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. 2020 Aug 5;17(5):e153–e161. doi: 10.1111/ajco.13371

TABLE 2.

Adverse drug reactions by time of onset in the safety analysis set (n = 17)

Adverse drug reaction Onset of adverse drug reaction (weeks)
Study 001 Study 002
0–24 25–48 49–72 73–96 97–120 121–144 145–168 ≥169
N 17 17 17 14 13 13 10 4
Pale feces 4 (23.5) 2 (11.8) 1 (5.9) 0 0 0 0 0
Flatulence 3 (17.6) 0 0 0 0 0 0 0
Injection site induration 2 (11.8) 4 (23.5) 4 (23.5) 1 (7.1) 1 (7.7) 1 (7.7) 1 (10.0) 1 (25.0)
Malaise 2 (11.8) 0 0 0 0 0 0 0
Abdominal distension 2 (11.8) 0 0 0 0 0 0 0
Diabetes mellitus 2 (11.8) 1 (5.9) 0 0 0 0 0 0
Injection site pruritus 1 (5.9) 0 0 0 0 0 0 0
Pyrexia 1 (5.9) 0 0 0 0 0 0 0
Abdominal pain 1 (5.9) 1 (5.9) 0 0 0 0 0 0
Diarrhea 1 (5.9) 1 (5.9) 0 0 0 0 0 0
Dental caries 1 (5.9) 0 0 0 0 0 0 0
Gingival bleeding 1 (5.9) 0 0 0 0 0 0 0
Nausea 1 (5.9) 0 0 0 0 0 0 0
Stomatitis 1 (5.9) 0 0 0 0 0 0 0
Impaired glucose tolerance 1 (5.9) 0 0 1 (7.1) 0 0 0 0
T2DM 1 (5.9) 0 0 0 0 0 0 0
Cholelithiasis 1 (5.9) 0 0 0 0 1 (7.7) 0 0
Hepatic steatosis 1 (5.9) 0 0 0 0 0 0 0
Increased ALT levels 1 (5.9) 1 (5.9) 1 (5.9) 0 0 0 0 0
Increased AST levels 1 (5.9) 1 (5.9) 1 (5.9) 0 0 0 0 0
Bronchopneumonia 1 (5.9) 0 0 0 0 0 0 0
Herpes zoster infection 1 (5.9) 0 0 0 0 0 0 0
Pharyngitis 1 (5.9) 0 0 0 0 0 0 0
Dizziness 1 (5.9) 0 0 0 0 0 0 0
Injection site pain 0 1 (5.9) 1 (5.9) 0 0 0 0 0
Upper abdominal pain 0 0 0 0 1 (7.7) 0 0 0
Pancreatitis 0 1 (5.9) 0 0 0 0 0 0
Hyperglycemia 0 1 (5.9) 0 0 0 0 0 0
Bile duct stone 0 1 (5.9) 0 0 1 (7.7) 0 0 0
Urticaria 0 0 1 (5.9) 0 0 0 0 0

Data are shown as n (%).

Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; T2DM, type 2 diabetes mellitus.