Findings Waterfall Plots

Specifies the variable used to define the groups to be comparec in the report. This variableis 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.

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.

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

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

Use this option to select the visits to be analyzed.

Note: Visits are selected from the Findings domain specified by the Domain widget only.

To Specify a Subset of Visits:

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

In this example, visits 1,5,6, and 9 were selected and added.

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:

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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.

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

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:

Use the drop down to specify whether to display the mean (specified by default), median, maximum, minimum, or last values to summarize the results of the trial period.

Options are defined in the following table:

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.

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:

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.

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.

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:

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

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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.

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.