Table 4:
Serious adverse events
| Stroke to day 30 | Stroke to end of follow-up | |||
|---|---|---|---|---|
| Body system classification | MISTIE (n=255) |
Medical (n=251) |
MISTIE (n=255) |
Medical (n=251) |
| Cardiac disorders | 4 (1.6%) | 1 (0.4%) | 8 (3.1%) | 6 (2.4%) |
| Gastrointestinal disorders | 3 (1.2%) | 4 (1.6%) | 4 (1.6%) | 6 (2.4%) |
| General disorders and administration site conditions | 13 (5.1%) | 26 (10.4%) | 25 (10.0%) | 37 (14.7%) |
| Hepatobiliary disorders | 0 | 0 | 1 (0.4%) | 1 (0.4%) |
| Infections, non-neurologic | 2 (0.8%) | 4 (1.6%) | 6 (2.4%) | 8 (3.2%) |
| Injury, poisoning, and procedural complications | 3 (1.2%) | 0 | 6 (2.4%) | 3 (1.2%) |
| Metabolism and nutrition disorders | 1 (0.4%) | 0 | 1 (0.4%) | 0 |
| Musculoskeletal and connective tissue disorders | 0 | 0 | 0 | 1 (0.4%) |
| Neoplasms (benign, malignant, and unspecified) | 1 (0.4%) | 0 | 2 (0.8%) | 1 (0.4%) |
| Nervous system disorders | 17 (6.7%) | 33 (13.1%) | 36 (14.5%) | 49 (19.5%) |
| Psychiatric disorders | 0 | 1 (0.4%) | 2 (0.8%) | 2 (0.8%) |
| Renal and urinary disorders | 0 | 1 (0.4%) | 0 | 1 (0.4%) |
| Respiratory, thoracic, and mediastinal disorders | 26 (10.2%) | 14 (5.6%) | 33 (13.3%) | 19 (7.6%) |
| Vascular disorders | 6 (2.4%) | 0 (0.0%) | 7 (2.8%) | 0 |
Data are n (%).