Trial Outcomes & Findings for Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease (NCT NCT00333788)

Last Updated: 2018-08-07

Results Overview

Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

233 participants

Primary outcome timeframe

Maximum 164 weeks

Results posted on

2018-08-07

Participant Flow

This study started in October 2006, with recruitment in the United States, Austria, Belgium, Canada, France, Germany, Italy, Spain, Sweden, Switzerland, the United Kingdom and the Netherlands. This study completed in April 2010.

The summary of Participant Flow is based on the All Subjects Population.

Participant milestones

Participant milestones
Measure	Certolizumab Pegol 400 mg 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Study STARTED	233
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	162

Reasons for withdrawal

Reasons for withdrawal
Measure	Certolizumab Pegol 400 mg 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Overall Study Adverse Event	44
Overall Study Lack of Efficacy	80
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	24
Overall Study Other: Non-compliance	2
Overall Study Other: Moved	2
Overall Study Other: Recurrent squamaous cell cancer	1
Overall Study Other: Investigator decision	1
Overall Study Other: Quality of life concern	1
Overall Study Other: Sponsor decision	1
Overall Study Other: Subject in need of an Entocort	1
Overall Study Other: Medical monitor decision	1
Overall Study Other: Physician decision	1
Overall Study Other: Signed consent for another study	1

Baseline Characteristics

Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	224 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	31.8 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	146 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants
Region of Enrollment France	20 participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants
Region of Enrollment Canada	20 participants n=5 Participants
Region of Enrollment Spain	6 participants n=5 Participants
Region of Enrollment Belgium	30 participants n=5 Participants
Region of Enrollment Austria	8 participants n=5 Participants
Region of Enrollment Netherlands	2 participants n=5 Participants
Region of Enrollment Germany	34 participants n=5 Participants
Region of Enrollment United Kingdom	9 participants n=5 Participants
Region of Enrollment Switzerland	4 participants n=5 Participants
Region of Enrollment Italy	24 participants n=5 Participants
Region of Enrollment Sweden	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Maximum 164 weeks

Population: Of the 233 subjects in the study, 229 are in the Intent to Treat (ITT) population and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)	92.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline (corresponding to Week 26 of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]

Population: Of the 233 subjects in the study, 166 are in the Intent to Treat (ITT) population and were in clinical response at Baseline of this study, and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.

Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). Subjects maintained their clinical response at Last Visit if they did not meet criteria for loss of response \[CDAI score \>150 points and a minimum increase in CDAI of 70 points versus Baseline of study C87042 (NCT00308581)\] at 2 consecutive visits. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects maintaining response at Last visit.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=166 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042).	61.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]

Clinical response is defined as at least a 100 point decrease from Baseline of study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI). CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects achieving clinical response at Last visit.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]	53.3 percentage of participants

SECONDARY outcome

Timeframe: Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]

Remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in remission at Last visit.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]	40.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline of study C87042 (NCT00308581) and Last Visit [Up to the maximum study duration observed in the study (Week 154) or the Withdrawal Visit for Premature Withdrawals]

Population: Of the 233 subjects in the study, 215 are in the Intent to Treat (ITT) population with Crohn's Disease Activity Index (CDAI) scores at Baseline and Last/Withdrawal visits and are included in this analysis. Note that the ITT population is the same as the Safety Set (SS) population.

CDAI is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=215 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals]	-121.52 score on a scale Standard Deviation 99.61

SECONDARY outcome

Timeframe: Maximum 154 weeks

Population: Of the 233 subjects in the study 153 are in the Modified Intent to Treat (MITT) population and are responders at Baseline of this study and are in this analysis. The MITT population includes subjects that are in the ITT population that were correctly randomized at Week 6 of study C87042 (NCT00308581).

Clinical response at Baseline of this study of at least a 100 point decrease from Baseline of study C87042 in Crohn's Disease Activity Index (CDAI) Loss of response = both a CDAI score \>150 points and a minimum increase in CDAI of 70 points versus Baseline (Week 26 of study C87042) as confirmed at 2 consecutive visits. Subjects losing response will be considered as having the event on the date of the first visit where response was lost. Subjects who discontinued the study without having lost response will be censored on the date of discontinuation (i.e. date of last visit performed).

