Table 3.

Frequency of bleeding (major + non-major clinical relevant) and thrombotic (major + minor) events in categories of increasing INR levels according to the available temporally related INR results

INR categories	Patient-years of follow up with temporally related INR results	Events with temporally related INR results n (% annually; CI)
Bleeding events
		n. 267 (32 NA)
<2.0	2157	45 (2.1; 1.5–2.7)
2.0–3.0	4960	135 (2.7; 2.2–3.2)
3.1–4.4	599	49 (8.1; 6.2–10)
≥4.5	48	6 (12.5; 5.8–24.7)
RR > 3.0 vs ≤3.0 INR (95% CI)		3.68 (2.66–5.01) p < 0.0001
RR ≥ 4.5 vs <4.5 INR (95% CI)		4.23 (1.53–9.75) p < 0.01
Thrombotic events
		n. 47 (5 NA)
<1.5	340	4 (1.18;0.5–2.9)
1.5–1.99	990	7 (0.70; 0.3–1.4)
2.0–3.0	4960	26 (0.52; 0.3–0.7))
>3	1093	5 (0.45; 0.2–1.1)
RR < 2.0 vs ≥2.0 (95% CI)		1.61 (0.73–3.30) p < 0.01

RR relative risk, CI 95% confidence interval, NA not available