TABLE 2.
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.