TABLE A6.

Summary of Safety

Variable	NSCLC Safety Population (n = 362)
	Any Causality	Related to Treatment
Any grade TEAE, No. (%)	362 (100.0)	347 (95.9)
Grade ≥3 TEAE, No. (%)	283 (78.2)	152 (42.0)
Serious TEAE, No. (%)	199 (55.0)	59 (16.3)
TEAE leading to dose withheld, No. (%)	254 (70.2)	189 (52.2)
TEAE leading to dose reduction, No. (%)a	177 (48.9)	166 (45.9)
TEAE leading to permanent treatment discontinuation, No. (%)b	40 (11.0)	16 (4.4)
Fatal TEAE, No. (%)c	26 (7.2)	0 (0.0)

Abbreviations: NSCLC, non–small cell lung cancer; TEAE, treatment-emergent adverse event.

^a When related to treatment, most commonly because of elevation of AST (n = 29 patients [8.0%]) and ALT (n = 38 patients [10.5%]) and drug hypersensitivity (5.0%).

^b When related to treatment, most commonly because of AST/ALT elevation, fatigue, drug hypersensitivity, proteinuria, and thrombocytopenia (each occurring in two patients [0.6%]).

^c Most commonly because of respiratory failure (n = 6 patients [1.7%]) and cardiac arrest (n = 4 patients [1.1]).