Table 4.
Example of Point Estimates of Rates of All-Cause Mortality (ACM) Versus ACM+ Endpoints (Study Dori-09)
| Nonventilated HABP | VABP | |||
|---|---|---|---|---|
| Endpoint and Timing | Study Drug (n = 160) |
Comparator (n = 160) |
Study Drug (n = 63) |
Comparator (n = 61) |
| Day 14 | ||||
| ACM | 9.6% | 3.1% | 9.5% | 14.9% |
| ACM+ | 14.1% | 6.3% | 19.0% | 19.8% |
| Day 28 | ||||
| ACM | 13.5% | 11.0% | 20.8% | 23.2% |
| ACM+ | 19.4% | 13.5% | 30.4% | 26.5% |
Abbreviations: ACM, all-cause mortality; ACM+, mortality plus (all-cause mortality plus toxic/septic shock standardized Medical Dictionary for Regulatory Activities query adverse events; HABP, hospital-acquired bacterial pneumonia; VABP, ventilator-associated bacterial pneumonia.