TABLE 9.
RMME model evaluating the relationship between absolute change in log10 CFU of P. aeruginosa from baseline and dose
| Variable | RMME model |
RMME model effect by dose |
||||
|---|---|---|---|---|---|---|
| Model-estimated effect | 95% CIa | P value | Dose (mg) | Model-estimated effect on day 7 for the avg patientb | 95% CI | |
| Dose (per 280 mg) | −0.615 | −1.01, −0.224 | 0.002 | Placebo | 0.174 | −0.369, 0.717 |
| Age (per yr) | −0.016 | −0.060, 0.029 | 0.497 | 70 | 0.020 | −0.464, 0.504 |
| BMI (per 5 kg/m2) | 0.300 | −0.325, 0.924 | 0.340 | 140 | −0.133 | −0.572, 0.305 |
| Baseline FEV1% predicted | −0.009 | −0.029, 0.011 | 0.362 | 280 | −0.441 | −0.846, −0.036 |
| Study day | —c | —c | 0.032 | 560 | −1.06 | −1.63, −0.479 |
a
CI, confidence interval.
b
The model-estimated effect for the average patient for each dose was calculated using age and BMI equal to the mean for all patients (i.e., a 22-year-old patient with a BMI of 20 kg/m2 and a baseline FEV1% predicted of 66%).
c
—, study day was evaluated as a categorical variable with values of 7, 14, 21, 28, and 35 days, yielding 4 effect estimates relative to day 7.