Analysis Sets Sample Clauses
The 'Analysis Sets' clause defines the specific groups of data or subjects that will be included in various analyses within a study or project. Typically, this clause outlines criteria for inclusion in different sets, such as intent-to-treat, per-protocol, or safety populations, and may specify how subjects are assigned to each set based on their participation or data completeness. By clearly delineating which data are analyzed in each context, the clause ensures consistency, transparency, and reproducibility in the interpretation of study results.
Analysis Sets. Five analysis sets will be defined:
a) All Enrolled – all subjects signing the informed consent form
b) Enrolled Dispensed – subjects/eyes from All Enrolled that have been exposed to study lenses
c) Enrolled Not Dispensed – subjects/eyes from All Enrolled that have not been exposed to study lenses
d) Completed – Enrolled Dispensed subjects/eyes completing the study e) Discontinued – Enrolled Dispensed subjects/eyes not completing the study
Analysis Sets. All analysis sets will be defined prior to final database closure. In addition to the analysis sets listed below, further exploratory analyses may be performed using other subgroups of patients.
Analysis Sets. Five analysis sets will be defined:
a) All Enrolled – all subjects signing the informed consent form
b) Enrolled Dispensed – subjects/eyes from All Enrolled that have been exposed to study lenses (not considering trial-fit lenses prior to randomization)
c) Enrolled Not Dispensed – subjects/eyes from All Enrolled that have not been exposed to study lenses (not considering trial-fit lenses prior to randomization)
d) Completed – Enrolled Dispensed subjects/eyes completing the study e) Discontinued – Enrolled Dispensed subjects/eyes not complete the study
Analysis Sets. 2.1 Definition of analysis sets
2.1.1 Intention to treat (ITT)
Analysis Sets. Only 1 analysis set will be defined, namely the safety analysis set. It will include all eyes exposed to any study lenses evaluated in this study. Eyes will be analyzed based upon the lens exposed at the time of the clinical assessment.
Analysis Sets. The analysis populations are as follows: • The primary analysis population is the modified intent-to-treat (mITT) population, which will include all randomized subjects who received at least 1 dose of study drug and have baseline and at least 1 post-baseline virology measurement. The primary analysis will also be performed on the per-protocol population of patients who completed treatment without a major protocol deviation. • The PK population will include subjects who receive at least 1 dose of the study drug and have sufficient concentration data to support accurate estimation of at least 1 PK parameter. • The safety population will include all subjects who receive at least 1 dose of study drug. • A per protocol population will include the subset of the modified intent-to-treat population who completed study drug treatment without a major protocol violation.
Analysis Sets. There will be one analysis population, the Safety set, which includes all patients who are enrolled in the study and receive at least 1 dose of eteplirsen.
Analysis Sets. The set of randomized patients will include all patients randomly assigned to a treatment at enrollment, regardless of whether or not a patient took any study drug. The safety analysis set will include all patients who took at least 1 dose of study drug. The full analysis set will include all patients in the safety analysis set.
Analysis Sets. The analysis populations are as follows: • The PK population will include subjects who receive at least 1 dose of aramchol and have sufficient concentration data to support accurate estimation of at least 1 PK parameter. In Part 1, subjects who experience vomiting within 6 hours after study drug dosing will be excluded from the PK analysis. • The safety population will include all subjects who receive at least 1 dose of aramchol.
Analysis Sets. Analysis datasets used for safety and effectiveness analyses of this study are defined as follows. The treatment-emergent safety analysis set will include all eyes with attempted implantation with the test article (successful or aborted after contact with the eye). All-Implanted Analysis Set (AAS) will include all eyes with successful test article implantation. Best-Case Analysis Set (BAS) will include all eyes with successful test article implantation that had ・ at least 1 postoperative visit; ・ no macular degeneration at any time; and ・ no major protocol violation