Table 4.
Frequency [n (%)] of Infant Adverse Events
| Event | Total (N = 49) | Cohort 1 (Second Trimester, n = 24) | Cohort 2 (Third Trimester, n = 25) |
|---|---|---|---|
| Serious adverse eventsa | 6 (12%); 95% CI: 5–25% | 4 (16.7%); 95% CI: 5–37% | 2 (8%); 95% CI: .1–26% |
| Neonatal sepsis | 4 | 3 | 1 |
| Hyperbilirubin | 2 | 1 | 1 |
| Neonatal respiratory distress | 1 | 1 | 0 |
| Premature birth (<32 weeks) | 1 | 1 | 0 |
| Anemia of prematurity | 1 | 1 | 0 |
| Small for gestational ageb | 1 | 0 | 1 |
| Subgaleal hematomaa | 1 | 0 | 1 |
| Adverse birth outcomesc | 8 (16%); 95% CI: 7–30% | 2 (8%); 95% CI: 1–27% | 6 (24%); 95% CI: 9–45% |
| Premature birth (<37 weeks) | 5 (10%); 95% CI: 3–22% | 1 (4%); 95% CI: .01–21% | 4 (16%); 95% CI: 5–36% |
| Low birth weight (<2500 g) | 4 (8%); 95% CI: 2–20% | 1 (4%); 95% CI: .01–22% | 3 (12%); 95% CI: 3–31% |
| Small for gestational ageb | 3 (7%); 95% CI: 4–12% | 1 (5%); 95% CI: .1–24% | 2 (9%); 95% CI: 1–29% |
| Intrauterine growth retardation | 1 (2%); 95% CI: .7–6% | 0 (0%); 95% CI: 0–16% | 1 (5%); 95% CI: .1–23% |
Abbreviation: CI, confidence interval; ICH, International Conference on Harmonization.
aInfants could have experienced >1 of the listed events.
bThere are 6 missing classification of newborn intrauterine growth and gestational age and only 1 of the 3 was a serious adverse event (had met ICH criteria of hospitalization).
c The adverse birth outcomes reported in this table are on the live born infants only, stillbirth is reported as a maternal adverse event in Table 3.