NCT02326298 · ADVERSE EVENTS

Adverse events

An Efficacy and Safety Study of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) · Source last updated 2019-11-07

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: Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).
Other-event reporting threshold: 5%

Participants randomized to PBO switched to CZP 200mg Q2W or CZP 400mg Q2W at Week 16. Participants randomized to CZP were exposed for up to 144 weeks, leading to a significantly lower exposure in the PBO than CZP arm. Considering the imbalance of such comparison, AEs reported while participants were on PBO are not included in this summary.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
CZP 200 mg Q2W (TCS) This arm consisted of all participants who received CZP 200 mg at any time during the study.	14 / 188	95 / 188	1 / 188
CZP 400 mg Q2W (TCS) This arm consisted of all participants who received CZP 400 mg at any time during the study.	19 / 167	85 / 167	1 / 167

Group identifiers: EG000: CZP 200 mg Q2W (TCS) · EG001: CZP 400 mg Q2W (TCS)

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
188
num Events
0
group Id
EG001
num Affected
1
num At Risk
167
num Events
1
term
Lymphadenitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Splenic haematoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
2
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Blepharochalasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Gastrointestinal necrosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Strangulated hernia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
188
num Events
0
group Id
EG001
num Affected
1
num At Risk
167
num Events
1
term
Injection site reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Cirrhosis alcoholic
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
188
num Events
0
group Id
EG001
num Affected
1
num At Risk
167
num Events
1
term
Anaphylactoid reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
188
num Events
0
group Id
EG001
num Affected
1
num At Risk
167
num Events
1
term
Anal abscess
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Urinary tract infection bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Borrelia infection

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
MedDRA18.1
stats
group Id
EG000
num Affected
54
num At Risk
188
num Events
86
group Id
EG001
num Affected
51
num At Risk
167
num Events
95
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
21
num At Risk
188
num Events
28
group Id
EG001
num Affected
26
num At Risk
167
num Events
42
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
14
num At Risk
188
num Events
16
group Id
EG001
num Affected
4
num At Risk
167
num Events
5
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
12
num At Risk
188
num Events
13
group Id
EG001
num Affected
11
num At Risk
167
num Events
12
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
9
num At Risk
188
num Events
18
group Id
EG001
num Affected
14
num At Risk
167
num Events
41
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
9
num At Risk
188
num Events
9
group Id
EG001
num Affected
5
num At Risk
167
num Events
5
term
Psoriasis

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
188
description
This arm consisted of all participants who received CZP 200 mg at any time during the study.
id
EG000
other Num Affected
95
other Num At Risk
188
serious Num Affected
14
serious Num At Risk
188
title
CZP 200 mg Q2W (TCS)
deaths Num Affected
1
deaths Num At Risk
167
description
This arm consisted of all participants who received CZP 400 mg at any time during the study.
id
EG001
other Num Affected
85
other Num At Risk
167
serious Num Affected
19
serious Num At Risk
167
title
CZP 400 mg Q2W (TCS)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
54
num At Risk
188
num Events
86
group Id
EG001
num Affected
51
num At Risk
167
num Events
95
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
21
num At Risk
188
num Events
28
group Id
EG001
num Affected
26
num At Risk
167
num Events
42
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
14
num At Risk
188
num Events
16
group Id
EG001
num Affected
4
num At Risk
167
num Events
5
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
12
num At Risk
188
num Events
13
group Id
EG001
num Affected
11
num At Risk
167
num Events
12
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
9
num At Risk
188
num Events
18
group Id
EG001
num Affected
14
num At Risk
167
num Events
41
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
9
num At Risk
188
num Events
9
group Id
EG001
num Affected
5
num At Risk
167
num Events
5
term
Psoriasis

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
188
num Events
0
group Id
EG001
num Affected
1
num At Risk
167
num Events
1
term
Lymphadenitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Splenic haematoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
2
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Blepharochalasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Gastrointestinal necrosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Strangulated hernia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
188
num Events
0
group Id
EG001
num Affected
1
num At Risk
167
num Events
1
term
Injection site reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Cirrhosis alcoholic
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
188
num Events
0
group Id
EG001
num Affected
1
num At Risk
167
num Events
1
term
Anaphylactoid reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
188
num Events
0
group Id
EG001
num Affected
1
num At Risk
167
num Events
1
term
Anal abscess
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Urinary tract infection bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
188
num Events
1
group Id
EG001
num Affected
0
num At Risk
167
num Events
0
term
Borrelia infection

time Frame

Adverse Events (AEs) were collected from Baseline (Week 0) until the Post Study Safety Follow-up Visit (Week 152).

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