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		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