Adverse events monitoring and interim analysis
DIABETIC KETOACIDOSIS, ADVERSE EVENT, EVENTS, HYPOGLYCAEMIA
Adverse events will be constantly monitored by investigators during the process of the study through regular medical check-ups, and the details will be immediately reported to the principal investigator once an AE occurs, regardless of the causal relationship with dapagliflozin. Only serious AEs and AEs of interest or those leading to premature study drug discontinuation, study drug interruption, or dose reduction are recorded. Adverse events of interest include volume depletion, renal events, major hypoglycaemia, and potential diabetic ketoacidosis.The collection of cardiovascular events and other serious AEs will be performed by two well-trained staff members, and they will follow up specifically for these events by telephone every month for every participant with a phone number who has given prior consent during enrolment. In addition, participants will also be taught and asked to report whether they have experienced any cardiovascular events or other serious AEs. All captive cardiovascular events and other serious AEs will be adjudicated and graded by two well-trained staff members in order to reach a consensus.Once 75% of the primary events are confirmed, an interim analysis will be performed by using a Haybittle–Peto rule, and if the superiority of dapagliflozin over placebo is demonstrated for the primary outcome with a sided level of 0.001, early termination of the trial can be recommended. The significance level of the final analysis will be determined by the Haybittle–Peto rule, depending on the actual number of events and the timing of the interim analysis.