Table 3 Summary of treatment-emergent adverse events
High-dose PXT3003 | Low-dose PXT3003 | Placebo | p | |
|---|---|---|---|---|
N = 113 | N = 109 | N = 101 | ||
Any TEAE | 87 (77.0) | 89 (81.7) | 83 (82.2) | 0.581 |
Treatment-related TEAEs | 38 (33.6%) | 39 (35.8%) | 34 (33.7%) | 0.935 |
Moderate or severe | 5 (4.4%) | 8 (7.3%) | 10 (9.9%) | 0.281 |
TEAE leading to drug withdrawal | 6 (5.3%) | 6 (5.5%) | 6 (5.9%) | 1 |
Treatment-related TEAEs | 2 (1.8%) | 3 (2.8%) | 2 (2.0%) | 0.898 |
Serious TEAEs | 3 (2.7%) | 10 (9.2%) | 5 (5.0%) | 0.108 |
Treatment-related TEAEs | Nil | Nil | Nil | |
Leading to drug withdrawal | Nil | 1 (0.9%) | Nil | |
Deaths | Nil | Nil | Nil |