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=153 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study	169.5 days Full Range 274.1 • Interval 85.0 to 814.0

SECONDARY outcome

Timeframe: Maximum 152 weeks

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the percentage of subjects with at least 1 hospital stay during the treatment period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 Hospital Stay During the Treatment Period	21.4 percentage of participants 0.730

SECONDARY outcome

Timeframe: Maximum 12 weeks

Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 hospital stay during the follow-up period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 Hospital Stay During the Follow-Up Period	21.8 percentage of participants 0.578

SECONDARY outcome

Timeframe: Maximum 164 weeks

Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 hospital stay during the overall period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 Hospital Stay During the During the Overall Period	37.6 percentage of participants 0.953

SECONDARY outcome

Timeframe: Maximum 152 weeks

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Length of Hospital Stays During the Treatment Period	1.838 days Standard Deviation 5.785

SECONDARY outcome

Timeframe: Maximum 12 weeks

Follow-up period starts the day after the last injection up to 84 days after last injection.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Length of Hospital Stays During the Follow-Up Period	2.782 days Standard Deviation 7.743

SECONDARY outcome

Timeframe: Maximum 164 weeks

Overall period corresponds to both treatment and follow-up periods in C87046.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Length of Hospital Stays During the Overall Period	4.620 days Standard Deviation 9.704

SECONDARY outcome

Timeframe: Maximum 152 weeks

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 Emergency Room Visit During the Treatment Period	13.1 percentage of participants 0.413

SECONDARY outcome

Timeframe: Maximum 12 weeks

Follow-up period starts the day after the last injection up to 84 days after last injection. Results are presented as the percentage of subjects with at least 1 emergency room visit during the follow-up period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period	6.1 percentage of participants 0.265

SECONDARY outcome

Timeframe: Maximum 164 weeks

Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the percentage of subjects with at least 1 emergency room visit during the overall period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 Emergency Room Visit During the Overall Period	19.2 percentage of participants 0.471

SECONDARY outcome

Timeframe: Maximum 152 weeks

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the treatment period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period Antibiotics	55.5 percentage of participants 2.889
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period Anti tumor necrosis factor (Anti-TNF)	0.4 percentage of participants 0.066
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period Immunosuppressants	3.9 percentage of participants 0.195
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period Corticosteroids	24.0 percentage of participants 0.733
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period 5- Aminosalicylic Acid (5-ASA)	5.2 percentage of participants 0.356

SECONDARY outcome

Timeframe: Maximum 12 weeks

Follow-up period start the day after the last injection up to 84 days after last injection. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the follow-up period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period Anti tumor necrosis factor (Anti-TNF)	16.2 percentage of participants 0.702
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period Immunosuppresants	5.2 percentage of participants 0.250
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period Corticosteroids	15.3 percentage of participants 0.622
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period 5- Aminosalicylic Acid (5-ASA)	2.2 percentage of participants 0.185
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period Antibiotics	14.0 percentage of participants 0.829

SECONDARY outcome

Timeframe: Maximum 164 weeks

Overall period corresponds to both treatment and follow-up periods in C87046. Medication categories are anti tumor necrosis factor (anti-TNFs), immunosuppressants, corticosteroids, 5 aminosalicylic acid (5-ASA) and antibiotics. Results are presented as the percentage of subjects with at least 1 concomitant medication potentially influencing Crohn's disease during the overall period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period Anti tumor necrosis factor (Anti-TNF)	16.2 percentage of participants 0.716
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period Immunosuppressants	8.3 percentage of participants 0.337
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period Corticosteroids	35.4 percentage of participants 0.986
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period 5- Aminosalicylic Acid (5-ASA)	7.0 percentage of participants 0.408
Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period Antibiotics	62.4 percentage of participants 2.974

SECONDARY outcome

Timeframe: Maximum 152 weeks

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who used at least 1 concomitant medication during the treatment period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 General Concomitant Medication During the Treatment Period	185 participants 10.172

SECONDARY outcome

Timeframe: Maximum 12 weeks

Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who used at least 1 concomitant medication during the follow-up period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period	71 participants 3.395

SECONDARY outcome

Timeframe: Maximum 164 weeks

Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who used at least 1 concomitant medication during the overall period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 General Concomitant Medication During the Overall Period	195 participants 10.948

SECONDARY outcome

Timeframe: Maximum 152 weeks

The Treatment Period is defined from the first administration of study drug in C87046 to the last/withdrawal study drug administration visit. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the treatment period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period.	148 participants 4.656

SECONDARY outcome

Timeframe: Maximum 12 weeks

Follow-up period start the day after the last injection up to 84 days after last injection. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the follow-up period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period	84 participants

SECONDARY outcome

Timeframe: Maximum 164 weeks

Overall period corresponds to both treatment and follow-up periods in C87046. Results are presented as the number of subjects who had at least 1 concurrent medical procedure during the overall period.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 400 mg n=229 Participants 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period	173 participants

