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Table 2 Recurrent VTE and bleeding in relation to renal function, treatment, and treatment period: EINSTEIN DVT and EINSTEIN PE patients combined*

From: Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment

  Entire analysis period Period up to 14 days Period after 14 days
  Rivaroxaban Enoxaparin/VKA Rivaroxaban Enoxaparin/VKA Rivaroxaban Enoxaparin/VKA
n = 4150 n = 4131 n = 4150 n = 4131 n = 4054 n = 4001
Recurrent VTE n/N (%)
 Total of recurrent VTE 86 95 38 37 48 58
 Normal renal function 50/2772 (1.8) 52/2797 (1.9) 23/2772 (0.8) 26/2797 (0.9) 27/2720 (1.0) 26/2716 (1.0)
 Mild renal impairment 25/1036 (2.4) 31/1001 (3.1) 10/1036 (1.0) 8/1001 (0.8) 15/1009 (1.5) 23/974 (2.4)
 Moderate renal impairment 11/323 (3.4) 10/313 (3.2) 5/323 (1.5) 2/313 (0.6) 6/307 (2.0) 8/296 (2.7)
 Severe renal impairment 0/10 (0) 1/11 (9.1) 0/10 (0) 1/11 (9.1) 0/10 (0) 0/8 (0)
 Missing 0/9 (0) 1/9 (11.1) 0/9 (0) 0/9 (0) 0/8 (0) 1/7 (14.3)
Major bleeding n/N (%)
 Total of major bleeding events 40 72 13 27 27 45
 Normal renal function 23/2763 (0.8) 29/2786 (1.0) 8/2763 (0.3) 11/2786 (0.4) 15/2689 (0.6) 18/2704 (0.7)
 Mild renal impairment 14/1030 (1.4) 30/1002 (3.0) 5/1030 (0.5) 10/1002 (1.0) 9/985 (0.9) 20/954 (2.1)
 Moderate renal impairment 3/320 (0.9) 12/310 (3.9) 0/320 (0) 5/310 (1.6) 3/305 (1.0) 7/285 (2.5)
 Severe renal impairment 0/9 (0) 1/11 (9.1) 0/9 (0) 1/11 (9.1) 0/9 (0) 0/6 (0)
 Missing 0/8 (0) 0/7 (0) 0/8 (0) 0/7 (0) 0/8 (0) 0/7 (0)
Major and clinically relevant nonmajor bleeding n/N (%)
 Total of major and clinically relevant nonmajor bleeding events 388 412 129 134 259 278
 Normal renal function 239/2763 (8.7) 245/2786 (8.8) 75/2763 (2.7) 73/2786 (2.6) 164/2627 (6.2) 172/2646 (6.5)
 Mild renal impairment 110/1030 (10.7) 123/1002 (12.3) 40/1030 (3.9) 40/1002 (4.0) 70/957 (7.3) 83/927 (9.0)
 Moderate renal impairment 37/320 (11.6) 43/310 (13.9) 14/320 (4.4) 20/310 (6.5) 23/291 (7.9) 23/272 (8.5)
 Severe renal impairment 2/9 (22.2) 1/11 (9.1) 0/9 (0) 1/11 (9.1) 2/9 (22.2) 0/6 (0)
 Missing 0/8 (0) 0/7 (0) 0/8 (0) 0/7 (0) 0/8 (0) 0/7 (0)
  1. VKA, Vitamin K antagonist; VTE, Venous thromboembolism.
  2. *Outcomes do not include censored patients or patients who had an event before Day 14.