Table 4 Summary of treatment-emergent adverse events (safety analysis set)
HIP1601 (n = 105) | HGP1705 (n = 106) | Total (n = 211) | |
|---|---|---|---|
Number of subjects with TEAEs* | 15 (14.3%) | 15(14.2%) | 30(14.2%) |
Intensity | |||
Mild | 13 (12.4%) | 13 (12.3%) | 26(12.3%) |
Moderate | 2 (1.9%) | 1 (0.9%) | 3 (1.4%) |
Severe | 0 (0.0%) | 1 (0.9%) | 1 (0.5%) |
Relationship | |||
Yes | 2 (1.9%) | 6 (5.7%) | 8 (3.8%) |
No | 13 (12.4%) | 9 (8.5%) | 22 (10.4%) |
Number of subjects with serious TEAE | 0 (0.0%) | 1 (0.9%) | 1 (0.5%) |
Number of subjects with TEAEs leading to withdrawal | 0 (0.0%) | 1 (0.9%) | 1 (0.5%) |