Table 2.
Summary of adverse events
| System organ class/preferred term | BI 409306 | Placebo (n = 10) n (%) |
Total (N = 40) n (%) |
||
|---|---|---|---|---|---|
| 25 mg (n = 10) n (%) |
50 mg (n = 10) n (%) |
100 mg (n = 10) n (%) |
|||
| Total with adverse events | 4 (40.0) | 9 (90.0) | 6 (60.0) | 4 (40.0) | 23 (57.5) |
| Infections and infestations | – | 1 (10.0) | 1 (10.0) | – | 2 (5.0) |
| Furuncle | – | 1 (10.0) | – | – | 1 (2.5) |
| Tooth infection | – | – | 1 (10.0) | – | 1 (2.5) |
| Psychiatric disorders | 1 (10.0) | – | 2 (20.0) | 1 (10.0) | 4 (10.0) |
| Agitation | – | – | 1 (10.0) | 1 (10.0) | 2 (5.0) |
| Anxiety | 1 (10.0) | – | 1 (10.0) | – | 2 (5.0) |
| Nervous system disorders | 1 (10.0) | 1 (10.0) | 2 (20.0) | – | 4 (10.0) |
| Dizziness | 1 (10.0) | – | – | – | 1 (2.5) |
| Headache | – | 1 (10.0) | 1 (10.0) | – | 2 (5.0) |
| Tremor | – | – | 1 (10.0) | – | 1 (2.5) |
| Visual field defect | – | – | 1 (10.0) | – | 1 (2.5) |
| Eye disorders | 2 (20.0) | 4 (40.0) | 2 (20.0) | 2 (20.0) | 10 (25.0) |
| Vision blurred | 2 (20.0) | 3 (30.0) | 1 (10.0) | 2 (20.0) | 8 (20.0) |
| Photopsia | – | 1 (10.0) | 1 (10.0) | – | 2 (5.0) |
| Visual impairment | 1 (10.0) | 1 (10.0) | – | – | 2 (5.0) |
| Gastrointestinal disorders | 2 (20.0) | – | 1 (10.0) | – | 3 (7.5) |
| Gastroesophageal reflux disease | 1 (10.0) | – | – | – | 1 (2.5) |
| Nausea | 1 (10.0) | – | – | – | 1 (2.5) |
| Toothache | – | – | 1 (10.0) | – | 1 (2.5) |
| Vomiting | 1 (10.0) | – | – | – | 1 (2.5) |
| Musculoskeletal and connective tissue disorders | – | 3 (30.0) | – | – | 3 (7.5) |
| Musculoskeletal pain | – | 2 (20.0) | – | – | 2 (5.0) |
| Back pain | – | 1 (10.0) | – | – | 1 (2.5) |
| General disorders and administration site conditions | – | – | 1 (10.0) | 1 (10.0) | 2 (5.0) |
| Pain | – | – | 1 (10.0) | – | 1 (2.5) |
| Pre-existing condition improved | – | – | – | 1 (10.0) | 1 (2.5) |
| Injury, poisoning, and procedural complications | – | 1 (10.0) | 1 (10.0) | – | 2 (5.0) |
| Excoriation | – | 1 (10.0) | 1 (10.0) | – | 2 (5.0) |
Percentages are calculated using total number of patients per treatment as the denominator