Table 3.

Reasons for early permanent study drug discontinuation in the analysis cohort

	All patients (N = 1181)	Rivaroxaban (N = 572)	Warfarin (N = 609)
Discontinued study drug early	448 (37.9%)	213 (37.2%)	235 (38.6%)
Reason for discontinuation (% among discontinuing patients)
Patient-driven discontinuation	116 (25.9%)	52 (24.4%)	64 (27.2%)
Consent withdrawn	100 (22.3%)	46 (21.6%)	54 (23.0%)
Noncompliant with study medication	16 (3.6%)	6 (2.8%)	10 (4.3%)
Lost to follow-up	0	0	0
Non-patient-driven discontinuation	332 (74.1%)	161 (75.6%)	171 (72.8%)
Adverse event	210 (46.9%)	109 (51.2%)	101 (43.0%)
Clinical efficacy endpoint reached	52 (11.6%)	24 (11.3%)	28 (11.9%)
Investigator decision	44 (9.8%)	19 (8.9%)	25 (10.6%)
Protocol violation	26 (5.8%)	9 (4.2%)	17 (7.2%)

Data presented as no. (%)