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NCT02953678 · OUTCOME

Percentage of Participants With Six-month Duration of Response (DOR)

A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1) · Source last updated 2021-11-24

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From Baseline up to 6 months

What was measured

Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were on the study completed the Day 180 visit.

Analysis population: Efficacy Evaluable Population included all participants enrolled in this study. Participants who achieved ORR were analyzed for this outcome measure.

Groups in this outcome

Ruxolitinib in Combination With Corticosteroids

Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID up to approximately 27 months. Participants did receive prednisone daily orally (PO) daily or methylprednisolone daily intravenously( IV) as per protocol.

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

Analysis denominator · Participants

GroupSource count
Ruxolitinib in Combination With Corticosteroids40

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids68.2Not reported49.681.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.6
        upper Limit
        81.2
        value
        68.2
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
Defined as the time from first response until graft-versus-host disease (GVHD) progression or death. DOR was assessed when all participants who were on the study completed the Day 180 visit.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID up to approximately 27 months. Participants did receive prednisone daily orally (PO) daily or methylprednisolone daily intravenously( IV) as per protocol.
    id
    OG000
    title
    Ruxolitinib in Combination With Corticosteroids
param Type
NUMBER
population Description
Efficacy Evaluable Population included all participants enrolled in this study. Participants who achieved ORR were analyzed for this outcome measure.
reporting Status
POSTED
time Frame
From Baseline up to 6 months
title
Percentage of Participants With Six-month Duration of Response (DOR)
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice