The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, selfefficacy, and quality of life in patients with Heart Failure. Time to First Adjudicated Hospitalisation for Heart Failure (HHF) Ĭhange from baseline in KCCQ (Kansas City cardiomyopathy questionnaire) clinical summary score at Week 52.Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.
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Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier. With time at risk calculated as: Sum of time at risk over all patients in a treatment group / 365.25. The incidence rate per 100 patient years (100 * number of patients with event /time at risk ) is presented. Time to the first event in the composite renal endpoint: chronic dialysis (with a frequency of twice per week or more for at least 90 days), renal transplant, or sustained reduction in Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr).
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