TABLE 3.
Incidence of TEAEs During the Double-blind Treatment Period of at Least 2% in Any Centanafadine Group and Greater Than Placebo in Study 1 (NCT03605680) and Study 2 (NCT03605836)
| CTN SR 200 mg/d (n = 294) | CTN SR 400 mg/d (n = 292) | Placebo (n = 290) | Total (N = 876) | |
|---|---|---|---|---|
| Subject with any TEAE*† | 74 (25.2) | 93 (31.8) | 51 (17.6) | 218 (24.9) |
| Gastrointestinal disorders | 23 (7.8) | 45 (15.4) | 10 (3.4) | 78 (8.9) |
| Constipation | 6 (2.0) | 2 (0.7) | 3 (1.0) | 11 (1.3) |
| Diarrhea | 5 (1.7) | 15 (5.1) | 2 (0.7) | 22 (2.5) |
| Dry mouth | 9 (3.1) | 17 (5.8) | 1 (0.3) | 27 (3.1) |
| Nausea | 6 (2.0) | 19 (6.5) | 6 (2.1) | 31 (3.5) |
| Infections and infestations | 15 (5.1) | 5 (1.7) | 7 (2.4) | 27 (3.1) |
| Upper respiratory tract infection | 15 (5.1) | 5 (1.7) | 7 (2.4) | 27 (3.1) |
| Metabolism and nutrition disorders | 15 (5.1) | 20 (6.8) | 5 (1.7) | 40 (4.6) |
| Decreased appetite | 15 (5.1) | 20 (6.8) | 5 (1.7) | 40 (4.6) |
| Nervous system disorders | 12 (4.1) | 19 (6.5) | 16 (5.5) | 47 (5.4) |
| Headache | 12 (4.1) | 19 (6.5) | 16 (5.5) | 47 (5.4) |
| Psychiatric disorders | 30 (10.2) | 35 (12.0) | 18 (6.2) | 83 (9.5) |
| Abnormal dreams | 2 (0.7) | 7 (2.4) | 2 (0.7) | 11 (1.3) |
| Anxiety | 7 (2.4) | 5 (1.7) | 3 (1.0) | 15 (1.7) |
| Depressed mood | 8 (2.7) | 2 (0.7) | 1 (0.3) | 11 (1.3) |
| Insomnia | 8 (2.7) | 13 (4.5) | 7 (2.4) | 28 (3.2) |
| Irritability | 10 (3.4) | 12 (4.1) | 5 (1.7) | 27 (3.1) |
| Skin and subcutaneous tissue disorders | 4 (1.4) | 11 (3.8) | 2 (0.7) | 17 (1.9) |
| Rash | 4 (1.4) | 11 (3.8) | 2 (0.7) | 17 (1.9) |
*All AEs that started after start of trial drug treatment; or if the event was continuous from baseline and was serious or study-drug related or resulted in death, discontinuation, interruption, or reduction of study therapy.
†Subjects were counted once, per term, for the most severe of multiple occurrences of a specific MedDRA preferred term.
MedDRA, Medical Dictionary for Regulatory Activities.