Table 3.
Frequency [n (%)] of Maternal Adverse Events
| Event | Total (N = 50) | Cohort 1 (Second Trimester, n = 25) | Cohort 2 (Third Trimester, n = 25) |
|---|---|---|---|
| Serious adverse eventsa | 5 (10%); 95% CI: 3–22% | 2 (8%); 95% CI: 1–26% | 3 (12%); 95% CI: 3–31% |
| Abruptio placentae | 2 | 2 | 0 |
| Hypertensive disorders | 3 | 1 | 2 |
| Postpartum hemorrhage | 1 | 0 | 1 |
| Death | 1 | 1 | 0 |
| Grade 3–4 adverse events | 9 (18%); 95% CI: 9–31% | 5 (20%); 95% CI: 7–41% | 4 (16%); 95% CI: 5–36% |
| Hematologic | 5 | 3 | 2 |
| Anemia | 4 | 2 | 2 |
| Elevated PT | 1 | 1 | 0 |
| Stillbirth | 1 | 1 | 0 |
| Premature delivery | 1 | 1 | 0 |
| Bacterial pneumonia | 1 | 1 | 0 |
| Drug-related grade 2 adverse events (muscle cramps) | 1 (2%); 95% CI: .05–11% | 1 (4%); 95% CI: .1–20% | 0 (0%); 95% CI: 0–14% |
| Permanent study drug discontinuation due to toxicity | 0 (0%); 95% CI: 0–7% | 0 (0%); 95% CI: 0–14% | 0 (0%); 95% CI: 0–14% |
Abbreviations: CI, confidence interval; PT, prothrombin time.
aParticipants could have experienced >1 of the listed events.