Table 3– Number of patients with ≥1 treatment-emergent serious adverse events throughout the course of the study
PlaceboGolimumabUstekinumab
Treated patients585560
Patients with events9 (15.5)7 (12.7)10 (16.7)
Infections and infestations3 (5.2)3 (5.5)5 (8.3)
Respiratory, thoracic and mediastinal disorders1 (1.7)3 (5.5)1 (1.7)
Cardiac disorders01 (1.8)1 (1.7)
General disorders and administration site conditions1 (1.7)1 (1.8)0
Metabolism and nutrition disorders01 (1.8)0
Musculoskeletal and connective tissue disorders01 (1.8)2 (3.3)
Psychiatric disorders1 (1.7)1 (1.8)1 (1.7)
Gastrointestinal disorders1 (1.7)01 (1.7)
Immune system disorders1 (1.7)01 (1.7)
Injury, poisoning and procedural complications1 (1.7)00
Investigations001 (1.7)
Neoplasms benign, malignant and unspecified, inclusive of cysts and polyps1 (1.7)00
Nervous system disorders1 (1.7)00
Renal and urinary disorders1 (1.7)00
Vascular disorders001 (1.7)
  • Data presented as n or n (%). Percentages were calculated with the number of patients treated in each arm as the denominator. Incidence is based on the number of patients experiencing at least one serious adverse event, not the number of events.