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NCT01789255 · OUTCOME

Mean Percent of Planned Dose Administered

Vorinostat, Tacrolimus, and Methotrexate in Preventing GVHD After Stem Cell Transplant in Patients With Hematological Malignancies · Source last updated 2018-07-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
percent of dose administered
Interval / dispersion
Full Range
Time frame
Up to day 30

What was measured

The addition of vorinostat to tacrolimus and methotrexate for GVHD prophylaxis will be considered feasible if 60% or more of the planned doses are administered.

Groups in this outcome

Supportive Care (Vorinostat, Tacrolimus, Methotrexate)

Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.

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

Analysis denominator · Participants

GroupSource count
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)12

Reported measurements

Source class 1
Values in percent of dose administered · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Supportive Care (Vorinostat, Tacrolimus, Methotrexate)82.5Not reported53.8100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        53.8
        upper Limit
        100
        value
        82.5
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
The addition of vorinostat to tacrolimus and methotrexate for GVHD prophylaxis will be considered feasible if 60% or more of the planned doses are administered.
dispersion Type
Full Range
groups
  1. description
    Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
    id
    OG000
    title
    Supportive Care (Vorinostat, Tacrolimus, Methotrexate)
param Type
MEAN
reporting Status
POSTED
time Frame
Up to day 30
title
Mean Percent of Planned Dose Administered
type
SECONDARY
unit Of Measure
percent of dose administered

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

Preserved source evidence · Not medical advice