TABLE 4.

Adverse Events Observed in Patients per Specific Safety Event Category

Preferred Term, n (%)	Squamous n = 30	Nonsquamous n = 33	Total N = 63
Nausea, vomiting, diarrhea	22 (73.3)	17 (51.5)	39 (61.9)
Asthenia/fatigue	14 (46.7)	17 (51.5)	31 (49.2)
Hyperglycemia	13 (43.3)	12 (36.4)	25 (39.7)
Liver toxicity	11 (36.7)	9 (27.3)	20 (31.7)
Hypersensitivity/rash	10 (33.3)	8 (24.2)	18 (28.6)
Mood disorders	3 (10.0)	5 (15.2)	8 (12.7)
Pneumonitis	3 (10.0)	0	3 (4.8)
QTc prolongation	1 (3.3)	0	1 (1.6)

Adverse events regardless of relationship to study drug treatment were described according to MedDRA v17.0, and are listed by specific safety event category in order of descending frequency in the “Total” column.

MedDRA, Medical Dictionary for Regulatory Activities.