Safety monitoring
death, arrhythmia, renal failure, perforation, hypercalcemia, hypercalciuria
ARRHYTHMIA, ADVERSE EVENTS, GASTROINTESTINAL BLEEDING, RENAL FAILURE, CARDIORESPIRATORY ARREST, HYPERCALCEMIA, NEPHROLITHIASIS, EVENTS, NEPHROCALCINOSIS
Three serious adverse events (SAEs) were defined a priori that would be considered both unexpected and potentially related to study drug. The events were: (i) gastrointestinal bleeding (requiring blood transfusion) and perforation (requiring surgery) within 48 h of study drug administration; (ii) persistent hypercalcemia (> 24 h in the absence of parenteral calcium administration) with renal failure requiring dialysis, nephrocalcinosis, hemodynamically significant arrhythmia, cardiorespiratory arrest or death; and (iii) new or worsening hypercalciuria with nephrolithiasis, or renal failure leading to dialysis or death. Ionized calcium levels and urine calcium:creatinine ratios from the research samples described above were monitored in real time by the site investigator for persistent hypercalcemia [In addition, we used the local site clinical laboratory, or the Qualigen FastPak® system, to measure plasma 25(OHD) concentration in real-time from the last blood sample collected prior to hospital discharge (referred to as the 