Table 2

Prespecified safety outcomes and other serious adverse events

rhTNK-tPArt-PAP value
0.1 mg/kg (N=60)0.25 mg/kg (N=57)0.32 mg/kg (N=60)0.9 mg/kg (N=59)
Symptomatic ICH at 36 hours (ECASS III)3 (5.0)0 (0.0)2 (3.3)1 (1.7)0.52
Death6 (10.0)1 (1.8)5 (8.3)6 (10.2)0.22
Asymptomatic intracranial haemorrhage4 (6.7)3 (5.3)5 (8.3)2 (3.4)0.75
Other extracranial bleeding18 (30.0)18 (31.6)22 (36.7)14 (23.7)0.49
Serious adverse events12 (20.0)7 (12.3)11 (18.3)14 (23.7)0.46
  • ECASS, European Cooperative Acute Stroke Study; ICH, intracranial haemorrhage; rhTNK-tPA, recombinant human tenecteplase tissue-type plasminogen activator.