ASCEND-5: safety summary
•
Grade 3/4 AEs: 89 (77.4%) patients receiving ceritinib and 72 (63.7%) patients receiving chemotherapy
•
AEs leading to dose interruptions: 84 (73.0%) patients receiving ceritinib and 27 (23.9%) patients receiving chemotherapy
•
AEs leading to dose reductions: 42 (36.5%) patients receiving ceritinib and 24 (21.2%) patients receiving chemotherapy
AE
(≥25% patients)
, %
No. of patients (%)
Ceritinib (n=115)
Chemotherapy (n=113)
All grades
Grades 3/4
All grades
Grades 3/4
Diarrhoea
72
4
18
1
Nausea
66
8
23
2
Vomiting
52
8
5
1
ALT increased
43
21
9
2
Decreased appetite
42
2
20
3
AST increased
37
14
4
1
Weight decreased
30
3
6
1
Fatigue
27
5
28
4
Scagliotti, et al. ESMO 2016
INDICACIÓN PENDIENTE DE APROBACIÓN,
