Table 2.

Toxicity assessment according to the Common Terminology Criteria for Adverse Events, version 3.0 (adverse events, n = 45).

Adverse event*	Grade
	1–2	3–4
	n (%)	n (%)
Non-haematological
Fatigue	39 (87)	5 (11)
Weight loss	29 (64)	1 (2)
Mucositis	24 (53)	3 (7)
Rash	22 (49)	0 (0)
Constipation	21 (47)	0 (0)
Neuropathy	21 (47)	0 (0)
Oedema	20 (44)	1 (2)
Urinary frequency/urgency	15 (33)	0 (0)
Nausea	14 (31)	0 (0)
Dyspnoea	11 (24)	1 (2)
Vomiting	10 (22)	0 (0)
Fever	9 (20)	0 (0)
Diarrhoea	7 (16)	0 (0)
Pain	6 (13)	1 (2)
Infection	0 (0)	6 (13)
Cough	6 (13)	0 (0)
Pneumonitis	5 (11)	1 (2)
Dysgeusia	4 (9)	0 (0)
Haemorrhage	2 (4)	1 (2)
Dehydration	0 (0)	2 (4)
Pruritis	2 (4)	0 (0)
Confusion	1 (2)	0 (0)
Dry mouth	1 (2)	0 (0)
Dry skin	1 (2)	0 (0)
Enteritis	1 (2)	0 (0)
Flushing	1 (2)	0 (0)
Heartburn	1 (2)	0 (0)
Hypoxia	1 (2)	1 (2)
Muscle weakness	1 (2)	0 (0)
Gastroesophageal reflux disease	1 (2)	0 (0)
Myositis	0 (0)	1 (2)
Renal failure	0 (0)	1 (2)
Arrhythmia	0 (0)	1 (2)
Laboratory
Anemia	39 (87)	9 (20)
Thrombocytopaenia	21 (47)	0 (0)
Leukopaenia	16 (36)	1 (2)
Neutropaenia	7 (16)	1 (2)
Lymphopaenia	0 (0)	5 (11)
Elevated aspartate aminotransferase	30 (67)	3 (7)
Elevated alanine aminotransferase	27 (60)	2 (4)
Elevated alkaline phosphatase	22 (49)	1 (2)
Hypoalbuminaemia	27 (60)	0 (0)
Hyperbilirubinaemia	1 (2)	1 (2)
Hyponatraemia	11 (24)	3 (7)
Hypernatraemia	7 (16)	0 (0)
Hypokalaemia	7 (16)	1 (2)
Hyperkalaemia	7 (16)	0 (0)
Hypophosphataemia	16 (36)	4 (9)
Hypomagnesaemia	6 (13)	0 (0)
Hyperglycaemia	42 (93)	5 (11)
Hypercholesterolaemia	29 (64)	0 (0)
Hypertriglyceridaemia	28 (62)	1 (2)
Elevated creatinine	26 (58)	1 (2)
International normalized ratio, abnormal	18 (40)	7 (16)
Partial thromboplastin time, abnormal	12 (27)	2 (4)

^*All adverse events with a suspected relationship with everolimus are listed, in addition to all adverse events that occurred in >10% of the study population, regardless of causality.