Table 4 Adverse events in Study 1 and Study 2
Group | Study 1 | Study 2 | |||||
|---|---|---|---|---|---|---|---|
Enerisant 25 mg | Enerisant 50 mg | Enerisant 100 mg | Placebo | Enerisant 5 mg | Enerisant 10 mg | Placebo | |
(n = 12) | (n = 13) | (n = 9) | (n = 12) | (n = 17) | (n = 18) | (n h 18) | |
Any AE | 10 (83.3) | 9 (69.2) | 9 (100.0) | 5 (41.7) | 12 (70.6) | 9 (50.0) | 5 (27.8) |
Serious AEs | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Discontinuations due to AEs | 7 (58.3) | 3 (23.1) | 2 (22.2) | 0 | 3 (17.6) | 0 | 1 (5.6) |
Most common AEs (> 10% of patients in any group) | |||||||
Headache | 3 (25.0) | 4 (30.8) | 2 (22.2) | 0 | 4 (23.5) | 3 (16.7) | 1 (5.6) |
Nausea | 3 (25.0) | 1 (7.7) | 2 (22.2) | 0 | 2 (11.8) | 2 (11.1) | 2 (11.1) |
Insomniaa | 7 (58.3) | 4 (30.8) | 8 (88.9) | 1 (8.3) | 4 (23.5) | 3 (16.7) | 0 |
Dizziness | 0 | 1 (7.7) | 0 | 0 | 3 (17.6) | 0 | 0 |
Dysmenorrhea | 0 | 0 | 0 | 0 | 0 | 2 (11.1) | 0 |
Palpitations | 1 (8.3) | 2 (15.4) | 0 | 1 (8.3) | 0 | 0 | 0 |
Nasopharyngitis | 0 | 0 | 0 | 2 (16.7) | 0 | 1 (5.6) | 0 |
Parosmia | 2 (16.7) | 0 | 0 | 0 | 0 | 0 | 0 |