Table 4. Risk of All-Cause Mortality With Ziritaxestat vs Placebo at the End of the ISABELA 1 and ISABELA 2 Trials.
| All-cause mortality | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 600 mg of Ziritaxestat (n = 428) | 200 mg of Ziritaxestat (n = 431) | Placebo (n = 422) | 600 mg of Ziritaxestat vs placebo | 200 mg of Ziritaxestat vs placebo | ||||||
| No. of events (%) | IR/100 patient-years of exposure | No. of events (%) | IR/100 patient-years of exposure | No. of events (%) | IR/100 patient-years of exposure | Between-group difference in IR (95% CI) |
Hazard ratio (95% CI) | Between-group difference in IR (95% CI) |
Hazard ratio (95% CI) | |
| ISABELA 1 | 14 (8.0) | 8.1 | 8 (4.6) | 4.3 | 11 (6.3) | 6.3 | 1.8 (−4.3 to 8.0) | 1.4 (0.6 to 3.1) | −1.9 (−7.5 to 3.6) | 0.7 (0.3 to 1.8) |
| ISABELA 2 | 24 (9.3) | 8.9 | 22 (8.5) | 8.1 | 12 (4.7) | 4.4 | 4.5 (0 to 9.1) | 2.1 (1.1 to 4.3) | 3.7 (−0.7 to 8.1) | 1.9 (0.9 to 3.8) |
| Pooled results (ISABELA 1 and 2) | 38 (8.9) | 8.6 | 30 (7.0) | 6.6 | 23 (5.5) | 5.1 | 3.5 (−0.1 to 7.1) | 1.8 (1.1 to 3.0) | 1.5 (−1.9 to 4.8) | 1.3 (0.8 to 2.3) |
Abbreviation: IR, incidence rate.