Table 5.
System Organ Class | Preferred Term | n (%) |
Gastrointestinal | 4 (3.1) | |
Abdominal pain | 2 (1.6) | |
Diarrhea | 1 (0.8) | |
Nausea | 2 (1.6) | |
Vomiting | 2 (1.6) | |
General | 4 (3.1) | |
Fatigue | 2 (1.6) | |
Irritability | 2 (1.6) | |
Investigations | 1 (0.8) | |
Weight decrease | 1 (0.8) | |
Metabolic/nutritional | 3 (2.3) | |
Anorexia | 2 (1.6) | |
Decreased appetite | 1 (0.8) | |
Nervous system | 2 (1.6) | |
Amnesia | 1 (0.8) | |
Psychomotor hyperactivity | 2 (1.6) | |
Tardive dyskinesia (lip-smacking) |
1 (0.8) | |
Psychiatric | 5 (3.9) | |
Insomnia/sleep disorder | 4 (3.1) | |
Suicidal ideation | 1 (0.8) | |
Tearfulness | 1 (0.8) |
TEAEs: treatment-emergent adverse events