Table 2. 10-year cumulative incidence, unadjusted and adjusted hazard ratios comparing incident severe bleeding and CRNSB among patients with FXI deficiency to their matched general population reference group.

	N events	10-year risk (95% CI)	Unadjusted HR (95% CI)	Fully adjusted HR (95% CI)
Severe bleeding
Severe FXI deficiency (<15%)
Factor XI cohort, n  = 209	1	0.50% (0.00–1.50%)	0.54 (0.07–4.15)	0.49 (0.06–3.95)
General population controls, n  = 1,463	13	1.60% (0.60–2.60%)	Ref.	Ref.
Partial FXI deficiency (15 to <50%)
Factor XI cohort, n  = 368	7	2.50% (0.60–4.40%)	5.38 (2.00–14.43)	5.27 (1.91–14.52)
General population controls, n  = 2,576	9	0.50% (0.20–0.90%)	Ref.	Ref.
Overall FXI deficiency (<50%)
Factor XI cohort, n  = 577	8	1.90% (0.50–3.20%)	2.53 (1.13–5.69)	2.56 (1.13–5.81)
General population controls, n  = 4,039	22	0.90% (0.50–1.30%)	Ref.	Ref.
Clinically relevant nonsevere bleeding
Severe FXI deficiency (<15%)
Factor XI cohort, n  = 213	21	13.80% (7.70–19.60%)	1.55 (0.97–2.49)	1.53 (0.94–2.47)
General population controls, n  = 1,491	99	10.80% (8.50–13.10%)	Ref.	Ref.
Partial FXI deficiency (15 to <50%)
Factor XI cohort, n  = 373	31	10.50% (6.60–14.30%)	1.44 (0.98–2.12)	1.41 (0.95–2.08)
General population controls, n  = 2,611	151	8.40% (7.00–9.80%)	Ref.	Ref.
Overall FXI deficiency (<50%)
Factor XI cohort, n  = 586	52	11.60% (8.30–14.80%)	1.48 (1.10–2.00)	1.45 (1.08–1.97)
General population controls, n  = 4,102	250	9.20% (8.00–10.40%)	Ref.	Ref.

Abbreviations: CI, confidence interval; CRNSB, clinically relevant nonsevere bleeding; FXI, factor XI; HR, hazard ratio.

Note: Adjusted HR included: age (continuous), sex, district, socioeconomic status, smoking status, BMI (continuous), Deyo–Charlson Index (continuous), comorbidities, and drug exposures in the past 6 months and the HAS-BLED score.