NCT00952289 · ADVERSE EVENTS

Adverse events

COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial · Source last updated 2018-03-12

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 randomization through data cut-off of the primary analysis (02 November 2010).
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Ruxolitinib Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.	43 / 155	150 / 155	Not reported / Not reported
Placebo Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.	53 / 151	147 / 151	Not reported / Not reported

Group identifiers: EG000: Ruxolitinib · EG001: Placebo

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 (Unspecified)
stats
group Id
EG000
num Affected
5
num At Risk
155
group Id
EG001
num Affected
3
num At Risk
151
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
0
num At Risk
151
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
0
num At Risk
151
term
Splenic haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
4
num At Risk
151
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
3
num At Risk
151
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
6
num At Risk
151
term
Abdominal pain

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 (Unspecified)
stats
group Id
EG000
num Affected
52
num At Risk
155
group Id
EG001
num Affected
14
num At Risk
151
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
45
num At Risk
155
group Id
EG001
num Affected
20
num At Risk
151
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
8
num At Risk
151
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
16
num At Risk
155
group Id
EG001
num Affected
58
num At Risk
151
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
36
num At Risk
155
group Id
EG001
num Affected
32
num At Risk
151
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
22
num At Risk
155
group Id
EG001
num Affected
29
num At Risk
151
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
20
num At Risk
155
group Id
EG001
num Affected
18
num At Risk
151
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
18
num At Risk
155
group Id
EG001
num Affected
15
num At Risk
151
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
13
num At Risk
155
group Id
EG001
num Affected
16
num At Risk
151
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
155
group Id
EG001
num Affected
13
num At Risk
151
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
155
group Id
EG001
num Affected
8
num At Risk
151
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
8
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Flatulence

Complete source fields

event Groups

description
Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
id
EG000
other Num Affected
150
other Num At Risk
155
serious Num Affected
43
serious Num At Risk
155
title
Ruxolitinib
description
Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
id
EG001
other Num Affected
147
other Num At Risk
151
serious Num Affected
53
serious Num At Risk
151
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
52
num At Risk
155
group Id
EG001
num Affected
14
num At Risk
151
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
45
num At Risk
155
group Id
EG001
num Affected
20
num At Risk
151
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
8
num At Risk
151
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
16
num At Risk
155
group Id
EG001
num Affected
58
num At Risk
151
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
36
num At Risk
155
group Id
EG001
num Affected
32
num At Risk
151
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
22
num At Risk
155
group Id
EG001
num Affected
29
num At Risk
151
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
20
num At Risk
155
group Id
EG001
num Affected
18
num At Risk
151
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
18
num At Risk
155
group Id
EG001
num Affected
15
num At Risk
151
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
13
num At Risk
155
group Id
EG001
num Affected
16
num At Risk
151
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
155
group Id
EG001
num Affected
13
num At Risk
151
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
9
num At Risk
155
group Id
EG001
num Affected
8
num At Risk
151
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
8
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Flatulence

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
5
num At Risk
155
group Id
EG001
num Affected
3
num At Risk
151
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Disseminated intravascular coagulation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
0
num At Risk
151
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
0
num At Risk
151
term
Splenic haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
4
num At Risk
151
term
Splenic infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
1
num At Risk
151
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
155
group Id
EG001
num Affected
3
num At Risk
151
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
155
group Id
EG001
num Affected
6
num At Risk
151
term
Abdominal pain

time Frame

From randomization through data cut-off of the primary analysis (02 November 2010).

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