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Table 2 Recurrent venous thromboembolic events during the comparison period

From: Derivation of the non-inferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism

Study Current standard of care, n/N (%) Placebo, ‘no treatment’ or ‘less intensive treatment’, n/N (%)
Barritt [7]* 0/16 (0.0) 11/19 (57.9)
Hull [8] 0/33 (0.0) 6/35 (17.1)
Holmgren [9] 3/66 (4.5) 6/69 (8.7)
Lagerstedt [10] 0/23 (0.0) 7/28 (25.0)
Hull [11] 3/58 (5.2) 11/57 (19.3)
Brandjes [12]§ 2/60 (3.3) 10/60 (16.7)
Raschke [13] 2/41 (4.9) 8/32 (25.0)
Levine [14] 1/109 (0.9) 9/105 (8.6)
Schulman [15] 4/454 (0.9) 26/443 (5.9)
Agnelli [16]** 4/134 (3.0) 11/133 (8.3)
Agnelli [17]†† 1/165 (0.6) 6/161 (3.7)
Kearon [18] 1/79 (1.3) 17/83 (20.5)
Pinede [19]‡‡ 1/361 (0.3) 6/375 (1.6)
Schulman [20] 3/116 (2.6) 23/111 (20.7)
Total number of recurrent events across studies 25/1715 (1.5) 157/1711 (9.2)
  1. *This includes one event in the no treatment group at 8 weeks. Only symptomatic recurrent events were considered. Based on figure one of the publication. When one treatment arm was shorter than 3 months, then only events that accumulated up to 3 months were counted. §Events after 3 months were excluded. Data provided by author. **Only events between 3 and 12 months were included. ††Only events between 3 and 12 months were included for patients with idiopathic PE and between 3 and 6 months for patients with provoked PE. ‡‡Only events between weeks 6 and 12 for patients with isolated calf DVT and between 3 and 6 months for patients with proximal DVT and/or PE.
  2. DVT: deep vein thrombosis; PE: pulmonary embolism.