Table 2.

Drug-related AEs occurring at any time during treatment with once daily OSI-906

Initial OSI-906 dose (mg)
AEs10 (n = 6)20 (n = 3)40 (n = 4)75 (n = 3)150 (n = 3)300 (n = 4)400 (n = 6)450 (n = 4)
Any AE, n (%)4 (67)2 (67)2 (50)3 (100)3 (100)2 (50)5 (83)4 (100)
Gastrointestinal3 (50)1 (33)03 (100)2 (67)2 (50)1 (17)3 (75)
 Vomiting3 (50)002 (67)1 (33)1 (25)02 (50)
 Nausea2 (33)002 (67)2 (67)002 (50)
 Diarrhea000002 (50)1 (17)0
 Abdominal pain00000002 (50)
General02 (67)2 (50)0003 (50)1 (25)
 Fatigue02 (67)2 (50)0003 (50)1 (25)
Skin and subcutaneous tissue01 (33)1 (25)2 (67)1 (33)2 (50)00
Metabolism and nutrition000002 (50)1 (17)3 (75)
 Hyperglycemia0000001 (17)3 (75)
 Anorexia000001 (25)01 (25)
Nervous system0002 (67)1 (33)1 (25)02 (50)
Renal and urinary0000002 (33)0

NOTE: Drug-related AEs of all patients who received at least one dose of OSI-906 (safety analysis set). Events during follow-up are excluded. AEs are sorted by decreasing incidence overall for the once-daily regimen, first by system organ class, then by preferred term, and then alphabetically for preferred terms with the same incidence overall.