Report Output | Overviews | Outliers

Outliers
This report identifies outliers and sites with excessive (or too few) outliers.
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:
Outliers Volcano Plot: Shows a volcano plot used to determine the deviation of the proportion of outliers at each study site with the overall proportions for the whole study. The x-axis is calculated using p(site) - p(reference), where p(site) is the proportion (or percent)of outliers in the site in question and p(reference) is the proportion of outliers in all other sites.
ECG Test Results (Outliers): Displays histograms showing distribution of ECG findings across study sites, tests, and visit numbers, as well as the frequencies and types of outliers.
Laboratory Test Results (Outliers): Displays histograms showing distribution of laboratory test findings across study sites, tests, and visit numbers, as well as the frequencies and types of outliers.
Vital Signs (Outliers): Displays histograms showing distribution of vital signs findings across study sites, tests, and visit numbers, as well as the frequencies and types of outliers.
Down Buttons
down buttons, provide you with an easy way to down into your data. The following down buttons are generated by this report:
Show Sites: Shows the rows of the data table for the selected points from the volcano plot. Clicking opens the following table:
Frequencies Barcharts: Select points on the volcano plot and click to display a bar chart for each point showing the proportions of outliers for the site as compared with the average of all of the other sites.
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.
General
Click to view the associated data tables. Refer to View Data for more information. Note: Numeric data for individual subjects come directly from the xxSTRESN1 variable from the domain data sets.
Click to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected sections.
Click to read user-generated notes. Refer to View Notes for more information.
Click the Options 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.
Methodology
This report compares the outlier status of tests with each site compared to all other sites taken together as a reference. A point is an outlier if it exceeds the upper outlier limit (Q3+1.5×IQR) or is less than the lower outlier limit (Q1-1.5×IQR), where Q1 and Q3 are first and third quartiles and IQR =Q3-Q1. It then compares the rate of outliers using Fisher's exact test. FDR p-values are calculated and the reference line is determined as described in How does JMP Clinical calculate the False Discovery Rate (FDR)?.

1
Where xx is the two-letter domain name.