Table 3. Pulmonary Exacerbation Rate Using the Modified Fuchs Definition by Chronic Inhaled Antibiotic Use (ITT Population).
| Population | Ataluren Rate | Placebo Rate | Rate Ratio |
|---|---|---|---|
| Overall | N=116 | N=116 | |
| Ratea (95% CI) | 1.42 (1.06, 1.95) | 1.78 (1.28, 2.68) | 0.77 (0.57, 1.05) |
| Nominal p-value | -- | -- | 0.0992 |
| Inhaled antibiotics = no | N=52 | N=53 | -- |
| Ratea (95% CI) | 1.30 (0.76, 1.85) | 2.15 (1.51, 278) | 0.57 (0.37, 0.89) |
| Nominal p-value | -- | -- | 0.0134 |
| Inhaled antibiotics = yes | N=64 | N=63 | -- |
| Ratea (95% CI) | 1.52 (1.01, 2.02) | 1.46 (0.97, 1.96) | 1.01 (0.67, 1.54) |
| Nominal p-value | -- | -- | 0.952 |
| Inhaled tobramycin = no | N=72 | N=74 | |
| Ratea (95% CI) | 1.42 (0.92,1.93) | 2.18 (1.62,2.74) | 0.60 (0.42, 0.86) |
| Nominal p-value | 0.006 | ||
| Inhaled tobramycin = yes | N=44 | N=42 | |
| Ratea (95% CI) | 1.42 (0.89,1.95) | 1.06 (0.67,1.45) | 1.33 (0.79,2,25) |
| Nominal p-value | 0.297 |
a
Rates are from observed data over 48 weeks and rate ratio was estimated using a generalized linear model.
Abbreviations: CI = confidence interval, ITT = intent-to-treat