EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)

Occurrence of Adjudicated Hospitalisation for Heart Failure (HHF) (First and Recurrent)

Reported is the total number of adjudicated HHF events (first and recurrent) which occurred.

Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.

eGFR (CKD-EPI) cr Slope of Change From Baseline

Glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR(CKD-EPI)cr) slope of change from baseline. Available on-treatment change-from-baseline data were used. The slope represents the long term effect of eGFR change from baseline and provides the yearly rate of decline. Timepoints after baseline were included in calculation of slope of change from baseline. The slope per patient was calculated using a random coefficient model with terms for treatment, region, baseline status of diabetes, age, sex, left ventricular ejection fraction (LVEF) and glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula (eGFR (CKD-EPI)cr) at baseline and in addition the factors "time", "treatment-by-time interaction", and "baseline eGFR (CKD-EPI)cr-by-time interaction".

Time frame: At baseline, week 4, 12, 32, 52, 76, 100, 124, 148, 172 and week 196, up to 1043 days.

Time to the First Event in the Composite Renal Endpoint: Chronic Dialysis, Renal Transplant, or Sustained Reduction in eGFR (CKD-EPI)cr

Chronic dialysis was defined as dialysis with a frequency of twice per week or more for at least 90 days. Sustained was determined by two or more consecutive post-baseline central laboratory measurement separated by at least 30 days. Reduction in glomerular filtration rate estimated by the chronic kidney disease epidemiology collaboration formula with serum creatinine measurement (eGFR (CKD-EPI)cr) was defined as reduction in eGFR from baseline ≥40%, eGFR \<15 mL/min/1.73 m\^2 for patients with baseline eGFR ≥30 mL/min/1.73 m\^2, or eGFR \<10 mL/min/1.73 m\^2 for patients with baseline eGFR \<30 mL/min/1.73 m\^2. The incidence rate per 100 patient years (100 \* number of patients with event / time at risk \[years\]) is reported. Time at risk \[year\] is calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25. Abbreviation: Patient-years (pt-yrs).

Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.

Time to First Adjudicated Hospitalisation for Heart Failure (HHF)

Time to first adjudicated HHF. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = Sum of time at risk \[days\] over all patients in a treatment group / 365.25. 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.

Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.

Time to Adjudicated Cardiovascular (CV) Death

Time to adjudicated CV death. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = Sum of time at risk \[days\] over all patients in a treatment group / 365.25. 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.

Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.

Time to All-cause Mortality

Time to all-cause mortality. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = Sum of time at risk \[days\] over all patients in a treatment group / 365.25. 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.

Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.

Time to Onset of Diabetes Mellitus (DM) in Patients With Pre-DM

Time to onset of DM (defined as HbA1c ≥6.5% or as diagnosed by the investigator) in patients with pre-DM. Pre-DM was defined as no history of DM and no HbA1c ≥6.5% before treatment, and a pre-treatment HbA1c value of ≥5.7% and \<6.5%. The incidence rate per 100 patient years (pt-yrs) is presented and calculated as followed: Incidence rate per 100 pt-yrs = 100 \* number of patients with event / time at risk \[years\]. Time at risk \[years\] = Sum of time at risk \[days\] over all patients in a treatment group / 365.25. 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.

Time frame: From randomization until completion of the planned treatment phase, to 1403 days.

Change From Baseline in Kansas City Cardiomyopathy Questionaire (KCCQ) Clinical Summary Score at Week 52

The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, self-efficacy, and quality of life in patients with Heart Failure. The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status. For patients who died, a worst score (score of 0) was imputed for the score at all subsequent scheduled visits after the date of death where the score would have been assessed. Change from baseline in KCCQ-score at week 52 was modeled using a MMRM with visit (week 12, 32 and 52) as repeated measures, adjusted mean (standard error) at week 52 is reported.

Time frame: At baseline and at week 12, week 32 and week 52.

Occurrence of All-cause Hospitalisation (First and Recurrent)

Occurrence of all-cause hospitalisation (first and recurrent). Total number of all cause hospitalisations is reported.

Time frame: From randomization until completion of the planned treatment phase, up to 1403 days.