Adverse Events

Certolizumab Pegol 400 mg

Serious events: 73 serious events

Other events: 190 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Certolizumab Pegol 400 mg n=229 participants at risk 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Blood and lymphatic system disorders Anaemia	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Cardiac disorders Supraventricular tachycardia	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Ear and labyrinth disorders Vertigo	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Ear and labyrinth disorders Vertigo positional	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Endocrine disorders Diabetes insipidus	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Abdominal hernia	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Abdominal pain	1.7% 4/229 • Number of events 5 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Anal fistula	0.87% 2/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Ascites	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Colonic stenosis	2.2% 5/229 • Number of events 5 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Constipation	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Crohn's disease	9.6% 22/229 • Number of events 23 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Faecal incontinence	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Frequent bowel movements	0.44% 1/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Gastrointestinal obstruction	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Hernial eventration	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Ileal stenosis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Intestinal obstruction	0.87% 2/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Intestinal stenosis	0.87% 2/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Pancreatitis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Rectal perforation	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Small intestinal obstruction	0.87% 2/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Small intestinal stenosis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Vomiting	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
General disorders Chest pain	1.3% 3/229 • Number of events 3 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
General disorders Pyrexia	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Hepatobiliary disorders Cholecystitis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Hepatobiliary disorders Hepatitis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Abdominal abscess	2.2% 5/229 • Number of events 5 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Abdominal wall abscess	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Anal abscess	0.87% 2/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Breast abscess	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Clostridial infection	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Empyema	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Fusobacterium infection	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Gastroenteritis viral	0.87% 2/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Infective tenosynovitis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Parotitis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Perianal abscess	2.2% 5/229 • Number of events 7 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Perineal abscess	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Perirectal abscess	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Pneumonia	0.87% 2/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Rectal abscess	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Sepsis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Septic shock	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Tuberculosis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Urinary tract infection	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Wound infection	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Injury, poisoning and procedural complications Anastomotic stenosis	0.87% 2/229 • Number of events 3 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Injury, poisoning and procedural complications Incisional hernia	0.87% 2/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Injury, poisoning and procedural complications Tendon rupture	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Injury, poisoning and procedural complications Wound complication	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Investigations Alanine aminotransferase increased	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Investigations Weight decreased	0.87% 2/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Metabolism and nutrition disorders Dehydration	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Metabolism and nutrition disorders Hypoalbuminaemia	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Metabolism and nutrition disorders Hypokalaemia	0.87% 2/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Metabolism and nutrition disorders Malnutrition	0.87% 2/229 • Number of events 2 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Musculoskeletal and connective tissue disorders Arthralgia	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Musculoskeletal and connective tissue disorders Fistula	0.87% 2/229 • Number of events 4 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Nervous system disorders Cerebral infarction	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Nervous system disorders Dizziness	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Nervous system disorders Hemiparesis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Nervous system disorders Hyporeflexia	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Nervous system disorders Syncope	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Nervous system disorders Wallenberg syndrome	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Psychiatric disorders Anxiety	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Psychiatric disorders Depression	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Psychiatric disorders Mental disorder	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Renal and urinary disorders Bladder prolapse	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Renal and urinary disorders Nephrolithiasis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Renal and urinary disorders Renal colic	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Renal and urinary disorders Renal failure acute	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Reproductive system and breast disorders Ovarian cyst	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.44% 1/229 • Number of events 1 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.

Other adverse events

Other adverse events
Measure	Certolizumab Pegol 400 mg n=229 participants at risk 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
Gastrointestinal disorders Abdominal pain	19.7% 45/229 • Number of events 63 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Abdominal pain upper	7.9% 18/229 • Number of events 23 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Anal fissure	6.1% 14/229 • Number of events 16 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Constipation	6.1% 14/229 • Number of events 20 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Crohn's disease	17.9% 41/229 • Number of events 48 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Diarrhoea	14.4% 33/229 • Number of events 44 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Haematochezia	6.1% 14/229 • Number of events 16 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Nausea	10.0% 23/229 • Number of events 43 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Gastrointestinal disorders Vomiting	10.5% 24/229 • Number of events 34 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
General disorders Asthenia	5.2% 12/229 • Number of events 15 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
General disorders Fatigue	9.2% 21/229 • Number of events 29 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
General disorders Pyrexia	20.5% 47/229 • Number of events 93 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Bronchitis	10.0% 23/229 • Number of events 33 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Gastroenteritis	7.0% 16/229 • Number of events 20 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Herpes simplex	10.5% 24/229 • Number of events 39 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Influenza	13.1% 30/229 • Number of events 35 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Nasopharyngitis	27.5% 63/229 • Number of events 117 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Sinusitis	10.0% 23/229 • Number of events 30 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Upper respiratory tract infection	5.2% 12/229 • Number of events 15 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Infections and infestations Urinary tract infection	8.3% 19/229 • Number of events 31 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Musculoskeletal and connective tissue disorders Arthralgia	19.2% 44/229 • Number of events 68 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Musculoskeletal and connective tissue disorders Back pain	11.8% 27/229 • Number of events 31 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Musculoskeletal and connective tissue disorders Muscle spasms	5.2% 12/229 • Number of events 16 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Musculoskeletal and connective tissue disorders Pain in extremity	5.2% 12/229 • Number of events 19 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Nervous system disorders Headache	20.5% 47/229 • Number of events 80 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Respiratory, thoracic and mediastinal disorders Cough	12.2% 28/229 • Number of events 31 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	9.2% 21/229 • Number of events 27 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.
Skin and subcutaneous tissue disorders Rash	8.7% 20/229 • Number of events 37 • Maximum of 166 weeks Adverse Event reporting is based on the Safety population; Participant flow is based on the All Subjects population.

Additional Information

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