Findings Time Trends

The Findings Time Trends report allows findings data, typically laboratory tests, to be summarized over time by treatment. Time typically involves both visits and time points. By default, the summarization for laboratory tests involves calculating the mean change from baseline and 95% confidence intervals, to determine whether laboratory test mean post-baseline values are trending up or down across visits. Other summarizations include the percent change from baseline and percent of baseline as well as the observed results, the latter including the upper limit of normal and lower limit of normal cutoff lines for the individual tests. A line graph with the means of each treatment group are displayed first, with a bar graph below, showing the number of records for the subjects containing the baseline and post-baseline values involved in the calculations. Finally, a line graph for each laboratory test for each subject over visit is displayed, allowing the investigator to evaluate each data point for every subject on the trial.

Methodology

 

Usage and Interpretation

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

Example 1:

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

Option Settings
Option Type Option Setting  
Data Domain LB (Laboratory Test Results)
Findings Tests (Blank)
Plot Findings Measurements as: Percent Change from Baseline
Calculate baseline using: Baseline flag
Display Laboratory Test Results Blood Urea Nitrogen
All other options set to default.

The report summarizes the change in laboratory values of selected tests over the course of the study, relative to baseline, and compare the effects or the different treatments on those values. It also plots the values over time for each subject. While no statistical testing is performed, there are observations to be made regarding the differences between treatment groups as well as relating to the severity of any changes.

 

Treatment Time Trends

Shows a plot for each quantitative findings test (for example, laboratory) in the Findings data set that was analyzed. Each plot contains a line for each treatment group representing the average measurements taken across time.

The plot displays the means of the measurements with 95% confidence intervals taken across time for each treatment arm in a study for blood urea nitrogen. The Y axis represents the change from baseline Time trend lines connect the points of measurement; each marker point represents the average findings measurement for subjects belonging to that treatment arm at the measured time point. The plots show a significant increase in

The time trend lines are interactive. Selecting a line selects all subjects belonging to the treatment group the selected line represents. You can then use the drill down buttons to profile, cluster, or show these subjects or to create a subject filter to do further analysis only with the selection of subjects. Selecting a treatment time trend line also selects and highlights all the individuals' subject time trend lines on the accompanying Subject Time Trends section that is part of the output from this report.

Associated Bar Charts showing the number of subjects in each treatment group at each visit.

Subject Time Trends

Shows a plot for each quantitative findings test (for example, laboratory) in the Findings data set that was analyzed. Each plot contains a line for each subject in the study representing the patient's measurements taken across time.

This section contains the following elements:

• A set of Subject Level Time Trends Plots also known as spaghetti plots

If findings test category (xxCAT) exists (where xx represents the two-letter domain abbreviation -- for example, LB), these plots are first ordered by xxCAT. Next, if findings test subcategory (xxSCAT) exists, plots are secondarily ordered by xxSCAT. If xxCAT is missing, plots are ordered by test short name (xxTESTCD), which is required. Findings tests with a missing xxCAT value are assigned to the “OTHER” category.

Note: Findings tests with a missing numeric result (xxSTRESN), as well as those taken on only one day, are excluded from these plots.

Tip: You can collapse categories (and simultaneously exclude them from any report that you create) by clicking on the gray triangles located to the left of the category labels.

Each plot displays the measurements taken across time for each subject in a study for a quantitative findings test. The value of xxTEST is displayed in the outline box for each plot and the test short name (xxTESTCD) is displayed along with the measurement units (where applicable) on the Y axis. The Y axis can represent the observed test result, the change from baseline, percent change from baseline, or percent of baseline, depending on the selection made for the Plot findings measurements as: parameter on the report dialog. Time, as either Study Day, Study Week, or Visit, is plotted on the X axis (according to yourTime Scale selection). Time trend lines connect the points of measurement; each marker point represents the findings measurement for each subject at the measured time point. If multiple measurements were taken for a subject on the same Study Day, Study Week, or Visit, the point represents the mean measurement for that subject.

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.

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.