Table 5.

Multivariable Regression Models for the Composite Outcome of Recurrent VTE or Major Bleeding

	Cause-Specific HR (95% CI) With Censoring at Death	Subdistribution HR (95% CI) Using Fine-Gray Method
Baseline covariates
ECOG status at baseline (0-2)	1.33 (0.78-2.30)	1.57 (0.74-3.34)
Age ≥65 y (vs <65 y)	0.90 (0.53-1.53)	0.96 (0.56-1.66)
Previous VTE	0.97 (0.39-2.43)	1.03 (0.41-2.63)
Regionally advanced cancer or metastatic disease	1.32 (0.74-2.38)	1.18 (0.65-2.15)
Prior surgery for cancer	0.89 (0.52-1.54)	0.97 (0.55-1.68)
Dalteparin (vs edoxaban)	1.24 (0.52-2.94)	1.32 (0.62-2.84)
Unsuspected PE (vs symptomatic PE)	2.90 (1.06-7.91)	2.34 (0.96-5.75)
Time-dependent covariates
ECOG status at follow-up (0-5)	2.13 (1.24-3.67)	1.64 (0.99-2.73)
Discontinuation of anticoagulation	0.89 (0.34-2.32)	0.84 (0.32-2.17)
Interaction terms
ECOG at follow-up (0-5)× randomization arm (dalteparin vs edoxaban)	0.88 (0.48-1.62)	0.81 (0.49-1.34)
ECOG at follow-up (0-5) × index PE event (unsuspected vs symptomatic)	0.59 (0.33-1.06)	0.72 (0.43-1.19)

ECOG = Eastern Cooperative Oncology Group; PE = pulmonary embolism; VTE = venous thromboembolism.