Table 4

Clinical events occurred in the investigated patients

Negative D-dimer, no anticoagulation (n = 528; 829 y)*Positive D-dimer, anticoagulation refused (n = 109; 171 y)*Positive D-dimer, anticoagulation resumed (n = 373; 601 y)*
Primary outcomes, n, % (95% CI) 25 (4.7%; 3.2-6.9) 15 (13.8%; 7.9-21.7)§ 4 (1.1%; 0.3-2.7) 
Incidence per 100 pt-y, % (95% CI) 3.0% (2.0-4.4) 8.8% (5.0-14.1) 0.7% (0.2-1.7) 
Type of event (idiopathic), n    
 DVT 16 (14) 8 (6) 1 
 PE 5 (5) 3 (3) 2 (1) 
 DVT+PE 4 (3) 4 (2) 1 
Other outcomes, n    
 Death† 1 0 5 
 Isolated distal DVT 9 2 0 
 SVT 19 2 2 
 Arterial vascular event 3 0 1 
Major bleeding, n, % (95% CI) 0 0 14‡ (3.7%; 2.1-6.2) 
Incidence per 100 pt-y, % (95% CI)   2.3% (1.3-3.9) 
Negative D-dimer, no anticoagulation (n = 528; 829 y)*Positive D-dimer, anticoagulation refused (n = 109; 171 y)*Positive D-dimer, anticoagulation resumed (n = 373; 601 y)*
Primary outcomes, n, % (95% CI) 25 (4.7%; 3.2-6.9) 15 (13.8%; 7.9-21.7)§ 4 (1.1%; 0.3-2.7) 
Incidence per 100 pt-y, % (95% CI) 3.0% (2.0-4.4) 8.8% (5.0-14.1) 0.7% (0.2-1.7) 
Type of event (idiopathic), n    
 DVT 16 (14) 8 (6) 1 
 PE 5 (5) 3 (3) 2 (1) 
 DVT+PE 4 (3) 4 (2) 1 
Other outcomes, n    
 Death† 1 0 5 
 Isolated distal DVT 9 2 0 
 SVT 19 2 2 
 Arterial vascular event 3 0 1 
Major bleeding, n, % (95% CI) 0 0 14‡ (3.7%; 2.1-6.2) 
Incidence per 100 pt-y, % (95% CI)   2.3% (1.3-3.9) 

SVT, superficial vein thrombosis.

*

Total follow-up.

†

No death could be attributed to thrombotic event.

‡

1 major bleeding was fatal.

§

P = .0008 patients with negative D-dimer.

P < .0009 vs patients with negative D-dimer.

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