NCT02953678 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)
Other-event reporting threshold: 5%

The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	59 / 71	69 / 71	46 / 71

Group identifiers: EG000: Ruxolitinib in Combination With Corticosteroids

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
71
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
71
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Pulseless electrical activity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Blindness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Eye disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
3
num At Risk
71
term
Diarrhoea

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
45
num At Risk
71
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
6
num At Risk
71
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
13
num At Risk
71
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
7
num At Risk
71
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
14
num At Risk
71
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
11
num At Risk
71
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
8
num At Risk
71
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
11
num At Risk
71
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
15
num At Risk
71
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
6
num At Risk
71
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
13
num At Risk
71
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
20
num At Risk
71
term
Diarrhoea

Complete source fields

description

The safety evaluable population includes all participants enrolled in the study who received at least 1 dose of study drug.

event Groups

deaths Num Affected
46
deaths Num At Risk
71
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
EG000
other Num Affected
69
other Num At Risk
71
serious Num Affected
59
serious Num At Risk
71
title
Ruxolitinib in Combination With Corticosteroids

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
45
num At Risk
71
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
6
num At Risk
71
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
13
num At Risk
71
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
7
num At Risk
71
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
14
num At Risk
71
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
11
num At Risk
71
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
8
num At Risk
71
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
11
num At Risk
71
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
15
num At Risk
71
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
6
num At Risk
71
term
Ascites
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
13
num At Risk
71
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
20
num At Risk
71
term
Diarrhoea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
71
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
2
num At Risk
71
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Palpitations
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Pulseless electrical activity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Blindness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Eye disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
1
num At Risk
71
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 19.1
stats
group Id
EG000
num Affected
3
num At Risk
71
term
Diarrhoea

time Frame

From signing the informed consent form up to 30-35 days after the last dose of study treatment (up to 24 months)

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

Preserved source evidence · Not medical advice