NCT02181673 · ADVERSE EVENTS

Adverse events

A Study of Golimumab in Participants With Active Psoriatic Arthritis · Source last updated 2017-12-21

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: Up to 60 Weeks
Other-event reporting threshold: 5%

Safety Population included all participants who received at least 1 dose of study agent.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo (Week 0-24) Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.	8 / 239	19 / 239	Not reported / Not reported
Placebo Then Golimumab 2 mg/kg (Week 24-60) Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.	5 / 220	25 / 220	Not reported / Not reported
Golimumab 2 mg/kg (Week 0-60) Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.	19 / 240	40 / 240	Not reported / Not reported

Group identifiers: EG000: Placebo (Week 0-24) · EG001: Placebo Then Golimumab 2 mg/kg (Week 24-60) · EG002: Golimumab 2 mg/kg (Week 0-60)

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
240
term
Cardiac failure acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Myocardial ischaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
240
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Oedematous pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Drug-induced liver injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Hepatitis acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Hepatitis chronic active
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
1
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
240
term
Empyema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Infected dermal cyst
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
1
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
240
term
Periodontitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
239
group Id
EG001
num Affected
1
num At Risk
220
group Id
EG002
num Affected
2
num At Risk
240
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
2
num At Risk
240
term
Pulmonary tuberculosis

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
13
num At Risk
239
group Id
EG001
num Affected
9
num At Risk
220
group Id
EG002
num Affected
14
num At Risk
240
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
5
num At Risk
239
group Id
EG001
num Affected
13
num At Risk
220
group Id
EG002
num Affected
25
num At Risk
240
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
5
num At Risk
239
group Id
EG001
num Affected
12
num At Risk
220
group Id
EG002
num Affected
19
num At Risk
240
term
Aspartate aminotransferase increased

Complete source fields

description

Safety Population included all participants who received at least 1 dose of study agent.

event Groups

description
Participants received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
id
EG000
other Num Affected
19
other Num At Risk
239
serious Num Affected
8
serious Num At Risk
239
title
Placebo (Week 0-24)
description
Participants who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.
id
EG001
other Num Affected
25
other Num At Risk
220
serious Num Affected
5
serious Num At Risk
220
title
Placebo Then Golimumab 2 mg/kg (Week 24-60)
description
Participants were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, participants received a placebo intravenous infusion to maintain the blind.
id
EG002
other Num Affected
40
other Num At Risk
240
serious Num Affected
19
serious Num At Risk
240
title
Golimumab 2 mg/kg (Week 0-60)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
13
num At Risk
239
group Id
EG001
num Affected
9
num At Risk
220
group Id
EG002
num Affected
14
num At Risk
240
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
5
num At Risk
239
group Id
EG001
num Affected
13
num At Risk
220
group Id
EG002
num Affected
25
num At Risk
240
term
Alanine aminotransferase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
5
num At Risk
239
group Id
EG001
num Affected
12
num At Risk
220
group Id
EG002
num Affected
19
num At Risk
240
term
Aspartate aminotransferase increased

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
240
term
Cardiac failure acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Myocardial ischaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
240
term
Cataract
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Oedematous pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Drug-induced liver injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Hepatitis acute
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Hepatitis chronic active
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
1
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
240
term
Empyema
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
1
num At Risk
240
term
Infected dermal cyst
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
1
num At Risk
220
group Id
EG002
num Affected
0
num At Risk
240
term
Periodontitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
1
num At Risk
239
group Id
EG001
num Affected
1
num At Risk
220
group Id
EG002
num Affected
2
num At Risk
240
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA Version 19.1
stats
group Id
EG000
num Affected
0
num At Risk
239
group Id
EG001
num Affected
0
num At Risk
220
group Id
EG002
num Affected
2
num At Risk
240
term
Pulmonary tuberculosis

time Frame

Up to 60 Weeks

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Preserved source evidence · Not medical advice