Table 2

Treatment-emergent adverse events in the safety population during the double-blind period

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 infestations37 (37.8%)35 (36.5%)
Serious AEs, n (%)7 (7.1%)5 (5.2%)
 Serious infections, n (%)1 (1.0%)2 (2.1%)
 Malignancies2 (2.0%)0
AE leading to death, n (%)00
AE leading to withdrawal*6 (6.1%)6 (6.3%)
Most common AE
System order class
 Preferred term
Infections and infestations37 (37.8%)35 (36.5%)
 Bronchitis5 (5.1%)3 (3.1%)
 Gastroenteritis3 (3.1%)1 (1.0%)
 Herpes simplex1 (1.0%)3 (3.1%)
 Influenza2 (2.0%)3 (3.1%)
 Nasopharyngitis11 (11.2%)10 (10.4%)
 Rhinitis2 (2.0%)3 (3.1%)
 Upper respiratory tract infection4 (4.1%)6 (6.3%)
 Urinary tract infection5 (5.1%)6 (6.3%)
Gastrointestinal disorders13 (13.3%)19 (19.8%)
 Diarrhoea6 (6.1%)5 (5.2%)
 Abdominal pain2 (2.0%)4 (4.2%)
 Abdominal pain upper1 (1.0%)3 (3.1%)
 Nausea5 (5.1%)5 (5.2%)
Nervous system disorders11 (11.2%)4 (4.2%)
 Headache5 (5.1%)0
Musculoskeletal and connective tissue disorders19 (19.4%)15 (15.6%)
 Rheumatoid arthritis5 (5.1%)3 (3.1%)
Cardiac disorders1 (1.0%)6 (6.3%)
 Tachycardia03 (3.1%)
Ear and labyrinth disorders3 (3.1%)1 (1.0%)
 Vertigo3 (3.1%)0
Vascular disorders4 (4.1%)3 (3.1%)
 Hypertension2 (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.