Trial Outcomes & Findings for Observation of Treatment With Certolizumab Pegol in Daily Practice (NCT NCT01069419)
NCT ID: NCT01069419
Last Updated: 2015-10-29
Results Overview
The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient's Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints. For the analysis, DAS28 values were categorized into the following groups: * DAS28 \< 2.6: clinical remission * DAS28 from 2.6 to ≤ 3.2: low disease activity * DAS28 from \> 3.2 to 5.1: moderate disease activity * DAS28 \> 5.1: high disease activity
Recruitment status
COMPLETED
Target enrollment
1117 participants
Primary outcome timeframe
From Baseline to Visit 9 (around Week 104)
Results posted on
2015-10-29
Participant Flow
This non-interventional study started to enroll participants in Germany in October 2009 and concluded in December 2014. Participant Flow refers to the Enrolled Set.
There were 13 patients with missing termination information. Therefore only safety data were analyzed for these 13 patients. Patients with missing termination information were neither considered as completer nor as non-completer in the Clinical Study Report. These patients are considered as non-completers in the summary below.
Participant milestones
| Measure |
Cimzia
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
|
|---|---|
|
Overall Study
STARTED
|
1117
|
|
Overall Study
Safety Set
|
1111
|
|
Overall Study
Full Analysis Set
|
851
|
|
Overall Study
COMPLETED
|
402
|
|
Overall Study
NOT COMPLETED
|
715
|
Reasons for withdrawal
| Measure |
Cimzia
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
|
|---|---|
|
Overall Study
Adverse Event
|
233
|
|
Overall Study
Lack of Efficacy
|
332
|
|
Overall Study
Lost to Follow-up
|
49
|
|
Overall Study
Remission of disease
|
11
|
|
Overall Study
Withdrawal by Subject
|
34
|
|
Overall Study
Other Reason
|
43
|
|
Overall Study
Missing termination information
|
13
|
Baseline Characteristics
Observation of Treatment With Certolizumab Pegol in Daily Practice
Baseline characteristics by cohort
| Measure |
Cimzia
n=1117 Participants
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
|
|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
848 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
268 Participants
n=5 Participants
|
|
Age, Customized
Missing
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
870 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
247 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Visit 9 (around Week 104)Population: Full Analysis Set (FAS) using Non-Responder Imputation (NRI). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.
The DAS28 was calculated using the tender and swollen joint counts, c-reactive Protein (CRP), or erythrocyte sedimentation rate (ESR), and the Patient's Global Assessment of Disease Activity (PtGADA). The joint assessment was carried out on 28 joints. For the analysis, DAS28 values were categorized into the following groups: * DAS28 \< 2.6: clinical remission * DAS28 from 2.6 to ≤ 3.2: low disease activity * DAS28 from \> 3.2 to 5.1: moderate disease activity * DAS28 \> 5.1: high disease activity
Outcome measures
| Measure |
Cimzia
n=851 Participants
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
|
|---|---|
|
Clinical Remission at Visit 9 (Around Week 104) Measured by Achieving a Disease Activity Score 28 (DAS28) of < 2.6
|
14.1 percentage of participants
Interval 11.8 to 16.4
|
SECONDARY outcome
Timeframe: From Baseline to Visit 9 (around Week 104)Population: Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.
Patients rated how much pain they were experiencing at the time of the visit caused by their Arthritis using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 100 (most severe pain). A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).
Outcome measures
| Measure |
Cimzia
n=845 Participants
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
|
|---|---|
|
Change From Baseline to Visit 9 (Around Week 104) in Patients's Arthritis Pain as Measured by Patient's Assessment of Arthritis Pain (PAAP) Visual Analog Scale (VAS)
|
-16.43 units on a scale
Standard Deviation 20.34
|
SECONDARY outcome
Timeframe: From Baseline to Visit 9 (around Week 104)Population: Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.
The HAQ-DI contains 20 items on a 4-point scale ranging from 0 (without any difficulty) to 3 (unable to do). The 20 items are grouped in 8 categories with 2 to 3 items each. The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).
Outcome measures
| Measure |
Cimzia
n=845 Participants
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
|
|---|---|
|
Change From Baseline to Visit 9 (Around Week 104) in Patient's Physical Function as Measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)
|
-0.26 units on a scale
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: From Baseline to Visit 9 (around Week 104)Population: Full Analysis Set (FAS) using Mixed Model with Repeated Measures imputation (MMRM). FAS is defined as all patients with a DAS28 ≥ 2.6 at baseline who took at least 1 dose of Certolizumab Pegol and had at least 1 valid post-Baseline DAS28 value.
The CDAI was calculated with the equation: CDAI= Tender Joint Count + Swollen Joint Count + PtGADA/10 + PhGADA/10 where PtGADA (mm) is the Patient's Global Assessment of Disease Activity using a Visual Analog Scale (VAS) ranging from 0 to 100, and PhGADA (mm) is the Physician's Global Assessment of Disease Activity using a VAS ranging from 0 to 100. Thus, the CDAI ranges from 0 to 76, with higher values indicating higher disease activity. If any individual term was missing, then the CDAI was set to missing. A negative value in Change from Baseline indicates an improvement from Baseline to Visit 9 (around Week 104).
