NCT02552212 · ADVERSE EVENTS

Adverse events

Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS · Source last updated 2022-08-18

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: From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
Other-event reporting threshold: 5%

Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo (SS) Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Safety Set (SS).	4 / 158	59 / 158	0 / 158
CZP 200 mg Q2W (SS) Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the SS.	8 / 159	75 / 159	0 / 159
Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	3 / 96	27 / 96	0 / 96
CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	1 / 20	7 / 20	0 / 20
SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).	15 / 243	69 / 243	0 / 243

Group identifiers: EG000: Placebo (SS) · EG001: CZP 200 mg Q2W (SS) · EG002: Placebo->OL CZP (SS) · EG003: CZP->OL CZP (SS) · EG004: SFE OL CZP 200 mg Q2W (SS)

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
Eye disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
159
num Events
1
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
243
num Events
0
term
Glaucoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Iridocyclitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Uveitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
159
num Events
1
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
243
num Events
0
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
243
num Events
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Gastrointestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Inguinal hernia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
2
term
Cholelithiasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
1
num At Risk
158
num Events
1
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
243
num Events
0
term
Sarcoidosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
159
num Events
1
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
243
num Events
0
term
Neuroborreliosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Encephalitis

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
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
10
num At Risk
158
num Events
10
group Id
EG001
num Affected
8
num At Risk
159
num Events
11
group Id
EG002
num Affected
1
num At Risk
96
num Events
1
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
4
num At Risk
243
num Events
4
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
16
num At Risk
158
num Events
23
group Id
EG001
num Affected
30
num At Risk
159
num Events
38
group Id
EG002
num Affected
10
num At Risk
96
num Events
14
group Id
EG003
num Affected
4
num At Risk
20
num Events
5
group Id
EG004
num Affected
21
num At Risk
243
num Events
31
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
13
num At Risk
158
num Events
17
group Id
EG001
num Affected
21
num At Risk
159
num Events
24
group Id
EG002
num Affected
10
num At Risk
96
num Events
13
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
26
num At Risk
243
num Events
33
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
5
num At Risk
158
num Events
5
group Id
EG001
num Affected
8
num At Risk
159
num Events
9
group Id
EG002
num Affected
5
num At Risk
96
num Events
5
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
10
num At Risk
243
num Events
11
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
4
num At Risk
158
num Events
4
group Id
EG001
num Affected
8
num At Risk
159
num Events
9
group Id
EG002
num Affected
1
num At Risk
96
num Events
1
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
3
num At Risk
243
num Events
3
term
Blood creatine phosphokinase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
10
num At Risk
158
num Events
12
group Id
EG001
num Affected
9
num At Risk
159
num Events
12
group Id
EG002
num Affected
2
num At Risk
96
num Events
2
group Id
EG003
num Affected
2
num At Risk
20
num Events
2
group Id
EG004
num Affected
6
num At Risk
243
num Events
6
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
12
num At Risk
158
num Events
13
group Id
EG001
num Affected
11
num At Risk
159
num Events
13
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
5
num At Risk
243
num Events
5
term
Axial spondyloarthritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
7
num At Risk
158
num Events
9
group Id
EG001
num Affected
11
num At Risk
159
num Events
15
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
3
num At Risk
20
num Events
3
group Id
EG004
num Affected
9
num At Risk
243
num Events
11
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
8
num At Risk
158
num Events
10
group Id
EG001
num Affected
6
num At Risk
159
num Events
6
group Id
EG002
num Affected
2
num At Risk
96
num Events
2
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
3
num At Risk
243
num Events
3
term
Cough

