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 time s or points in the study. Time s can be specified using a list of bracketed times or, alternatively, a number of time s can be set to create time s 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.
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.
Presents several Box Plots representing the values chosen in
Plot findings measurements as: option.The name of this section varies based on the domain chosen.
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 tables presents the associated statics.
Use the Findings Domain to Analyze option to specify whether to plot the distribution of measurements from either the Electrocardiogram (
EG), Laboratory (
LB), or Vital Signs (
VS) findings domains. LB is selected by default.
You can use the Findings Domain Tests for Analysis option to plot the distributions of one or more selected findings tests. Leaving the field blank (the default selection) plots the distributions for all available findings tests.
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 the ARM or
TRTxxP (planned treatment) or
ACTARM or
TRTxxA (actual treatment) from the CDISC models as a surrogate variable to serve as a comparator. Finally, you can select
None to plot the data without segregating it by a treatment variable.
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.
By default, time is measured by visits. However, you can change the Time Scale to measure time in either weeks or days. This option is useful for assessing report graphics for exceptionally long studies.
To establish a baseline measurement for each finding, you must specify the time period (usually prior to day one of the study) and whether to use on or more than one measurement. Use the Baseline Time Window option to specify the time period during which baseline measurements are taken and the
Calculate baseline as: option to use the last pre-dose measurement or the mean of all the measurements taken during the baseline time window as the baseline measurement.
When analyzing findings results by either days or weeks instead of by visit, you must specify one or more time window parameters. Time windows are defined blocks of time within the study where findings results are considered in a single time point regardless of where within the window they were collected. The Time Window Method option enables you to specify either a number of time points of equal length that span the study, several individual time points of varying define lengths that might or might not span the study, or no time windows. In that case, each time is considered individually. If you select
None, no other time window parameters are specified. If you select
Set Number of Time Windows, you must also specify the
Number of Time Windows. If you select
Use Time Windows list, you must specify the start and end days for each of the
Trial Time Windows.
When you select None as the
Time Window Method, box plots for the maximum, mean, median, and minimum values are shown for each subject across the entire trial for each subject. When you list or select a number of time trials, only one statistic is shown. Use the
Summary Statistic to Compute Within Time Windows or Visits option to specify the statistic to be displayed.