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NCT01596257 · OUTCOME

Number of Participants Assessed for Toxicities

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
2 years

What was measured

Participants will be assessed for toxicities with the NCI-Common Terminology for Adverse Events (CTCAE), version 4.0.

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 SCT61
Fractionated SCT55

Reported measurements

Source class 1

Participants who experienced toxicities

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bulk SCT38Not reportedNot reportedNot reportedNot reported
Fractionated SCT36Not reportedNot reportedNot reportedNot reported

Participants who did not experience toxicities

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bulk SCT23Not reportedNot reportedNot reportedNot reported
Fractionated SCT19Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        36
      title
      Participants who experienced toxicities
    2. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        19
      title
      Participants who did not experience toxicities
denoms
  1. counts
    1. group Id
      OG000
      value
      61
    2. group Id
      OG001
      value
      55
    units
    Participants
description
Participants will be assessed for toxicities with the NCI-Common Terminology for Adverse Events (CTCAE), version 4.0.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
2 years
title
Number of Participants Assessed for Toxicities
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice