Note : JMP Clinical uses a special protocol for data including non-unique Findings test names. Refer to How does JMP Clinical handle non-unique Findings test names? for more information.Running this report with the Nicardipine sample setting generates the report shown below.The Report contains the following elements:
• One Data Filter .Enables you to subset subjects based on country of origin, study site and/or Test. Refer to Data Filter for more information.
• The volcano plot is used to determine the deviation of the proportion of findings frequencies at each site with the overall proportions for the findings across the whole study. Each “bubble” represents a single Findings test for a specific site, which is compared to a reference (all other sites).The X axis represents the maximum difference in proportions between each value of the Findings test between the site and the reference set (all other sites).You can mouse over points of interest to see their labels or select points by dragging a mouse rectangle over them (as shown above). Selected rows are highlighted in other plots and you can also then click on various Down Buttons for further analyses on those specific sites. For example, if you click , the following opens with comparisons of sites 18 and 40 with all sites not site 18 or 40, respectively.
• Data Filter : Enables you to filter data based on study site and country.
• Distributions : Displays histograms showing distribution of ECG findings across study sites, tests, and visit numbers, study sites, categories, and tests.
• Data Filter : Enables you to filter data based on study site and country.
• Distributions : Displays histograms showing distributions of laboratory test findings across study sites, tests, and visit numbers, and tests.
• Data Filter : Enables you to filter data based on study site and country.
• Distributions : Displays histograms showing distribution of vital signs findings across study sites, tests, and visit numbers,
• Show Sites : Shows the rows of the data table for the selected points from the volcano plot . Clicking opens the following table:
• Frequency Bar Chart : Select points on the volcano plot and click to display a bar chart for each point showing the proportions of each value of the Findings Test for the site as compared to the distribution of all of the other sites combined.
• 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.
• 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 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.This report compares the observed distribution of categorical tests with each site compared to all other sites taken together as a reference, ordering by numeric equivalent if available. For example, if character variable lists none, mild moderate, severe, very severe with corresponding numeric value ( xxSTRESN ) listed as 0, 1, 2, 3, 4, the intended order of the column variable levels are maintained.
l 1 l 2 l J FDR p -values are calculated and the reference line is determined as described in How does JMP Clinical calculate the False Discovery Rate (FDR)? .Analyze all tests from all findings domains , Findings Tests , Analyze: , Consider BY variables in the analysisSummarize sites with at least this many subjects: , Generate summary statistics by visit , Remove unscheduled visits
Subject-specific filters must be created using the Create Subject Filter report prior to your analysis.
For more information about how to specify a filter using this option, see The SAS WHERE Expression .