Table 5 Fetal and neonatal adverse events in the all treated population
Adverse Event Preferred Term | Pooled Placebo (n = 32)a | Pooled Serelaxin (n = 40)a |
|---|---|---|
| Â | Number (%) of Fetuses | |
Tachycardia | 2 (6.3) | 1 (2.5) |
Hypoxia | 3 (9.4) | 3 (7.5) |
| Â | Number (%) of Neonates | |
Conjunctivitis | 4 (12.5) | 1 (2.5) |
Regurgitation of food | 1 (3.1) | 3 (7.5) |
Cerebral ischemia | 8 (25.0) | 3 (7.5) |
Torticollis | 4 (12.5) | 2 (5.0) |
Hypertonia | 3 (8.4) | 0 (0.0) |
Hypoglycemia | 3 (9.4) | 2 (5.0) |
Jaundice | 2 (6.3) | 5 (12.5) |
Neonatal hypoxia | 7 (21.9) | 7 (17.5) |
Neonatal agitation | 7 (21.9) | 4 (10.0) |
Hypotonia | 6 (18.8) | 6 (15.0) |
Neonatal asphyxia | 6 (18.8) | 4 (10.0) |
Poor weight gain | 1 (3.1) | 3 (7.5) |
Postmature baby | 7 (21.9) | 1 (2.5) |
Umbilical cord around neck | 5 (15.6) | 3 (7.5) |
Dermatitis diaper | 3 (9.4) | 1 (2.5) |