Interventions Distribution

This report compares distributions of interventions and demographic variables across treatment arms. It reports each subject only once per intervention regardless of how many incidents of the intervention occur.

Click below to view a video summary of this report or scroll to read detailed descriptions of the report results and options.

Methodology

No testing is performed. Analysis is restricted to tabulating counts/percentages of subjects experiencing interventions. The unique record to display for each intervention is determined by sorting the data by Unique Subject Identifier (USUBJID), the group level, the term level, and the day the intervention started and picking the first record for each term level.

Note: Records marked as not occurring (xxOCCUR = N) are excluded from this analysis.

Usage and Interpretation

Note: Click on the figures below to enlarge.

Example 1:

Report Results Description

Running this report for Nicardipine using default settings generates the report shown below.

The report contains the following elements:

Bar Chart

Using a Bar Chart, this section summarizes the counts (or percentage of subjects) receiving the specified type of intervention during the course of the study. Results can be displayed either as total counts or percentages. Unique events are determined by evaluating both Study Day and Start Date.

In the example shown here, counts of concomitant medications administered by treatment are displayed.

Tabulate

The Tabulate section contains one Table detailing the counts (and Percentages) for each treatment group, for each intervention within each specified term and group level. The counts, represented by n, are the number of subjects who experienced the given intervention. The All row at the bottom of the table is the number of subjects who experienced at least one intervention.

The Tabulate section contains one Table detailing the counts (and Percentages) for each treatment group, for each dictionary-derived term within each body system or organ class.

Options

Data

Domain

Treatment or Comparison Variable

Include missing Treatment or Comparison Variable values

Term and Group Level

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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:

Term and Group Level

Corresponding Variable

Function

Body System or Organ Class

AEBODSYS in AE

•

Uses Body System or Organ Class level of adverse events as categories.

High Level Group Term (HLGT)

AEHLGT in AE

•

A superordinate descriptor for multiple higher level terms (HLTs)

High Level Term (HLT)

AEHLT in AE

•

A superordinate descriptor for multiple preferred terms (PTs).

Dictionary-Derived Term

AEDECOD in AE

•

Uses Dictionary-Derived Term level of adverse events as categories.

Reported Term for the Adverse Event

AETERM in AE

•

Uses Reported Term for the Adverse Event level of adverse events as categories.

Intervention Type

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Use this feature to specify the inclusion of particular type of intervention in the analysis. By default, all interventions are included in the analysis.

Available options are listed in the following table:

Option:

Select when you want to:

All intervention types

•

Include all interventions.

Pre treatment interventions

•

Include interventions that occur before dosing for treated subjects or any event for untreated subjects.

Treatment emergent interventions

•

Include interventions that occur on or after the first dose of study drug.

Note: For information about how treatment emergent interventions are defined in JMP Clinical, please refer to How does JMP Clinical determine whether an Event Is a Treatment Emergent Adverse Event?.

On treatment interventions

•

Include interventions that occur on or after the first dose of study drug and at or before the last dose of drug.

Off treatment follow up interventions

•

Include interventions that occur after the last dose of drug.

Note: When crossover is detected, only those interventions that occur within the specified treatment period dates are shown. This is true even when All Intervention Types has been selected.

Ignore available treatment emergent flags

Stack

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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:

Option:	Select when you want to:
None	Display all of the occurrences of each adverse events with no indications of levels within each class.
Serious Event	Display each adverse event bar in two colors - one representing serious events, the other color representing non-serious events.
Severity/Intensity	Display each adverse event bar in three colors - one representing mild events, the second color representing severe events, and the third color representing moderate events.
Outcome of the Adverse Event	Display each adverse event bar in six colors. Colors represent the following: Recovered/Resolved, Recovered/Resolved with Sequelae, Recovering/Resolving, Not Recovering/Not Resolved, Fatal, and Unknown.
Causality	Display each adverse event bar in four colors. Colors represent the following: not related to the treatment, unlikely related to the treatment, possibly related to the treatment, and related to the treatment
Action Taken with Study Treatment	Display each adverse event bar in fivecolors. Colors represent the following: Dose Not Changed, Not Applicable, Unknown, Dose Modified, and Drug Withdrawn.
Period	This option is displayed only when multiple treatment periods have been detected and displayed. Pre-treatment is been assigned to period=0. Displayed counts indicate the number of subjects experiencing an event in each period. Note: This is selected by default when crossover data is detected.

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.

Snapshot Records to Include

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.