Table 2

Adverse eventsa
Brodalumab
Placebo SC IV
Adverse events SC IV All 50 mg 140 mg 210 mg 420 mg 700 mg All Total
(N= 6) (N= 4) (N =10) (N= 6) (N= 6) (N= 6) (N= 6) (N= 6) (N= 30) (N= 40)
Adverse events, n (%)
 Any 3 (50) 4 (100) 7 (70) 5 (83) 5 (83) 4 (67) 5 (83) 4 (67) 23 (77) 30 (75)
 Seriousb 0 (0) 1 (25) 1 (10) 0 (0) 0 (0) 0 (0) 1 (17) 0 (0) 1 (4) 2 (5)
 Fatal 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
 Leading to study discontinuation 0 (0) 1 (25) 1 (10) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (3)
 Leading to IP discontinuation 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (17) 0 (0) 0 (0)
Common adverse eventsc
 Headache 2 (33) 2 (50) 4 (40) 1 (17) 1 (17) 2 (33) 2 (33) 2 (33) 8 (27) 12 (30)
 Cough 2 (33) 0 (0) 2 (20) 1 (17) 0 (0) 0 (0) 1 (17) 0 (0) 3 (10) 5 (13)
 Abdominal pain 0 (0) 0 (0) 0 (0) 0 (0) 2 (33) 1 (17) 1 (17) 1 (17) 4 (13) 4 (10)
 Constipation 1 (17) 1 (25) 2 (20) 0 (0) 0 (0) 2 (33) 0 (0) 0 (0) 2 (7) 4 (10)
 Diarrhea 0 (0) 0 (0) 0 (0) 0 (0) 2 (33) 2 (33) 0 (0) 0 (0) 4 (13) 4 (10)
 Upper respiratory tract infection 0 (0) 1 (25) 1 (10) 1 (17) 1 (17) 0 (0) 0 (0) 1 (17) 3 (10) 4 (10)
 Rash 0 (0) 1 (0) 1 (10) 0 (0) 2 (33) 0 (0) 0 (0) 0 (0) 2 (7) 3 (8)

aIP investigational product; IV, intravenous; SC subcutaneous. bA serious adverse event was defined as an event that was fatal or life-threatening, either required or prolonged hospitalization or caused persistent or substantial disability or incapacity or congenital anomaly or birth defect or an event that was considered by the investigator to be a medically important event. cCommon adverse events were those that were reported in at least three patients from all brodalumab-treated groups combined.

Martin et al.

Martin et al. Arthritis Research & Therapy 2013 15:R164   doi:10.1186/ar4347

Open Data