Heart Failure Outcomes Captured by Adverse Event Reporting in Participants with Type 2 Diabetes and Atherosclerotic Cardiovascular Disease: Observations from the VERTIS CV Trial

Figures

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  Figure 1. Incidence of first and total adverse events (AEs) and serious AEs (SAEs) of heart failure (HF), and first and total adjudication‐confirmed hospitalizations for HF (HHF), in VERTIS CV. aHF AEs and SAEs were captured through AE reporting in VERTIS CV, based on the narrow standardized Medical Dictionary for Regulatory Activities (MedDRA) query ‘cardiac failure’. Terms with one or more AE identified included ‘acute pulmonary oedema’; ‘cardiac failure’; ‘cardiac failure, acute’; ‘cardiac failure, chronic’; ‘cardiac failure, congestive’; ‘cardiogenic shock’; ‘cardiopulmonary failure’; ‘left ventricular failure’; ‘pulmonary oedema’; and ‘right ventricular failure’. SAEs were reported as serious by the investigator. HHF were adjudication‐confirmed events from the primary analyses. 5 , 6

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  Figure 2. Treatment effect of ertugliflozin (ERTU) versus placebo (PBO) on time to (A) first adverse event of heart failurea and (B) first serous adverse event of heart failurea,b in VERTIS CV. aBased on the narrow standardized Medical Dictionary for Regulatory Activities (MedDRA) query ‘cardiac failure’. Terms with one or more adverse event identified included ‘acute pulmonary oedema’; ‘cardiac failure’; ‘cardiac failure, acute’; ‘cardiac failure, chronic’; ‘cardiac failure, congestive’; ‘cardiogenic shock’; ‘cardiopulmonary failure’; ‘left ventricular failure’; ‘pulmonary oedema’; and ‘right ventricular failure’. bReported as serious by the investigator. CI, confidence interval; HR, hazard ratio.

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  Figure 3. Treatment effect of ertugliflozin (ERTU) versus placebo (PBO) on first and total heart failure (HF) adverse events (AEs) and serious AEs (SAEs), first peripheral oedema AEs, and first orthopnoea/dyspnoea AEs in VERTIS CV. aBased on the narrow standardized Medical Dictionary for Regulatory Activities (MedDRA) query ‘cardiac failure’. Terms with one or more AE identified included ‘acute pulmonary oedema’; ‘cardiac failure’; ‘cardiac failure, acute’; ‘cardiac failure, chronic’; ‘cardiac failure, congestive’; ‘cardiogenic shock’; ‘cardiopulmonary failure’; ‘left ventricular failure’; ‘pulmonary oedema’; and ‘right ventricular failure’. bReported as serious by the investigator. cIdentified using the MedDRA preferred terms: ‘peripheral oedema’; ‘oedema’; and ‘peripheral swelling’. dIdentified using the MedDRA preferred terms: ‘orthopnoea’ and ‘dyspnoea’. CI, confidence interval; HR, hazard ratio; pt‐yrs, participant‐years.

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  Figure 4. Treatment effect of ertugliflozin (ERTU) versus placebo (PBO) on time to (A) first adverse event of peripheral oedema and (B) first adverse event of orthopnoea/dyspnoea in VERTIS CV. aIdentified using the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms: ‘peripheral oedema’; ‘oedema’; and ‘peripheral swelling’. bIdentified using the MedDRA preferred terms: ‘orthopnoea’ and ‘dyspnoea’. CI, confidence interval; HR, hazard ratio.