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NCT02953678 · OUTCOME

Failure-free Survival (FFS)

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
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)

What was measured

Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD).

Analysis population: Efficacy Evaluable Participants

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. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.

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 Corticosteroids71

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids85.0Not reported42.0158.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.0
        upper Limit
        158.0
        value
        85.0
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    units
    Participants
description
Defined as the time from first dose of ruxolitinib to the earliest date that a participant died, had a relapse/progression of the underlying malignancy, required additional therapy for aGVHD, or demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD).
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. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
    id
    OG000
    title
    Ruxolitinib in Combination With Corticosteroids
param Type
MEDIAN
population Description
Efficacy Evaluable Participants
reporting Status
POSTED
time Frame
From Baseline until death, withdrawal of consent, or the end of the study, whichever occurs first (up to approximately 24 months)
title
Failure-free Survival (FFS)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice