Table 2—

Phase 1: outcome data#

Suspected PE patients
TotalSuitable for early dischargeUnsuitable for early discharge
End of acute LMWH treatment
 Subjects n22598127
 Thromboembolic event0 (0; 0.0–1.6)0 (0; 0.0–3.7)0 (0; 0.0–2.9)
 Bleeding complications
  Minor bleed1 (0.4; 0.0–2.5)0 (0; 0.0–3.7)1 (0.8; 0.0–4.3)
  Major bleed0 (0; 0.0–1.6)0 (0; 0.0–3.7)0 (0; 0.0–2.9)
 Deaths0 (0; 0.0–1.6)0 (0; 0.0–3.7)0 (0; 0.0–2.9)
3 months after start of PE treatment
 Subjects n20285117
 Thromboembolic event6 (3.0; 1.1–6.4)2 (2.4; 0.3–8.2)4 (3.4; 0.9–8.5)
 Bleeding complications
  Minor bleed4 (2.0; 0.5–5.0)3 (3.5; 0.7–10.0)1 (0.9; 0.0–4.7)
  Major bleed6 (3.0; 1.1–6.4)3 (3.5; 0.7–10.0)3 (2.6; 0.5–7.3)
 Deaths9 (4.5; 2.1–8.3)3 (3.5; 0.7–10.0)6 (5.1; 1.9–10.8)
  • Data are presented as n (%; 95% confidence interval), unless otherwise stated. PE: pulmonary embolism; LMWH: low molecular weight heparin. #: n = 225, 3-month follow-up data available for 202.