Findings Shift Plots

This report displays shift plots to compare test measurements for a specified findings domain at baseline versus on-therapy values and performs a matched pairs analysis on average score during baseline and a summary score during the trial. A separate analysis is done for each findings measurement.

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 Shift Plots for Nicardipine using default settings generates the report shown below.

It contains the following elements:

• One set of Shift Plots for each finding observed in the study.

These plots show how findings levels change from baseline values as a result of treatment. Blue points represent patients treated with nicardipine. Gray points represent patients receiving the placebo. The approximately square spread of points (with a diagonal line splitting approximately even across it) indicates similar variability of measurements before and after treatment.

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.

Summary Statistic for Trial Data

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

Normalization of Lab Measurements

Use this widget to select a normalization to be applied to the baseline and on-therapy measurements. Refer to Normalization of Lab Measurements for more information.

By default, JMP Clinical reports unaltered laboratory measurement values. In any cases, simply examining the raw numbers can make interpretation somewhat confusing. Normalization of Lab Measurements to accepted values can often ease these difficulties. JMP Clinical offers two options for normalizing your data.

Selecting LLN normalizes the data to the lower limit of the expected normal range and is best used when you expect the values to fall below the normal. Normalized values less than one are considered to be lower than normal.

Selecting ULN normalizes the data to the upper limit of the expected normal range and is best used when you expect the values to exceed the normal range. Normalized values greater than one are considered to be higher than normal.

Note: This option is not available for domains lacking upper or lower limits of normal variables.

log Transformation of Findings Measurements

Log transformations can make certain response distributions closer to Gaussian with constant variance and can enable you to draw more accurate statistical conclusions under standard modeling assumptions. They are especially useful for ratio-type measurements or measurements that are always positive and skewed to the right. You can use the log Transformation of Findings Measurements options to either use non-transformed data or to log2- or log10-transform your measurements.

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 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.

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.

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

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:

• 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 calculating simple statistics of post-baseline findings results or their log transformed and/or normalized values against baseline values.