Table 3.
Clinical adverse reactions and causality analysis.
| Therapeutic failures | 3 |
| Acute myocardial infarction | 2 |
| Ischemic stroke and death | 1 |
| Bleedings (all minor) | 19 |
| Ecchymosis | 7 |
| Epistaxis | 4 |
| Gingivorrhagia | 2 |
| Hematemesis | 1 |
| Petechiae | 1 |
| Rectorrhagia | 1 |
| Spontaneous bruising | 2 |
| Uterine hemorrhage | 1 |
| Causality (ADR excluding FT cases) | |
| Probable | 8 |
| Possible | 11 |
| Unclassifiable | (fatal cases) |
Causality was evaluated using the Naranjo algorithm. Abbreviations: ADR: adverse drugs reactions, FT; fatal cases.