Important: Before clicking
Profile Subjects, you must select the subjects of interest by clicking in a graph or selecting rows in the corresponding table.
For example, run the DM Distribution report for the
Nicardipine study and select subjects less than
20 years old from the
Age distribution histogram. Clicking the
Profile Subjects action button then generates the window shown below. Output is organized into panes and sections. Each tab contains one or more plots, data panels, data filters, or other elements that facilitate your analysis.
The Profile Subjects window contains the following elements:
•
|
Manage Display Templates: Click to open the Manage Display Templates window. This window enables you to specify domain elements and colors along with other saved attributes such as display mode and frame sizes of the subject profile graphs and tables.
|
•
|
Click the Options arrow to reopen the completed report dialog used to generate this output.
|
The General tab contains the following elements:
Note: The study must have a defined reference start date (
RFSTDTC). If this variable is blank, dates in the Demographics table will be empty and a warning is displayed, as shown below.
This is the principal display. Time
1 is displayed along the
x-axis and data values from available domains are grouped along the
y-axis. When duration information is available, points are joined with a horizontal line. The color and shape of points is domain dependent and is described in the
Legend pane in the
lower right corner.
•
|
One Medical History pane.
|
Note: If both age (
AGE) and birthdate (
BRTHDTC) are unavailable, or if the start date of an event (
MHSTDTC) is unavailable, then the age of medical history (
AGEMH) is displayed as
0.
The top panel (shown below) denotes symbols and colors used for
adverse events.
Note: Serious conditions are generally, but not necessarily, severe.
The middle panel (shown below) denotes line formats and symbols used for dates and times of different events and interventions.
Events or interventions with a defined range are indicated by a solid line spanning the ranges. Events or interventions with unknown start or end dates are indicated by a dashed line. Flagged events are indicated by left (prior) or right (ongoing) arrows. Conflicts are indicated by and question mark
2. Start and End dates are denoted by a filled-circle (
).
The bottom panel (shown below) denotes symbols used for numeric findings.
Findings that exceed the specified maximum reference value (also defined as the upper limit of normal or ULN) are indicated by an upward arrow (
). Findings that fall below the specified minimum reference value (also defined as the lower limit of normal or
LLN) are indicated by a downward arrow (
). Findings between the
ULN and
LLN are indicated by a filled-circle (
). The color of the filled-circle symbol indicates where the value falls within the
distribution observed for the study
population, as indicated by the color scale located on the right side of the primary display (for example,
). The ends of the color scale are the 10
th and 90
th percentiles of all subjects in the study.
Note: The color scales are typically different for each numeric finding.
If no reference values are specified, the normal range is considered to be the median value over all subjects +/- 1.5 x the interquartile range (
IQR).. Findings falling within that range are considered normal and are indicated by a filled-circle (
). Findings falling outside of that range are considered outliers and are indicated by an asterisk (
). As before, the color of the symbols indicates where the value falls within the distribution observed for the study population.
The Tables tab is shown below:
The Tables tab lists and summarizes subject-level for all profiled subjects in tabular form.
The Demographics tab contains the following elements:
When processing the flag variables xxSTRF and
xxENRF, the patient profiler checks for the following keywords: "NOT RECOVERED/NOT RESOLVED", "NOT RECOVERED/RESOLVED", "NOT RECOVERED", "NOT RESOLVED", "RECOVERING/RESOLVING", "RECOVERING", "RESOLVING", "CONTINUING", "ONGOING". If one of these keywords is specified and also a corresponding start or end date is specified, the profile will display a "?" to represent a data conflict.