Table 3.

Range of PT covariate and exposure adjustment factors in phase III trials

Indication (N)		Minimum	5th percentile	Median	95th percentile	Maximum
AF (5,681)	PT covariate	0.55	0.77	1.02	1.56	3.19
	AUC0–24 adjustment factor	0.55	0.77	1.03	1.58	3.24
	Cmax adjustment factor	0.70	0.85	1.01	1.37	2.44
	Ctrough adjustment factor	0.10	0.60	1.18	2.41	6.10
Treatment of VTE (3,582)	PT covariate	0.58	0.83	1.06	1.39	2.95
	AUC0–24 adjustment factor	0.58	0.84	1.07	1.41	3.00
	Cmax adjustment factor	0.72	0.89	1.04	1.26	2.28
	Ctrough adjustment factor	0.18	0.75	1.27	2.02	5.55
Prevention of VTE in patients undergoing hip or knee replacement surgery (5,293)	PT covariate	0.71	0.88	1.05	1.41	2.81
	AUC0–24 adjustment factor	0.71	0.89	1.06	1.42	2.86
	Cmax adjustment factor	0.81	0.92	1.03	1.27	2.19
	Ctrough adjustment factor	0.47	0.86	1.25	2.05	5.25

AF, atrial fibrillation; AUC_0–24, area under the plasma concentration–time curve from 0 to 24 hours; C_max, maximum concentration; C_trough, trough concentration at the end of the dosing interval before the next dose; PT, prothrombin time; VTE, venous thromboembolism.