Table 1.

Number (%) of Patients in ECG Outlier Categories

	15, 30 mg	60 mg	120 mg	240 mg	300, 360 mg	480 mg	All
Study A	(n = 6)	(n = 4)	(n = 7)	(n = 75)	(n = 8)	(n = 6)	(n = 106)
QTcF >450 to ≤480 ms	0 (0)	1 (25)	1 (14.3)	7 (9.3)	0 (0)	0 (0)	9 (8.5)
QTcF >480 to ≤500 msa	0 (0)	0 (0)	0 (0)	1 (1.3)	0 (0)	1 (16.7)	2 (1.9)
ΔQTcF >30 to ≤60 msa	0 (0)	0 (0)	0 (0)	2 (2.7)	1 (12.5)	0 (0)	3 (2.8)
PR >200 ms and ≥25% increase from baseline	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)b	0 (0)
QRS >120 ms and ≥25% increase from baseline	0 (0)	0 (0)	0 (0)	0 (0)	1 (12.5)	0 (0)	1 (0.9)
HR <50 bpm and ≤25% decrease from baseline	0 (0)	0 (0)	0 (0)	2 (2.7)	0 (0)	0 (0)	2 (1.9)
HR >100 bpm and ≥25% increase from baseline	1 (16.7)	0 (0)	0 (0)	6 (8.0)	0 (0)	0 (0)	7 (6.6)

	60 mg	90 mg	180 mg	240 mg	360 mg	All
Study B	(n = 4)	(n = 4)	(n = 5)	(n = 3)	(n = 10)	(n = 26)
QTcF >450 to ≤480 ms	0 (0)	2 (50.0)	1 (20.0)	1 (33.3)	5 (50.0)	9 (34.6)
QTcF >480 to ≤500 msa	0 (0)	1 (25.0)	0 (0)	0 (0)	0 (0)	1 (3.8)
ΔQTcF >30 to ≤60 msa	0 (0)	2 (50.0)	1 (20.0)	2 (66.7)	2 (20.0)	7 (26.9)
PR >200 ms and ≥25% increase from baseline	0 (0)	0 (0)	1 (20.0)	0 (0)	0 (0)	1 (3.8)
QRS >120 ms and ≥25% increase from baseline	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
HR <50 bpm and ≤25% decrease from baseline	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
HR >100 bpm and ≥25% increase from baseline	0 (0)	0 (0)	1 (20.0)	1 (33.3)	1 (10.0)	3 (11.5)

ΔQTcF, change from baseline QT corrected using the Fridericia formula; HR, heart rate; n, number of patients in each treatment group.

QTcF, QT corrected using the Fridericia formula.

HR in bpm was calculated as 60,000/RR (ms).

^a No patients had QTcF >500 ms or ΔQTcF >60 ms.

^b n = 5 (1 patient did not have any PR data).