Safety assessment
hypophosphatemia
HYPOPHOSPHATEMIA, ADVERSE EVENTS, ADVERSE EVENT, EVENT, ADVERSE EVENT
The investigators recorded and assessed all adverse events up until the final follow-up visit including clinical assessment of various laboratory parameters measured at each follow-up visit (complete blood count, C-reactive protein [CRP], alanine aminotransferase [ALAT], bilirubin, sodium, potassium, calcium, phosphate, urea, creatinine, and albumin). An adverse event was defined as an event that occurred or increased in severity after the first dose of medication was administered. Investigators assessed all adverse events for relatedness to trial treatment, severity, and seriousness. Adverse events were categorised using the Medical Dictionary for Regulatory Activities (version 20.0). Safety assessments also included the incidence of hypophosphatemia (phosphate < 2 mg/dL), severe hypophosphatemia (phosphate < 1 mg/dL), and discontinuations due to lack of response or intolerance.In addition, pre-defined obstetric and perinatal outcomes occurring up to seven days postpartum were retrieved from medical records.