NCT00382109 · OUTCOME

Rate of Relapses

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 2 years

What was measured

An event is defined as relapse.

Analysis population: 2 ineligible patients on experimental arm excluded from analysis.Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.

Groups in this outcome

Experimental

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

Group	Source count
Experimental	74
Control	70

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Experimental	41	Not reported	29	57	Not reported
Control	33	Not reported	23	49	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
29
upper Limit
57
value
41
group Id
OG001
lower Limit
23
upper Limit
49
value
33

denoms

counts
group Id
OG000
value
74
group Id
OG001
value
70
units
Participants

description

An event is defined as relapse.

dispersion Type

95% Confidence Interval

groups

description
Tacro-MTX/Sirolimus GVHD Prophylaxis
id
OG000
title
Experimental
description
Tacro-MTX GVHD Prophylaxis
id
OG001
title
Control

param Type

NUMBER

population Description

2 ineligible patients on experimental arm excluded from analysis.Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.

reporting Status

POSTED

time Frame

At 2 years

title

Rate of Relapses

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice