TABLE 2.
Incidence of treatment-emergent adverse events (TEAEs) categorized as related to study drug summarized by system organ class and preferred terma
| Adverse events | No. (%) for ST-246 treatment |
||||
|---|---|---|---|---|---|
| Placebo (n = 6) | 250 mg (n = 8) | 400 mg (n = 8) | 800 mg (n = 8) | Total active treatment (250-800 mg) (n = 24) | |
| Total no. of TEAEs | 5 | 5 | 0 | 11 | 16 |
| Subjects reporting at least one TEAE | 2 (33.3) | 3 (37.5) | 0 (0.0) | 5 (62.5) | 8 (33.3) |
| Eye disorders: abnormal sensation in eye | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (4.2) |
| Gastrointestinal disorders | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (37.5) | 3 (12.5) |
| Dry mouth | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (4.2) |
| Flatulence | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (25.0) | 2 (8.3) |
| Nausea | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (4.2) |
| General disorders and administration site conditions: fatigue | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) | 1 (4.2) |
| Nervous system disorders | 1 (16.7) | 3 (37.5) | 0 (0.0) | 3 (37.5) | 6 (25.0) |
| Headache | 1 (16.7) | 3 (37.5) | 0 (0.0) | 2 (25.0) | 5 (20.8) |
| Somnolence | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (12.5) | 1 (4.2) |
| Skin and subcutaneous tissue disorders: urticaria | 1 (16.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
a
TEAEs are nonserious adverse events on or after day 1 postdose through week 4 follow-up and serious adverse events starting on or after day 1 postdose through week 7 study completion. For the number of subjects with TEAEs, subjects were counted once for each system organ class and once for each preferred term. Adverse events are coded in accordance with the MedDRA (Medical Dictionary for Regulatory Activities, version 10.0; www.meddramsso.com). Percentages are based on the number of subjects in each treatment group.