Statistics
EVENTS, EVENT, ADVERSE EVENT, CHRONIC KIDNEY DISEASE
Data assessed in the current integrated analyses were based on an electronic data capture date of March 3, 2021. All data were from completed trials, or from trials that had been unblinded and locked at primary endpoint analysis.Data were analyzed according to the incidence of events and using descriptive summary statistics of laboratory results. The incidence of events was based on confirmed test results for liver, kidney, hematology, and electrolytes. All study data were included for analysis of the incidence of events. Baseline was defined as the last nonmissing value before the first dose. An event was defined as data falling outside the normal range or reaching the specified threshold, as defined by protocol stopping rules, standard reporting, or an event that meets the criteria established in the Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) [A confirmed event was defined as a consecutive abnormal laboratory value on a different day. If there was no consecutive test to confirm, then the initial observation was presumed confirmed. If there were multiple values on the same day, but sampled at different times, the worst value was used. A persistent event was defined as elevated levels on two consecutive measurements at least 7 days apart, with all values between the initial and subsequent test also meeting the specified threshold. The estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation [The over-time analysis of laboratory test results included all study data during the treatment period, which were defined as first dose to 10 days after the last dose for subjects dosed weekly, 17 days after the last dose for those dosed every other week, and 31 days after the last dose for those dosed monthly.A meta-analysis using subject-level data was performed to compare ASO-treated dose groups with the placebo group. The endpoints evaluated were the absolute changes from baseline. Data were compared between GalNAcStatistical analyses were performed using SAS version 9.3.