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Table 3 Bleeding-related outcomes, safety population

From: Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials

Outcome Dabigatran 220 mg Enoxaparin Risk difference vs. enoxaparin, % p value
(n = 2,156) (n = 2,157) (95 % CI)
Bleeding Events     
Major, Total no. patients, % (95 % CI)a 37 (1.7, 1.2-2.4 %) 27 (1.3, 0.8-1.8 %) 0.5 % (–0.2, 1.2) 0.20
 Fatal 1 (0.05) 0 (0)   
 In a critical organ 2 (0.1) 0 (0)   
 Clinically overt associated with 20 g/L or more fall in hemoglobin 31 (1.4) 19 (0.9)   
 Clinically overt leading to transfusion of two or more units of packed cells or whole blood 33 (1.5) 22 (1.0)   
 Warranting treatment cessation 1 (0.05) 1 (0.05)   
 Leading to re-operation 2 (0.1) 3 (0.1)   
Onset of events – No. events/total no. patients (%)     
  -Before the first oral dose 19/37 (51.4) 10/28 (35.7)   
  -After the first oral dose 18/37 (48.6) 18/28 (64.3)   
Clinically relevant non-major bleeding 71 (3.3) 60 (2.8)   
Major or clinically relevant non-major bleeding 108 (5.0) 87 (4.0) 1.0 % (–0.3, 2.2) 0.13
Minor bleeding 131 (6.1) 128 (5.9)   
Any bleeding events 239 (11.1) 215 (10.0)   
Patients receiving blood transfusions - n/N (%) 858/2,138 (40.1) 880/2,134 (41.2)   
  1. Data are given as number (%) of patients except where indicated
  2. CI confidence interval
  3. aPatients may have been included in more than one category