Table 1.
Patient disposition
| Disposition, n (%) | BPI disorder (n=22) |
MDD (n=12) |
Schizophrenia (n=15) |
Total (N=49) |
|---|---|---|---|---|
| Screened | 51 | |||
| Screen failure | 2 | |||
| Enrolled | 22 (100) | 12 (100) | 15 (100) | 49 (100) |
| Treated | 22 (100) | 12 (100) | 15 (100) | 49 (100) |
| Completed | 17 (77.3) | 10 (83.3) | 11 (73.3) | 38 (77.6) |
| Discontinued before observation phasea | 4 (18.2) | 2 (16.7) | 3 (20) | 9 (18.4) |
| Adverse event | 1 (4.5) | 0 | 0 | 1 (2) |
| Lost to follow-up | 0 | 1 (8.3) | 0 | 1 (2) |
| Noncompliant with patch wearing | 2 (9.1) | 1 (8.3) | 1 (6.7) | 4 (8.2) |
| Patient decision | 0 | 0 | 1 (6.7) | 1 (2) |
| Physician decision | 1 (4.5) | 0 | 0 | 1 (2) |
| Otherb | 0 | 0 | 1 (6.7) | 1 (2) |
| Discontinued during observation phase | 1 (4.5) | 0 | 1 (6.7) | 2 (4.1) |
| Patient decision | 1 (4.5) | 0 | 0 | 1 (2) |
| Otherb | 0 | 0 | 1 (6.7) | 1 (2) |
| Analyzed for safetyc | 22 (100) | 12 (100) | 15 (100) | 49 (100) |
| Intent to treatd | 22 (100) | 12 (100) | 15 (100) | 49 (100) |
Notes:
a
Discontinuations that occurred before the observation phase included those that occurred during the prospective phase;
b
discontinued due to patch not adhering to skin;
c
patients who received ≥1 dose of aripiprazole + IEM were included in the safety analysis;
d
patients who entered the trial and used the DMS. Percentages based on the number of enrolled patients.
Abbreviations: BP, bipolar; MDD, major depressive disorder; DMS, digital medicine system; IEM, ingestible event marker.