TABLE 1.
Adverse events/adverse drug reactions in the safety analysis set (n = 17)
| Events, n (%) | Safety analysis set (n = 17) | |
|---|---|---|
| AE | ADR | |
| Any AE/ADR | 17 (100.0) | 16 (94.1) |
| Any serious AE/ADR | 4 (23.5) | 1 (5.9) |
| Treatment discontinuation due to AE/ADR | 0 | 0 |
| Treatment interruption due to AE/ADR | 4 (23.5) | 1 (5.9) |
| AE/ADR of severity grade ≥3 | 7 (41.2) | 4 (23.5) |
| Specific AEs/ADRs of any grade occurring in >2 patients | ||
| Nasopharyngitis | 10 (58.8) | 0 |
| Pale feces | 5 (29.4) | 5 (29.4) |
| Dental caries | 4 (23.5) | 1 (5.9) |
| Diarrhea | 4 (23.5) | 2 (11.8) |
| Injection site induration | 4 (23.5) | 4 (23.5) |
| Flatulence | 3 (17.6) | 3 (17.6) |
| Nausea | 3 (17.6) | 1 (5.9) |
| Decrease in blood glucose levels | 3 (17.6) | 0 |
| Diabetes mellitus | 3 (17.6) | 3 (17.6) |
| Vertigo | 3 (17.6) | 0 |
Abbreviations: ADR, adverse drug reaction; AE, adverse event.