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NCT01093586 · OUTCOME

Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0

Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies · 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
by day +42

What was measured

Number of participants that experienced toxicity related to the transplant

Analysis population: Patients that received transplant

Groups in this outcome

Arm I

PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.

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 I11

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
Number of participants that experienced toxicity related to the transplant
groups
  1. description
    PREPARATIVE REGIMEN: Patients receive oral busulfan on days -8 to -5, cyclophosphamide IV on days -4 to -3, and anti-thymocyte globulin or methylprednisolone IV on days -3 to -1. TRANSPLANTATION: Patients undergo a double-unit umbilical cord blood allogeneic stem cell transplantation on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Beginning on day -2, patients receive cyclosporine IV and taper beginning on day 100. Patients also receive mycophenolate mofetil IV or orally on days -3 to 45.
    id
    OG000
    title
    Arm I
param Type
COUNT_OF_PARTICIPANTS
population Description
Patients that received transplant
reporting Status
POSTED
time Frame
by day +42
title
Toxicity Related to UCB Transplantation and Cytoreduction as Assessed by CTC v3.0
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice