Findings Box Plots

This report displays box plots by treatment group that represent the change from baseline in measurements for each test within the specified findings domain across various study time point. Time points can be specified using a list of bracketed times or, alternatively, by specifying a number of time points to be generated across the entire study duration.

If the variable xxBLCHG (where xx represents the selected domain's 2-letter code) exists, it is used to plot change from baseline. Otherwise, a measurement is identified as a baseline measurement using the ABLFL or xxBLFL variable for analysis. If this variable does not exist, baseline is calculated from measurements taken on or before Study day 1. A time can be specified to determine baseline measurements.

Note: JMP Clinical uses a special protocol for handling data with 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 the selected findings test at each visit.

Usage and Interpretation

The Findings Box Plots report supports the exploratory review of continuous findings data across visits. The report can be used to evaluate distributions, identify outliers, compare treatment groups, assess changes from baseline, and identify subjects who might warrant additional investigation. Visual patterns and summary statistics can help identify trends, outliers, and potential safety signals, but differences observed are not based on formal statistical testing. The following examples illustrate common review scenarios.

Note: Click on the figures below to enlarge.

Example 1: Mean Change from Baseline in BUN Over Time by Treatment

In this example, report options were set as shown in the following table:

Option Settings
Option Type Option Setting  
Display Laboratory Test Results Blood Urea Nitrogen (mMol/L)
All other options set to the default.

The Laboratory Test Results (LB) domain is selected, unscheduled visits are excluded, and the baseline value is determined using the baseline flag. Change from baseline is selected as the findings measurement.

This example, which corresponds to Example 1 in the Findings Time Trends Report documentation, summarizes changes from baseline in Blood Urea Nitrogen (BUN). The plotted distributions and summary statistics in this report help characterize patterns and evaluate within-subject changes from baseline in BUN values across visits and between treatment groups. Individual subjects can be identified from the plots, allowing further exploration of the subject’s safety profile, findings, or other outcomes experienced during the trial.

Figure 1: Box Plots Showing BUN Change from Baseline

Figure 1 displays the distribution of change-from-baseline BUN values at each follow-up visit. Numerous outlying observations are evident in the upper portion of the distributions, representing subjects who experienced large changes from baseline in BUN at various follow-up visits. These subjects might warrant additional review to determine whether the changes are associated with renal impairment, adverse events, concomitant medications, or other clinically relevant factors. Large positive changes from baseline can be observed in subjects from both treatment groups. Hovering over an outlier at Visit 14 identifies a subject in the Nicardipine group with a change-from-baseline BUN value of 43.554 mmol/L. As part of a safety review, it might be useful to evaluate this subject’s renal markers (for example, creatinine and eGFR) to better understand the observed change and its relationship to adverse events, drug exposure, concomitant medications, and the overall subject profile. TheAcute Kidney Injury report and the Patient Profiles report might provide additional insights into the safety profile of this subject or other subjects with unusual change-from-baseline values. The upward shift in the median lines and boxes across visits suggests increasing change-from-baseline BUN values over time, particularly in the Nicardipine group, while the widening interquartile ranges indicate increasing variability among subjects. These interpretations and observations are not based on statistical tests of significance but might suggest areas for further statistical investigation, as deemed appropriate by those conducting the trial. When interpreting changes across visits, reviewers should also consider changes in sample size, as later visits might include fewer subjects than earlier visits.

Accompanying the plot in this report is a table (Figure 2) summarizing the min, max, median, mean, standard deviation, and sample size (n) for change-from-baseline BUN values at each visit by treatment group. In the Nicardipine group, the mean change from baseline ranges from 0.4 mmol/L to 4.4 mmol/L over the follow-up period. In the Placebo group, the mean change from baseline ranges between 0.3 and 2.4 mmol/L across the study. Because outliers can substantially influence the mean, the median might provide a more robust measure for comparing treatment groups. The median change across visits ranges from -0.4 to 2.9 mmol/L in the Nicardipine group, compared with a range from 0.3 to 2.4 mmol/L in the Placebo group, suggesting a gradual increase in BUN values over time in both groups. Sample sizes vary across follow-up visits, which is worth noting as well, and might reflect subject discontinuation, missed visits, or incomplete follow-up assessments. Related reports that can support further investigation include the Study Flow Diagram, Study Visits report, and Missing Findings report.

Figure 2: Stats Table for BUN Change from Baseline.

