Demographics Distribution
This report displays the Demographic characteristics for a clinical study. It accomplishes this using both a graphical histogram display (Demographic Details) and a tabular display (Demographic Tables). Optionally, but not by default, it can display statistical comparisons as well.
Report Results Description
Running this report with the Nicardipine sample setting using the default options generates the output shown below.
The Demographics Distribution report initially shows two sections Distribution Details and Demographic Tables. Use the available options in each section to drill-down into the data.
Distribution Details
Presents histograms for available demographic characteristics such as age, treatment, sex, race, ethnicity. Histograms of the, Study Site Identifier and Country are also presented. Should more than one Country be presented in the DM domain, a world map is presented with color indicating the count of subjects from each Country. See JMP Documentation on Distribution for more information.
The Distribution Details section contains the following elements:
| • | One or more Histograms. |
The height (or length) of each bar is an indication of the number of subjects exhibiting each demographic characteristic. Numbers above (or to the right of) each bar reflect a count of the number of subjects. Counts or percents can be added or removed using Histogram Options, which can be viewed by selecting the red triangle (
).
Quantiles and summary statistics are provided for continuous variables like Age, and frequencies are provided for categorical variables like Sex. These can be viewed by clicking the triangles (
).
See Distribution for more information.
| • | Possibly one Global Map. (See Geographical Map.) |
In lieu of a histogram, should Country have more than one level, a map summarizes the geographic location of individuals. Color is reflective of the number of subjects from each Country.
See maps for more information.
Demographic Tables
The Demographic Tables section contains the following elements:
| • | Tables detailing the subject population by Treatment, Age, Age Group, Sex, Race, and Study Site. |
Counts and percentages are provided for each level in each table.
Action Buttons
Action buttons, provide you with an easy way to drill down into your data. The following action buttons are generated by this report:
| • | Convert Character Date: Click  to open the data tables associated with this report. |
| • | Create Static Report: Click  to create a PDF, RTF, or PowerPoint-formatted report containing the plots and charts of selected tabs. |
| • | View Notes |
| • | View Notes: Click  to read user-generated notes. |
| • | Review Subject Filter: Click  to open the Review Subject Filter to explore selected subjects in the study. |
| • |
| • | Profile Subjects: Select subjects and click  to generate the patient profiles. See Profile Subjects for additional information. |
| • | Show Subjects: Select subjects and click  to open the ADSL (or DM if ADSL is unavailable) of selected subjects. |
| • | Demographic Counts: Select subjects and click  to create a data set of USUBJIDs, which subsets all subsequently run report to those selected subjects. The currently available filter data set can be applied by selecting Apply Subject Filter in any report dialog. |
General
| • | Click  to view the associated data tables. Refer to View Data for more information. |
| • | Click  to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected sections. |
| • | Click  to take notes, and store them in a central location. Refer to Add Notes for more information. |
| • | Click  to read user-generated notes. Refer to View Notes for more information. |
| • | Click to open and view the Subject Explorer/Review Subject Filter. |
| • | Click  to specify Derived Population Flags that enable you to divided the subject population into two distinct groups based on whether they meet very specific criteria. |
| • | Click the arrow to reopen the completed report dialog used to generate this output. |
| • | Click the gray border to the left of the Options tab to open a dynamic report navigator that lists all of the reports in the review. Refer to Report Navigator for more information. |
Report Options
Treatment or Comparison Variable:
When specifying a treatment or comparison variable, a distribution of the selected variable is shown in the output and the demographic tables are categorized by the values of the variable.
Available variables include Planned, which is selected when the treatments patients received exactly match what was planned and Actual, which is selected when treatment deviates from what was planned. You can also specify any demographic variable from DM and/or ADSL as a surrogate for the treatment variables. Finally you can select None to plot the data without segregating it by a treatment variable.
See Treatment or Comparison Variable to Use, Treatment or Comparison Variable for more information.
Filtering the Data:
Filters enable you to restrict the analysis to a specific subset of subjects or to select specific populations of patients (those who complete the study, for example).
You can also subdivide the subjects and run separate analyses for distinct groups by specifying one or more BY variables. For example, selecting SEX as a BY variable groups subjects by gender and conducts separate gender-specific analyses, as shown below:
See Select the analysis population, Select saved subject filter1, Additional Filter to Include Subjects, Subset of Visits to Analyze for Findings, and By Variables for more information.
Results
Statistical Output:
When the Perform treatment comparison analysis for demographic variables option is checked, this report performs aone-way ANOVA (analysis of variance) to detect statistical differences using the Treatment or Comparison Variable specified for continuous demographic variables (e.g. Age) and contingency analyses for character/categorical variables (e.g. sex, race). If the Treatment or Comparison Variable is set to None, this option is ignored.
See Perform treatment comparison analysis for demographic variables for more information.
Use the Create additional distributions for selected variables to select additional variables for which to show distribution details. When variables are selected that are not already shown by default, a new Distribution section called Additional Distributions is generated in the output for these customized distributions.
Groupings:
Setting age groups allows you to select custom ranges for grouping subjects by age in the Age Group Demographic Tables; otherwise the default grouping of 0-39, 40-64, and 65 and above is used, as shown below.
Note: You must specify non-overlapping exclusive age groups.
Note: Any subjects not falling within the specified age groups are still included in the analysis but are classified as Missing in the demographic tables.
See Set Age Groups and Group 1 for more information.
As shown below, for the Nicardipine example, there are no significant demographic differences between the treatment arms.
You can also subdivide the subjects and run analyses for distinct groups by specifying one or more By Variables.