Adverse events (AEs)
| KPS1301 study | KPS1305 study | ||||
| Placebo (n=123) | Rovatirelin 1.6 mg (n=125) | Rovatirelin 2.4 mg (n=126) | Placebo (n=102) | Rovatirelin 2.4 mg (n=101) | |
| Any AE, n (%) | 78 (63.4) | 85 (68.0) | 89 (70.6) | 66 (64.7) | 78 (77.2) |
| AE related to study drug | 12 (9.8) | 37 (29.6) | 45 (35.7) | 16 (15.7) | 33 (32.7) |
| Death | 0 | 0 | 0 | 0 | 0 |
| Serious AE | 5 (4.1) | 1 (0.8) | 6 (4.8) | 3 (2.9) | 4 (4.0) |
| AE leading to treatment discontinuation | 3 (2.4) | 9 (7.2) | 15 (11.9) | 5 (4.9) | 8 (7.9) |
| Severity of AE,* no of events | |||||
| Mild | 167 | 192 | 258 | 119 | 196 |
| Moderate | 13 | 18 | 16 | 9 | 17 |
| Severe | 0 | 0 | 4 | 3 | 1 |
| AE in ≥5% of patients, n (%) | |||||
| Nasopharyngitis | 14 (11.4) | 16 (12.8) | 19 (15.1) | 10 (9.8) | 19 (18.8) |
| Nausea | 1 (0.8) | 11 (8.8) | 14 (11.1) | 1 (1.0) | 9 (8.9) |
| Weight loss | 0 | 8 (6.4) | 11 (8.7) | 2 (2.0) | 13 (12.9) |
| Contusion | 11 (8.9) | 8 (6.4) | 8 (6.3) | 10 (9.8) | 18 (17.8) |
| Periodontitis | 1 (0.8) | 2 (1.6) | 8 (6.3) | 0 | 2 (2.0) |
| Abdominal discomfort | 3 (2.4) | 1 (0.8) | 7 (5.6) | 1 (1.0) | 1 (1.0) |
| Cough | 2 (1.6) | 8 (6.4) | 1 (0.8) | 1 (1.0) | 4 (4.0) |
| Excoriation | 3 (2.4) | 7 (5.6) | 1 (0.8) | 1 (1.0) | 2 (2.0) |
| Decreased appetite | 0 | 2 (1.6) | 6 (4.8) | 1 (1.0) | 7 (6.9) |
| Back pain | 3 (2.4) | 4 (3.2) | 2 (1.6) | 1 (1.0) | 6 (5.9) |
| Insomnia | 0 | 0 | 5 (4.0) | 0 | 5 (5.0) |
| AE leading to treatment discontinuation in ≥2 patients, n (%) | |||||
| Nausea | 0 | 3 (2.4) | 1 (0.8) | 0 | 2 (2.0) |
| Decreased appetite | 0 | 0 | 2 (1.6) | 0 | 1 (1.0) |
| Insomnia | 0 | 0 | 2 (1.6) | 0 | 0 |
*The definitions were as follows; mild: normal daily life is not interrupted; moderate: normal daily life is partially interrupted; severe: normal daily life is severely affected.