NCT00787761 · OUTCOME

Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)

Early Administration of ATG Followed by Cyclophosphamide, Busulfan and Fludarabine Before a Donor Stem Cell Transplant in Patients With Hematological Cancer · Source last updated 2012-10-01

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: 2 years

What was measured

Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.

Analysis population: 23 patients were able to be analyzed for severe gvhd

Groups in this outcome

RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan

All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 \& -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6

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

Analysis denominator · Participants

Group	Source count
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan	23

Reported measurements

Source class 1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan	13	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
13

denoms

counts
group Id
OG000
value
23
units
Participants

description

Patients who had post-transplant complication (GVHD) as seen by clinical evidence including but not limited to skin rash, elevated liver function tests, nausea/vomiting/diarrhea.

groups

description
All patients received ATG 1mg/kg Day-16 and then 3.5 mg/kg Day -15 Fludarabine 30mg/m2/day on days -7 to -3 Busulfan 130 mg/m2 on days -4 \& -3 Cyclophosphamide 1.5 g/m2 on day -2 Tacrolimus begins 0.03mg/kg bid on Day -1 Stem Cell transplant on Day 0 Methotrexate 5mg/m2 given D+1, +3 and +6
id
OG000
title
RIC Transplant Using ATG, Busulfan, Fludarabine and Cytoxan

param Type

NUMBER

population Description

23 patients were able to be analyzed for severe gvhd

reporting Status

POSTED

time Frame

2 years

title

Number of Patients Experiencing Extensive Chronic Graft Versus Host Disease (GVHD)

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice