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NCT01246206 · OUTCOME

Determine Time to Engraftment ("G500")

Tacrolimus and Thymoglobulin, as GvHD Prophylaxis in Patients Undergoing Related Donor HCT · Source last updated 2018-06-18

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
Followed for up to two years post transplant

What was measured

The number of days until engraftment ("G500")

Analysis population: All paarticipants

Groups in this outcome

Tacrolimus and Thymoglobulin

Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or "transplant." Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours.

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

Analysis denominator · Participants

GroupSource count
Tacrolimus and Thymoglobulin20

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Tacrolimus and Thymoglobulin11Not reported712Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7
        upper Limit
        12
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
The number of days until engraftment ("G500")
dispersion Type
Full Range
groups
  1. description
    Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or "transplant." Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours.
    id
    OG000
    title
    Tacrolimus and Thymoglobulin
param Type
MEDIAN
population Description
All paarticipants
reporting Status
POSTED
time Frame
Followed for up to two years post transplant
title
Determine Time to Engraftment ("G500")
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice