Table 4.
Summary of adverse events (treated set)
| Adverse eventsa | Treatment arm | |||
|---|---|---|---|---|
| MET 500 mg bid (N = 289) | LINA/MET 500 mg bid (N = 290) | MET 1000 mg bid (N = 291) | LINA/MET 1000 mg bid (N = 290) | |
| All adverse events | 149 (51.6) | 146 (50.3) | 159 (54.6) | 155 (53.4) |
| Serious adverse events | 4 (1.4) | 3 (1.0) | 8 (2.7) | 6 (2.1) |
| Adverse events leading to discontinuation of study drug | 6 (2.1) | 7 (2.4) | 15 (5.2) | 9 (3.1) |
| Any hypoglycemia | 3 (1.0) | 7 (2.4) | 7 (2.4) | 3 (1.0) |
| Severe hypoglycemia | 0 (0.0) | 0 (0.0) | 1 (0.3) | 0 (0.0) |
| Gastrointestinal adverse events | 37 (12.8) | 46 (15.9) | 60 (20.6) | 59 (20.3) |
Values in table are presented as a number (of patients) with the percentage in parenthesis
The treated set included all patients (N = 1160) who were treated with at least one dose of study drug
aThe Medical Dictionary for Regulatory Activities version 17.0 (https://www.meddra.org/) was used for reporting adverse events