Table 2.
Mortality rates from clinical trials and European Safety and Exposure Survey (ESES)
Clinical trials | ESES | |
---|---|---|
Patients (n) | 3031 | 8608 |
Deaths (n) | 29 | 35 |
All-cause mortality/100 PYE (CI)* | 1.52 (0.96–2.13) | 0.92 (0.64–1.35) |
Cardiac mortality/100 PYE (CI)* | 0.31 (0.11–0.688) | 0.35 (0.17–0.65) |
CI = 95% Confidence Intervals.