Safety summary for the entire treatment period (safety set)
| Safety events | TP1 | TP2 | Entire secukinumab exposure period | |
| Secukinumab, N=86 | Secukinumab, N=37 | Placebo, N=38 | Total, N=86 | |
| AEs, n (%) (PT) | 56 (65.1) | 34 (91.9) | 29 (76.3) | 79 (91.9) |
| SAE, n (%) (PT) | 2 (2.3) | 5 (13.5) | 0 | 11 (12.8) |
| AEs leading to study discontinuation | 1 (1.2) | 2 (5.4) | 5 (13.2) | 8 (9.3) |
| Death | 0 | 0 | 0 | 0 |
| Most frequent TEAEs, n (%) (PT) | ||||
| Nasopharyngitis | 5 (5.8) | 14 (37.8) | 6 (15.8) | 27 (31.4) |
| Nausea | 6 (7.0) | 7 (18.9) | 3 (7.9) | 19 (22.1) |
| Upper respiratory tract infection | 6 (7.0) | 6 (16.2) | 6 (15.8) | 19 (22.1) |
| Diarrhoea | 1 (1.2) | 9 (24.3) | 2 (5.3) | 17 (19.8) |
| Cough | 1 (1.2) | 7 (18.9) | 4 (10.5) | 13 (15.1) |
| Arthralgia | 2 (2.3) | 6 (16.2) | 3 (7.9) | 12 (14.0) |
| Oropharyngeal pain | 5 (5.8) | 4 (10.8) | 2 (5.3) | 12 (14.0) |
| Headache | 5 (5.8) | 3 (8.1) | 3 (7.9) | 12 (14.0) |
| Fever | 2 (2.3) | 6 (16.2) | 2 (5.3) | 12 (14.0) |
Secukinumab and placebo in TP2 groups have not been compared as the study design and the exposure times for these groups were different over the entire TP. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1.
AE, adverse event; IR, incidence rate per 100 subject years; PT, preferred term; SAE, serious adverse event; SOC, primary system organ class; TEAEs, treatment emergent AEs; TP, treatment period.