Table 4.
Adverse Events (AE), coded according to MedDRA19.0
| Adverse Events, n (% of patients) | |
|---|---|
| Any AE | 153 (42.2) |
| TRAE | 133 (39.7) |
| Specific TRAE occurring in ≥5% of patients | |
| Medication taken at inappropriate timea | 60 (24.8) |
| TRAEs related to extrapyramidal symptoms | 7 (2.9) |
| Akathisia | 1 (0.4) |
| Dystonia | 0 (0) |
| Extrapyramidal disorder | 1 (0.4) |
| Muscle rigidity | 0 (0) |
| Muscle spasms | 1 (0.4) |
| Tremor | 2 (0.8) |
| Parkinsonism | 1 (0.4) |
| Parkinson gait | 1 (0.4) |
| TRAEs related to weight change | 1 (0.4) |
| Weight increased | 1 (0.4) |
| Weight decreased | 0 (0) |
Treatment related adverse events (TRAE) were defined as events probably or possibly caused by the medication as estimated by the treating clinician
aIn most cases, oral aripiprazole was discontinued at an earlier time than recommended