NCT00889863 · ADVERSE EVENTS

Adverse events

Flare Prevention Study of Canakinumab in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA) · Source last updated 2012-10-16

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Canakinumab: Part I In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period.	15 / 177	138 / 177	Not reported / Not reported
Canakinumab: Part II Participants received 4 mg/kg canakinumab subcutaneous injection in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.	6 / 50	40 / 50	Not reported / Not reported
Placebo: Part II Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.	6 / 50	35 / 50	Not reported / Not reported

Group identifiers: EG000: Canakinumab: Part I · EG001: Canakinumab: Part II · EG002: Placebo: Part II

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 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
3
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Medical device complication
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Drug hypersensitivity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Acute sinusitis

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
Infections and infestations
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
27
num At Risk
177
group Id
EG001
num Affected
7
num At Risk
50
group Id
EG002
num Affected
7
num At Risk
50
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
23
num At Risk
177
group Id
EG001
num Affected
3
num At Risk
50
group Id
EG002
num Affected
3
num At Risk
50
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
20
num At Risk
177
group Id
EG001
num Affected
8
num At Risk
50
group Id
EG002
num Affected
6
num At Risk
50
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
18
num At Risk
177
group Id
EG001
num Affected
7
num At Risk
50
group Id
EG002
num Affected
5
num At Risk
50
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
18
num At Risk
177
group Id
EG001
num Affected
6
num At Risk
50
group Id
EG002
num Affected
5
num At Risk
50
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
18
num At Risk
177
group Id
EG001
num Affected
1
num At Risk
50
group Id
EG002
num Affected
4
num At Risk
50
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
17
num At Risk
177
group Id
EG001
num Affected
6
num At Risk
50
group Id
EG002
num Affected
4
num At Risk
50
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
17
num At Risk
177
group Id
EG001
num Affected
1
num At Risk
50
group Id
EG002
num Affected
3
num At Risk
50
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
17
num At Risk
177
group Id
EG001
num Affected
5
num At Risk
50
group Id
EG002
num Affected
7
num At Risk
50
term
Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
14
num At Risk
177
group Id
EG001
num Affected
1
num At Risk
50
group Id
EG002
num Affected
1
num At Risk
50
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
10
num At Risk
177
group Id
EG001
num Affected
12
num At Risk
50
group Id
EG002
num Affected
5
num At Risk
50
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
9
num At Risk
177
group Id
EG001
num Affected
2
num At Risk
50
group Id
EG002
num Affected
2
num At Risk
50
term
Abdominal pain upper

Complete source fields

event Groups

description
In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period.
id
EG000
other Num Affected
138
other Num At Risk
177
serious Num Affected
15
serious Num At Risk
177
title
Canakinumab: Part I
description
Participants received 4 mg/kg canakinumab subcutaneous injection in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
id
EG001
other Num Affected
40
other Num At Risk
50
serious Num Affected
6
serious Num At Risk
50
title
Canakinumab: Part II
description
Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a \>0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
id
EG002
other Num Affected
35
other Num At Risk
50
serious Num Affected
6
serious Num At Risk
50
title
Placebo: Part II

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
27
num At Risk
177
group Id
EG001
num Affected
7
num At Risk
50
group Id
EG002
num Affected
7
num At Risk
50
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
23
num At Risk
177
group Id
EG001
num Affected
3
num At Risk
50
group Id
EG002
num Affected
3
num At Risk
50
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
20
num At Risk
177
group Id
EG001
num Affected
8
num At Risk
50
group Id
EG002
num Affected
6
num At Risk
50
term
Cough
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
18
num At Risk
177
group Id
EG001
num Affected
7
num At Risk
50
group Id
EG002
num Affected
5
num At Risk
50
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
18
num At Risk
177
group Id
EG001
num Affected
6
num At Risk
50
group Id
EG002
num Affected
5
num At Risk
50
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
18
num At Risk
177
group Id
EG001
num Affected
1
num At Risk
50
group Id
EG002
num Affected
4
num At Risk
50
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
17
num At Risk
177
group Id
EG001
num Affected
6
num At Risk
50
group Id
EG002
num Affected
4
num At Risk
50
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
17
num At Risk
177
group Id
EG001
num Affected
1
num At Risk
50
group Id
EG002
num Affected
3
num At Risk
50
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
17
num At Risk
177
group Id
EG001
num Affected
5
num At Risk
50
group Id
EG002
num Affected
7
num At Risk
50
term
Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
14
num At Risk
177
group Id
EG001
num Affected
1
num At Risk
50
group Id
EG002
num Affected
1
num At Risk
50
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
10
num At Risk
177
group Id
EG001
num Affected
12
num At Risk
50
group Id
EG002
num Affected
5
num At Risk
50
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
9
num At Risk
177
group Id
EG001
num Affected
2
num At Risk
50
group Id
EG002
num Affected
2
num At Risk
50
term
Abdominal pain upper

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
2
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
3
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Medical device complication
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Drug hypersensitivity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.0
stats
group Id
EG000
num Affected
1
num At Risk
177
group Id
EG001
num Affected
0
num At Risk
50
group Id
EG002
num Affected
0
num At Risk
50
term
Acute sinusitis

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