Table 4.
Prespecified secondary safety outcomes
| Secondary safety outcomes |
n |
% (95% CI) |
|---|---|---|
| Clinically significant hypotension1 | 2 | 6.1 (0–14.2) |
| Symptomatic hemorrhagic conversion2 | 1 | 3.0 (0–8.9) |
| Neurological worsening3 | 5 | 15.2 (2.9–27.4) |
| Progression of stroke | 1 | 3.0 (0–8.9) |
| Infections4 | 5 | 15.2 (2.9–27.4) |
| Depression | 2 | 6.1 (0–14.2) |
| Dysphagia | 2 | 6.1 (0–14.2) |
| Speech disorder | 3 | 9.1 (0–18.9) |
1
Defined as development of new symptoms or signs (syncope, decreased mental status, new neurological deficit, decline in NIHSS ≥2 points) attributed to a decline in systolic or diastolic blood pressure of ≥10 mm Hg. Other causes of these symptoms must have been excluded.
2
Defined as a decline of ≥2 points on the NIHSS and CT evidence of new hemorrhage.
3
Defined as a decline of ≥2 points on the NIHSS in the absence of any new hemorrhage on the CT scan.
4
Defined as infections that require treatment with antibiotics, are life-threatening, result in additional disability or prolonged hospitalization (including – but not limited to – urinary tract infections, bacteremia, pneumonia, and cellulitis).