NCT01356602 · ADVERSE EVENTS

Adverse events

Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients · Source last updated 2014-01-29

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: 12 weeks
Other-event reporting threshold: 5%

Only 389 subjects (including one subject with 3 placebo injections) received study drug (Safety set). Subjects who received more than one active dose were counted in each treatment group, leading to an artificial safety set of 399 subjects.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Canakinumab, Pre-filled Syringes (PFS) Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.	6 / 133	0 / 133	Not reported / Not reported
Canakinumab, Lyophilizate (LYO) The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.	6 / 133	0 / 133	Not reported / Not reported
Triamcinolone Acetonide The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.	5 / 133	0 / 133	Not reported / Not reported

Group identifiers: EG000: Canakinumab, Pre-filled Syringes (PFS) · EG001: Canakinumab, Lyophilizate (LYO) · EG002: Triamcinolone Acetonide

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
Cardiac disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
1
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
1
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
1
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
1
num At Risk
133
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
1
num At Risk
133
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
1
num At Risk
133
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
1
num At Risk
133
term
Drug ineffective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
1
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Respiratory tract infection viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
1
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Staphylococcal bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
1
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Viral infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
1
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Wound infection staphylococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
1
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Muscle rupture

Other reported adverse events

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

Complete source fields

description

event Groups

description
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
id
EG000
other Num Affected
0
other Num At Risk
133
serious Num Affected
6
serious Num At Risk
133
title
Canakinumab, Pre-filled Syringes (PFS)
description
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
id
EG001
other Num Affected
0
other Num At Risk
133
serious Num Affected
6
serious Num At Risk
133
title
Canakinumab, Lyophilizate (LYO)
description
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
id
EG002
other Num Affected
0
other Num At Risk
133
serious Num Affected
5
serious Num At Risk
133
title
Triamcinolone Acetonide

frequency Threshold

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
1
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Angina unstable
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
1
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
1
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Coronary artery disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
1
num At Risk
133
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
1
num At Risk
133
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
1
num At Risk
133
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
1
num At Risk
133
term
Drug ineffective
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
1
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Respiratory tract infection viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
0
num At Risk
133
group Id
EG001
num Affected
1
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Staphylococcal bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
1
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Viral infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
1
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Wound infection staphylococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 14.1
stats
group Id
EG000
num Affected
1
num At Risk
133
group Id
EG001
num Affected
0
num At Risk
133
group Id
EG002
num Affected
0
num At Risk
133
term
Muscle rupture

time Frame

12 weeks

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Preserved source evidence · Not medical advice