FLAURA safety summary
AE, any cause*, n (%)
Osimertinib (n=279)
SoC (n=277)
Any AE
273 (98)
271 (98)
Any AE Grade ≥3
94 (34)
124 (45)
Any AE leading to death
6 (2)
10 (4)
Any serious AE
60 (22)
70 (25)
Any AE leading to discontinuation
37 (13)
49 (18)
AE, possibly causally related
#
, n (%)
Any AE
253 (91)
255 (92)
Any AE Grade ≥3
49 (18)
78 (28)
Any AE leading to death
0
1 (<1)
Any serious AE
22 (8)
23 (8)
Ramalingam et al ESMO 2017 #LBA2; Soria NEJM 2017