Trial Outcomes & Findings for A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] (NCT NCT00160524)

Last Updated: 2018-08-01

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

596 participants

Primary outcome timeframe

Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)

Results posted on

2018-08-01

Participant Flow

This multicenter study started to enroll subjects in July 2004 in order to end up with 206 centers in 29 countries with enrolled subjects. Participant Flow refers to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].

All subjects who completed the Week 26 assessment in feeder studies C87031 and C87032 were eligible to enter this open-label follow-on study C87033.

Participant milestones

Participant milestones
Measure	Certolizumab Pegol 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Overall Study STARTED	595
Overall Study COMPLETED	117
Overall Study NOT COMPLETED	478

Reasons for withdrawal

Reasons for withdrawal
Measure	Certolizumab Pegol 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Overall Study Adverse Event	119
Overall Study Adverse Event and Other	94
Overall Study Protocol Violation	16
Overall Study Protocol Violation and Other	2
Overall Study Withdrawal by Subject	141
Overall Study Withdrawal by Subject and Other	17
Overall Study Physician Decision	27
Overall Study Physician Decision and Other	6
Overall Study Lost to Follow-up	13
Overall Study Lost to Follow-up and Other	1
Overall Study Lack of Efficacy	21
Overall Study Lack of Efficacy and Other	1
Overall Study Other	20

Baseline Characteristics

A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Certolizumab Pegol n=595 Participants 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Age, Categorical <=18 years	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	574 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	38.1 years STANDARD_DEVIATION 11.87 • n=5 Participants
Sex: Female, Male Female	307 Participants n=5 Participants
Sex: Female, Male Male	288 Participants n=5 Participants
Region of Enrollment Belarus	12 participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants
Region of Enrollment Serbia	29 participants n=5 Participants
Region of Enrollment Estonia	4 participants n=5 Participants
Region of Enrollment Hong Kong	2 participants n=5 Participants
Region of Enrollment Spain	1 participants n=5 Participants
Region of Enrollment Ukraine	18 participants n=5 Participants
Region of Enrollment Israel	13 participants n=5 Participants
Region of Enrollment Russian Federation	22 participants n=5 Participants
Region of Enrollment Italy	14 participants n=5 Participants
Region of Enrollment Denmark	21 participants n=5 Participants
Region of Enrollment Australia	30 participants n=5 Participants
Region of Enrollment South Africa	45 participants n=5 Participants
Region of Enrollment Latvia	4 participants n=5 Participants
Region of Enrollment Slovenia	15 participants n=5 Participants
Region of Enrollment Lithuania	1 participants n=5 Participants
Region of Enrollment Austria	4 participants n=5 Participants
Region of Enrollment Czech Republic	54 participants n=5 Participants
Region of Enrollment Hungary	48 participants n=5 Participants
Region of Enrollment Canada	17 participants n=5 Participants
Region of Enrollment Belgium	6 participants n=5 Participants
Region of Enrollment Poland	72 participants n=5 Participants
Region of Enrollment Singapore	2 participants n=5 Participants
Region of Enrollment Georgia	1 participants n=5 Participants
Region of Enrollment Bulgaria	20 participants n=5 Participants
Region of Enrollment Germany	21 participants n=5 Participants
Region of Enrollment Norway	7 participants n=5 Participants
Region of Enrollment New Zealand	10 participants n=5 Participants
Region of Enrollment Sweden	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)

Population: All 595 subjects in the Safety Population are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=595 Participants 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)	88.2 percentage of subjects

PRIMARY outcome

Timeframe: Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)

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

Outcome measures
Measure	Certolizumab Pegol n=595 Participants 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)	40.3 percentage of subjects

SECONDARY outcome

Timeframe: Study Completion Visit (Week 364) / (Early) Withdrawal Visit

Population: Of the 594 subjects in the Intention-To-Treat (ITT) Population, 592 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

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

Outcome measures
Measure	Certolizumab Pegol n=592 Participants 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit or (Early) Withdrawal Visit	54.7 percentage of subjects Interval 50.7 to 58.7

SECONDARY outcome

Timeframe: From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit

Population: All 594 subjects in the Intention-To-Treat (ITT) Population are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. 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

Outcome measures
Measure	Certolizumab Pegol n=594 Participants 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change >=3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032	21.7 percentage of subjects Interval 18.4 to 25.0

SECONDARY outcome

Timeframe: Study Completion Visit (Week 364) / (Early) Withdrawal Visit

Population: Of the 595 subjects in the Safety Population, 590 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].

Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=590 Participants 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit	5.578 μg/mL Interval 4.898 to 6.352

SECONDARY outcome

Timeframe: From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)

Population: Of the 595 subjects in the Safety Population, 593 subjects are included in the analysis of this outcome measure. Safety Population includes all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].

Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels \> 2.4 units/mL.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=593 Participants 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033	22.6 percentage of subjects

SECONDARY outcome

Timeframe: Study Completion Visit (Week 364) / (Early) Withdrawal Visit

Population: Of the 594 subjects in the Intention-To-Treat (ITT) Population, 593 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=593 Participants 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit	7.93 mg/L Interval 7.14 to 8.81

SECONDARY outcome

Timeframe: Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258

Population: Of the 594 subjects in the Intention-To-Treat (ITT) Population, 567 subjects are included in the analysis of this outcome measure. ITT Population includes all subjects of the Safety Population who provide at least one efficacy measurement after Week 0 of this study.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol n=567 Participants 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258	302.540 μg/g stool Interval 267.759 to 341.839

Adverse Events

Certolizumab Pegol

Serious events: 240 serious events

Other events: 410 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Certolizumab Pegol n=595 participants at risk 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Blood and lymphatic system disorders Anaemia	1.0% 6/595 • Number of events 6 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Blood and lymphatic system disorders Neutropenia	0.50% 3/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Blood and lymphatic system disorders Iron deficiency anaemia	0.34% 2/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Blood and lymphatic system disorders Lymphadenitis	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Blood and lymphatic system disorders Pancytopenia	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Blood and lymphatic system disorders Leukopenia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Blood and lymphatic system disorders Thrombocytopenia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Cardiac disorders Cardiac failure	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Cardiac disorders Myocardial ischaemia	0.17% 1/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Crohn's disease	11.3% 67/595 • Number of events 75 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Small intestinal obstruction	2.2% 13/595 • Number of events 16 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Intestinal obstruction	1.7% 10/595 • Number of events 10 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Abdominal pain	1.5% 9/595 • Number of events 9 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Ileal stenosis	1.2% 7/595 • Number of events 7 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Perirectal abscess	0.84% 5/595 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Anal fistula	0.67% 4/595 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Pancreatitis acute	0.50% 3/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Subileus	0.50% 3/595 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Vomiting	0.50% 3/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Gastritis	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Inguinal hernia	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Intestinal mass	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Large intestine perforation	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Nausea	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Rectovaginal fistula	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Abdominal hernia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Anal haemorrhage	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Anal inflammation	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Anal stenosis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Colonic stenosis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Constipation	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Dyspepsia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Dysphagia	0.17% 1/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Enterovesical fistula	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Gastric ulcer	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Gastrointestinal mucosal disorder	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Gastrooesophageal reflux disease	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Haemorrhoids	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Intestinal fistula	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Intestinal stenosis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Jejunal stenosis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Mouth ulceration	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Oesophageal perforation	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Oesophageal stenosis acquired	0.17% 1/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Pancreatitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Peritoneal adhesions	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Proctalgia	0.17% 1/595 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Rectal haemorrhage	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Small intestinal perforation	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Small intestinal stricture	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Stomatitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
General disorders General physical health deterioration	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
General disorders Impaired healing	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
General disorders Pain	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Hepatobiliary disorders Cholelithiasis	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Hepatobiliary disorders Autoimmune hepatitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Hepatobiliary disorders Biliary cirrhosis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Hepatobiliary disorders Biliary colic	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Hepatobiliary disorders Gallbladder non-functioning	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Hepatobiliary disorders Hepatic cirrhosis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Hepatobiliary disorders Liver disorder	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Immune system disorders Sarcoidosis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Perianal abscess	1.5% 9/595 • Number of events 10 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Abdominal abscess	1.3% 8/595 • Number of events 9 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Pneumonia	1.2% 7/595 • Number of events 7 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Gastroenteritis	1.0% 6/595 • Number of events 7 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Cellulitis	0.50% 3/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Disseminated tuberculosis	0.50% 3/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Pulmonary tuberculosis	0.50% 3/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Urinary tract infection	0.50% 3/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Bronchitis	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Bronchopneumonia	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Gastroenteritis viral	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Postoperative abscess	0.34% 2/595 • Number of events 4 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Pyelonephritis	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Sepsis	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Staphylococcal infection	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Subcutaneous abscess	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Abscess	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Abscess intestinal	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Acute tonsillitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Anal abscess	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Bronchitis acute	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Campylobacter gastroenteritis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Candidiasis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Cellulitis orbital	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Chronic tonsillitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Clostridial infection	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Enterocolitis infectious	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Epiglottitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Erysipelas	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Fungal infection	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Gastroenteritis clostridial	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Groin abscess	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Herpes Zoster	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Lobar pneumonia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Localised infection	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Lung abscess	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Oesophageal candidiasis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Osteomyelitis acute	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Pelvic abscess	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Pelvic inflammatory disease	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Perineal abscess	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Pneumonia bacterial	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Pneumonia haemophilus	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Pneumonia streptococcal	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Rectal abscess	0.17% 1/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Salpingitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Staphylococcal sepsis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Streptococcal sepsis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Tracheobronchitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Viral infection	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Wound infection	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Postoperative fever	0.34% 2/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Tibia fracture	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Animal bite	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Ankle fracture	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Femur fracture	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Haemothorax	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Hand fracture	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Hip fracture	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Incisional hernia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Joint dislocation	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Lower limb fracture	0.17% 1/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Meniscus lesion	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Pelvic fracture	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Pneumothorax traumatic	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Polytraumatism	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Post procedural diarrhoea	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Post procedural pain	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Tendon injury	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Injury, poisoning and procedural complications Wrist fracture	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Investigations Autoantibody positive	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Investigations International normalised ratio increased	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Investigations Weight decreased	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Metabolism and nutrition disorders Dehydration	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Metabolism and nutrition disorders Hypoalbuminaemia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Metabolism and nutrition disorders Malnutrition	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.50% 3/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Arthralgia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Bone erosion	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Chondropathy	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Fistula	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Flank pain	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Sacroiliitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Scleroderma	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Spondylolisthesis acquired	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Synovitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.50% 3/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lentigo maligna stage unspecified	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip neoplasm malignant stage unspecified	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Nervous system disorders Spinal column stenosis	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Nervous system disorders Arachnoid cyst	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Nervous system disorders Cauda equina syndrome	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Nervous system disorders Cerebral infarction	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Nervous system disorders Cerebrovascular accident	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Nervous system disorders Sciatica	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Nervous system disorders Transient ischaemic attack	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Nervous system disorders Trigeminal neuralgia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Pregnancy, puerperium and perinatal conditions Pregnancy	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Pregnancy, puerperium and perinatal conditions Unintended pregnancy	0.34% 2/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Pregnancy, puerperium and perinatal conditions Pregnancy on oral contraceptive	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Psychiatric disorders Suicide attempt	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Renal and urinary disorders Nephrolithiasis	0.84% 5/595 • Number of events 5 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Renal and urinary disorders Calculus ureteric	0.34% 2/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Renal and urinary disorders Dysuria	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Renal and urinary disorders Glomerulonephritis focal	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Renal and urinary disorders Renal colic	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Renal and urinary disorders Renal tubular acidosis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Reproductive system and breast disorders Ovarian cyst	0.50% 3/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Reproductive system and breast disorders Azoospermia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Reproductive system and breast disorders Dysfunctional uterine bleeding	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Reproductive system and breast disorders Endometriosis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Reproductive system and breast disorders Epididymitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Reproductive system and breast disorders Female genital-digestive tract fistula	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Reproductive system and breast disorders Menometrorrhagia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Reproductive system and breast disorders Metrorrhagia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Reproductive system and breast disorders Ovarian disorder	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Reproductive system and breast disorders Prostatitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Respiratory, thoracic and mediastinal disorders Asphyxia	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Skin and subcutaneous tissue disorders Alopecia totalis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Skin and subcutaneous tissue disorders Dermatitis allergic	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Skin and subcutaneous tissue disorders Psoriasis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Social circumstances Pregnancy of partner	0.50% 3/595 • Number of events 3 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Surgical and medical procedures Abortion induced	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Vascular disorders Deep vein thrombosis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Vascular disorders Haematoma	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Vascular disorders Lymphangitis	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Vascular disorders Raynaud's phenomenon	0.17% 1/595 • Number of events 2 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Vascular disorders Thrombophlebitis superficial	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Vascular disorders Venous thrombosis limb	0.17% 1/595 • Number of events 1 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].

