Double-blind period | ||
---|---|---|
Placebo (n=98) | CZP (n=96) | |
Any AE, n (%) | 66 (67.3%) | 66 (68.8%) |
Drug related, n (%) | 26 (26.5%) | 29 (30.2%) |
Infections and infestations | 37 (37.8%) | 35 (36.5%) |
Serious AEs, n (%) | 7 (7.1%) | 5 (5.2%) |
Serious infections, n (%) | 1 (1.0%) | 2 (2.1%) |
Malignancies | 2 (2.0%) | 0 |
AE leading to death, n (%) | 0 | 0 |
AE leading to withdrawal* | 6 (6.1%) | 6 (6.3%) |
Most common AE† | ||
System order class | ||
Preferred term | ||
Infections and infestations | 37 (37.8%) | 35 (36.5%) |
Bronchitis | 5 (5.1%) | 3 (3.1%) |
Gastroenteritis | 3 (3.1%) | 1 (1.0%) |
Herpes simplex | 1 (1.0%) | 3 (3.1%) |
Influenza | 2 (2.0%) | 3 (3.1%) |
Nasopharyngitis | 11 (11.2%) | 10 (10.4%) |
Rhinitis | 2 (2.0%) | 3 (3.1%) |
Upper respiratory tract infection | 4 (4.1%) | 6 (6.3%) |
Urinary tract infection | 5 (5.1%) | 6 (6.3%) |
Gastrointestinal disorders | 13 (13.3%) | 19 (19.8%) |
Diarrhoea | 6 (6.1%) | 5 (5.2%) |
Abdominal pain | 2 (2.0%) | 4 (4.2%) |
Abdominal pain upper | 1 (1.0%) | 3 (3.1%) |
Nausea | 5 (5.1%) | 5 (5.2%) |
Nervous system disorders | 11 (11.2%) | 4 (4.2%) |
Headache | 5 (5.1%) | 0 |
Musculoskeletal and connective tissue disorders | 19 (19.4%) | 15 (15.6%) |
Rheumatoid arthritis | 5 (5.1%) | 3 (3.1%) |
Cardiac disorders | 1 (1.0%) | 6 (6.3%) |
Tachycardia | 0 | 3 (3.1%) |
Ear and labyrinth disorders | 3 (3.1%) | 1 (1.0%) |
Vertigo | 3 (3.1%) | 0 |
Vascular disorders | 4 (4.1%) | 3 (3.1%) |
Hypertension | 2 (2.0%) | 3 (3.1%) |
Results are shown as n (%) of patients.
*Temporary or permanent discontinuation of the drug.
†Treatment-emergent adverse events occurring in >3% (by preferred term) of the safety population in the specified period (in either certolizumab pegol or placebo group).
AE, Adverse event.