TABLE 2.
Treatment-Emergent Adverse Events
| Event, n (%) | Prior CTN SR 200 mg (n = 154) |
Prior CTN SR 400 mg (n = 149) |
Prior Placebo (n = 184) |
De Novo (n = 166) |
Total (N = 653) |
|---|---|---|---|---|---|
| Any TEAE | 98 (63.6) | 89 (59.7) | 123 (66.8) | 91 (54.8) | 401 (61.4) |
| Serious TEAEs | 1 (0.6) | 1 (0.7) | 7 (3.8) | 3 (1.8) | 12 (1.8) |
| TEAEs leading to discontinuation | 20 (13.0) | 21 (14.1) | 29 (15.8) | 10 (6.0) | 80 (12.3) |
| Possibly abuse potential–related TEAEs | 9 (5.8) | 5 (3.4) | 7 (3.8) | 10 (6.0) | 31 (4.7) |
| TEAEs with incidence ≥5% | |||||
| Insomnia | 9 (5.8) | 10 (6.7) | 19 (10.3) | 14 (8.4) | 52 (8.0) |
| Nausea | 11 (7.1) | 7 (4.7) | 19 (10.3) | 13 (7.8) | 50 (7.7) |
| Diarrhea | 11 (7.1) | 6 (4.0) | 13 (7.1) | 16 (9.6) | 46 (7.0) |
| Headache | 7 (4.5) | 11 (7.4) | 14 (7.6) | 14 (8.4) | 46 (7.0) |
| Decreased appetite | 6 (3.9) | 7 (4.7) | 16 (8.7) | 14 (8.4) | 43 (6.6) |
| Anxiety | 8 (5.2) | 6 (4.0) | 12 (6.5) | 11 (6.6) | 37 (5.7) |
| Nasopharyngitis | 8 (5.2) | 5 (3.4) | 16 (8.7) | 4 (2.4) | 33 (5.1) |
| Upper respiratory tract infection | 6 (3.9) | 8 (5.4) | 11 (6.0) | 5 (3.0) | 30 (4.6) |
CTN SR indicates centanafadine sustained release; TEAE, treatment-emergent adverse event.