Table 4 Treatment-emergent adverse events reported for ≥3 participants in either treatment group in Study 1 and Study 2
| Â | Study 1 | Study 2 | ||
|---|---|---|---|---|
FKB327 N = 65 | RP N = 65 | FKB327 N = 65 | RP N = 65 | |
Participants with ≥1 TEAEs, n (%) | 25 (38.5) | 29 (44.6) | 20 (30.8) | 31 (47.7) |
Participants with ≥1 TESAEs, n (%) | 0 | 0 | 0 | 1 (1.5) |
Participants in either group with ≥3TEAEs | ||||
 Injection-site reaction, n (%) | 3 (4.6) | 9 (13.8) | 9 (13.8) | 13 (20.0) |
 Nasopharyngitis, n (%) | 9 (13.8) | 8 (12.3) | 3 (4.6) | 8 (12.3) |
 Headache, n (%) | 7 (10.8) | 4 (6.2) | 1 (1.5) | 0 |
 Rash, n (%) | 1 (1.5) | 0 | 2 (3.1) | 3 (4.6) |
 Diarrhea, n (%) | 1 (1.5) | 1 (1.5) | 2 (3.1) | 3 (4.6) |
 Alanine aminotransferase increased, n (%) | 0 | 0 | 3 (4.6) | 2 (3.1) |
 Arthralgia, n (%) | 0 | 0 | 3 (4.6) | 1 (1.5) |