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. 2016 Dec 31;9(2):163–169. doi: 10.14740/jocmr2829w

Table 3. Efficacy and Safety End Points (n = 86).

Variables Group I (TNK; n = 45) Group II (placebo; n = 41) P-value
Primary composite outcome within 7 days 2 (4.5%) 8 (20%) 0.04
Secondary end points
  All cause death 2 (4.5%) 2 (5%) 0.3
  Hemodynamic decompensation 2 (4.5%) 8 (20%) 0.04
  Recurrent PE within 7 days 2 (4.5%) 1 (2%) 0.3
  Rehospitalization within 30 days 2 (4.5%) 4 (10%) 0.29
  Death within 30 days 2 (4.5%) 2 (5%) 0.18
Others
  Mean PASP at D7 (mm Hg) 32.80 ± 4.02 38.13 ± 4.49 0.04
  Mean ↓ in PASP from baseline (mm Hg) 14.10 ± 3.95 11.08 ± 4.23 0.003
  Improvement in RV function 31 (70%) 16 (40%) 0.001
  Need for mechanical ventilation 2 (4.5%) 2 (5%) 0.6
  Mean hospital stay (days) 8.1 ± 2.51 11.1 ± 2.14 0.001
Safety end points (bleeding within D7)
  Major bleeding 1 (2%) 1 (2%) 0.45
  Minor Bleeding 7 (16%) 5 (12%) 0.04
  Hemorrhagic stroke 1 (2%) 0 (0%) 0

PE: pulmonary embolism; PASP: pulmonary artery systolic pressure; RV: right ventricle.