Primary efficacy outcome and secondary efficacy outcome in the intention-to-treat and per-protocol populations at 90 days
| rhTNK-tPA | rt-PA | |||
| 0.1 mg/kg | 0.25 mg/kg | 0.32 mg/kg | 0.9 mg/kg | |
| Intention-to-treat analysis | N=60 | N=57 | N=60 | N=59 |
| Primary efficacy outcome | ||||
| Improvement on NIHSS at 14 days | ||||
| n (%) | 38 (63.3) | 44 (77.2) | 40 (66.7) | 37 (62.7) |
| OR (95% CI) | 1.03 (0.49 to 2.16) | 2.01 (0.89 to 4.54) | 1.19 (0.56 to 2.52) | ref. |
| Secondary efficacy outcomes | ||||
| mRS score ≤1 point at 3 months | ||||
| n.(%) | 33 (55.0) | 35 (63.6) | 36 (62.1) | 35 (59.3) |
| OR (95% CI) | 0.84 (0.41 to 1.73) | 1.20 (0.56 to 2.56) | 1.12 (0.53 to 2.36) | ref. |
| mRS score ≤2 point at 3 months | ||||
| n.(%) | 41 (68.3) | 42 (76.7) | 41 (70.7) | 43 (72.9) |
| OR (95% CI) | 0.80 (0.36 to 1.77) | 1.20 (0.52 to 2.80) | 0.90 (0.40–2.01) | ref. |
| Ordinal distribution of mRS at 3 months | ||||
| OR (95% CI) | 0.91 (0.47 to 1.73) | 1.12 (0.57 to 2.17) | 1.00 (0.52 to 1.92) | ref. |
| Per-protocol analysis | N=55 | N=47 | N=56 | N=57 |
| Primary efficacy outcome | ||||
| Improvement on NIHSS at 14 days | ||||
| n (%) | 37 (67.3) | 37 (78.7) | 39 (69.6) | 37 (64.9) |
| OR (95% CI) | 1.11 (0.51 to 2.43) | 2.00 (0.83 to 4.85) | 1.24 (0.56 to 2.73) | ref. |
| Secondary efficacy outcomes | ||||
| mRS score ≤1 point at 3 months | ||||
| n (%) | 32 (58.2) | 29 (63.0) | 35 (63.6) | 34 (59.7) |
| OR (95% CI) | 0.94 (0.44 to 2.00) | 1.15 (0.52 to 2.57) | 1.18 (0.55 to 2.54) | ref. |
| mRS score ≤2 point at 3 months | ||||
| n (%) | 38 (69.1) | 35 (76.1) | 40 (72.7) | 42 (73.7) |
| OR (95% CI) | 0.80 (0.35 to 1.82) | 1.14 (0.46 to 2.79) | 0.95 (0.41 to 2.20) | ref. |
| Ordinal distribution of mRS at 3 months | ||||
| OR (95% CI) | 0.95 (0.49 to 1.86) | 1.17 (0.58 to 2.37) | 1.03 (0.53 to 2.02) | ref. |
mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; rhTNK-tPA, recombinant human tenecteplase tissue-type plasminogen activator.