Safety overview
| n (%)a | Mothers (n=21)b | Infants (n=16) |
| Any TEAEs | 15 (71.4) | 5 (31.3) |
| Mild TEAEs | 4 (19.0) | 2 (12.5) |
| Moderate TEAEs | 9 (42.9) | 2 (12.5) |
| Severe TEAEs | 2 (9.5) | 1 (6.3) |
| Discontinuation due to TEAEs | 2 (9.5) | 0 |
| Drug-related TEAEs | 3 (14.3) | 1 (6.3) |
| Serious TEAEsc | 7 (33.3) | 2 (12.5) |
| Deaths | 0 | 0 |
| Serious TEAEs by mother–infant pair | ||
| SF | Placental insufficiency Premature baby | N/A |
| 1 | Arrested labour | None |
| 2 | Arrested labour | None |
| 3 | Prolonged labour | None |
| 4 | Gestational diabetes Polyhydramnios | None |
| 5 | None | Hypoglycaemia Infection |
| 6 | Perineal abscess | None |
| 7 | Vaginal laceration | Macrosomia Meconium in amniotic fluid |
TEAEs were defined as any adverse event (AE) captured from the time of informed consent until the safety follow-up; bold text indicates severe TEAEs.
a Number of mothers or infants reporting at least one AE for the indicated category.
b Safety set for mothers (includes five screen failures).
c Serious TEAEs were classified using the United States Food and Drug Administration regulatory definition of serious AEs.
TEAE, treatment-emergent adverse event; SF, screen failure; N/A, not applicable.