Exposure-adjusted Event Rates

This option allows for changing between MedDRA terms with the option to choose a single MedDRA term or a grouping of two MedDRA terms like Dictionary-Derived Term grouped by Body System or Organ Class. Switching this option swaps out the term plotted on the x-axis of the graph as well as the term in the first column of the tabulate.

Dictionary-Derived Term, grouped by Body System or Organ Class is selected by default.

Possible term and group levels are listed in the following table:

Use this option to specify how to calculate each subject's duration in patient years.

Use this option to select a multiplier for incidence rates for better interpretability and comparison among studies.

The selection of the incidence rate multiplier may be dependent on the number of subjects in a study and the cumulative time on study/treatment.

For example, a 4 month study of 450 subjects would be equivalent to 150 patient years. If subjects experienced 42 occurrences of a given event (e.g. Headache), then the incidence rate of a headache event would be a rate of 42/150 or .28 per patient years. If the multiplier value 100 is chosen with this option, the incidence rate would be interpreted as .28 * 100 = rate of 28 per 100 patient years.

Use this option to specify whether patient years and event inclusion are based on study date variables or from derived patient years/time at risk and event inclusion flags.

Use this option to specify the number of days after the last date of study or exposure for calculation of patient time at risk and adverse event variable inclusion.

For example, if you specify 30 days as the offset, 30 days is added to the end date day to calculate risk for experiencing adverse events.

Use this widget to specify an end date for subjects that are continuing in the clinical trial.

Last Modification Date

When the Last Modification Date option is selected, the last modification date/time stamp of the Adverse Events study data set is used as the end date for subjects that are ongoing on a clinical trial and therefore missing values for the Study or Exposure End Date Variable. For example: if RFENDTC is missing in DM for a patient record because that patient is still ongoing on the clinical trial, the date of the last modification to AE or ADAE table in the study data directory is used as the end date value.

Note: If a valid end date variable exists and is populated, the end date value is always used for subjects who have completed the trial and have a valid end date value, regardless of whether this option is checked. The date of the last modification to the AE data table is used only when this option is checked and only for the subjects who do not have a valid end date value. The date of the last modification is used for all subjects only when the end date variable either does not exist or contains no valid end date values.

Specified Below

When the Specified Below option is selected, the following text box appears.

You can either enter the date manually or click to bring up a calendar window that can be used to specify the desired date.

The date must be in ISO-8601 format. For example, September 1, 2011 must be entered as 2011-09-01.

Check this option to add a Missing category for any missing values in the demographic grouping variable. If missing values are detected, a Missing section will be added to the graph, and columns for Missing will be added to the tabulate. This option allows for switching between demographic variables such as treatment group, sex, race, and country. When this option is changed, it changes the group displayed on the right y-axis of the bar chart and the grouping variable on the top of the tabulate.

Use this widget to distinguish different levels within each of the adverse events summarized by the bars in the plots.

By default, this option is set to None, but can be changed to seriousness, severity, and other adverse event characteristics. When something other than None is selected, the bars in the bar chart will be stacked by the selected variable, and the tabulate will split each demographic grouping column by the stack variable.

Potential options are listed in the following table:

Note: The options available are dependent on the presence of the relevant variables in the data. For example, Severity is listed only when AESEV is present in the data tables.

Use this widget to specify which updated snapshot records to include in your analysis. This option is surfaced only in studies where the number of snapshots is greater than 0.

The default state of this option is to show new, modified, and stable - effectively all - snapshot records. To see specific records, you must remove undesired records from the analysis. For example, to surface only the new records, select both Modified and Stable and click . Click to restore deleted records.

Note: JMP Clinical now relies on the JMP Compare Data Tables platform to detect new records. When duplicate rows appear, the platform evaluates them based on their row order. As a result, records are no longer labeled as Non‑Unique or Previously Non‑Unique, and the corresponding options to include those records have been removed.

The Adverse Events field is an optional parameter that enables you to filter rows from the AE data set to choose the appropriate records to subset to adverse events of interest. Risk indicators are calculated using this subset of adverse events only.

This filter uses JMP WHERE clauses to Select Rows that meet the specified criteria. To use this filter, you must enter the JSL (JMP Scripting Language) expressions that constitute the WHERE clause in the appropriate text box for specific filtering of AEs. Note: This is an advanced concept that not only requires some basic knowledge of the JSL WHERE clause syntax (similar to, but different from, SQL), but also an understanding of the exact variables in the tables in the study.

To filter subjects with a specific event or finding, one could also use the Subpopulation Builder on any domain of interest. For example, filter to all subjects that exhibit cardiac failure ( :Customized Query 01 Name == "Cardiac failure" ) and run all reports on those.

To specify an Adverse Events filter:

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Click to open the WHERE Clause Builder to construct the desired filter.

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Click to clear the filter.

The report filter limits the bar chart and the tabulate to only those records that meet the filter selection. For example, if the lower bound of the Overall Percent Occurrence is set to 5, then only adverse events occurring in at least 5% of all subjects will be displayed. The filter builds upon itself, so if Serious Event equals Y and Outcome of Event equals Fatal are both selected, then only serious events that were fatal will be displayed.

Refer to Data Filter for more information.

Note: Filter specifications are reapplied when any widget options are changed.