Table 2.
Phase 2b Study: Patient Discontinuationsa
| Patients, n (%) | Centanafadine-SR n=79 | Placebo n=74 |
|---|---|---|
| Discontinued | 18 (22.8) | 7 (9.5) |
| Reason | ||
| Adverse eventb | 11 (13.9) | 1 (1.4) |
| Consent withdrawal | 2 (2.5) | 1 (1.4) |
| Lost to follow-up | 4 (5.1) | 1 (1.4) |
| Investigator discretion | 0 | 1 (1.4) |
| Other | 1 (1.3) | 3 (4.1) |
Notes: aNo patients in either arm discontinued due to noncompliance, protocol violation, lack of efficacy, or trial termination/suspension by sponsor. bAdverse events resulting in discontinuation, by target dose group, were as follows: centanafadine SR 800 mg/d (n=8) (4 rash, 3 nausea, 1 anxiety); centanafadine SR 600 mg/d (n=2) (1 rash, 1 acne); centanafadine SR 400 mg/d (n=1) (agitation); placebo mg/d (n=1) (1 chest tightness).
Abbreviation: SR, sustained-release.