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NCT01596257 · OUTCOME

Median Time to Platelet Engraftment

Bulk Versus Fractionated Stem Cell Infusions in Patients With Hematologic Malignancies Undergoing Stem Cell Transplantation · Source last updated 2022-12-29

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
Up to 365 days

What was measured

The area under the hematopoietic recovery curve for the factors: ALC, CD4, CD8, and platelet count. The area under the curve will be computed based on recordings at days 30, 60, 100, 180, 365. Determine days to platelet engraftment by platelet count.

Groups in this outcome

Bulk SCT

Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS

Fractionated SCT

Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS

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

Analysis denominator · Participants

GroupSource count
Bulk SCT38
Fractionated SCT36

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bulk SCT18Not reported9112Not reported
Fractionated SCT18Not reported447Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9
        upper Limit
        112
        value
        18
      2. group Id
        OG001
        lower Limit
        4
        upper Limit
        47
        value
        18
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    2. group Id
      OG001
      value
      36
    units
    Participants
description
The area under the hematopoietic recovery curve for the factors: ALC, CD4, CD8, and platelet count. The area under the curve will be computed based on recordings at days 30, 60, 100, 180, 365. Determine days to platelet engraftment by platelet count.
dispersion Type
Full Range
groups
  1. description
    Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on day 0. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
    id
    OG000
    title
    Bulk SCT
  2. description
    Patients receive reduced intensity or myeloablative conditioning regimen, GVHD prophylaxis, and undergo T cell depleted or no T cell depleted allogeneic SCT on days 0, 2, 4, and 6. After completion of study treatment, patients are followed up every 6-8 weeks for up to 24 months allogeneic hematopoietic stem cell transplantation: Undergo allogeneic hematopoietic stem cell transplant CliniMACS
    id
    OG001
    title
    Fractionated SCT
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 365 days
title
Median Time to Platelet Engraftment
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice