NCT02326272 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) · Source last updated 2019-10-03

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%

As per design, participants randomized to PBO either switched to CZP 200mg Q2W or escaped to CZP 400mg Q2W at Week 16, leading to a significantly lower exposure in PBO arm than in CZP arm. Considering the limitations of such comparison, AEs reported while the 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.	24 / 170	76 / 170	1 / 170
CZP 400 mg Q2W (TCS) This arm consisted of all participants who received CZP 400 mg at any time during the study.	12 / 149	75 / 149	1 / 149

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
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Disseminated intravascular coagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
170
num Events
0
group Id
EG001
num Affected
1
num At Risk
149
num Events
1
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
170
num Events
0
group Id
EG001
num Affected
1
num At Risk
149
num Events
2
term
Tolosa-Hunt syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Haemorrhagic necrotic pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Pharyngo-oesophageal diverticulum
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Rectal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Hepatic failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
2
num At Risk
170
num Events
2
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Drug-induced liver injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
170
num Events
0
group Id
EG001
num Affected
1
num At Risk
149
num Events
1
term
Anaphylactic reaction

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
33
num At Risk
170
num Events
55
group Id
EG001
num Affected
35
num At Risk
149
num Events
45
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
19
num At Risk
170
num Events
20
group Id
EG001
num Affected
18
num At Risk
149
num Events
21
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
13
num At Risk
170
num Events
15
group Id
EG001
num Affected
4
num At Risk
149
num Events
4
term
Sinusitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
10
num At Risk
170
num Events
12
group Id
EG001
num Affected
4
num At Risk
149
num Events
4
term
Pharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
11
num At Risk
170
num Events
15
group Id
EG001
num Affected
10
num At Risk
149
num Events
14
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
8
num At Risk
170
num Events
8
group Id
EG001
num Affected
5
num At Risk
149
num Events
5
term
Ligament sprain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
6
num At Risk
170
num Events
6
group Id
EG001
num Affected
8
num At Risk
149
num Events
8
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
9
num At Risk
170
num Events
10
group Id
EG001
num Affected
6
num At Risk
149
num Events
6
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
3
num At Risk
170
num Events
3
group Id
EG001
num Affected
8
num At Risk
149
num Events
8
term
Pruritus
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
170
num Events
10
group Id
EG001
num Affected
12
num At Risk
149
num Events
19
term
Psoriasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
7
num At Risk
170
num Events
8
group Id
EG001
num Affected
9
num At Risk
149
num Events
9
term
Hypertension

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
170
description
This arm consisted of all participants who received CZP 200 mg at any time during the study.
id
EG000
other Num Affected
76
other Num At Risk
170
serious Num Affected
24
serious Num At Risk
170
title
CZP 200 mg Q2W (TCS)
deaths Num Affected
1
deaths Num At Risk
149
description
This arm consisted of all participants who received CZP 400 mg at any time during the study.
id
EG001
other Num Affected
75
other Num At Risk
149
serious Num Affected
12
serious Num At Risk
149
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
33
num At Risk
170
num Events
55
group Id
EG001
num Affected
35
num At Risk
149
num Events
45
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
19
num At Risk
170
num Events
20
group Id
EG001
num Affected
18
num At Risk
149
num Events
21
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
13
num At Risk
170
num Events
15
group Id
EG001
num Affected
4
num At Risk
149
num Events
4
term
Sinusitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
10
num At Risk
170
num Events
12
group Id
EG001
num Affected
4
num At Risk
149
num Events
4
term
Pharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
11
num At Risk
170
num Events
15
group Id
EG001
num Affected
10
num At Risk
149
num Events
14
term
Urinary tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
8
num At Risk
170
num Events
8
group Id
EG001
num Affected
5
num At Risk
149
num Events
5
term
Ligament sprain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
6
num At Risk
170
num Events
6
group Id
EG001
num Affected
8
num At Risk
149
num Events
8
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
9
num At Risk
170
num Events
10
group Id
EG001
num Affected
6
num At Risk
149
num Events
6
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
3
num At Risk
170
num Events
3
group Id
EG001
num Affected
8
num At Risk
149
num Events
8
term
Pruritus
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
170
num Events
10
group Id
EG001
num Affected
12
num At Risk
149
num Events
19
term
Psoriasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
7
num At Risk
170
num Events
8
group Id
EG001
num Affected
9
num At Risk
149
num Events
9
term
Hypertension

serious Events

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
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Disseminated intravascular coagulation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
170
num Events
0
group Id
EG001
num Affected
1
num At Risk
149
num Events
1
term
Cardiac failure congestive
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
170
num Events
0
group Id
EG001
num Affected
1
num At Risk
149
num Events
2
term
Tolosa-Hunt syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Haemorrhagic necrotic pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Pharyngo-oesophageal diverticulum
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Rectal haemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
1
num At Risk
170
num Events
1
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Hepatic failure
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
2
num At Risk
170
num Events
2
group Id
EG001
num Affected
0
num At Risk
149
num Events
0
term
Drug-induced liver injury
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA18.1
stats
group Id
EG000
num Affected
0
num At Risk
170
num Events
0
group Id
EG001
num Affected
1
num At Risk
149
num Events
1
term
Anaphylactic reaction

time Frame

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

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice