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Table 2 Efficacy outcomes, modified ITT population. Data are given as n/N (%)

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 40 mg Risk difference vs. enoxaparin, % (95 % CI)a p value
Total VTE and all-cause mortality   
 Pooled data 114/1,672 (6.8) 129/1,683 (7.7) –0.8 (–2.6, 0.9) 0.35
 RE-NOVATE 53/880 (6.0) 60/897 (6.7) –0.7 (–2.9, 1.6)  
 RE-NOVATE II 61/792 (7.7) 69/786 (8.8) –1.1 (–3.8, 1.6)  
Major VTEb and VTE-related mortalityc    
 Pooled data 46/1,714 (2.7) 69/1,712 (4.0) –1.4 (–2.6, –0.2) 0.03
 RE-NOVATE 28/909 (3.1) 36/917 (3.9) –0.8 (–2.5, 0.8)  
 RE-NOVATE II 18/805 (2.2) 33/795 (4.2) –1.9 (–3.6, –0.2)  
Symptomatic events    
 Symptomatic VTEd 17/2,138 (0.8) 16/2,134 (0.7)   
 Symptomatic DVT 6/2,138 (0.3) 5/2,134 (0.2)   1.00
 Symptomatic PE 6/2,138 (0.3) 5/2,134 (0.2)   1.00
 Death 3/2,138 (0.1) 1/2,134 (0.0)   0.62
Total asymptomatic DVT 100/1,665 (6.0) 122/1,677 (7.3)   
 Proximal 35/1,709 (2.0) 63/1,706 (3.7)   
 Distal only 65/1,666 (3.9) 59/1,679 (3.5)   
Total study period (treatment + follow-up)    
 Symptomatic VTE + all-cause mortality 18/2,048 (0.9) 19/2,059 (0.9)   0.09
  1. N = number of patients included within each population with percentage in parentheses
  2. CI confidence interval, DVT deep vein thrombosis, ITT intention-to-treat, PE pulmonary embolism, VTE venous thromboembolism
  3. aBased on normal approximation of binomial distribution for single trial and the fixed effects approach using a weighted average (inverse variance) for pooled analyses; bMajor VTE was defined as venographic and symptomatic proximal DVT and/or non-fatal PE; cVTE-related mortality included fatal PE and deaths where VTE cannot be excluded; dIncludes any symptomatic DVT (proximal or distal) and non-fatal or fatal symptomatic PE in patients in the safety population who had undergone surgery