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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