Time to first serious exacerbation — summary statistical and Cox regression analysis
| QMF149 (n=749) | MF (n=759) | |
|---|---|---|
| Patients with serious asthma exacerbation | 2 (0.3%) | 6 (0.8%) |
| Difference in cumulative incidences % (95% CI) | −0.52 (−1.25 to 0.21) | p=0.160 |
| Follow-up time, median months (range) | 13.3 (0–19.6) | 13.4 (0–20.3) |
| Event-free rates % (95% CI) | ||
| 6 months | 99.7 (98.8 to 99.9) | 99.7 (98.9 to 99.9) |
| 12 months | 99.7 (98.8 to 99.9) | 99.3 (98.2 to 99.7) |
| 18 months | 99.7 (98.8 to 99.9) | 99.0 (97.6 to 99.5) |
| 21 months | – | – |
| Cox regression analysis | ||
| HR QMF149/MF (95% CI) | 0.31 (0.06 to 1.54) | p=0.151 |
Data are n (%) unless otherwise specified. Patients who did not experience a serious asthma exacerbation were censored at their last follow-up date. Follow-up time=time from randomisation until the first serious asthma exacerbation or censoring. Event-free time rates were calculated by the Kaplan Meier method. The Cox regression model included the terms for treatment and region, stratified by history of asthma related hospitalisation in the past 12 months (yes/no), history of asthma worsening in the past 12 months (yes/no) and African-American patient (yes/no). A HR <1 favours QMF149.
CI, confidence interval; MF, mometasone furoate; MR, mometasone.