Table 7 Summary of overall safety and adverse drug reactions during the 8 weeks treatment
|  | Placebo | TS-141 30 mg | TS-141 60 mg | TS-141120 mg | P-value | ||||
|---|---|---|---|---|---|---|---|---|---|
N = 52 | (%) | N = 54 | (%) | N = 52 | (%) | N = 53 | (%) | ||
AE | 19 | (36.5) | 28 | (51.9) | 24 | (46.2) | 26 | (29.1) | p(a) = 0.420 |
AE leading to death | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | – |
Serious Adverse Event | 1 | (1.9) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | – |
AE leading to discontinuation | 1 | (1.9) | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) | – |
Adverse drug reactions | 2 | (3.8) | 3 | (5.6) | 9 | (17.3) | 2 | (3.8) | p(b) = 0.050 |
 Constipation |  |  |  |  | 1 | (1.9) |  |  |  |
 Nausea |  |  |  |  |  |  | 1 | (1.9) |  |
 Decreased appetite |  |  |  |  | 1 | (1.9) |  |  |  |
 Headache |  |  | 1 | (1.9) |  |  |  |  |  |
 Somnolence | 2 | (3.8) | 2 | (3.7) | 5 | (9.6) |  |  |  |
 Inappropriate affect |  |  |  |  | 2 | (3.8) |  |  |  |
 Insomnia |  |  |  |  | 1 | (1.9) |  |  |  |
 Eczema |  |  |  |  |  |  | 1 | (1.9) |  |