Serious adverse drug reactions at two children’s hospitals in South Africa

BMC Pediatrics

Table 2 Patient characteristics (n = 1050) at first admission to two children’s hospitals, South Africa, 2015

	All patients (n = 1050)	Patients with ADR(s) (any seriousness) (n = 119)	Patients without ADR(s) (n = 931)	P-value
Age
Median (IQR) months	11 (2 to 41)	20 (5 to 68)	10 (2 to 37)	P = 0.0010^e
Age categories^a
Preterm neonates	32 (3.1%)^{b, c}	6 (5.0%)	26 (2.8%)	P = 0.002^f
Term neonates	96 (9.1%)^c	2 (1.7%)	94 (10%)
Infants	421 (40%)	42 (35%)	379 (41%)
Toddlers	139 (13%)	13 (11%)	126 (14%)
Early childhood	198 (19%)	30 (25%)	168 (18%)
Middle childhood	123 (12%)	18 (15%)	105 (11%)
Early adolescence	41 (3.9%)	8 (6.7%)	33 (3.5%)
Weight-for-age z-score mean (SD)
Infants	−1.3 (2.0) (n = 418)	−2.4 (2.2) (n = 42)	−1.2 (2.0) (n = 376)	P = 0.0002^g
Toddlers	−0.45 (1.5) (n = 137)	−0.78 (1.2) (n = 13)	−0.41 (1.5) (n = 124)	P = 0.3870^g
Early childhood	−0.54 (1.6) (n = 165)	−0.54 (1.7) (n = 24)	− 0.54 (1.5) (n = 141)	P = 0.9969^g
Sex
Male	590 (56%)	69 (58%)	521 (56%)	P = 0.676^h
Female	460 (44%)	50 (42%)	410 (44%)	P = 0.676^h
HIV infection / exposure status
HIV negative	887 (84%)	91 (76%)	796 (86%)	P = 0.003^f
HIV indeterminate	134 (13%)	19 (16%)	115 (12%)
HIV infected	29 (2.8%)^d	9 (7.6%)	20 (2.1%)
Number of admissions
One	1001 (95%)	109 (92%)	892 (96%)	P = 0.134^f
Two	43 (4.1%)	9 (7.6%)	34 (3.7%)
Three	5 (0.48%)	1 (0.84%)	4 (0.43%)
Four	1 (0.10%)	0 (0%)	1 (0.11%)

^aPreterm neonate, born before 37 completed weeks’ gestation; term neonate, from birth to 27 days; infancy, 28 days to 12 months; toddler, 13 months to 24 months; early childhood, 25 months to 5 years; middle childhood, 6 years to 11 years; early adolescence, 12 years to 18 years
^bPreterm neonates included 16/32 (50%) moderate to late preterm (32 to < 37 weeks’ gestation), 12/32 (38%) very preterm (28 to < 32 weeks’ gestation), and 4/32 (13%) extremely preterm (< 28 weeks’ gestation) neonates
^cAmong all neonates (n = 128): 93/128 (73%) normal or high birth weight (≥2500 g), 18/128 (14%) low birth weight (1500 to 2499 g), 11/128 (8.6%) very low birth weight (1000 to 1499 g), and 6/128 (4.7%) extremely low birth weight (≤999 g)
^dOf whom 5/29 (17%) not yet on ART, and 24/29 (83%) on ART before and during admission. ART regimens were: 15/24 (63%) on abacavir (ABC) + lamivudine (3TC) + ritonavir-boosted lopinavir (LPV/r), 3/24 (13%) on ABC + 3TC + efavirenz (EFV), 2/24 (8.3%) on zidovudine (AZT) + 3TC + LPV/r, 1/24 (4.2%) on stavudine (D4T) + 3TC + LPV/r, 1/24 (4.2%) on AZT + 3TC + nevirapine (NVP), 1/24 (4.2%) on AZT + 3TC + EFV, and 1/24 (4.2%) on an unknown ART regimen
^eWilcoxon rank-sum test
^fFisher’s exact test
^gStudent’s t test
^hChi-square test
ADR adverse drug reaction; IQR interquartile range; SD standard deviation

ISSN: 1471-2431