Safety monitoring
arrhythmia, syncope, acute kidney dysfunction, SAEs, hypotension, disability, diabetes
ARRHYTHMIA, ADVERSE EVENTS, EVENT, EVENTS, DIABETES
Patient safety will be carefully monitored. Safety outcomes include serious adverse events (SAEs) and selected AEs. SAEs are adverse events that are fatal or life threatening, result in significant or persistent disability, require or prolong hospitalization, or are important medical events that investigators judge to represent significant hazards or harm to research participants. In addition, a selected list of other important events that lead to emergency room visits will also be reported in BPROAD. The selected AEs include symptomatic hypotension, arrhythmia, acute kidney dysfunction, electrolyte abnormalities, injurious falls, syncope, and unexpected events for which the investigator believes that the BPROAD intervention might cause the event or might contribute to the immediate cause of the event. Participants will be queried for SAEs and selected AEs at each follow‐up visit. Participants are also encouraged to report SAEs and selected AEs between visits.In addition, an independent Data and Safety Monitoring Board (DSMB) will be responsible for monitoring signs of adverse trends in morbidity/mortality and treatment‐related SAEs. The BPROAD DSMB members are experts in antihypertensive clinical trials, diabetes, cardiology, nephrology, neurology, and biostatistics. Before each DSMB meeting, the Coordinating Center at Ruijin Hospital will prepare and provide data on SAEs and selected AEs and any other safety information requested by the DSMB for discussion during open and closed sessions. The DSMB members vote during the closed sessions on recommendations to continue or terminate the study based on safety or efficacy data.