TABLE 2.
Numbers and Percentage of Healthy Infants With Normal Versus Abnormal Laboratory Values by Severity Level Using DAIDS Toxicity Tables 2004 and Age Ranges—Kampala Uganda
| DAIDS Adverse Event Severity Grading | ||||||||
|---|---|---|---|---|---|---|---|---|
| CBC | Infant Age Groups | Normal | Mild | Moderate | Severe | Life Threatening | Total | d’* |
| Hemoglobin, g/dL | Birth 21 days | 96 (95%) | 3 (3%) | 2 (2%) | 0 | 0 | 101 | 9 |
| 22–35 days | 29 (97%) | 0 | 1 (3%) | 0 | 0 | 30 | 4 | |
| 36–56 days | 31 (3.90%) | 2 (6.10%) | 0 | 0 | 0 | 33 | 4 | |
| ≥57 days | 48 (53%) | 25 (28%) | 14 (16%) | 2 (2%) | 1 (1%) | 90 | 8† | |
| Absolute neutrophil count, × 103/µL | Birth | 8 (80%) | 1 (10%) | 0 | 1 (10%) | 0 | 10 | 2† |
| 1–7 days | 62 (95%) | 2 (3%) | 0 | 1 (2%) | 0 | 65 | 6 | |
| >Than 7 days | 144 (80.40%) | 16 (8.90%) | 12 (6.70%) | 6 (3.40%) | 1 (0.60%) | 179 | 14† | |
| Platelets decreased × 103/µL | NA | 248 (97.60%) | 2 (0.80%) | 2 (0.80%) | 1 (0.40%) | 1 (0.40%) | 254 | 19 |
| White blood cell decreased × 103/µL | NA | 254 (100%) | 0 | 0 | 0 | 0 | 254 | 19 |
| Chemistry | ||||||||
| Total bilirubin, mg/dL | ≤14 days nonhemolytic | 84 (100%) | 0 | 0 | 0 | 0 | 84 | 8 |
| <14 days hemolytic | 84 (100%) | 0 | 0 | 0 | 0 | 84 | 8 | |
| Sodium high, mEq/L | Not applicable | 204 (99.50%) | 1 (0.50%) | 0 | 0 | 0 | 205 | 16 |
| Sodium low, mEq/L | Not applicable | 135 (65.50%) | 70 (34.50%) | 0 | 0 | 0 | 205 | 16† |
For each group The DAIDS Adverse Event grading categories were based on the values in the DAIDS Toxicity Tables December, 2004 Version 1.0.
Nineteen (19) infants from Malawi did not have ANC results. There were 14 clotted samples and for 5 samples the machine could not read neutrophils.
Critical values indicate that having this number or more observed individuals in the subgroup should prompt us to consider possible differences in the biological characteristics of our sample population and that of the DAIDS population, and thus, consider whether new reference intervals should be developed for this sampled population.
Indicates that the observed number of individuals outside of the reference intervals for a given age group is equal or greater than the critical number that is consistent with the expected DAIDS tables’ population distributional properties.