Complete source fields

description

event Groups

deaths Num Affected
0
deaths Num At Risk
158
description
Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Safety Set (SS).
id
EG000
other Num Affected
59
other Num At Risk
158
serious Num Affected
4
serious Num At Risk
158
title
Placebo (SS)
deaths Num Affected
0
deaths Num At Risk
159
description
Certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards. Subjects formed the SS.
id
EG001
other Num Affected
75
other Num At Risk
159
serious Num Affected
8
serious Num At Risk
159
title
CZP 200 mg Q2W (SS)
deaths Num Affected
0
deaths Num At Risk
96
description
Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.
id
EG002
other Num Affected
27
other Num At Risk
96
serious Num Affected
3
serious Num At Risk
96
title
Placebo->OL CZP (SS)
deaths Num Affected
0
deaths Num At Risk
20
description
Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.
id
EG003
other Num Affected
7
other Num At Risk
20
serious Num Affected
1
serious Num At Risk
20
title
CZP->OL CZP (SS)
deaths Num Affected
0
deaths Num At Risk
243
description
Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
id
EG004
other Num Affected
69
other Num At Risk
243
serious Num Affected
15
serious Num At Risk
243
title
SFE OL CZP 200 mg Q2W (SS)

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
10
num At Risk
158
num Events
10
group Id
EG001
num Affected
8
num At Risk
159
num Events
11
group Id
EG002
num Affected
1
num At Risk
96
num Events
1
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
4
num At Risk
243
num Events
4
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
16
num At Risk
158
num Events
23
group Id
EG001
num Affected
30
num At Risk
159
num Events
38
group Id
EG002
num Affected
10
num At Risk
96
num Events
14
group Id
EG003
num Affected
4
num At Risk
20
num Events
5
group Id
EG004
num Affected
21
num At Risk
243
num Events
31
term
Upper respiratory tract infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
13
num At Risk
158
num Events
17
group Id
EG001
num Affected
21
num At Risk
159
num Events
24
group Id
EG002
num Affected
10
num At Risk
96
num Events
13
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
26
num At Risk
243
num Events
33
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
5
num At Risk
158
num Events
5
group Id
EG001
num Affected
8
num At Risk
159
num Events
9
group Id
EG002
num Affected
5
num At Risk
96
num Events
5
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
10
num At Risk
243
num Events
11
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
4
num At Risk
158
num Events
4
group Id
EG001
num Affected
8
num At Risk
159
num Events
9
group Id
EG002
num Affected
1
num At Risk
96
num Events
1
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
3
num At Risk
243
num Events
3
term
Blood creatine phosphokinase increased
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
10
num At Risk
158
num Events
12
group Id
EG001
num Affected
9
num At Risk
159
num Events
12
group Id
EG002
num Affected
2
num At Risk
96
num Events
2
group Id
EG003
num Affected
2
num At Risk
20
num Events
2
group Id
EG004
num Affected
6
num At Risk
243
num Events
6
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
12
num At Risk
158
num Events
13
group Id
EG001
num Affected
11
num At Risk
159
num Events
13
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
5
num At Risk
243
num Events
5
term
Axial spondyloarthritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
7
num At Risk
158
num Events
9
group Id
EG001
num Affected
11
num At Risk
159
num Events
15
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
3
num At Risk
20
num Events
3
group Id
EG004
num Affected
9
num At Risk
243
num Events
11
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
8
num At Risk
158
num Events
10
group Id
EG001
num Affected
6
num At Risk
159
num Events
6
group Id
EG002
num Affected
2
num At Risk
96
num Events
2
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
3
num At Risk
243
num Events
3
term
Cough

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
159
num Events
1
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
243
num Events
0
term
Glaucoma
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Iridocyclitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Uveitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Pancreatitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
159
num Events
1
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
243
num Events
0
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
1
num At Risk
20
num Events
1
group Id
EG004
num Affected
0
num At Risk
243
num Events
0
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Gastrointestinal obstruction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Inguinal hernia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
2
term
Cholelithiasis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
1
num At Risk
158
num Events
1
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
243
num Events
0
term
Sarcoidosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
1
num At Risk
159
num Events
1
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
0
num At Risk
243
num Events
0
term
Neuroborreliosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA19.0
stats
group Id
EG000
num Affected
0
num At Risk
158
num Events
0
group Id
EG001
num Affected
0
num At Risk
159
num Events
0
group Id
EG002
num Affected
0
num At Risk
96
num Events
0
group Id
EG003
num Affected
0
num At Risk
20
num Events
0
group Id
EG004
num Affected
1
num At Risk
243
num Events
1
term
Encephalitis

time Frame

From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)

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

Preserved source evidence · Not medical advice