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NCT01408563 · OUTCOME

Number of Participants With a Clinically Significant Infection

Reduced Intensity Double Umbilical Cord Blood Transplantation · Source last updated 2019-01-23

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
1 Year

What was measured

The one year significant infection rate (infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation. The data is shown as the number of significant infections participants experienced during the first year, measured from the start of treatment.

Analysis population: The two participants found to be ineligible after being consented and registered were excluded from the analysis.

Groups in this outcome

Fludarabine/Melphalan/TBI

All patients receive same therapy Fludarabine: 30 mg/m2/day IV x 6 days Melphalan: 100 mg/m2/day IV x 1 day Total Body Radiation: 200 cGy on Day 0 Cord Blood: 2 cord blood units IV

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

Analysis denominator · Participants

GroupSource count
Fludarabine/Melphalan/TBI31

Reported measurements

Source class 1

0 Infections

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine/Melphalan/TBI12Not reportedNot reportedNot reportedNot reported

1 Infection

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine/Melphalan/TBI14Not reportedNot reportedNot reportedNot reported

2 Infections

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine/Melphalan/TBI5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      title
      0 Infections
    2. measurements
      1. group Id
        OG000
        value
        14
      title
      1 Infection
    3. measurements
      1. group Id
        OG000
        value
        5
      title
      2 Infections
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
The one year significant infection rate (infections requiring medical intervention) after double umbilical cord blood transplant using a novel conditioning regimen of fludarabine/melphalan/low dose total body radiation. The data is shown as the number of significant infections participants experienced during the first year, measured from the start of treatment.
groups
  1. description
    All patients receive same therapy Fludarabine: 30 mg/m2/day IV x 6 days Melphalan: 100 mg/m2/day IV x 1 day Total Body Radiation: 200 cGy on Day 0 Cord Blood: 2 cord blood units IV
    id
    OG000
    title
    Fludarabine/Melphalan/TBI
param Type
COUNT_OF_PARTICIPANTS
population Description
The two participants found to be ineligible after being consented and registered were excluded from the analysis.
reporting Status
POSTED
time Frame
1 Year
title
Number of Participants With a Clinically Significant Infection
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice