Cardiology

Twelve-lead ECG waveform metadata and machine-overread annotations from the central core lab (Banook Group). Includes QT/QTcF, PR, QRS intervals at scheduled timepoints.

Total cholesterol, LDL-C (calculated and direct), HDL-C, triglycerides from Q² Solutions central laboratory across cardiovascular studies.

Composite definition of adjudicated heart failure hospitalization endpoint per ESC 2023 / ACC/AHA criteria. Used across CV outcomes trials and aligned with FDA endpoint guidance.

Home BP cuff readings ingested from connected devices (Omron HEM-9210T, A&D Medical) for hypertension RWE programs in the J-HOMECARE registry.

hs-Troponin I, NT-proBNP, hs-CRP, ST2 measurements from central biomarker lab. Linked to enrolled CV outcomes trial cohorts.

Time-to-event analysis dataset for the CV-OUTCOMES-401 trial primary endpoint (3-point MACE). Conforms to ADaM IG 1.3 with PARAM/PARAMCD structure.