Table 3

Safety outcomes at 3 months grouped by onset to treatment times

OutcomeOnset to treatment times, minTenecteplaseAlteplaseOR (95%CI)P value
No/total no (%)
 Symptomatic intracranial haemorrhage within 36 hours
0–900/43 (0)0/41 (0)----
91–1807/309 (2.3)5/313 (1.6)1.43 (0.45 to 4.55)0.55
181–2708/356 (2.3)8/350 (2.3)0.98 (0.37 to 2.65)0.97
 Symptomatic intracranial haemorrhage within 90 days
0–900/43 (0)0/41 (0)----
91–1807/309 (2.3)7/313 (2.2)1.01 (0.35 to 2.92)0.98
181–27010/356 (2.8)8/350 (2.3)1.24 (0.48 to 3.17)0.66
 PH2 intracranial haemorrhage within 36 hours
0–900/43 (0)0/41 (0)----
91–1805/309 (1.6)0/313 (0)----
181–2705/356 (1.4)3/350 (0.9)1.65 (0.39 to 6.95)0.50
 Any intracranial haemorrhage within 90 days
0–901/43 (2.3)1/41 (2.4)0.95 (0.06 to 15.75)0.97
91–18023/309 (7.4)22/313 (7.0)1.06 (0.58 to 1.95)0.84
181–27020/356 (5.6)27/350 (7.7)0.71 (0.39 to 1.30)0.27
 Other significant haemorrhage events within 90 days
0–900/43 (0)0/41 (0)----
91–1802/309 (0.7)3/313 (1.0)0.67 (0.11 to 4.06)0.67
181–2703/356 (0.8)2/350 (0.6)1.48 (0.25 to 8.90)0.67
 Deaths
0–903/43 (7.0)1/41 (2.4)3.00 (0.30 to 30.07)0.35
91–18016/309 (5.2)12/313 (3.8)1.37 (0.64 to 2.95)0.42
181–27026/356 (7.3)22/350 (6.3)1.18 (0.65 to 2.12)0.59
 Adverse events
0–9040/43 (93.0)38/41 (92.7)1.05 (0.20 to 5.54)0.95
91–180275/309 (89.0)271/313 (86.6)1.25 (0.77 to 2.03)0.36
181–270292/356 (82.0)302/350 (86.3)0.73 (0.48 to 1.09)0.12
 Serious adverse events
0–9010//43 (23.3)5/41 (12.2)2.18 (0.68 to 7.05)0.19
91–18048/309 (15.5)44/313 (14.1)1.12 (0.72 to 1.75)0.60
181–27057/356 (16.0)57/350 (16.3)0.98 (0.66 to 1.46)0.92
  • PH2, parenchymal haematoma 2.