Example 2: Mean Diastolic Blood Pressure Over Time by Treatment

In this example, report options were set as shown in the following table:

Option Settings
Option Type Option Setting  
Data Domain VS (Vital Signs)
Plot findings measurements as: Observed Result
Removed unscheduled visits unchecked
Display Vital Signs Diastolic Blood Pressure (mmHg)
All other options set to the default.

This example uses the Findings Box Plot Report to evaluate Diastolic Blood Pressure (DBP in mmHg) measurements collected at each study visit. The plotted distributions and summary statistics help characterize patterns in DBP within and between treatment groups. Observed outliers and extreme values might warrant further investigation with respect to the safety profiles of individual subjects in the study.

Figure 3: Observed DBP Over Time

From the plot (Figure 3), several outliers are observed at both the upper and lower ends of the distributions, including DBP values below 40 mmHg and above 100 mmHg. At Visit 1, which represents the baseline visit, there appears to be a modest imbalance between the Nicardipine and Placebo groups, with DBP values generally lower in the Nicardipine group. This pattern of relatively lower DBP values in the Nicardipine group persists throughout the study.

Figure 4: Summary Statistics on Observed DBP Over Time

The summary statistics (Figure 4) show that, at baseline, the median DBP in the Nicardipine group is 68.0 mmHg, compared with 76.0 mmHg in the Placebo group. Across post-baseline visits, the mean DBP in the Nicardipine group ranges from 66.2 mmHg to 75.9 mmHg, whereas the mean DBP in the Placebo group ranges from 76.4 mmHg to 80.4 mmHg.

To determine whether the nominally lower DBP values observed in the Nicardipine group at post-baseline visits are simply a result of the lower initial baseline DBP, we can switch to evaluate the change from baseline for subjects at each visit. This is done by setting the Findings Measurement option to Change from baseline. The resulting change-from-baseline graph is shown in Figure 5.

Figure 5: Change from Baseline in DBP Over Time

After selecting the Change from Baseline measurement, differences between treatment groups appear to be minimal. This observation suggests that the apparent differences in post-baseline DBP values observed between treatment groups in Figure 3 might be largely attributable to the baseline imbalance between the treatment groups.

The summary statistics for change-from-baseline DBP values (Figure 6) provide additional details on the mean and median changes from baseline in each treatment group. The number of DBP observations at Visits 13 and 14 (168 to 210 observations) is substantially lower than the numbers at Visits 2 and 3 (443 to 454 observations), suggesting increased rates of missed visits, study discontinuation, or both at later visits in the trial. Related reports that can support further investigation include the Study Visits report,Disposition Distribution report, and Exposure Summary report.

Figure 6: Summary Statistics on Change from Baseline in DBP Over Time

Options

Data

Treatment or Comparison Variable

Specifies the variable used to define the groups to be compared in the report. This variable is typically a planned or actual treatment variable, such as ARM, ACTARM, TRTxxA, or TRTxxP, but it can also be another variable that defines meaningful comparison groups, such as SEX or RACE.

Select None to display the data without grouping by a treatment or comparison variable.

Domain

Use this widget to specify whether to analyze 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

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

This box is checked by default.

By Variables

Use this field to specify one or more By variables from ADSL to use in your analysis.

Selecting a By variable will split the bar chart and tabulate by the grouping variables selected in this option as well as by the variable selected for the comparison or treatment variable.

By Variables

By variables are optional (in most reports)variable specifications whose values define groups of observations, such as hour, month, or year. By variables can enable analyses to be performed separately on different groups as defined by that variable. Choosing a By variable such as gender (ADSL variable = SEX), for example, groups the subjects by gender and conducts two separate analyses: one for males and one for females.

Alternatively, specifying a By variable enables you to animate an image so that you can see how response values change according to some grouping, like over time.

To Specify One or More By Variables:
8 Click to open the Add window (shown below) that lists each variable contained in domain and SUPPxx (if merged) specific to this report

Note: In Demographics Distribution only, variables are taken from ADSL, in addition to the report-specific DS and SUPPPDS (if available) data sets.

8 Select the variables you want to include in the analysis and click to add those variables to the text box.

In this example, AGE Group 1, RACE, and SEX were selected and added.

Note: If no By variables are specified, the analysis is conducted across all the subjects

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 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 might 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
• Those taken prior to Study Day 1

Choose Last recorded pre-dose measurement to use the last recorded predose 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 predose 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, where 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 domains.

Action Buttons

Action buttons provide an easy way for you to drill down into your data. The following action buttons are generated by this report:

• Click to re-run 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 that contains 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 and 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 subjects from the selected visits.

Default Settings

Refer to Set Study Preferences for default Subject Level settings.