatched at the allele level for any 2 class I loci.

Class II Mismatch

Patients mismatched at the antigen or allele level for class II loci HLA-DRB1 and/or DQB1. Must be matched for at least one DRB1 allele and one DQB1 allele.

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

Analysis denominator · Participants

GroupSource count
Class I Mismatch51
Class II Mismatch25

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Class I Mismatch15Not reportedNot reportedNot reportedNot reported
Class II Mismatch12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        12
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    2. group Id
      OG001
      value
      25
    units
    Participants
description
Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
groups
  1. description
    Patients 1) mismatched at antigen level for any single class I locus (HLA-A, -B, -C) +/- an additional class mismatch at the allele level, or 2) mismatched at the allele level for any 2 class I loci.
    id
    OG000
    title
    Class I Mismatch
  2. description
    Patients mismatched at the antigen or allele level for class II loci HLA-DRB1 and/or DQB1. Must be matched for at least one DRB1 allele and one DQB1 allele.
    id
    OG001
    title
    Class II Mismatch
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
100 days post-transplant
title
Number of Patients With Grade II-IV Acute Graft Versus Host Disease (GVHD)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice