Table 2. Serious Adverse Events.
| Characteristic | No. (%) | RR (95% CI) | P Value | |
|---|---|---|---|---|
| Placebo (n = 14) | Ad5.hAC6 (n = 42) | |||
| ≥1 SAEa | 5 (36) | 18 (43) | 1.20 (0.59-3.75) | .76b |
| HF admissions | 4 (28.6) | 4 (9.5) | 0.33 (0.08-1.36) | .10c |
| Death | 1 (7) | 1 (2) | 0.33 (0.01-11.10) | .40b |
Abbreviations: Ad5.hAC6, adenovirus 5 encoding adenylyl cyclase 6; HF, heart failure; RR, relative risk; SAE, serious adverse event.
a
A minority of SAEs were procedure or vector related: 1 (2%) each: groin hematoma, fever, cerebrovascular accident; and 3 (5%) troponin I level elevations at initial catheterization: placebo, 1 (7%); and Ad5.hAC6, 2 (5%).
b
Analysis conducted using Fisher exact test, as described in Methods section.
c
Analysis conducted using Z-test for Poisson rates, as described in Methods section.