Table III.
Maternal and fetal/neonatal TEAEs.
| Oral DYD (30 mg) | MVP (600 mg) | All | |
|---|---|---|---|
| (n = 518) | (n = 511) | (n = 1029) | |
| Maternal population, n (%)a | |||
| All TEAEs | 290 (56.0) | 276 (54.0) | 566 (55.0) |
| At least one serious TEAE | 56 (10.8) | 68 (13.3) | 124 (12.1) |
| At least one severe TEAE | 37 (7.1) | 54 (10.6) | 91 (8.8) |
| TEAEs leading to study discontinuation | 64 (12.4) | 82 (16.0) | 146 (14.2) |
| Deaths (maternal) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Liver enzyme analysis | 1 (0.2) | 2 (0.4) | 3 (0.3) |
| Alanine aminotransferase increased | 1 (0.2) | 1 (0.2) | 2 (0.2) |
| Hepatic enzyme increased | 0 (0.0) | 1 (0.2) | 1 (0.1) |
| Vascular disorders | 18 (3.5) | 18 (3.5) | 36 (3.5) |
| Peripheral embolism and thrombosis | 1 (0.2) | 1 (0.2) | 2 (0.2) |
| Reproductive system and breast disorders | 113 (21.8) | 94 (18.4) | 207 (20.1) |
| Vaginal hemorrhage | 60 (11.6) | 47 (9.2) | 107 (10.4) |
| Gastrointestinal disorders | 99 (19.1) | 88 (17.2) | 187 (18.2) |
| Nervous system disorders | 40 (7.7) | 42 (8.2) | 82 (8.0) |
| Fetal/neonatal population, n (%)b | |||
| At least one serious AE | 9 (4.2) | 9 (5.7) | 18 (4.9) |
| TEAEs of special interest relating to congenital, familial and genetic disorders, n (%)c | |||
| Congenital, familial and genetic disorders | 5 (1.0) | 6 (1.2) | 11 (1.1) |
| Congenital hand malformation | 0 (0.0) | 1 (0.2) | 1 (0.1) |
| Congenital hydrocephalus | 0 (0.0) | 1 (0.2) | 1 (0.1) |
| Congenital tricuspid valve atresia | 0 (0.0) | 1 (0.2) | 1 (0.1) |
| Interruption of aortic arch | 1 (0.2) | 0 (0.0) | 1 (0.1) |
| Kidney malformation | 0 (0.0) | 1 (0.2) | 1 (0.1) |
| Pulmonary artery atresia | 0 (0.0) | 1 (0.2) | 1 (0.1) |
| Spina bifida | 0 (0.0) | 1 (0.2) | 1 (0.1) |
| Talipes | 1 (0.2) | 0 (0.0) | 1 (0.1) |
| Tracheo-esophageal fistula | 1 (0.5) | 0 (0.0) | 1 (0.1) |
| Univentricular heart | 0 (0.0) | 1 (0.2) | 1 (0.1) |
| Ventricular septal defect | 2 (0.4) | 0 (0.0) | 2 (0.2) |
| Trisomy 21 | 1 (0.2) | 2 (0.4) | 3 (0.3) |
| Trisomy 13 | 0 (0.0) | 1 (0.2) | 1 (0.1) |
| Turner's syndrome | 1 (0.2) | 0 (0.0) | 1 (0.1) |
aPercentages are calculated based on the Safety Sample.
bPercentages are calculated based on the infant population (i.e. N = 212 for the oral DYD group and N = 159 for the MVP group).
cPercentages are calculated based on the Safety Sample. Detection and reporting of the congenital, familial, and genetic disorders occurred during with the pre- or post-natal period; some fetuses/neonates had more than one disorder.
AE, adverse event; DYD, dydrogesterone; MVP, micronized vaginal progesterone; TEAE, treatment-emergent adverse event.