Fixed dose artesunate amodiaquine – a phase IIb, randomized comparative trial with non-fixed artesunate amodiaquine

Table 5 Median (interquartile range) and median changes from baseline of the Bazett’s corrected QT interval, heart rate, and PR and QRS intervals for both artesunate amodiaquine arms combined*

Statistical parameter	Median	Lower quartile	Upper quartile	∆ vs D0	p vs D0	Median	Lower quartile	Upper quartile	∆ vs D0	p vs D0
Variable	QTcB interval ms					Heart rate b/min
D0, pre-dose	410	394	425			92	80	103
D0 + 2 h	412	398	428	2	0.3652	85	74	98	−5	0.0012
D0 + 4 h	416.5	397	429	3.5	0.2593	79	71	89	−8.5	<.0001
D2, pre-dose	411	388	423	−4.5	0.2551	59	53	64	−35	<.0001
D2 + 2 h	415	393	433.5	3	0.4897	59.5	54	64.5	−36	<.0001
D2 + 4 h	420	400	431	7.5^†	0.0059	59	55	65	−31.5	<.0001
D28	398	384	418	−10.5	0.0016	66	59	74	−25	<.0001
Variable	QRS interval ms					PR interval ms
D0, pre-dose	78	72	88			151.5	140.5	172.5
D0 + 2 h	82	72	89	2	0.2572	158	146	176	5	0.0061
D0 + 4 h	82	76	88	1.5	0.1122	161	153	175	10	<.0001
D2, pre-dose	84	74	96	2.5	0.0084	163	154	185	12	<.0001
D2 + 2 h	85	79	95.5	6	0.0001	167	155.5	184.5	13.5	<.0001
D2 + 4 h	86	78	95	5	0.0003	172	151	187	15	<.0001
D28	86	76	92	5.5	0.0073	164	147	179	12	<.0001

*Only the QTcB data are normally distributed but the median interquartile ranges are shown for all parameters for clarity.
^†Corresponding mean 95% confidence intervals are: 9.02 (2.72-15.31) ms.

ISSN: 1475-2875