Everolimus safety and efficacy for renal angiomyolipomas associated with tuberous sclerosis complex: a Spanish expanded access trial

Table 2 Dose-limiting safety (N = 19)

Outcome	n (%)
Patients with grade 3/4 adverse events	4 (21.1)^a
Patients with serious adverse events	1 (5.3)^b
Patients with adverse events leading to treatment modification:	8 (42.1)
Adverse events leading to dose reduction	3 (15.8)
Adverse events leading to temporary treatment interruption	3 (15.8)
Adverse events leading to dose reductions and temporary treatment interruption	2 (10.5)
Adverse events leading to permanent treatment withdrawal	0 (0.0)

All adverse events were graded as per the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (version 4.03)
^aFour patients experienced five grade 3 adverse events (i.e. transaminases increased n = 1, hypertriglyceridaemia n = 2, hypertension n = 1, mucosal inflammation n = 1); no grade 4 adverse event was reported
^bThe only serious adverse event was grade 2 pneumonia

ISSN: 1750-1172