Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure

Number of patients with adverse events (AEs) is reported.

Number of patients with unexpected adverse events is reported.

Number of patients with unexpected adverse drug reaction in JARDIANCE® treated patients is reported.

Number of patients with serious adverse events is reported.

Number of patients with serious adverse drug reaction in JARDIANCE® treated patients is reported.

Number of patients with drug-related adverse events in JARDIANCE® treated patients is reported.

Number of patients with non-serious adverse drug reaction in JARDIANCE® treated patients is reported.

Number of patients with adverse event of special interest is reported.

Number of patients with adverse events leading to discontinuation is reported.

Occurrence of hospitalisation for heart failure (first and recurrent) after 12 weeks and 24 weeks of treatment from baseline was reported.

Occurrence of cardiovascular death after 12 weeks and 24 weeks of treatment was reported.

Changes from baseline in New York Heart Association (NYHA) functional class after 12 weeks of treatment was reported.

The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort. Participants who remain in the same class as at baseline through week 12 will also be presented.

Changes from baseline in New York Heart Association (NYHA) functional class after 24 weeks of treatment was reported.

The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort. Participants who remain in the same class as at baseline through week 24 will also be presented.

Changes in Ejection Fraction (EF) at 12 weeks and 24 weeks compared to baseline was reported.

Changes in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) at 12 weeks and 24 weeks compared to baseline was reported. The results are presented after natural log transformation.

Changes in Glycosylated Hemoglobin (HbA1c) after 12 weeks and 24 weeks of treatment was reported.

Change from baseline in Estimated Glomerular Filtration Rate (eGFR) after 12 weeks and 24 weeks of treatment was reported.

Change from baseline in Body weight after 12 weeks and 24 weeks of treatment was reported.

Change from baseline in Systolic Blood Pressure (SBP) after 12 weeks and 24 weeks of treatment was reported.

Change from baseline in Diastolic Blood Pressure (DBP) after 12 weeks and 24 weeks of treatment was reported.

The result of investigator's overall evaluation at the final visit was reported. The final visit represents each patient's last assessment among Week 12 or Week 24.

For the final effectiveness evaluation, the three items (Improved, Unchanged, Worsening) are evaluated by the changes from baseline of the NYHA Class at the end of last visit.

• Improved: If determined as there is any effect of maintaining or improving disease related factors.
• Unchanged: If disease related factors have not been changed compared with before administration and not determined as there is any effect of maintaining symptoms.
• Worsening: If disease related factors are worse than before administration. 'Improved' and 'Unchanged' are assessed as "Effective" and 'Worsening' is assessed as "Ineffective".