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NCT02953678 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)

What was measured

AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious AE was any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. TEAE was an AE that was reported for the first time, or worsening of a pre-existing event after the first dose of study drug (until 30 days after the last dose of study drug). Severity of AEs was described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). Grade 3 and above would constitute a severe, life-threatening, or death event.

Analysis population: Safety Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug.

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

TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids71Not reportedNot reportedNot reportedNot reported
Serious TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids59Not reportedNot reportedNot reportedNot reported
Grade 3 or Higher TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib in Combination With Corticosteroids69Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        71
    title
    TEAEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        59
    title
    Serious TEAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        69
    title
    Grade 3 or Higher TEAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    units
    Participants
description
AE was any unfavorable and unintended sign, symptom, or disease temporally associated with use of medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Serious AE was any untoward medical occurrence that results in death; is life-threatening; requires inpatient hospitalization or prolongation of present hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect or is a medically important event that may not be immediately life-threatening or result in death or hospitalization. TEAE was an AE that was reported for the first time, or worsening of a pre-existing event after the first dose of study drug (until 30 days after the last dose of study drug). Severity of AEs was described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03). Grade 3 and above would constitute a severe, life-threatening, or death event.
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
COUNT_OF_PARTICIPANTS
population Description
Safety Evaluable Population included all participants enrolled in the study who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
title
Number of Participants With Treatment-emergent Adverse Events (TEAES), Serious TEAEs, And Grade 3 or Higher TEAEs
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice