Table 3.

Adverse events of any cause experienced by ≥10 % patients over the study (N = 19)

Adverse event, n (%)	All grades	Grade 1	Grade 2	Grade 3
Aphthous stomatitis	11 (57.9)	11 (57.9)	0 (0.0)	0 (0.0)
Hypercholesterolaemia	11 (57.9)	5 (26.3)	6 (31.6)	0 (0.0)
Hypertriglyceridaemia	8 (42.1)	3 (15.8)	3 (15.8)	2 (10.5)
Urinary tract infection	8 (42.1)	2 (10.5)	6 (31.6)	0 (0.0)
Mucosal inflammation	7 (36.8)	5 (26.3)	1 (5.3)	1 (5.3)
Hypertension	6 (31.6)	3 (15.8)	2 (10.5)	1 (5.3)
Dermatitis acneiform	5 (26.3)	5 (26.3)	0 (0.0)	0 (0.0)
Insomnia	5 (26.3)	5 (26.3)	0 (0.0)	0 (0.0)
Catarrh	4 (21.1)	4 (21.1)	0 (0.0)	0 (0.0)
Diarrhoea	4 (21.1)	3 (15.8)	1 (5.3)	0 (0.0)
Amenorrhoea	3 (15.8)	3 (15.8)	0 (0.0)	0 (0.0)
Asthenia	3 (15.8)	3 (15.8)	0 (0.0)	0 (0.0)
Headache	3 (15.8)	3 (15.8)	0 (0.0)	0 (0.0)
Dysgeusia	3 (15.8)	3 (15.8)	0 (0.0)	0 (0.0)
Pharyngitis	3 (15.8)	3 (15.8)	0 (0.0)	0 (0.0)
Nasopharyngitis	3 (15.8)	2 (10.5)	1 (5.3)	0 (0.0)
Cough	3 (15.8)	3 (15.8)	0 (0.0)	0 (0.0)
Menstrual disorder	3 (15.8)	3 (15.8)	0 (0.0)	0 (0.0)
Conjunctivitis	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Dermatitis	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Back pain	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Abdominal pain upper	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Epistaxis	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Erythema	2 (10.5)	1 (5.3)	1 (5.3)	0 (0.0)
Rash	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Oral herpes	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Dizziness	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Menorrhagia	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Myalgia	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Pyrexia	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Vomiting	2 (10.5)	2 (10.5)	0 (0.0)	0 (0.0)
Gamma-glutamyltransferase increased	2 (10.5)	0 (0.0)	2 (10.5)	0 (0.0)
Transaminases increased	2 (10.5)	0 (0.0)	1 (5.3)	1 (5.3)

All adverse events were coded using the Medical Dictionary for Regulatory Activities (MedDRA) preferred term and graded as per the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (version 4.03)