Findings Box Plots

This report displays the box plots by treatment group representing the change from baseline in measurements for each test for specified findings domain across various times or points in the study. Times can be specified using a list of bracketed times or, alternatively, a number of times can be set to create times that span across the entire study.

If the variable xxBLCHG (where xx is substituted with the chosen domain 2 letter code) exists, this variable is used in plotting change from baseline. Otherwise, a measurement is determined to be a baseline measurement by the ABLFL or xxBLFL variable where xx is substituted with the 2-letter code for the chosen domain for analysis. If this variable does not exist, baseline is calculated from measurements taken on or before day 1 of the study. A time can be specified to determine baseline measurements.

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.

Methodology

Counts of subjects with findings results are tabulated for each visit. Mean, median, standard deviation, minimum and maximum values are computed for selected findings test for each visit.

Usage and Interpretation

The Findings Box Plots report was run with Nicardipine sample data set under several scenarios to demonstrate usage and interpretation of results.

Example 1:

Running Findings Box Plots for Nicardipine using default settings generates the report shown above. Output from the report is organized into sections. Each section contains one or more plots, data panels, data filters, or other elements that facilitate your analysis.

Box Plots display values chosen in the Plot findings measurements as: option. Findings results (LB, VS, or EG) displayed depend on the domain selected using the Domain option. Use the column switcher to the left of the plots to select the findings test results to display.

Each box plot set represents an xxTESTCD from the selected domain. For example, in the graph above, the first figure represents the change from baseline for APTT (Activated Partial Thromboplastin Time) at each visit for both treatment arms. The table presents the associated statistics.

You may notice a difference in baseline vital signs results between JMP Clinical v8.1 and v19. This can happen when the baseline calculation is for the mean of recorded predose measurements for findings that have "Y" as a value for VSBLFL if some of those rows are missing a value for VSDY. v8.1 computes the mean for all rows that have a value of "Y" as a value for VSBLFL, regardless of the value of VSDY. v19 ignores any rows lacking a value for VSDY and computes baseline means using just the rows that both have a value of "Y" as a value for VSBLFL, and some value for VSDY.

A table summarizing the statistics of the specified finding(s) from baseline across visits is shown at the bottom of the report. In this table, n represents the number of subjects at each visit.

Options

Data

Domain

Use this widget to specify whether to plot the distribution of measurements from either the Electrocardiogram (EG), Laboratory (LB), or Vital Signs (VS) findings domains.

LB is selected by default.

Findings Tests

Use this widget to select specific Findings tests. If you leave this field blank, all tests are run.

8 Click to open the Add window (shown below) that lists available test names (shown below).

8 Select the desired test(s) and click to add them to the text box.

Show all Findings Tests

Check this box will show all the graphs for every findings tests instead of one graph with a column switcher.

This box is checked by default.

Plot findings measurements as:

Use this widget to specify whether to plot the results either as observed or how they relate to the baseline measurement.

Available options are listed in the following table:

Option

Description

Observed result

Plots observed values of the xxSTRESNvariable at or within time points or specified time periods.

Change from baseline

Plots the change from the findings baseline measurements.

Percent change from baseline

Plots 100*((xxSTRESN - Baseline)/Baseline) across trial time points.

Percent of baseline

Plots 100*(xxSTRESN/Baseline).

Remove unscheduled visits

You might or might not want to include unscheduled visits when you are analyzing findings by visit.

By default, this box is checked. When it is checked, records are excluded from the analysis if the VISIT variable exists and contains the text "unscheduled" for those records. If the box is not checked all records are included regardless of the VISIT status.

For some reports, you may have to specify Visits as the Time Scale to enable this field.

Include missing visits/time points

Check the box to include missing visits/time points in the plots and tables.

Calculate baseline as:

Use this widget to use the flagged baseline record, last recorded pre-dose measurement or the mean of all the measurements taken during the baseline time window as the baseline measurement.

By default, the flagged baseline record is used.

The following test measurements are considered when forming the baseline measurement:

• those flagged as baseline, and
• those taken prior to Study Day 1

Choose Last recorded pre-dose measurement to use the last recorded pre-dose test measurement (out of the test measurement pool generated from the above list) as the baseline measurement.

Choose Mean of recorded pre-dose measurements to average these pre-dose test measurements to form the baseline measurement.

Note: When the selected option to calculate baseline is to use the baseline flag and there are two records flagged as baseline, JMP Clinical uses the last record. This differs from JMP Clinical version 8.1, wherein the mean of the flagged baseline values was used.

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.

Additional Filters - Findings

This filter lets you restrict your analysis to only those subjects that meet specific criteria at the level of the specified Findings domain (EG, LB, or VS) .

This filters 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 findings. 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.

Risk indicators are calculated using this subset only.

To specify a Findings filter:

8 Click to open the Where Clause Builder to construct the desired filter.
8 Click to clear the filter.

Note: 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.

Display

Test Results/Vital Signs

This option lists all of the tests performed over the course of the study. The list is specific to the selected Findings domain and changes when you change the selected domain.

8 Select one or more tests to display only the results for the selected domain(s).

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:

• Click to rerun the report using default settings.
• Click to view the associated data tables. Refer to Show Tables for more information.
• Click to generate a standardized PDF- or RTF-formatted report containing the plots and charts of selected sections.
• Click to generate a JMP Live report. Refer to Create Live Report for more information.
• 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.
• Select one or more subjects, then click to apply the Review Subject Filter and filter all reports in the review builder on the selected subjects.
• Select a group of subjects and click to specify Derived Population Flags that enable you to distinguish the selected group of subjects from the general population.
• Select one or more points (from the same visit or different visits) on the box plot and click to surface a table listing the findings results for the selected subject(s) from the selected visit(s).

Default Settings

Refer to Set Study Preferences for default Subject Level settings.