Table 3.
Adverse Events.
| Category (number of patients in safety analysis) | Ondansetron (n=48) | Placebo (n=44) |
|---|---|---|
| no. of events | ||
| Serious Adverse Events (SAEs) | ||
| Maternal | ||
| Suicidal ideation | 1 | |
| C-section superficial wound infection | 1 | |
| Neonatal | ||
| Readmission for NOWS observation | 2 | |
| Hyperbilirubinemia | 1 | |
| Late onset NOWS | 1 | |
| Intermittent seizures | 1 | |
| Hypoxic encephalopathy | 1 b | |
| Adverse Events (AEs) | ||
| Maternal | ||
| Subcutaneous hematoma drainage from C-section incision | 1 | |
| Vaginal bleeding | 1 | |
| Neonatal | ||
| Prolonged QTc | 14 a | 12 |
| Short QTc | 3 | 2 |
| Cyanotic episode | 1 | |
| Seizure | 1 b | |
| Sepsis | 1 b | |
| Laryngomalacia | 1 b | |
| Left brachial plexus injury | 1 b | |
| Secundum atrial septal defect | 1 a | |
| Total AE and SAE | 23 | 24 |
a
One neonate had two AEs (prolonged QTc and secundum atrial septal defect).
b
One neonate had one SAE (hypoxic encephalopathy) and four AEs (seizure, sepsis, laryngomalacia, and left brachial plexus injury). The neonate was excluded for per-protocol analysis due to complications during the birth.