Overall summary of AEs
| Endpoints N (%) | Present trial (treated population) | ECASS III (intention-to-treat population) | |
| Alteplase arm (n=120) | Alteplase arm (n=120*) | Placebo arm (n=120*) | |
| Drug-related AEs | 15 (12.5) | – | – |
| SAEs | 23 (19.2) | – | – |
| ICH | 10 (8.3) | – | – |
| sICH† | 3 (2.5)‡ | 2 (1.7) | 0 (0.0) |
| Death within 3 months | 6 (5.0) | 7 (5.8) | 7 (5.8) |
| Death within overall period | 7 (5.8) | 8 (6.7) | 7 (5.8) |
| Symptomatic oedema | 3 (2.5) | – | – |
| Cerebral herniation | 2 (1.7) | – | – |
*The number of patients was based on Propensity Score Matching (PSM) method.
† sICH defined according to ECASS III criteria.
‡Exact 95% CI 0.5 to 7.1; 95% Wilson Score 95% CI 0.9 to 7.1.
AE, adverse event; ECASS III, European Cooperative Acute Stroke Study III; SAE, serious adverse event; sICH, symptomatic intracranial haemorrhage.