Table 3.

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

Initial OSI-906 dose (mg)
AEs20 (n = 5)40 (n = 3)75 (n = 3)150 (n = 39)200 (n = 3)
Any AE, n (%)2 (40)1 (33)2 (67)37 (95)3 (100)
Metabolism and nutrition2 (40)1 (33)014 (36)2 (67)
 Hyperglycemia2 (40)008 (21)1 (33)
 Anorexia01 (33)03 (8)1 (33)
 Hyponatremia0003 (8)0
 Hypoalbuminemia0002 (5)0
 Hypokalemia0002 (5)0
Gastrointestinal1 (20)01 (33)13 (33)3 (100)
 Nausea001 (33)11 (28)2 (67)
 Vomiting001 (33)4 (10)2 (67)
 Constipation0002 (5)1 (33)
Investigations00015 (38)2 (67)
 ALT increased0002 (5)1 (33)
 AST increased0002 (5)1 (33)
 Blood creatinine increased0003 (8)0
 Hemoglobin decreased0003 (8)0
 Weight decreased0003 (8)0
 Gamma-glutamyltransferase increased0002 (5)0
General002 (67)13 (33)1 (33)
 Fatigue002 (67)11 (28)0
Nervous system00011 (28)3 (100)
 Lethargy0007 (18)3 (100)
 Dizziness0003 (8)0
Skin and subcutaneous tissue0009 (23)0
 Hyperhidrosis0003 (8)0
 Pruritus0003 (8)0
Musculoskeletal and connective tissue0005 (13)0
 Muscle spasms0002 (5)0
 Musculoskeletal pain0002 (5)0
 Myalgia0002 (5)0
Renal and urinary0003 (8)0
Respiratory, thoracic, and mediastinal0003 (8)0
 Cough0002 (5)0
Cardiac disorders0002 (5)0

NOTE: Drug-related AEs of all patients who received at least one dose of OSI-906 (safety analysis set) including those in the expansion cohorts (n = 29; 20 in colorectal cancer and 9 in diabetic patients cohort). 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. Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.