Findings Waterfall Plots

A waterfall plot shows changes from baseline to a final value for each subject. Subjects are sorted by the magnitude of change, making it easy to visualize the direction and extent of change across the study population. Use the waterfall plot to compare the magnitude of change across subjects, identify subjects with the largest increases or decreases, and evaluate the overall response patterns within and between treatment groups.

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.

Report Results Description

Running Findings Waterfall Plots with the Nicardipine sample setting and LB findings domain generates the report shown below.

Waterfall Plots

There is one Waterfall Plot for each quantitative findings test (for example, laboratory tests) in the Findings data set that was analyzed. Output data set is a stacked data set of findings measurements at subject level; subject level drill downs are available. Hovering over a bar displays information for an individual subject while clicking a bar selects a subject. Press and hold the Ctrl key while clicking multiple bars to select multiple subjects.

Use the filter at left to select the finding plot to view. Each plot shows a summary of the findings test measurements on the Y axis for each subject (on X axis) ordered by that measurement. Caption boxes in the upper right corner of each graph (optional) display a summary statistic across all subjects (in a treatment or BY variable group) to aid in understanding the differences in the center/spread of the group distributions.

In this example, the plot displays changes in activated thromboplastin for individual patients treated with either nicardipine or placebo. Decreases from baseline appear below the zero change line, and increases appear above the line. In this example, we observe more subjects having decreases from the baseline than increases.

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.

Findings Tests

Use this widget to select specific Findings tests.

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

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

Subset of Visits to Analyze

Use the Subset of Visits to Analyze option to select the visits to be included in the analysis.

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. Refer to Plot findings measurements as: for more information.

Summary Statistic for Trial Data

Use the Summary Statistic for Trial Data widget to specify whether to display the mean, median, maximum, minimum, or last values to summarize the results of the trial period.

Remove unscheduled visits

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

Calculate baseline as:

Use the Calculate baseline using: widget to use the last recorded pre-dose measurement or the mean of all the measurements taken during the baseline time window as the baseline measurement.

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). See Findings for more information.

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

Use this widget to select the findings results to display in the plot.

General and Drill Down Buttons

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

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Click to rerun the report using default settings.

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Click to view the associated data tables. Refer to Show Tables for more information.

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Click to generate a standardized pdf- or rtf-formatted report containing the plots and charts of selected sections.

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Click to generate a JMP Live report. Refer to Create Live Report for more information.

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Click to take notes, and store them in a central location. Refer to Add Notes for more information.

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Click to read user-generated notes. Refer to View Notes for more information.

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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.

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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 based on their meeting specific criteria.

Default Settings

Refer to Set Study Preferences for default Subject Level settings.

Methodology

No testing is performed. Analysis is restricted to calculating simple statistics of findings results.