Table 2 Reported treatment emergent adverse events (TEAEs)
Variables | Placebo group (n = 24) | 200 mg group (n = 31) | 400 mg group (n = 24) | P1 | P2 | P3 |
|---|---|---|---|---|---|---|
Total TEAEs reported | 45 | 51 | 29 | |||
Severity (%) of TEAEs | ||||||
1 | 5 (20.8) | 17 (54.8) | 10 (41.7) | 0.0107* | 0.1195 | 0.3325 |
2 | 7 (29.2) | 4 (12.9) | 2 (8.3) | 0.1804 | 0.1365 | 0.6862 |
3 | 0 | 0 | 2 (8.3) | NA | 0.4894 | 0.1859 |
4 | 1 (4.2) | 0 | 1 (4.2) | 0.4364 | > 0.9999 | 0.4364 |
5 | 0 | 0 | 0 | NA | NA | NA |
Total cases of CTCAE ≥ 3 | 1 (4.2) | 0 | 3 (12.5) | 0.4364 | 0.6085 | 0.0771 |
Drug related ADEs | 13 (54.2) | 21 (67.7) | 14 (58.3) | 0.3041 | 0.7711 | 0.4719 |
Several ADE | 0 | 0 | 0 | NA | NA | NA |
ADE inducing drug withdrawal | 0 | 0 | 0 | NA | NA | NA |
ADE inducing reduction of dose | 0 | 0 | 0 | NA | NA | NA |
ADE causing death | 0 | 0 | 0 | NA | NA | NA |