Table 4– Number of patients with ≥1 treatment-emergent adverse events ≥10% through the end of the study
PlaceboGolimumabUstekinumab
Treated patients585560
Patients with events54 (93.1)53 (96.4)56 (93.3)
Cough15 (25.9)11 (20.0)13 (21.7)
Arthralgia16 (27.6)13 (23.6)9 (15.0)
Fatigue8 (13.8)11 (20.0)12 (20.0)
Headache12 (20.7)7 (12.7)12 (20.0)
Upper respiratory tract infection13 (22.4)6 (10.9)10 (16.7)
Dyspnoea11 (19.0)11 (20.0)4 (6.7)
Diarrhoea11 (19.0)6 (10.9)9 (15.0)
Bronchitis9 (15.5)8 (14.5)8 (13.3)
Pain in extremity11 (19.0)3 (5.5)8 (13.3)
Back pain6 (10.3)6 (10.9)9 (15.0)
Nausea6 (10.3)7 (12.7)8 (13.3)
Rash6 (10.3)6 (10.9)6 (10.0)
Sarcoidosis3 (5.2)4 (7.3)11 (18.3)
Sinusitis9 (15.5)3 (5.5)5 (8.3)
Oedema peripheral5 (8.6)8 (14.5)4 (6.7)
Vomiting7 (12.1)4 (7.3)6 (10.0)
Nasopharyngitis2 (3.4)4 (7.3)9 (15.0)
Skin lesion8 (13.8)1 (1.8)6 (10.0)
Oropharyngeal pain4 (6.9)2 (3.6)7 (11.7)
  • Data presented as n or n (%). Percentages were calculated with the number of patients treated in each arm as the denominator. Incidence was based on the number of patients experiencing at least one adverse event, not the number of events.