NCT00886769 · ADVERSE EVENTS

Adverse events

Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA) · Source last updated 2017-03-29

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: 4%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Canakinumab Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections.	2 / 43	17 / 43	Not reported / Not reported
Placebo Patients received a single dose matching placebo of canakinumab on day 1.	2 / 41	3 / 41	Not reported / Not reported

Group identifiers: EG000: Canakinumab · 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
1
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Leukopenia
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
43
group Id
EG001
num Affected
0
num At Risk
41
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Bronchopneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Varicella
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
43
group Id
EG001
num Affected
1
num At Risk
41
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
43
group Id
EG001
num Affected
1
num At Risk
41
term
Histiocytosis haematophagic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Rash maculo-papular

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
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
43
group Id
EG001
num Affected
1
num At Risk
41
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
43
group Id
EG001
num Affected
1
num At Risk
41
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
43
group Id
EG001
num Affected
1
num At Risk
41
term
Headache

Complete source fields

event Groups

description
Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections.
id
EG000
other Num Affected
17
other Num At Risk
43
serious Num Affected
2
serious Num At Risk
43
title
Canakinumab
description
Patients received a single dose matching placebo of canakinumab on day 1.
id
EG001
other Num Affected
3
other Num At Risk
41
serious Num Affected
2
serious Num At Risk
41
title
Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
43
group Id
EG001
num Affected
1
num At Risk
41
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
43
group Id
EG001
num Affected
1
num At Risk
41
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
3
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
2
num At Risk
43
group Id
EG001
num Affected
1
num At Risk
41
term
Headache

serious Events

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
43
group Id
EG001
num Affected
0
num At Risk
41
term
Leukopenia
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
43
group Id
EG001
num Affected
0
num At Risk
41
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Hepatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Bronchopneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Varicella
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
0
num At Risk
43
group Id
EG001
num Affected
1
num At Risk
41
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
43
group Id
EG001
num Affected
1
num At Risk
41
term
Histiocytosis haematophagic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (Unspecified)
stats
group Id
EG000
num Affected
1
num At Risk
43
group Id
EG001
num Affected
0
num At Risk
41
term
Rash maculo-papular

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Preserved source evidence · Not medical advice