Table 3.
Treatment‐emergent adverse events during TP2, by pooled treatment groups (TP2 safety set)
| Pooled switched treatment group N = 196 n (%) | Pooled continued treatment group N = 301 n (%) | |
|---|---|---|
| Treatment‐emergent AEs (total, n ) | 116 | 168 |
| Any treatment‐emergent AE | 72 (36.7) | 105 (34.9) |
| Any SAE | 6 (3.1) | 3 (1.0) |
| Any treatment‐related treatment‐emergent AE | 26 (13.3) | 37 (12.3) |
| Discontinuations due to treatment‐emergent AE | 6 (3.1) | 3 (1.0) |
| Deaths | 0 | 0 |
| TEAEs (Preferred term) with a ≥2% incidence in any treatment group | ||
| Injection site reaction | 9 (4.6) | 13 (4.3) |
| Headache | 5 (2.6) | 5 (1.7) |
| Pharyngitis | 5 (2.6) | 10 (3.3) |
| Viral upper respiratory tract infection | 5 (2.6) | 4 (1.3) |
| Back pain | 4 (2.0) | 4 (1.3) |
| Nasopharyngitis | 4 (2.0) | 8 (2.7) |
| Psoriasis | 4 (2.0) | 4 (1.3) |
Patients experiencing multiple events were counted only once within each treatment group.
Events occurring with an incidence of ≥2% in any treatment group during treatment period 2 (safety set) are presented and sorted by descending order of frequency within the pooled switched treatment group column.
AE terms are coded using MedDRA version 17.0.
Total number of treatment‐emergent AEs is inclusive of injection site reactions.
MedDRA, medical dictionary for regulatory activities; SAE, serious adverse event; TEAE, treatment‐emergent adverse event; TP2, treatment period 2.