Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

Overview of the Two Co-primary Outcomes

First co-primary outcome was defined as the first event among stroke, systemic arterial embolism, Myocardial Infarctions \[MI\], or cardiovascular death. Second co-primary outcome was defined as the first event among unscheduled cardiovascular hospitalization or death from any cause. Both co-primary outcomes were determined based on the central review and adjudication by a blinded Adjudication Committee of all reported deaths (from any cause), MI, systemic arterial embolisms, strokes, Transient Ischemic Attacks \[TIA\], Heart Failure hospitalization and unplanned hospitalisations for cardiovascular cause.

Time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Time to First Co-primary Outcome (Cumulative Incidence Function)

Time to first co-primary outcome was defined as the time from randomization to the first event among stroke, systemic arterial embolism, MI or cardiovascular death. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation.

Time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)

Time to Second Co-primary Outcome (Cumulative Incidence Function)

Time to second co-primary outcome was defined as the time from randomization to the first event among unscheduled cardiovascular hospitalization or death from any cause. Cumulative incidence function in each treatment group was calculated using non-parametric Kaplan-Meier estimate. 95% confidence interval was computed at each time-point using Greenwood's variance estimation.

Time frame: From randomization up to the CSED which occurred at study termination (maximum follow-up of 1 year)