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) |