Table 6.
Adverse events occurring in neonates*
| Adverse event | Retosiban n = 30 (%) | Placebo n = 34 (%) |
|---|---|---|
| Hypoglycaemia | 2 (7) | 1 (3) |
| Hyperbilirubinaemia | 1 (3) | 5 (15) |
| Jaundice | 1 (3) | 1 (3) |
| Anaemia | 0 | 2 (6) |
| Hypercalcaemia | 0 | 2 (6) |
| Malnutrition† | 0 | 2 (6) |
Listed are all adverse events, regardless of treatment group. Neonates with more than one occurrence of the same type of adverse event are listed only once.
Medical Dictionary for Regulatory Activities (MedDRA) preferred term for event reported as nutrition imbalance (infant).