Only applies if Type of Units Analyzed is specified. Of Units Analyzed, in each arm/group and the entire study population (total).ĭefinition: Indicate whether the baseline measure analysis is based on participants or units other than participants. Number of Baseline Participants, in each arm/group and the entire study population (total).ĭefinition: The number of units analyzed for the baseline measure, if different from the Overall Number
Study-Specific Baseline Measure Title(s) ĭefinition: If "Study-Specific Measure" is chosen, provide the name of the measure.ĭefinition: Additional descriptive information about the baseline measure, such as a description of the metric used to characterize the specific baseline measure.ĭefinition: The type of data for the baseline measure. Required baseline measures include Age, Sex/Gender, Race, Ethnicity (if collected under the protocol), and any other measure(s) that were assessed at baseline and used in the analysis of the primary outcome measure(s). Participants (or units) assigned to the arm or comparison group and in the entire study population (total),Ī brief description of the reason(s) for the difference such as how the analysis population was determined.ĭefinition: A description of each baseline or demographic characteristic measured in the clinical study.
Overall Number of Baseline Participants *ĭefinition: Number of all participants for whom baseline characteristics were measured, in each arm/groupĪnd in the entire study population (total).ĭefinition: If the analysis is based on a unit other than participants, the number of all units for whichīaseline measures were measured and analyzed, in each arm/group and in the entire study population (total).ĭefinition: If the analysis is based on a unit other than participants, a description of the unit of analysis (for example, eyes, lesions, implants).īaseline Analysis Population Description ĭefinition: If the Overall Number of Baseline Participants (or units) differs from the number of