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NCT01408563 · OUTCOME

Median Time to Neutrophil Engraftment

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
MEDIAN
Unit
Days
Interval / dispersion
Full Range
Time frame
From the time of transplantation, until the time of neutrophil engraftment, median duration of 24 days

What was measured

The median number of days measured from the time of transplantation, until the first documented neutrophil engraftment. neutrophil engraftment is defined as the first of 3 consecutive days of absolute neutrophil count \> 500 neutrophils per microliter of blood.

Analysis population: The two participants found to be ineligible after being consented and registered were excluded from the analysis. In addition to those two participants, the 8 participants that did not achieve engraftment were not included in 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/TBI23

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Fludarabine/Melphalan/TBI24Not reported154Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        54
        value
        24
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
The median number of days measured from the time of transplantation, until the first documented neutrophil engraftment. neutrophil engraftment is defined as the first of 3 consecutive days of absolute neutrophil count \> 500 neutrophils per microliter of blood.
dispersion Type
Full Range
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
MEDIAN
population Description
The two participants found to be ineligible after being consented and registered were excluded from the analysis. In addition to those two participants, the 8 participants that did not achieve engraftment were not included in the analysis.
reporting Status
POSTED
time Frame
From the time of transplantation, until the time of neutrophil engraftment, median duration of 24 days
title
Median Time to Neutrophil Engraftment
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice