Table 2.

Summary of treatment-related AEs by AE type and highest grade for patients stratified by stratum.

	Term	A (Na = 23)		B (Na = 7)
		G1	G2	G1	G2	G3
Gastrointestinal disorders	Abdominal pain	2 (8.7%)
	Constipation	1 (4.3%)	1 (4.3%)	1 (14.3%)
	Diarrhea	2 (8.7%)
	Dry mouth	1 (4.3%)
	Gastrointestinal disorders - dry lips	1 (4.3%)
	Nausea	4 (17.4%)	1 (4.3%)	1 (14.3%)
	Stomach pain	2 (8.7%)
	Vomiting	1 (4.3%)
General disorders and administration site conditions	Chills	1 (4.3%)
	Fatigue	2 (8.7%)	2 (8.7%)		1 (14.3%)	1 (14.3%)
	Flu-like symptoms	2 (8.7%)
	General disorders and administration site conditions – Mucosa dryness	1 (4.3%)
Investigations	Investigations – Alanine aminotransferase increased and Aspartate aminotransferase increased		1 (4.3%)
Metabolism and nutrition disorders	Anorexia	2 (8.7%)
	Hypertriglyceridemia		1 (4.3%)
Musculoskeletal and connective tissue disorders	Arthralgia	1 (4.3%)		1 (14.3%)
	Bone pain		1 (4.3%)
	Myalgia		1 (4.3%)
	Pain in extremity	2 (8.7%)
Nervous system disorders	Facial nerve disorder		1 (4.3%)
	Headache	1 (4.3%)
Psychiatric disorders	Agitation	2 (8.7%)	2 (8.7%)
	Depression		1 (4.3%)	1 (14.3%)
	Insomnia		1 (4.3%)
	Psychiatric disorders – emotionally fragile			1 (14.3%)
Reproductive system and breast disorders	Breast pain	3 (13.0%)
	Vaginal dryness	2 (8.7%)
Skin and subcutaneous tissue disorders	Alopecia	1 (4.3%)
	Dry skin	10 (43.5%)	2 (8.7%)	3 (42.9%)	1 (14.3%)
	Pruritus	1 (4.3%)	2 (8.7%)	1 (14.3%)
	Rash maculopapular	2 (8.7%)	2 (8.7%)	1 (14.3%)		1 (14.3%)
	Skin and subcutaneous tissue disorders – Pimple inguinal	1 (4.3%)
	Skin atrophy		1 (4.3%)
Vascular disorders	Hot flashes	2 (8.7%)

^aNumber of patients who had treatment-related AEs.

AE, adverse event.