Exposure-adjusted incidence of treatment-emergent CV AEs in the ASPIRE and ENDEAVOR trials
| . | ASPIRE . | ENDEAVOR . | ||||||
|---|---|---|---|---|---|---|---|---|
| KRd . | Rd . | Kd . | Vd . | |||||
| Total person time (100 subject years)* . | Exposure adjusted risk estimate (95% CI) . | Total person time (100 subject years)* . | Exposure adjusted risk estimate (95% CI) . | Total person time (100 subject years)* . | Exposure adjusted risk estimate (95% CI) . | Total person time (100 subject years)* . | Exposure adjusted risk estimate (95% CI) . | |
| Cardiac failure | 6.3 | 3.94 (2.66-5.83) | 5.1 | 3.14 (1.92-5.12) | 3.4 | 11.23 (8.17-15.44) | 2.5 | 5.17 (3.00-8.90) |
| Hypertension | 5.7 | 10.62 (8.26-13.65) | 5.0 | 6.05 (4.23-8.66) | 2.9 | 41.97 (35.09-50.19) | 2.3 | 19.04 (14.17-25.59) |
| Dyspnea | 5.6 | 15.82 (12.84-19.50) | 4.5 | 15.66 (12.39-19.79) | 2.6 | 54.37 (46.15-64.05) | 2.2 | 36.02 (28.85-44.97) |
| Ischemic heart disease | 6.3 | 3.63 (2.41-5.46) | 5.1 | 3.53 (2.22-5.60) | 3.4 | 3.79 (2.20-6.53) | 2.5 | 3.59 (1.87-6.90) |
| . | ASPIRE . | ENDEAVOR . | ||||||
|---|---|---|---|---|---|---|---|---|
| KRd . | Rd . | Kd . | Vd . | |||||
| Total person time (100 subject years)* . | Exposure adjusted risk estimate (95% CI) . | Total person time (100 subject years)* . | Exposure adjusted risk estimate (95% CI) . | Total person time (100 subject years)* . | Exposure adjusted risk estimate (95% CI) . | Total person time (100 subject years)* . | Exposure adjusted risk estimate (95% CI) . | |
| Cardiac failure | 6.3 | 3.94 (2.66-5.83) | 5.1 | 3.14 (1.92-5.12) | 3.4 | 11.23 (8.17-15.44) | 2.5 | 5.17 (3.00-8.90) |
| Hypertension | 5.7 | 10.62 (8.26-13.65) | 5.0 | 6.05 (4.23-8.66) | 2.9 | 41.97 (35.09-50.19) | 2.3 | 19.04 (14.17-25.59) |
| Dyspnea | 5.6 | 15.82 (12.84-19.50) | 4.5 | 15.66 (12.39-19.79) | 2.6 | 54.37 (46.15-64.05) | 2.2 | 36.02 (28.85-44.97) |
| Ischemic heart disease | 6.3 | 3.63 (2.41-5.46) | 5.1 | 3.53 (2.22-5.60) | 3.4 | 3.79 (2.20-6.53) | 2.5 | 3.59 (1.87-6.90) |
Cardiac failure and hypertension events are listed as standardized MedDRA query, narrow scope, and ischemic heart disease is listed as standardized MedDRA query, broad scope. Dyspnea is a high-level term.
Total person time is the sum of the time to first treatment-emergent AE for all patients in each treatment group.