Table 3.

On-treatment VTEs, PTS, bleeding events, and fatal events at 12 months by age strata (treated set)

DabigatranTotal, N = 203
12 to <18 y, n = 1532 to <12 y, n = 420 to <2 y, n = 8
Recurrent VTE event, n (%) 2 (1.3) 0 0 2 (1.0) 
 Subgroup analysis,* n/N (%)     
  Sex     
   Male 0/87 (0.0) 0/21 (0.0) 0/5 (0.0) 0/113 (0.0) 
   Female 2/66 (3.0) 0/21 (0.0) 0/3 (0.0) 2/90 (2.2) 
PTS,†n (%) 2/128 (1.6) 0/27 (0.0) 0/7 (0.0) 2/162 (1.2) 
 Subgroup analysis,* n/N (%)     
  Sex     
   Male 2/80 (2.5) 0/12 (0.0) 0/5 (0.0) 2/97 (2.1) 
   Female 0/48 (0.0) 0/15 (0.0) 0/2 (0.0) 0/65 (0.0) 
Bleeding events, n (%) 37 (24.2) 2 (4.8) 1 (12.5) 40 (19.7) 
 Major 3 (2.0) 0 0 3 (1.5) 
 Clinically relevant non-major 1 (0.7) 1 (2.4) 0 2 (1.0) 
 Minor 34 (22.2) 2 (4.8) 1 (12.5) 37 (18.2) 
All-cause death, n (%) 0 0 0 0 
DabigatranTotal, N = 203
12 to <18 y, n = 1532 to <12 y, n = 420 to <2 y, n = 8
Recurrent VTE event, n (%) 2 (1.3) 0 0 2 (1.0) 
 Subgroup analysis,* n/N (%)     
  Sex     
   Male 0/87 (0.0) 0/21 (0.0) 0/5 (0.0) 0/113 (0.0) 
   Female 2/66 (3.0) 0/21 (0.0) 0/3 (0.0) 2/90 (2.2) 
PTS,†n (%) 2/128 (1.6) 0/27 (0.0) 0/7 (0.0) 2/162 (1.2) 
 Subgroup analysis,* n/N (%)     
  Sex     
   Male 2/80 (2.5) 0/12 (0.0) 0/5 (0.0) 2/97 (2.1) 
   Female 0/48 (0.0) 0/15 (0.0) 0/2 (0.0) 0/65 (0.0) 
Bleeding events, n (%) 37 (24.2) 2 (4.8) 1 (12.5) 40 (19.7) 
 Major 3 (2.0) 0 0 3 (1.5) 
 Clinically relevant non-major 1 (0.7) 1 (2.4) 0 2 (1.0) 
 Minor 34 (22.2) 2 (4.8) 1 (12.5) 37 (18.2) 
All-cause death, n (%) 0 0 0 0 
*

Missing data for 1 adolescent.

†

Calculated over the number of patients with deep vein thrombosis (other than central-line and cerebral venous thrombosis) or central-line thrombosis.

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