Table 4.

Sensitivity Analyses

	All n=2508	Normal Responders, n=1627	Sensitive and Highly Sensitive Responders, n=881	Hazard Ratio [95% Confidence Interval]	Adjusted Hazard Ratio [95% Confidence Interval]
Bleeding events (whole follow-up), n	226	149	77	1.03 [0.79, 1.36]	1.07 a[0.82, 1.42]
Events per 100 patient-years	4.6	4.5	4.7
Follow-up time, days, median [IQR]	318 [114–1070]	329 [119–1126]	286 [109–974]
Bleeding events during 90 days follow-up, n	48	163	85	1.01 [0.56, 1.82]	1.01 a[0.56, 1.83]
Events per 100 patient-years	4.1	4.5	5.0
Follow-up time, days, median [IQR]	90 [90–90]	365 [127–730]	295 [111–988]
Bleeding events combined with high INR, nc	50	39	14	0.66 [0.35, 1.25]	0.68a[0.36, 1.29]
Events per 100 patient-years	1.8	2.0	1.4
Follow-up time, days, median [IQR]	342 [120–730]	364 [126–730]	319 [113–730]
Thromboembolic events (recurrent events excluded), n	98	50	48	1.82 [1.23, 2.71]	1.78 b[1.19, 2.64]
Events per 100 patient-years	3.7	2.8	5.3
Follow-up time, days, median [IQR]	320 [111–730]	348 [120–730]	272 [103–730]

Notes: ^aAdjusted for sex, age, use of interacting drugs that increase the bleeding risk, a diagnosis of cancer, and the indication for warfarin use; ^bAdjusted for sex, age, a diagnosis of cancer, and the indication for warfarin use. The use of interacting drugs that increase the risk of thromboembolic events was not used as a covariate because of the low number of drug users ^cA primary event defined as a bleeding outcome combined with concurrent INR test result of >3. Follow-up of 730 days.

Abbreviations: INR, international normalized ratio; IQR, interquartile range.