Table 3.

All Adverse Events^* by System Organ Class

All Adverse Events	Metronidazole and Antibiotic Regimen per Standard of Care (N=55)
System Organ Class (Preferred Term)	Patients with Event N (%)	Total Events N
Blood and lymphatic system disorders	4 (7.3%)	4
Anemia	3 (5.5%)	3
Anemia neonatal	1 (1.8%)	1
Cardiac disorders	2 (3.6%)	2
Cardiopulmonary failure	1 (1.8%)	1
Tachycardia	1 (1.8%)	1
Congenital, familial and genetic disorders	1 (1.8%)	2
Atrial septal defect	1 (1.8%)	1
Pulmonary artery stenosis congenital	1 (1.8%)	1
Eye disorders	1 (1.8%)	1
Retinal detachment	1 (1.8%)	1
Gastrointestinal disorders	3 (5.5%)	3
Abdominal distension	1 (1.8%)	1
Gastroesophageal reflux disease	1 (1.8%)	1
Hematemesis	1 (1.8%)	1
Hepatobiliary disorders	1 (1.8%)	1
Hyperbilirubinemia	1 (1.8%)	1
Infections and infestations	2 (3.6%)	3
Enterobacter pneumonia	1 (1.8%)	1
Peritonitis bacterial	1 (1.8%)	1
Skin candida	1 (1.8%)	1
Injury, poisoning, and procedural complications	1 (1.8%)	1
Wound	1 (1.8%)	1
Investigations	3 (5.5%)	4
Bilirubin conjugated increased	1 (1.8%)	1
Blood alkaline phosphatase increased	1 (1.8%)	1
Blood triglycerides increased	1 (1.8%)	1
Hematocrit decreased	1 (1.8%)	1
Metabolism and nutrition disorders	5 (9.1%)	8
Hyperchloremia	1 (1.8%)	1
Hyperkalemia	1 (1.8%)	1
Hypoalbuminemia	1 (1.8%)	1
Hypokalemia	2 (3.6%)	2
Hypomagnesaemia	1 (1.8%)	1
Hyponatremia	1 (1.8%)	1
Metabolic acidosis	1 (1.8%)	1
Renal and urinary disorders	1 (1.8%)	1
Hydronephrosis	1 (1.8%)	1
Respiratory, thoracic, and mediastinal disorders	3 (5.5%)	3
Infantile apnea	1 (1.8%)	1
Pneumothorax	1 (1.8%)	1
Respiratory failure	1 (1.8%)	1
Vascular disorders	2 (3.6%)	2
Hemorrhage	1 (1.8%)	1
Hypoperfusion	1 (1.8%)	1

^*Adverse events: metronidazole and antibiotic regimen per standard of care (N=55)