Table 4.
Safety Outcomes in the Final Analysis Population Assigned to Treatment
| Treatment Group (n = 94) |
Control Group (n = 99) |
Difference or RR (95% CrI) | |
|---|---|---|---|
| Safety outcomes | |||
| Acute kidney injury | 65 (69.1) | 69 (69.7) | RR, 0.82 (0.39–1.70) |
| Class 1 | 17 (18.1) | 20 (20.2) | |
| Class 2 | 11 (11.7) | 22 (22.2) | |
| Class 3 | 37 (39.3) | 27 (27.2) | |
| RRT | 33 (35.1) | 22 (22.2) | RR, 1.65 (0.78–3.56) |
| Hemodynamic instability during weaning | 0 (0) | ||
| MetHb > 5% | |||
| Events/treatment days overall | 8/1,282 | ||
| Events/treatment days at 80 ppm | 7/292 | ||
| Events requiring dose reduction | 5 | ||
| MetHb highest daily level, % | |||
| Overall | 1.4 (0.7–1.5) | ||
| At 80 ppm | 2.2 (1.5–3.0) | ||
| NO2 > 3 ppm | |||
| Events/treatment days overall | 1/1,282 | ||
| Events/treatment days at 80 ppm | 1/292 | ||
| Events requiring dose reduction | 1 | ||
| NO2 highest daily level, ppm | |||
| Overall | 0.8 (0.0–1.0) | ||
| At 80 ppm | 1.0 (1.0–1.8) | ||
Definition of abbreviations: CrI = credible interval; MtHb = methemoglobin; RR = risk ratio; RRT = renal replacement therapy.
Data are presented as median (interquartile range), n, or n (%).