Table 2.

Overview of TEAE

	N = 321
	n (%)
Patients with TEAE	284 (88.5)
Patients with drug-related TEAE	252 (78.5)
Patients with TEAE leading to death*	17 (5.3)
Patients with TEAE leading to discontinuation of sonidegib‡	59 (18.4)
Patients with TEAE leading to dose reduction	73 (22.7)
Patients with TEAE leading to interruption	98 (30.5)
Patients with serious TEAE	87 (27.1)
Patients with serious drug-related TEAE#	13 (4.1)

^*Considered not drug-related by investigator

^‡The only TEAE leading to discontinuation that occurred in more than 2% of patients was basal cell carcinoma (n = 17, 5.3%)

^#Myocardial infarction, vertigo, nausea, vomiting, fatigue, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatine phosphokinase increased, hepatic enzyme increased, muscle spasms, basosquamous carcinoma, squamous cell carcinoma of skin, chronic obstructive pulmonary disease, and dyspnoea