Table 5 TEAEs Leading to Discontinuation by System Organ Class and Preferred Term (All Occurrences: Safety Population, N = 129)
System Organ Class | Preferred Term | n (%) |
|---|---|---|
Gastrointestinal | Â | 4 (3.1) |
| Â | Abdominal pain | 2 (1.6) |
| Â | Diarrhea | 1 (0.8) |
| Â | Nausea | 2 (1.6) |
| Â | Vomiting | 2 (1.6) |
General | Â | 4 (3.1) |
| Â | Fatigue | 2 (1.6) |
| Â | Irritability | 2 (1.6) |
Investigations | Â | 1 (0.8) |
| Â | Weight decrease | 1 (0.8) |
Metabolic/nutritional | Â | 3 (2.3) |
| Â | Anorexia | 2 (1.6) |
| Â | Decreased appetite | 1 (0.8) |
Nervous system | Â | 2 (1.6) |
| Â | Amnesia | 1 (0.8) |
| Â | Psychomotor hyperactivity | 2 (1.6) |
| Â | Tardive dyskinesia (lip-smacking) | 1 (0.8) |
Psychiatric | Â | 5 (3.9) |
| Â | Insomnia/sleep disorder | 4 (3.1) |
| Â | Suicidal ideation | 1 (0.8) |
| Â | Tearfulness | 1 (0.8) |