Data Sets Analyzed Sample Clauses

Data Sets Analyzed. The intent to treat (ITT) population, defined as all subjects randomized at Visit 1 (Day 0), will be used for all subject disposition, secondary, exploratory, and safety summaries. The per-protocol analysis (PPA) population, defined as all subjects who meet criteria as specified in the SAP, will be used for the primary analyses in both Study A and Study B, with sensitivity analyses repeated on the ITT population. Select secondary analyses will also be run on the PPA population. Demographic and Baseline Characteristics Treatment arms within Study A and Study B will be descriptively summarized with respect to baseline demographic and clinical characteristics including sex at birth, CFTR genotype, race, height, weight, and all randomization strata.
Sample 1Sample 2
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Data Sets Analyzed. All analyses will be performed using a modified intent-to-treat (m-ITT) population, which is defined as all randomized subjects who took at least one dose of the study drug. Subjects who are discontinued from study drug temporarily or permanently are encouraged to complete all remaining study visits and will remain in the analysis population according to ITT. Subjects will be analyzed according to the treatment arm to which they were randomized. The safety population will be used to summarize all safety measures and is identical to the m-ITT population. The primary efficacy analysis and key secondary analyses will be repeated in the per-protocol population, which is defined as subjects having completed >70% of study drug doses based on subject diary and having incurred no major protocol violations. The per-protocol analyses will analyze subjects according to the treatment they received.
Sample 1
Data Sets Analyzed. All eligible subjects who provide informed consent will be included in the analyses. The core and sub-studies will be linked so that associations between primary and secondary endpoints from each sub-study and clinical parameters (e.g., spirometry, weight, or sweat chloride, etc.) collected as part of the CORE Study may be explored in the future. Parts A and B will be analyzed separately; however, visits that were performed as Part A in subjects who went onto Part B may be treated as baseline visits for Part B. No imputation will be made for missing data. As a sensitivity analysis, select missing data methods will be employed to assess the impact of missing data on the primary endpoint. For both the CORE STUDIES and each SUB-STUDY, all formal hypothesis testing will be performed at the two-sided alpha 0.05 level. All protocol violations will be included as a listing.
Sample 1
Data Sets Analyzed. ‌ Intent-to-Treat Population: All subjects who are randomized and has study drug infusion started will comprise the intent-to-treat (ITT) population. The ITT population will be analyzed for the primary and secondary endpoint analyses and will comprise the safety population used for all safety analyses.
Sample 1

Related to Data Sets Analyzed

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