TABLE 8.
RMME model evaluating the relationship between relative change in FEV1% predicted 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) | 4.97 | 2.56, 7.38 | <0.001 | Placebo | 1.16 | −2.11, 4.43 |
| Age (per yr) | −0.232 | −0.518, 0.054 | 0.108 | 70 | 2.40 | −0.509, 5.31 |
| BMI (per 5 kg/m2) | −0.595 | −4.54, 3.35 | 0.764 | 140 | 3.64 | 1.01, 6.28 |
| Baseline FEV1% predicted | −0.219 | −0.343, −0.094 | <0.001 | 280 | 6.13 | 3.68, 8.58 |
| Study day | —c | —c | 0.0432 | 560 | 11.1 | 7.54, 14.7 |
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 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 56 days, yielding 4 effect estimates relative to day 7.