|
Adverse Event Preferred Term
|
Pooled Placebo (n = 32)a
|
Pooled Serelaxin (n = 40)a
|
|---|
| |
Number (%) of Fetuses
|
|
Tachycardia
|
2 (6.3)
|
1 (2.5)
|
|
Hypoxia
|
3 (9.4)
|
3 (7.5)
|
| |
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)
|
- Listed are fetal and neonatal AEs occurring in >5 % in either arm
-
aThe pooled placebo group includes all fetuses or neonates from Parts A and B treated with placebo and the pooled serelaxin group includes all subjects from Parts A and B treated with any dose of serelaxin
