Table 2

Safety overview

n (%)a Mothers (n=21)b Infants (n=16)
Any TEAEs15 (71.4)5 (31.3)
 Mild TEAEs4 (19.0)2 (12.5)
 Moderate TEAEs9 (42.9)2 (12.5)
 Severe TEAEs2 (9.5)1 (6.3)
Discontinuation due to TEAEs2 (9.5)0
Drug-related TEAEs3 (14.3)1 (6.3)
Serious TEAEsc 7 (33.3)2 (12.5)
Serious TEAEs by mother–infant pair
SF Placental insufficiency
Premature baby
1 Arrested labourNone
2 Arrested labour None
3 Prolonged labour None
4 Gestational diabetes
5 NoneHypoglycaemia
6 Perineal abscessNone
7 Vaginal lacerationMacrosomia
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.