Table 2.
Summary of adverse events (safety population)*
| AE, n (%) | Placebo 1st (n = 20) | Placebo 2nd (n = 4) | BI 409306 | Total (n = 79) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0.5 mg sol EM (n = 6) | 2 mg sol EM (n = 6) | 5 mg sol EM (n = 6) | 5 mg tab EM (n = 6) | 10 mg tab EM (n = 6) | 25 mg tab EM (n = 6) | 50 mg tab EM (n = 6) | 50 mg sol EM (n = 8) | 100 mg tab EM (n = 5) | 200 mg tab EM (n = 6) | 350 mg tab EM (n = 6) | 10 mg tab PM (n = 6) | 100 mg tab PM (n = 6) | ||||
| Nervous system disorders | 1 (5.0) | 1 (25.0) | – | 2 (33.3) | – | 1 (16.7) | – | – | – | – | 2 (40.0) | 2 (33.3) | 1 (16.7) | 2 (33.3) | 2 (33.3) | 14 (17.7) |
| Headache | 1 (5.0) | – | – | 1 (16.7) | – | 1 (16.7) | – | – | – | – | – | 1 (16.7) | – | 2 (33.3) | 2 (33.3) | 8 (10.1) |
| Dizziness | – | 1 (25.0) | – | 1 (16.7) | – | – | – | – | – | – | – | – | – | – | – | 2 (2.5) |
| Paraesthesia | – | – | – | – | – | – | – | – | – | – | 1 (20.0) | – | – | – | – | 1 (1.3) |
| Parosmia | – | – | – | – | – | – | – | – | – | – | 1 (20.0) | – | – | – | – | 1 (1.3) |
| Presyncope | – | – | – | – | – | – | – | – | – | – | – | – | – | – | 1 (16.7) | 1 (1.3) |
| Somnolence | – | – | – | – | – | – | – | – | – | – | – | 1 (16.7) | 1 (16.7) | – | ‐ | 2 (2.5) |
| Eye disorders | – | – | – | – | – | – | – | – | – | – | 1 (20.0) | 3 (50.0) | 3 (50.0) | – | 2 (33.3) | 9 (11.4) |
| Photopsia | – | – | – | – | – | – | – | – | – | – | 1 (20.0) | 2 (33.3) | 2 (33.3) | – | 1 (16.7) | 6 (7.6) |
| Photophobia | – | – | – | – | – | – | – | – | – | – | 1 (20.0) | 1 (16.7) | 1 (16.7) | – | ‐ | 3 (3.8) |
| Chromatopsia | – | – | – | – | – | – | – | – | – | – | – | – | 1 (16.7) | – | 1 (16.7) | 2 (2.5) |
| Blurred vision | – | – | – | – | – | – | – | – | – | – | – | – | 1 (16.7) | – | – | 1 (1.3) |
| Cardiac disorders | – | – | – | – | – | – | – | – | 1 (16.7) | – | 1 (20.0) | – | 1 (16.7) | – | – | 3 (3.8) |
| Sinus tachycardia | – | – | – | – | – | – | – | – | – | – | 1 (20.0) | – | 1 (16.7) | – | – | 2 (2.5) |
| Extrasystoles | – | – | – | – | – | – | – | – | 1 (16.7) | – | – | – | – | – | – | 1 (1.3) |
| Palpitations | – | – | – | – | – | – | – | – | 1 (16.7) | – | – | – | – | – | – | 1 (1.3) |
| Gastrointestinal disorders | 1 (5.0) | – | – | 1 (16.7) | – | – | – | – | – | – | – | – | 2 (33.3) | 1 (16.7) | – | 5 (6.3) |
| Diarrhoea | 1 (5.0) | – | – | – | – | – | – | – | – | – | – | – | – | 1 (16.7) | – | 2 (2.5) |
| Dry mouth | – | – | – | – | – | – | – | – | – | – | – | – | 1 (16.7) | – | – | 1 (1.3) |
| Nausea | – | – | – | 1 (16.7) | – | – | – | – | – | – | – | – | 1 (16.7) | – | – | 2 (2.5) |
AE, adverse event; EM, extensive metabolizers; PM, poor metabolizers; sol, oral solution; tab, tablet
*
Includes all subjects dispensed study medication and documented to have taken ≥1 dose of study drug