Outcome measures
| Measure |
Cimzia
n=846 Participants
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
|
|---|---|
|
Change From Baseline to Visit 9 (Around Week 104) in Disease Activity Measured by Clinical Disease Activity Index (CDAI)
|
-14.57 units on a scale
Standard Deviation 10.24
|
Adverse Events
Cimzia
Serious events: 212 serious events
Other events: 111 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cimzia
n=1111 participants at risk
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
|
|---|---|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Coronary artery disease
|
0.36%
4/1111 • Number of events 4 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.27%
3/1111 • Number of events 3 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Cardiac failure
|
0.18%
2/1111 • Number of events 3 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Myocardial infarction
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Dilatation ventricular
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Arrhythmia
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Tachycardia
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Atrial fibrillation
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Sinus tachycardia
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Endocrine disorders
Hyperthyroidism
|
0.09%
1/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Eye disorders
Cataract
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Eye disorders
Iridocyclitis
|
0.09%
1/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Eye disorders
Retinal artery occlusion
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Eye disorders
Retinal detachment
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Nausea
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Melaena
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Ascites
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Parotid gland enlargement
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
General disorders
Death
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
General disorders
Unevaluable event
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
General disorders
Local swelling
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
General disorders
Chest pain
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
General disorders
Drug intolerance
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Immune system disorders
Hypersensitivity
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Immune system disorders
Anaphylactic reaction
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Diverticulitis
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Gastroenteritis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Gastrointestinal infection
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Peritonitis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Arthritis bacterial
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Cellulitis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Cellulitis gangrenous
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Mastitis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Cystitis escherichia
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Escherichia sepsis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Gallbladder empyema
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Liver abscess
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Herpes zoster
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Abscess
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Abscess limb
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Localised infection
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Postoperative wound infection
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Influenza
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Pneumonia
|
0.90%
10/1111 • Number of events 10 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Bronchopneumonia
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Bronchitis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Epididymitis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Muscle abscess
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Sepsis
|
0.36%
4/1111 • Number of events 4 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Erysipelas
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Tuberculosis
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Urinary tract infection
|
0.27%
3/1111 • Number of events 4 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Cystitis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Infections and infestations
Viral infection
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Fall
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Injection related reaction
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.09%
1/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Investigations
Anti-cyclic citrullinated peptide antibody positive
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Investigations
Liver function test abnormal
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Investigations
Blood pressure increased
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Metabolism and nutrition disorders
Gout
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.27%
3/1111 • Number of events 3 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Bone cyst
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Bone infarction
|
0.09%
1/1111 • Number of events 3 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.27%
3/1111 • Number of events 3 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Wrist deformity
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.27%
3/1111 • Number of events 3 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.63%
7/1111 • Number of events 7 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
2.0%
22/1111 • Number of events 23 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Felty's syndrome
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid nodule
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.45%
5/1111 • Number of events 8 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer recurrent
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Cerebral infarction
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Syncope
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Facial paresis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Sciatica
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Dizziness
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Paraesthesia
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Hemiparesis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Paralysis flaccid
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.36%
4/1111 • Number of events 4 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Psychiatric disorders
Depression
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Psychiatric disorders
Schizoaffective disorder depressive type
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Renal and urinary disorders
Renal failure
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Renal and urinary disorders
Renal failure acute
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Renal and urinary disorders
Urethral polyp
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord cyst
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.27%
3/1111 • Number of events 3 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.27%
3/1111 • Number of events 3 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Skin and subcutaneous tissue disorders
Erythema nodosum
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.36%
4/1111 • Number of events 4 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Skin and subcutaneous tissue disorders
Dermatitis psoriasiform
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Surgical and medical procedures
Analgesic therapy
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Surgical and medical procedures
Synovectomy
|
0.27%
3/1111 • Number of events 3 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Surgical and medical procedures
Polypectomy
|
0.09%
1/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Vascular disorders
Hypertensive crisis
|
0.18%
2/1111 • Number of events 2 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Vascular disorders
Haematoma
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Vascular disorders
Deep vein thrombosis
|
0.36%
4/1111 • Number of events 4 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Vascular disorders
Varicophlebitis
|
0.09%
1/1111 • Number of events 1 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
|
Vascular disorders
Hypertension
|
0.27%
3/1111 • Number of events 3 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
Other adverse events
| Measure |
Cimzia
n=1111 participants at risk
All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
10.0%
111/1111 • Number of events 143 • Adverse Events were collected from Visit 2 (Week 6) up to Visit 10 (Week 116).
Adverse Events refer to the Safety Set consisting of all enrolled subjects who took at least one dose of Certolizumab Pegol.
|
Additional Information
UCB (Study Director)
UCB Clinical Trial Call Center
Phone: +1887 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60