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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