Safety
toxicity, cardiac arrest
ADVERSE EVENT, ADVERSE EVENT, CARDIAC ARREST
Mean 24‐hour urine calcium levels decreased from 392 mg/24 h at baseline to 220 mg/24 h in participants treated with TransCon PTH compared with 329 mg/24 h at baseline to 292 mg/24 h with placebo (Fig. Twenty four‐hour urine calcium with TransCon PTH treatment. Box plot of 24‐hour urine calcium. Within each box, horizontal lines denote median values and the square (TransCon PTH), and circle (placebo) denote mean values; boxes extend from the 25th to the 75th percentile of each treatment group's distribution of values; vertical extending lines denote adjacent values within 1.5 interquartile range of the 25th and 75th percentile of each group; dots outside the box denote data points outside the range of adjacent values. Mean 24‐hour urine calcium values decreased from 390 mg/24 h at baseline to 220 mg/24 h at week 26 in participants treated with TransCon PTH, and from 329 to 292 mg/24 h in participants who received placebo. The mean change from baseline was statistically significant in the TransCon PTH group (Albumin‐Adjusted Serum Calcium Excursions by Time Period
Abbreviations: EBT, end of blinded treatment; PTH, parathyroid hormone.Treatment‐emergent AEs were reported in 50/61 (82%) participants treated with TransCon PTH and in 21/21 (100%) participants treated with placebo (Tables Summary: Overall Treatment‐Emergent Adverse EventsAbbreviatiions: ER, emergency room; PTH, parathyroid hormone; TEAE, treatment‐emergent adverse event.Percentages are calculated based on the number of participants in the safety analysis population. In the severity categories, participants are displayed for the highest severity only. TEAEs occurring before the first dose of open‐label treatment are included.AE severity is assessed by the World Health Organization toxicity grading scale.One participant experienced a fatal cardiac arrest (grade 4 TEAE), which subsequently led to discontinuation of the study drug and trial.Treatment‐Emergent Adverse Events in ≥5% of ParticipantsAbbreviations: PTH, parathyroid hormone; TEAE, treatment‐emergent adverse event.Percentages are calculated based on the number of participants in the safety analysis population.