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.

Report Results Description

Running Findings Box Plots for Nicardipine using default settings generates the report shown below. 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.

LB Box Plots

Presents a Box Plot displaying values chosen in the Plot findings measurements as: option. The name of this section varies based on the domain chosen.

Note: The name of this section and the findings results (LB, VS, or EG) displayed depend on the domain selected using the Domain option.

It contains one or more set of Box Plots with a box for each treatment.

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.

Note: The value given for n in the Summary Statistics table represents the number of records at each visit, not total number of subjects.

Use the drop down menu to the left of the plots to select the findings test results to display

Note: You may notice a difference in baseline vital signs results between JMP Clinical v8.1 and v18.1. This can happen when the baseline calculation is for the mean of recorded predose measurements for findings that have "Y" as a value for VSBLF 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 VSBLF, regardless of the value of VSDY. v18.1 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 VSBLF, and some value for VSDY.

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.

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.

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.

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 using:

Use the widget to specify how the baseline is to be calculated. Refer to for more information.

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.

Display

Laboratory Test Results

Highlight the Findings test you want to diplay.

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:

Click to rerun the report using default settings.

• Click to view the associated data tables. Refer to Show Tables/View Data 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.
• Click to open and view the Review Subject Filter.
• Click to specify Derived Population Flags that enable you to divided the subject population into two distinct groups based on whether they meet very specific criteria.

Default Settings

Refer to Set Study Preferences for default Subject Level settings.

Methodology

No testing is performed. Analysis is restricted to tabulating counts/frequencies of subjects exhibiting constant findings results.