Secondary Efficacy Measures Sample Clauses

Secondary Efficacy Measures. COPD Exacerbation Rate Six exacerbation-related measures (see Section 6.3.3.2 for details), providing information on differing dimensions of this event and its impact, will be analysed in this trial. One of these, the rate of moderate and severe exacerbations, has been selected as a secondary measure, with other measures considered as supporting. This measure can be interpreted as a measure of the overall exacerbation burden experienced by patients during the period on treatment. As such, it is regarded as most clinically relevant. Other exacerbation measures are considered clinically important but provide a more limited view of the data. The rate of moderate and severe exacerbations will be analysed using a Negative Binomial model, adjusting for region of recruitment, age, sex, baseline smoking status, BMI, number of exacerbations in the 12 months prior to Screening and baseline disease severity and will also include a term for duration on treatment (to censorship or end of study as appropriate). For this analysis, data will not be imputed beyond end of study drug treatment. Only linguistically valid translations, completed in the same language throughout the study (i.e. same as that completed at Baseline (Visit 2)), will be included in the analyses of SGRQ. A transformed score will be calculated for each of the three domains (symptoms, impacts and activity) of the SGRQ and the overall total score, in accordance with the developer’s scoring guidelines. Descriptive statistics will be reported for the domains and total scores for baseline, and for all subsequent visits and at withdrawal. Change from baseline scores will be calculated by subtracting the baseline score from the score at the particular visit. Treatment comparisons for change from baseline will be analysed using repeated measures ANCOVA with smoking status, age, sex, baseline disease severity, baseline SGRQ Total score, BMI, region and visit as covariates. These comparisons will be carried out for the total score and for each of the three domains. A logistic proportional odds analysis of change in health status (improvement, no change, and deterioration based on a clinically meaningful change of 4 units), adjusting for smoking status, age, sex, baseline disease severity, baseline SGRQ Total Score, and BMI, will also be carried out as a supportive analysis. This will provide a means to assess the qualitative effect of treatment. The odds of having an improvement in health status for one treatmen...