Table 6.

Determinants of Adverse Drug Reaction Occurrence After Taking Amodiaquine–Artesunate During 28 Days of Follow-Up in Both Active and Passive Surveillance

		Active Surveillance				Passive Surveillance
		Univariate		Multivariable		Univariate		Multivariable
		HR (95% CI)	pvalue	Adj. HR (95% CI)	p value	HR (95% CI)	p value	Adj. HR (95% CI)	p value
Fixed Effect
Sex	Male	1		1		1
	Female	0.76 (0.68; 0.86)	<0.001	0.95 (0.80; 1.12)	0.38	1.07 (0.6; 1.89)	0.18	1.41 (0.63; 3.15)	0.25
Age (years)	≥18	1		1		1
	14–17	0.56 (0.36; 0.88)	0.001	0.53 (0.29; 0.95)	<0.001	1.03 (0.19; 5.53)	0.97	1.12 (0.19; 6.75)	0.86
	6–13	0.44 (0.35; 0.55)	<0.001	0.44 (0.24; 0.82)	<0.001	0.49 (0.14; 1.65)	0.16	0.33 (0.02; 5.03)	0.27
	0–5	0.15 (0.12; 0.17)	<0.001	0.18 (0.08; 0.39)	<0.001	0.35 (0.14; 0.88)	0.007	0.30 (0.01; 8; 04)	0.32
Weight		1.04 (1.03; 1.04)	<0.001	1.00 (0.99; 1.02)	0.82	1.02 (1.01; 1.04)	0.006	0.99 (0.92; 1.07)	0.82
Symptoms at day 0	≤2	1		1		–		–
	>2	1.47 (1.26; 1.71)	<0.001	0.93 (0.78; 1.12)	0.31	–		–
Concomitant medication	<2	1		1		1		1
	≥2	1.27 (0.98; 1.63)	0.07	2.18 (1.54; 3.09)	<0.001	5.10 (2.91; 8.93)	<0.001	4.70 (2.11; 10.46)	<0.001
Temperature at day 0	<37.5	1				1		1
	≥37.5	0.61 (0.53; 0.69)	<0.001	0.92 (0.76; 1.12)	0.24	1.52 (0.76; 3.05)	0.20	1.05 (0.40; 2.77)	0.90
Drug use before day 0	No	1		1		1		1
	Yes	1.49 (1.31; 1.69)	<0.001	1.60 (1.34; 1.91)	<0.001	1.53 (0.75; 3.13)	0.14	1.54 (0.65; 3.63)	0.17
Transmission season	Low	1		1		1		1
	High	0.37 (0.33; 0.41)	<0.001	0.45 (0.38; 0.53)	<0.001	0.49 (0.27; 0.88)	0.017	0.45 (0.20; 0.92)	0.005
Random effect				SD				SD
Patient specific				0.385				1.892
HF specific				0.006				1.378

Abbreviations: HF, health facility; HR, hazard ratio; adj. HR, adjusted hazard ratio; SD, standard deviation.