Safety outcomes at 3 months grouped by onset to treatment times
Outcome | Onset to treatment times, min | Tenecteplase | Alteplase | OR (95%CI) | P value |
No/total no (%) | |||||
Symptomatic intracranial haemorrhage within 36 hours | |||||
0–90 | 0/43 (0) | 0/41 (0) | -- | -- | |
91–180 | 7/309 (2.3) | 5/313 (1.6) | 1.43 (0.45 to 4.55) | 0.55 | |
181–270 | 8/356 (2.3) | 8/350 (2.3) | 0.98 (0.37 to 2.65) | 0.97 | |
Symptomatic intracranial haemorrhage within 90 days | |||||
0–90 | 0/43 (0) | 0/41 (0) | -- | -- | |
91–180 | 7/309 (2.3) | 7/313 (2.2) | 1.01 (0.35 to 2.92) | 0.98 | |
181–270 | 10/356 (2.8) | 8/350 (2.3) | 1.24 (0.48 to 3.17) | 0.66 | |
PH2 intracranial haemorrhage within 36 hours | |||||
0–90 | 0/43 (0) | 0/41 (0) | -- | -- | |
91–180 | 5/309 (1.6) | 0/313 (0) | -- | -- | |
181–270 | 5/356 (1.4) | 3/350 (0.9) | 1.65 (0.39 to 6.95) | 0.50 | |
Any intracranial haemorrhage within 90 days | |||||
0–90 | 1/43 (2.3) | 1/41 (2.4) | 0.95 (0.06 to 15.75) | 0.97 | |
91–180 | 23/309 (7.4) | 22/313 (7.0) | 1.06 (0.58 to 1.95) | 0.84 | |
181–270 | 20/356 (5.6) | 27/350 (7.7) | 0.71 (0.39 to 1.30) | 0.27 | |
Other significant haemorrhage events within 90 days | |||||
0–90 | 0/43 (0) | 0/41 (0) | -- | -- | |
91–180 | 2/309 (0.7) | 3/313 (1.0) | 0.67 (0.11 to 4.06) | 0.67 | |
181–270 | 3/356 (0.8) | 2/350 (0.6) | 1.48 (0.25 to 8.90) | 0.67 | |
Deaths | |||||
0–90 | 3/43 (7.0) | 1/41 (2.4) | 3.00 (0.30 to 30.07) | 0.35 | |
91–180 | 16/309 (5.2) | 12/313 (3.8) | 1.37 (0.64 to 2.95) | 0.42 | |
181–270 | 26/356 (7.3) | 22/350 (6.3) | 1.18 (0.65 to 2.12) | 0.59 | |
Adverse events | |||||
0–90 | 40/43 (93.0) | 38/41 (92.7) | 1.05 (0.20 to 5.54) | 0.95 | |
91–180 | 275/309 (89.0) | 271/313 (86.6) | 1.25 (0.77 to 2.03) | 0.36 | |
181–270 | 292/356 (82.0) | 302/350 (86.3) | 0.73 (0.48 to 1.09) | 0.12 | |
Serious adverse events | |||||
0–90 | 10//43 (23.3) | 5/41 (12.2) | 2.18 (0.68 to 7.05) | 0.19 | |
91–180 | 48/309 (15.5) | 44/313 (14.1) | 1.12 (0.72 to 1.75) | 0.60 | |
181–270 | 57/356 (16.0) | 57/350 (16.3) | 0.98 (0.66 to 1.46) | 0.92 |
PH2, parenchymal haematoma 2.