Table 3

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 hours3 (4.0%)2 (3.3%)1.30 (0.20 to 8.41)0.78
sICH within 90 days3 (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 days10 (13.2%)7 (11.5%)1.22 (0.45 to 3.32)0.68
Deaths11 (14.5%)12 (19.7%)0.68 (0.31 to 1.51)0.36
Adverse events70 (92.1%)56 (91.8%)1.02 (0.92 to 1.13)0.66
Serious adverse events15 (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.