Table 3. Safety Outcomes in Patients Reported as Treated and Who Received at Least Some Dose of Either Thrombolytic Agent.
| No./total No. (%) | Risk difference (95% CI) | P value | ||
|---|---|---|---|---|
| IV tenecteplase (n = 261) | IV alteplase (n = 254) | |||
| Death within 90 d of randomization | 52/261 (19.9) | 46/254 (18.1) | 1.8 (−5.0 to 8.6) | .60 |
| Symptomatic intracerebral hemorrhage | 16/261 (6.1) | 11/254 (4.3) | 1.8 (−2.0 to 5.6) | .43 |
| Imaging identified intracranial hemorrhage | 71/259 (27.4) | 83/249 (33.3) | −5.9 (−13.9 to 2.1) | .15 |
| Subarachnoid hemorrhage | 32/259 (12.4) | 31/249 (12.4) | 0.0 (−5.8 to 5.6) | .99 |
| Subdural hemorrhage | 1/259 (0.4) | 2/249 (0.8) | −0.4 (−1.8 to 0.9) | .62 |
| Intraventricular hemorrhagea | 12/259 (4.6) | 9/249 (3.6) | 1.0 (−2.5 to 4.5) | .66 |
| HI1 (scattered small petechiae) | 5/259 (1.9) | 13/249 (5.2) | −3.3 (−6.6 to 0.1) | .06 |
| HI2 (confluent petechiae) | 26/259 (10.0) | 35/249 (14.1) | −4.0 (−9.6 to 6.3) | .17 |
| PH1 (hematoma occupying <30% of infarct with no substantive mass effect) | 10/259 (3.9) | 12/249 (4.8) | −1.0 (−4.6 to 2.6) | .67 |
| PH2 (hematoma occupying ≥30% of infarct with obvious mass effect) | 13/259 (5.0) | 11/249 (4.4) | 0.6 (−3.1 to 4.2) | .84 |
| Remote PH-1 | 4/259 (1.5) | 2/249 (0.8) | 0.7 (−1.1 to 2.6) | .69 |
| Remote PH-2 | 1/259 (0.4) | 2/249 (0.8) | −0.4 (−1.8 to 0.9) | .62 |
| Any PH | 27/259 (10.4) | 26/249 (10.4) | 0.0 (−5.3 to 5.3) | .99 |
Abbreviations: HI, hemorrhagic infarction; PH, parenchymal hematoma.
a
Imaging-identified intracranial hemorrhages were assessed using the Heidelberg classification.