Table 3. Adverse events observed during the study of voglibose/metformin fixed-dose combination (FDC) and coadministered metformin and voglibose in healthy Korean subjects.
System organ class Preferred term |
Voglibose/metformin FDC† (n = 28) | Co-administered voglibose and metformin† (n = 28) |
---|---|---|
Gastrointestinal disorders | ||
Loose stools | 3 (3)‡ | 3 (3)‡ |
Epigastric discomfort | 1 (1)‡ | |
Periodontitis | 1 (1) | |
Body as a whole/general disorders | ||
Fever | 1 (1) | |
Total (adverse events) | 5 (5) | 4 (3) |
Total (adverse drug reactions) | 3 (3) | 4 (3) |
†Data represents number of cases (number of subjects); ‡Considered to be study drug-related.