Table 5.
Incidence of adverse events observed for test and branded formulation of dalteparin in this bioequivalence study (n = 88).
| Body system/Adverse event | Test product (T) | Branded product (R) |
|---|---|---|
| Body as a whole | ||
| Lightheaded | 1 | 0 |
| Headache | 7 | 4 |
| Diaphoretic | 1 | 0 |
| Elevated ALT | 1 | 0 |
| Elevated AST | 1 | 0 |
| Anemia | 1 | 0 |
| Anxiety | 0 | 1 |
| Chills | 1 | 0 |
| Gastrointestinal | ||
| Nausea | 3 | 0 |
| Diarrhea | 1 | 0 |
| Anorexia | 1 | 0 |
| Respiratory | ||
| Rhinorrhea | 1 | 0 |
| Cough | 1 | 0 |
| Abdomen | ||
| Bruising at injection site | 1 | 2 |
| Burning sensation at injection site | 1 | 2 |
| Pain at injection site | 1 | 0 |
| Tenderness at injection site | 0 | 1 |
| Upper right quadrant discomfort | 1 | 0 |
| Tenderness upper right quadrant | 1 | 0 |
| Abdominal pain upper right quadrant | 1 | 0 |
| Total | 26 | 10 |