Study Visits
The Study Visits report generates graphical and tabulation displays of study visit attendance. Additionally, a distribution of study days for each specified visit is shown.
Report Results Description
Running this report with the Nicardipine sample setting and default options generates the output shown below.
The Report initially displays Visit Counts and a series of Visit Day Distributions.
Visit Counts:
Presents a stacked Bar Chart colored by treatment and a table summarizing the number of subjects in each treatment ARM that attended each visit.
Visit Day Distributions:
Presents a Histogram by visit of the study days on which the visits occur. Useful to identify whether subjects have gotten off schedule or if visit dates have been entered incorrectly. There is a separate distribution for each visit.
It contains the following elements:
| • | One Histogram and associated statistics for each visit. |
The histograms show the distribution of the study day for the start date of study visits by visit. They are useful in identifying whether subjects have gotten off schedule or whether visit dates have been entered incorrectly.
See Distribution for more information.
Data Filter
This enables you to subset subjects based on demographic characteristics and Standardized Disposition Terms. Refer to Data Filter for more information.
Action Buttons
Action buttons, provide you with an easy way to drill down into your data. The following action buttons are generated by this report:
| • | Profile Subjects: Select subjects and click  to generate the patient profiles. See Profile Subjects for additional information. |
| • | Show Subjects: Select subjects and click  to open the ADSL (or DM if ADSL is unavailable) of selected subjects. |
| • | Cluster Subjects: Select subjects and click  to cluster them using data from available covariates. See Cluster Subjects for additional information. |
| • | Demographic Counts: Select subjects and click  to create a data set of USUBJIDs, which subsets all subsequently run reports to those selected subjects. The currently available filter data set can be applied by selecting Apply Subject Filter in any report dialog. |
General
| • | Click  to view the associated data tables. Refer to 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 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 Subject Explorer/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. |
| • | Click the arrow to reopen the completed report dialog used to generate this output. |
| • | Click the gray border to the left of the Options tab to open a dynamic report navigator that lists all of the reports in the review. Refer to Report Navigator for more information. |
Report Options
Treatment or Comparison Variable:
When specifying a treatment or comparison variable, distributions of the variables are shown in the output.
Available variables include Planned, which is selected when the treatments patients received exactly match what was planned and Actual, which is selected when treatment deviates from what was planned. You can also specify a variable other than TRTxxP (planned treatment) or TRTxxA (actual treatment). Finally you can select None to plot the data without segregating it by a treatment variable.
See Treatment or Comparison Variable to Use, or Treatment or Comparison Variable for more information.
Unscheduled Visits
Unscheduled visits can occur for a variety of reasons and can complicate analyses. By default, these are excluded from this analysis. However, by unchecking the Remove unscheduled visits box, you have the option of including them.
Filtering the Data:
Filters enable you to restrict the analysis to a specific subset of subjects and/or specific visits, based on values within variables. You can also filter based on population flags (Safety is selected by default) within the study data.
If there is a supplemental domain (SUPPxx) associated with your study, you can opt to merge the non-standard data contained therein into your data.
You can also subdivide the subjects and run analyses for distinct groups by specifying one or more BY variables.
See Select the analysis population, Select saved subject filter1, Additional Filter to Include Subjects, and Subset of Visits to Analyze for Findings for more information.