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NCT00914940 · OUTCOME

Number of Participants With Acute Graft-vs-host Disease (GVHD): Grade I-IV, Including Those With no Reportable Acute GVHD

Selective Depletion of CD45RA+T Cells From Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD · Source last updated 2020-08-20

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
Within 360 days of transplant

What was measured

Number of participants with aGVHD and severity of aGVHD within the first 360 days post-transplant as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Acute GVHD is graded by standard criteria, and all suspected cases of acute GVHD will be confirmed histologically by biopsy of an affected organ. The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. Grade I is characterized as mild disease, Grade II as moderate, Grade III as severe (involvement of any organ system), and Grade IV as life-threatening.

Groups in this outcome

Overall Study Participants

CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for 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
Overall Study Participants41

Reported measurements

Source class 1

No acute GVHD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study Participants11Not reportedNot reportedNot reportedNot reported

Grade I acute GVHD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study Participants2Not reportedNot reportedNot reportedNot reported

Grade II acute GVHD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study Participants25Not reportedNot reportedNot reportedNot reported

Grade III acute GVHD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study Participants3Not reportedNot reportedNot reportedNot reported

Grade IV acute GVHD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study Participants0Not reportedNot reportedNot reportedNot reported

Steroid refractory acute GVHD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Overall Study Participants0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      title
      No acute GVHD
    2. measurements
      1. group Id
        OG000
        value
        2
      title
      Grade I acute GVHD
    3. measurements
      1. group Id
        OG000
        value
        25
      title
      Grade II acute GVHD
    4. measurements
      1. group Id
        OG000
        value
        3
      title
      Grade III acute GVHD
    5. measurements
      1. group Id
        OG000
        value
        0
      title
      Grade IV acute GVHD
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      Steroid refractory acute GVHD
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    units
    Participants
description
Number of participants with aGVHD and severity of aGVHD within the first 360 days post-transplant as graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Acute GVHD is graded by standard criteria, and all suspected cases of acute GVHD will be confirmed histologically by biopsy of an affected organ. The severity of acute GVHD is determined by an assessment of the degree of involvement of the skin, liver, and gastrointestinal tract. Grade I is characterized as mild disease, Grade II as moderate, Grade III as severe (involvement of any organ system), and Grade IV as life-threatening.
groups
  1. description
    CD34+ enriched allogeneic peripheral blood stem cells (PBSC) followed by CD45RA+ T-cell-depleted allogeneic PBSC and tacrolimus for GVHD prophylaxis
    id
    OG000
    title
    Overall Study Participants
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Within 360 days of transplant
title
Number of Participants With Acute Graft-vs-host Disease (GVHD): Grade I-IV, Including Those With no Reportable Acute GVHD
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice