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Table 3 Clinical outcomes

From: Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies

  EINSTEIN-DVT EINSTEIN-PE EINSTEIN pooled
Outcome Rivaroxaban Enoxaparin/VKA Rivaroxaban Enoxaparin/VKA Rivaroxaban Enoxaparin/VKA
Efficacy     
Intention-to-treat population–N 1731 1718 2419 2413 4150 4131
First recurrent VTE–n (%) 36 (2.1) 51 (3.0) 50 (2.1) 44 (1.8) 86 (2.1) 95 (2.3)
 Fatal PE 0 0 2 1 2 (<0.1) 1 (<0.1)
 Death (PE cannot be excluded) 2 6 8 5 10 (0.2) 11 (0.3)
 DVT and PE 1 0 0 2 1 (<0.1) 2 (<0.1)
 DVT only 14 28 18 17 32 (0.8) 45 (1.1)
 PE only 19 17 22 19 41 (1.0) 36 (0.9)
Death from any cause–n (%) 38 (2.2) 49 (2.9) 58 (2.4) 50 (2.1) 96 (2.3) 99 (2.4)
 PE/PE not ruled out 4 6 11 7 15 (0.4) 13 (0.3)
 Bleeding 1 5 5 4 6 (0.1) 9 (0.2)
 Cardiovascular 2 4 10 3 12 (0.3) 7 (0.2)
 Other 31 34 32 36 63 (1.5) 70 (1.7)
Safety     
N 1718 1711 2412 2405 4130 4116
First major plus nonmajor clinically relevant bleeding event–n (%) 139 (8.1) 138 (8.1) 249 (10.3) 274 (11.4) 388 (9.4) 412 (10.0)
First major bleeding event–n (%)       
 Any 14 (0.8) 20 (1.2) 26 (1.1) 52 (2.2) 40 (1.0) 72 (1.7)
 Fatal bleeding 1 (<0.1) 5 (0.3) 2 (<0.1) 3 (0.1) 3 (<0.1) 8 (0.2)
  Retroperitoneal 0 0 0 1 (<0.1) 0 1 (<0.1)
  Intracranial 0 2 (0.1) 2 (<0.1) 2 (<0.1) 2 (<0.1) 4 (<0.1)
  GI/thorax 1 (<0.1) 3 (0.2) 0 0 1 (<0.1) 3 (<0.1)
Nonfatal in a critical site* 3 (0.2) 3 (0.2) 7 (0.3) 26 (1.1) 10 (0.2) 29 (0.7)
 Retroperitoneal 0 1 (<0.1) 1 (<0.1) 6 (0.2) 1 (<0.1) 7 (0.2)
 Intracranial 2 (0.1) 0 1 (<0.1) 9 (0.4) 3 (<0.1) 9 (0.2)
 Intraocular 1 (<0.1) 0 2 (<0.1) 2 (<0.1) 3 (<0.1) 2 (<0.1)
 Pericardial 0 2 (<0.1) 0 2 (<0.1)
 Intra-articular 0 1 (<0.1) 0 3 (0.1) 0 4 (<0.1)
 Adrenal/pulmonary/abdominal 3 (<0.1) 2 (<0.1) 3 (<0.1) 2 (<0.1)
Nonfatal, noncritical site but associated with a fall in hemoglobin ≥2 g/dl and/or transfusions ≥2 units 10 (0.6) 12 (0.7) 17 (0.7) 25 (1.0) 27 (0.7) 37 (0.9)
Nonmajor clinically relevant bleeding–n (%) 126 (7.3) 119 (7.0) 228 (9.5) 227 (9.4) 354 (8.6) 346 (8.4)
  1. *Columns may fail to sum because of additional bleeding events at other sites. Refers to all nonmajor clinically relevant bleeding events, not just the first event.
  2. DVT Deep-vein thrombosis, GI Gastrointestinal, PE Pulmonary embolism, VKA Vitamin K antagonist, VTE Venous thromboembolism.