Other adverse events

Other adverse events
Measure	Certolizumab Pegol n=595 participants at risk 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362. Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
Blood and lymphatic system disorders Anaemia	5.7% 34/595 • Number of events 43 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Crohn's disease	21.8% 130/595 • Number of events 189 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Abdominal pain	15.0% 89/595 • Number of events 152 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Diarrhoea	10.8% 64/595 • Number of events 85 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Nausea	8.4% 50/595 • Number of events 83 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Dyspepsia	6.6% 39/595 • Number of events 46 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Gastrointestinal disorders Vomiting	5.5% 33/595 • Number of events 48 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
General disorders Pyrexia	9.4% 56/595 • Number of events 98 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Nasopharyngitis	15.3% 91/595 • Number of events 201 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Urinary tract infection	13.8% 82/595 • Number of events 160 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Influenza	12.1% 72/595 • Number of events 105 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Upper respiratory tract infection	10.6% 63/595 • Number of events 110 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Sinusitis	7.2% 43/595 • Number of events 77 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Gastroenteritis	6.9% 41/595 • Number of events 52 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Infections and infestations Bronchitis	6.2% 37/595 • Number of events 52 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Arthralgia	11.8% 70/595 • Number of events 99 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Musculoskeletal and connective tissue disorders Back pain	6.9% 41/595 • Number of events 52 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Nervous system disorders Headache	10.1% 60/595 • Number of events 99 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Psychiatric disorders Insomnia	5.0% 30/595 • Number of events 39 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Respiratory, thoracic and mediastinal disorders Cough	5.9% 35/595 • Number of events 42 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Skin and subcutaneous tissue disorders Rash	6.7% 40/595 • Number of events 51 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].
Vascular disorders Hypertension	5.7% 34/595 • Number of events 37 • Adverse Events (AEs) were collected up to approximately 7 years, from Study Entry (Week 0) to the Safety Follow-up (Week 374). Adverse Events refer to the Safety Population, including all enrolled subjects who received at least one injection of study treatment in feeder study C87031 \[NCT00152490\] or C87032 \[NCT00152425\].

Additional Information

UCB Clinical Trial Call Center

UCB

Phone: +1 877 822 9493 (UCB)

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60