Table 3.

Overall Summary of TEAEs and ADRs (Safety Set)

	Fimasartan (N=155)	Valsartan (N=161)	Olmesartan (N=53)	Total (N=369)
Number of Subjects with TEAEs	23(14.84) [29]	20(12.42) [24]	6(11.32) [8]	49(13.28) [61]
95% confidence interval	(9.24, 20.44)	(7.33, 17.52)	(2.79, 19.85)	(9.82, 16.74)
P-value				0.7384
Number of Subjects with Serious TEAEs	0	0	0	0
95% confidence interval	(0.00, 2.35)	(0.00, 2.27)	(0.00, 6.72)	(0.00, 0.99)
P-value				-
Number of Subjects with TEAEs Leading to IP Discontinuation	8(5.16) [8]	7(4.35) [7]	2(3.77) [2]	17(4.61) [17]
95% confidence interval	(1.68, 8.64)	(1.20, 7.50)	(0.00, 8.90)	(2.47, 6.75)
P-value				0.8973
Number of Subjects with TEAEs Leading to Fatality	0	0	0	0
Exact 95% confidence interval	(0.00, 2.35)	(0.00, 2.27)	(0.00, 6.72)	(0.00, 0.99)
P-value				–
Number of Subjects with ADRs	10(6.45) [11]	7(4.35) [10]	2(3.77) [3]	19(5.15) [24]
95% confidence interval	(2.58, 10.32)	(1.20, 7.50)	(0.00, 8.90)	(2.89, 7.40)
P-value				0.6202
Number of Subjects with Serious ADRs	0	0	0	0
95% confidence interval	(0.00, 2.35)	(0.00, 2.27)	(0.00, 6.72)	(0.00, 0.99)
P-value				–
Number of Subjects with ADRs Leading to IP Discontinuation	6(3.87) [6]	1(0.62) [1]	1(1.89) [1]	8(2.17) [8]
95% confidence interval	(1.43, 8.23)	(0.02, 3.41)	(0.05, 10.07)	(0.94, 4.23)
P-value				0.0959
Number of Subjects with ADRs Leading to Fatality	0	0	0	0
95% confidence interval	(0.00, 2.35)	(0.00, 2.27)	(0.00, 6.72)	(0.00, 0.99)
P-value				–

Notes: Denominator of percentage is the number of subjects in the column. Severity is displayed as number of events, and the others are displayed as number of subjects (percentage of subjects) [number of events]. Difference among the treatment groups (chi-squares test of Fisher’s exact test). ADRs related to study drug as “Certain” or “Probable/Likely” or “Possible” or “Unassessible/unclassifiable”.

Abbreviations: ADRs, Adverse Drug Reactions; TEAE, treatment-exposure adverse events; IP, investigational product.