Published subgroup results for time to first exacerbation, ciprofloxacin DPI 14-day on/off versus pooled placebo, in the replicate Phase III RESPIRE 1 and RESPIRE 2 trials in non-CF bronchiectasis.
Usage
data(respire_age)Format
A data frame with 4 rows and 10 variables:
- study
RESPIRE 1orRESPIRE 2.- subgroup
Age stratum (
<65,>=65).- n
Subgroup sample size.
- hr
Published hazard ratio.
- ci_lower,ci_upper
Published HR confidence limits.
- ci_level
Confidence level of those limits (
0.975or0.951).- yi
\(\log(\mathrm{HR})\).
- sei
Standard error of
yifrom the published CI.- vi
sei^2.
Source
Subgroup estimates were extracted from FDA review / briefing materials for the ciprofloxacin dry-powder inhalation (DPI) RESPIRE program (14-day on/off regimen versus pooled placebo). Interval levels match the primary-endpoint multiplicity adjustments in the publications:
De Soyza A, Aksamit T, Bandel T-J, et al. (2018). RESPIRE 1: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J, 51(1), 1702052. https://doi.org/10.1183/13993003.02052-2017
Aksamit T, De Soyza A, Bandel T-J, et al. (2018). RESPIRE 2: a phase III placebo-controlled randomised trial of ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis. Eur Respir J, 51(1), 1702053. https://doi.org/10.1183/13993003.02053-2017
Details
Columns hr, ci_lower, ci_upper, and ci_level are the original
published values. yi, sei, and vi are derived by log_hr_from_ci();
RESPIRE 1 uses 97.5% intervals and RESPIRE 2 uses 95.1% intervals.
See vignette("worked-examples").