Electrocardiographic safety evaluation of extended artemether-lumefantrine treatment in patients with uncomplicated Plasmodium falciparum malaria in Bagamoyo District, Tanzania

Table 4 ECG data

Arm	Correction formula	Day	QTc (ms)	Absolute QTc prolongation		Change from baseline
Arm	Correction formula	Day	Mean QTc (SD)	QTc > 480 ms	QTc > 500 ms	ΔQTc > 60 ms	Mean (95% CI)	P value*
Intervention (n = 103)	Bazett’s	0	410.2 (25.4)	1	1	1	1.9 (− 3.9–7.8)	0.513
	Bazett’s	5	412.1 (25.0)	0	0	1	1.9 (− 3.9–7.8)	0.513
	Fridericia’s	0	375.3 (26.0)	0	0	6	16.2 (10.6–21.7)	< 0.001
	Fridericia’s	5	391.5 (21.2)	0	0	6	16.2 (10.6–21.7)	< 0.001
	QTc-age	0	393.4 (31.2)	0	0	4	9.1 (3.2–15.0)	0.003
	QTc-age	5	402.5 (25.7)	0	0	4	9.1 (3.2–15.0)	0.003
Control (n = 92)	Bazett’s	0	416.8 (32.1)	4	1	1	− 9.4 (− 15.8–(− 3.0)	0.004
	Bazett’s	5	407.4 (27.5)	1	0	1	− 9.4 (− 15.8–(− 3.0)	0.004
	Fridericia’s	0	383.6 (30.2)	1	0	2	2.7 (− 3.3–8.8)	0.371
	Fridericia’s	5	386.3 (23.4)	0	0	2	2.7 (− 3.3–8.8)	0.371
	QTc-age	0	400.9 (35.2)	2	1	1	− 3.0 (− 9.7–3.6)	0.367
	QTc-age	5	397.9 (27.7)	0	0	1	− 3.0 (− 9.7–3.6)	0.367

Italic values indicate significance of p value (p < 0.05)
* P values were calculated using the paired t-test for change in mean QTc interval between day 0 and 5 in each treatment arm with Bazett’s and Fridericia’s formulae and age adjusted QTc values (QTc-age), respectively. All QT intervals were manually derived

ISSN: 1475-2875