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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.
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Thrombosis Journal

ISSN: 1477-9560

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