. 2021 Apr 8;16(4):e0249940. doi: 10.1371/journal.pone.0249940

Table 2. Cumulative incidence and SHR of bleeding and thromboembolic outcomes: Rivaroxaban versus warfarin.

Outcomes	Rivaroxaban (n = 173)	Warfarin (n = 3185)	Crude SHR (95% CI)	P-value	Adjusted SHR^* (95% CI)	P-value
Major bleeding
No. of events	23	560	0.88 (0.51–1.51)	0.64	0.86 (0.50–1.47)	0.59
CICR (%)	21.5	24.1	0.88 (0.51–1.51)	0.64	0.86 (0.50–1.47)	0.59
Non-major clinically relevant bleeding
No. of events	53	1267	0.79 (0.53–1.18)	0.25	0.74 (0.48–1.13)	0.16
CICR (%)	41.4	49.3	0.79 (0.53–1.18)	0.25	0.74 (0.48–1.13)	0.16
Gastrointestinal bleeding
No. of events	32	1010	0.62 (0.39–0.99)	0.04	0.56 (0.34–0.91)	0.02
CICR (%)	27.1	40.1	0.62 (0.39–0.99)	0.04	0.56 (0.34–0.91)	0.02
Intracranial bleeding
No. of events	7	236	0.62 (0.24–1.61)	0.32	0.62 (0.24–1.61)	0.33
CICR (%)	6.2	9.8	0.62 (0.24–1.61)	0.32	0.62 (0.24–1.61)	0.33
Composite endpoints of ischemic stroke or systemic embolism
No. of events	10	520	0.38 (0.17–0.82)	0.01	0.36 (0.17–0.79)	0.01
CICR (%)	8.4	20.9	0.38 (0.17–0.82)	0.01	0.36 (0.17–0.79)	0.01
Ischemic stroke
No. of events	7	236	0.62 (0.24–1.61)	0.32	0.62 (0.24–1.61)	0.33
CICR (%)	6.2	9.8	0.62 (0.24–1.61)	0.32	0.62 (0.24–1.61)	0.33
Systemic embolism
No. of events	6	311	0.38 (0.12–1.24)	0.10	0.36 (0.11–1.12)	0.08
CICR (%)	4.9	12.2	0.38 (0.12–1.24)	0.10	0.36 (0.11–1.12)	0.08

*Adjusted for sex, age, Charlson–Deyo index, CHA₂DS₂-VASc score, ORBIT score, comorbidities, and medications listed in Table 1. CI = confidence interval; CICR = cumulative incidence for competing risk; SHR = subdistribution hazard ratio.