Table 2.
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 = 0.0010e |
Age categoriesa | ||||
Preterm neonates | 32 (3.1%)b, c | 6 (5.0%) | 26 (2.8%) | P = 0.002f |
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 = 0.0002g |
Toddlers | −0.45 (1.5) (n = 137) | −0.78 (1.2) (n = 13) | −0.41 (1.5) (n = 124) | P = 0.3870g |
Early childhood | −0.54 (1.6) (n = 165) | −0.54 (1.7) (n = 24) | − 0.54 (1.5) (n = 141) | P = 0.9969g |
Sex | ||||
Male | 590 (56%) | 69 (58%) | 521 (56%) | P = 0.676h |
Female | 460 (44%) | 50 (42%) | 410 (44%) | |
HIV infection / exposure status | ||||
HIV negative | 887 (84%) | 91 (76%) | 796 (86%) | P = 0.003f |
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 = 0.134f |
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