Safety outcomes within 90 days in the safety analysis population
Tenecteplase (n=76) | Alteplase (n=61) | Effect size (95% CI)* | P value | |
sICH within 36 hours | 3 (4.0%) | 2 (3.3%) | 1.30 (0.20 to 8.41) | 0.78 |
sICH within 90 days | 3 (4.0%) | 2 (3.3%) | 1.30 (0.20 to 8.41) | 0.78 |
Parenchymal haematoma two intracranial haemorrhage within 36 hours* | 1 (1.3%) | 0 (0.0%) | – | – |
Any intracranial haemorrhage within 90 days | 10 (13.2%) | 7 (11.5%) | 1.22 (0.45 to 3.32) | 0.68 |
Deaths | 11 (14.5%) | 12 (19.7%) | 0.68 (0.31 to 1.51) | 0.36 |
Adverse events | 70 (92.1%) | 56 (91.8%) | 1.02 (0.92 to 1.13) | 0.66 |
Serious adverse events | 15 (19.7%) | 16 (26.2%) | 0.79 (0.40 to 1.56) | 0.50 |
*Risk ratio with its 95% CI was not able to be calculated due to the small size of outcome events.
sICH, symptomatic intracranial haemorrhage.