Table 5.
Serious adverse events
| Event diagnosis |
Dose tier mg/kg |
Outcome |
Study drug action |
Related to study medication |
|
|---|---|---|---|---|---|
| 67-year-old non-Hispanic man |
recurrent stroke |
3 |
resolved with sequelae |
none |
not related |
| 42-year-old non-Hispanic white woman |
TIA |
3 |
resolved |
none |
not related |
| Same patient |
TIA |
3 |
resolved |
none |
not related |
| 77-year-old Hispanic woman |
recurrent stroke |
3 |
resolved with sequelae |
none |
not related |
| 78-year-old Hispanic woman |
atrial fibrillation |
3 |
resolved |
none |
not related |
| 69-year-old non-Hispanic woman |
acute renal failure |
6 |
resolved |
permanently discontinued |
possibly |
| 56-year-old non-Hispanic woman |
extension of infarct secondary to hypovolemia and hypoperfusion |
6 |
resolved |
none |
not related |
| 72-year-old non-Hispanic man |
intermittent dysarthria, bradycardia |
6 |
resolved |
none |
possibly |
| Same patient | urinary tract infection | 6 | resolved | none | possibly |
TIA = Transient ischemic attack.