Trial Outcomes & Findings for A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease (NCT NCT00552344)
NCT ID: NCT00552344
Last Updated: 2018-08-09
Results Overview
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
403 participants
Primary outcome timeframe
From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Results posted on
2018-08-09
Participant Flow
The study started to enroll patients in May 2008 and concluded in Dec 2014. Participant Flow refers to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
406 subjects were screened: 3 subjects were considered as screen failures and were not enrolled. 403 subjects entered the study from C87085. 1 subject was enrolled in this study, but did not receive any open-label study medication and was withdrawn from the study; this subject was, therefore, not included in any of the analyses.
Participant milestones
| Measure |
Certolizumab Pegol
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
402
|
|
Overall Study
COMPLETED
|
87
|
|
Overall Study
NOT COMPLETED
|
315
|
Reasons for withdrawal
| Measure |
Certolizumab Pegol
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
55
|
|
Overall Study
Loss of efficacy
|
75
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Withdrawal by Subject
|
48
|
|
Overall Study
SAE, non-fatal
|
6
|
|
Overall Study
AE, non-serious non-fatal
|
38
|
|
Overall Study
SAE,non-fatal+AE,non-serious non-fatal
|
62
|
|
Overall Study
SAE, fatal + AE, non-serious non-fatal
|
1
|
|
Overall Study
Other Reason
|
22
|
Baseline Characteristics
A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease
Baseline characteristics by cohort
| Measure |
Certolizumab Pegol
n=402 Participants
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
|
|---|---|
|
Age, Customized
18 - < 65 years
|
393 Participants
n=5 Participants
|
|
Age, Customized
65 - < 85 years
|
9 Participants
n=5 Participants
|
|
Age, Customized
>= 85 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
221 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
181 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From study start to the end of the Safety Follow-up Period (up to 272 weeks)Population: Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Certolizumab Pegol
n=402 Participants
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
|
|---|---|
|
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)
|
89.6 percentage of subjects
|
PRIMARY outcome
Timeframe: From study start to the end of the Safety Follow-up Period (up to 272 weeks)Population: Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.
Outcome measures
| Measure |
Certolizumab Pegol
n=402 Participants
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
|
|---|---|
|
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)
|
37.1 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 262Population: Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.
HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
Outcome measures
| Measure |
Certolizumab Pegol
n=397 Participants
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
|
|---|---|
|
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)
|
11.6 percentage of subjects
Interval 8.4 to 14.7
|
SECONDARY outcome
Timeframe: Week 262Population: Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.
IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.
Outcome measures
| Measure |
Certolizumab Pegol
n=397 Participants
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
|
|---|---|
|
Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)
|
7.8 percentage of subjects
Interval 5.2 to 10.4
|
SECONDARY outcome
Timeframe: Week 52Population: Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Outcome measures
| Measure |
Certolizumab Pegol
n=402 Participants
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
|
|---|---|
|
Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)
|
6.317 μg/mL
Interval 5.407 to 7.381
|
SECONDARY outcome
Timeframe: From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)Population: Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 \[NCT00552058\] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels \> 2.4 units/mL.
Outcome measures
| Measure |
Certolizumab Pegol
n=402 Participants
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
|
|---|---|
|
Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088
|
10.2 percentage of subjects
|
Adverse Events
Certolizumab Pegol
Serious events: 149 serious events
Other events: 351 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Certolizumab Pegol
n=402 participants at risk
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
|
|---|---|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.75%
3/402 • Number of events 3 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Cardiac disorders
Atrial flutter
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Endocrine disorders
Goitre
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Eye disorders
Cataract
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Eye disorders
Retinal artery occlusion
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
6/402 • Number of events 6 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Anal fistula
|
0.50%
2/402 • Number of events 3 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Crohn's disease
|
12.7%
51/402 • Number of events 59 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Enteritis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Enterocolonic fistula
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.25%
1/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal mucosal disorder
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Ileal fistula
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.7%
11/402 • Number of events 11 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Proctitis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
6/402 • Number of events 6 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Subileus
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
General disorders
Chest pain
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
General disorders
Incarcerated hernia
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
General disorders
Mass
|
0.25%
1/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
General disorders
Pyrexia
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
General disorders
Unevaluable event
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Hepatobiliary disorders
Hepatic necrosis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Abdominal abscess
|
1.00%
4/402 • Number of events 4 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Abdominal sepsis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Abdominal wall abscess
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Anal abscess
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Appendicitis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Clostridium difficile infection
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Dengue fever
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Ear infection
|
0.25%
1/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Infectious mononucleosis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Mastoiditis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Otitis externa
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Perirectal abscess
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Peritonsillar abscess
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Pharyngitis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Pneumonia
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Psoas abscess
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Sepsis
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Septic shock
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
5/402 • Number of events 5 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Vulval abscess
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Injury, poisoning and procedural complications
Transfusion-related acute lung injury
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Investigations
Colonoscopy
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Investigations
Investigation
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.00%
4/402 • Number of events 4 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Nervous system disorders
Brain oedema
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Nervous system disorders
Convulsion
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Nervous system disorders
Demyelination
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Nervous system disorders
Migraine
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Nervous system disorders
Sciatica
|
0.25%
1/402 • Number of events 5 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Nervous system disorders
Syncope
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
1.2%
5/402 • Number of events 5 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Psychiatric disorders
Acute psychosis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Psychiatric disorders
Depression
|
0.75%
3/402 • Number of events 3 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Psychiatric disorders
Depression suicidal
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Renal and urinary disorders
Calculus urinary
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
5/402 • Number of events 5 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Renal and urinary disorders
Renal colic
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.50%
2/402 • Number of events 2 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vasculitis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Social circumstances
Physical assault
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Social circumstances
Social stay hospitalisation
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Social circumstances
Victim of abuse
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Vascular disorders
Arteritis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Vascular disorders
Hypotension
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Vascular disorders
Varicose vein
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Vascular disorders
Venous thrombosis
|
0.25%
1/402 • Number of events 1 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
Other adverse events
| Measure |
Certolizumab Pegol
n=402 participants at risk
Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.5%
34/402 • Number of events 45 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Crohn's disease
|
31.6%
127/402 • Number of events 191 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.7%
75/402 • Number of events 122 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.2%
61/402 • Number of events 93 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Nausea
|
11.4%
46/402 • Number of events 63 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
43/402 • Number of events 60 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.0%
32/402 • Number of events 37 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.0%
24/402 • Number of events 28 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
General disorders
Pyrexia
|
13.4%
54/402 • Number of events 106 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
General disorders
Influenza like illness
|
5.7%
23/402 • Number of events 40 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.7%
63/402 • Number of events 99 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
11.4%
46/402 • Number of events 88 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Influenza
|
7.5%
30/402 • Number of events 35 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Sinusitis
|
7.2%
29/402 • Number of events 48 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
25/402 • Number of events 31 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Infections and infestations
Bronchitis
|
5.2%
21/402 • Number of events 32 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.2%
57/402 • Number of events 79 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.0%
36/402 • Number of events 40 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Nervous system disorders
Headache
|
11.2%
45/402 • Number of events 58 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.7%
39/402 • Number of events 49 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
23/402 • Number of events 27 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
27/402 • Number of events 39 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
|
Vascular disorders
Hypertension
|
7.0%
28/402 • Number of events 30 • Adverse Events presented below where collected from the Final Visit in Feeder study C87085 (Week 0) over the whole study period until the Safety-Follow-Up Visit (up to 274 weeks).
Adverse Events refer to the Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.
|
Additional Information
UCB (Study Director)
UCB Cares
Phone: +1 887 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60