Table 4.
Safety in Children Up to 6 Months After Birth
| Intensification Group (N = 89) | Observational Group (N = 235) | P * | All Women (N = 324) | |
|---|---|---|---|---|
|
| ||||
| At least one SAE, n (%) | 11 (12%) | 49 (21%) | 0.108 | 60 (19%) |
| SAE, n | 11 | 50 | 61 | |
| Infections, n | 4 | 22 | 26 | |
| Birth related, n | 3 | 13 | 16 | |
| HIV related, n | 0 | 0 | 0 | |
| Anemia/neutropenia, n | 0 | 5 | 5 | |
| Congenital anomalies, n | 1 | 4 | 5† | |
| Others, n | 3 | 6 | 9 | |
| Deaths | 1‡ (1%) | 3§ (1%) | >0.999 | 4 (1%) |
| Neonatal death (within 28 days after birth) | 0 (0%) | 1 (0.48%) | >0.999 | 1 (0.31%) |
| Metabolic toxicity at least once at any visit, n (%) | 25 (28%) | 97 (41%) | 0.030 | 122 (38%) |
| Anemia grade ≥2 at 1 mo, n (%) | 25 (30%) | 97 (48%) | 0.008 | 122 (42%) |
| Alanine aminotransferase grade ≥2 at 7–10 days, n (%) | 0 (0%) | 0 (0%) | — | 0 (0%) |
| Hemoglobin grade ≥2, n (%) | 25 (30%) | 97 (48%) | 0.008 | 122 (42%) |
| Abnormal hematocrit (<26%), n (%) | 20 (23%) | 66 (29%) | 0.325 | 86 (27%) |
| White blood cells grade ≥2, n (%) | 0 (0%) | 0 (0%) | — | 0 (0%) |
| Absolute neutrophils grade ≥2, n (%) | 5 (6%) | 13 (6%) | >0.999 | 18 (6%) |
| Abnormal absolute lymphocytes (<6000 cells/mm3), n (%) | 36 (43%) | 93 (46%) | 0.697 | 129 (45%) |
| Platelets grade ≥2, n (%) | 1 (1%) | 0 (0%) | 0.296 | 1 (0.3%) |
| Creatinine grade ≥2, n (%) | 0 (0%) | 0 (0%) | — | 0 (0%) |
| SGPT grade ≥2, n (%) | 3 (4%) | — | — | 3 (4%) |
| Total bilirubin grade ≥2, n (%) | 1 (1%) | — | — | 1 (1%) |
*
The Fisher exact test was used to compare the proportions, and the Wilcoxon rank-sum test was used to compare median.
†
Congenital anomalies: one polydactyly of right thumb, one Down syndrome, one 4–5 toe syndactyly of left foot, one ankyloglossia, and one deformity of the fourth right toe.
‡
Sudden death at 35 days (unconfirmed uninfected).
§
One death at birth from severe prematurity (indeterminate HIV status); one death at 15 days from Down syndrome and sepsis (unconfirmed uninfected); and one death at 156 days from fever and seizures (confirmed uninfected).