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NCT01572662 · OUTCOME

Non-Relapse Mortality Rate (NRM)

Allogeneic Transplantation Using Timed Sequential Busulfan and Fludarabine Conditioning · Source last updated 2023-06-29

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

What was measured

Number of participants expired within the first 100 days after transplant not due to relapsed disease.

Groups in this outcome

Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l

Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.

Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.

Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.

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

Analysis denominator · Participants

GroupSource count
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l49
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.150

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l2Not reportedNot reportedNot reportedNot reported
Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      150
    units
    Participants
description
Number of participants expired within the first 100 days after transplant not due to relapsed disease.
groups
  1. description
    Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
    id
    OG000
    title
    Arm 1: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 16,000 Umol/l
  2. description
    Allogeneic stem cell transplant for patients with hematologic malignancies: The randomization was stratified equally for the first 100 patients at study entry and conditioned regimen with Fludarabine/Timed Sequential (TS) Busulfan AUC 16,000umol/l vs. Fludarabine/Timed sequential Busulfan AUC 20,000umol/l.
    id
    OG001
    title
    Arm 2: Participants w/Hematologic Malignancies Treated w/Fludarabine/TS Busulfan AUC 20,000umol/l.
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
100 days
title
Non-Relapse Mortality Rate (NRM)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice