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NCT02953678 · OUTCOME

Overall Response Rate (ORR)

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 to days 14, 56, and 100

What was measured

Defined as the percentage of participants demonstrating a CR, VGPR, or PR.

Analysis population: Efficacy Evaluable Population included all participants enrolled in this study.

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 Corticosteroids71

Reported measurements

Day 14
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids62.0Not reported49.773.2Not reported
Day 56
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids36.6Not reported25.548.9Not reported
Day 100
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids32.4Not reported21.844.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.7
        upper Limit
        73.2
        value
        62.0
    title
    Day 14
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        25.5
        upper Limit
        48.9
        value
        36.6
    title
    Day 56
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.8
        upper Limit
        44.5
        value
        32.4
    title
    Day 100
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    units
    Participants
description
Defined as the percentage of participants demonstrating a CR, VGPR, or PR.
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.
reporting Status
POSTED
time Frame
From baseline to days 14, 56, and 100
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice