Table 3.

Overall summary of AEs

Adverse events, n (%)	Osimertinib (N = 1350)
Any protocol-specified AE#	389 (28.8)
AE leading to dose modification	124 (9.2)
AE leading to discontinuation	95 (7.0)
AE of special interest*	62 (4.6)
Lung disease/pneumonitis like event	3 (0.2)
QTc prolongation event	59 (4.4)
Serious AE	297 (22.0)
Treatment related serious AE	52 (3.9)
AE leading to death	92 (6.8)
Treatment related AE leading to death	14 (1.0)
Protocol-specified AEs by preferred term, reported in ≥ 1% of patients
Electrocardiogram QT prolonged	65 (4.8)
Pneumonia	39 (2.9)
Death	27 (2.0)
Cerebral infarction	18 (1.3)
Pulmonary embolism	16 (1.2)

Data are presented as n (%)

AE adverse event

^#Safety assessment included serious AEs, AEs leading to dose modification, AEs leading to treatment discontinuation, and AEs of special interest (interstitial lung disease/pneumonitis-like events and QTc prolongation events)

*Interstitial lung disease/pneumonitis-like events and QTc prolongation events