CR Toolkit™ Overview

Report Module Descriptions

This section contains brief descriptions of the CR Toolkit Report Modules. The table below is a guide to how report modules are used. Report module selection is based upon the structure of the source data. Examples of the types of data are listed in the table.

Report macros are used to generate standard tables.
Graphic macros are used to generate charts or plots.

Report Type Dataset Structure
One Record Per Patient
(ADaM Subject-Level Analysis Dataset (ADSL))

demographics, subject characteristics, study conclusions, efficacy
Multiple RecordsPer Patient
(ADaM Occurrence Dataset)

adverse events, medications, histories, symptoms, efficacy
Multiple Parameters or Time Points Per Patient
(ADaM Basic Data Structure (BDS))

physical exams, labs, vital signs, ecg, efficacy
Listing %PRINT1 %PRINT1 %PRINT1
Frequency Table %DEMOG, %DISP1 %AE1, %AE2, %AE3, %DISP1 %DISP1, %SHIFT1
Descriptive Statistics %DEMOG %TABLE3, %TABLE4 %TABLE3, %TABLE4
Range Shift %SHIFT1 %SHIFT1 %SHIFT1, %TABLE5
Graphic Presentation %GRAPH1 %GRAPH2 %GRAPH3, %GRAPH4


Modules

PRINT1
PRINT1 generates data listings using PROC REPORT. This macro enables long fields to be split over multiple lines and allows long lines to be wrapped. View PRINT1 Examples
AE1 generates a table of frequency and percent (nnn (xx.x%)) of group. Examples of this type of table are adverse events, medications or physical exams. Results are split out across a grouping variable (usually dose). Results may be ordered by frequency or term values. Counts of subjects or events are optional. View AE1 Examples
Similar to AE1, AE2 generates a table of frequency and percent of group (nnn (xx.x%)) where the terms are displayed in one column, with each term level indented. View AE2 Examples
Similar to AE1, AE3 generates a table of frequency of subjects, percent of subjects in group and frequency of total number of events (nnn (xx.x%) yyy ). View AE3 Examples
DEMOG is used with subject-level data (i.e. data which is structured one record per subject), producing a table with N and percent of treatment group of discrete variables such as age, sex, etc. and summary statistics for continuous variables such as weight, height, etc. View DEMOG Examples
DISP1 generates frequency tables with options to define the layout and denominator used for percentages one row at a time. View DISP1 Examples
SHIFT1 is a general-use macro that produces shift tables for any kind of baseline to post-baseline category shifts. Lab data, ECG, physical exam, etc. can be reported. Two levels of column stratification are supported. Options include control of category order and labeling, calculation of percentages, pageby and total category displays. In most cases, SHIFT1 replaces TABLE2. View SHIFT1 Examples
TABLE2 is used to produce a baseline vs post subject counts of a classification for a parameter. Examples of this type of table are physical examination and ECGs. The input dataset is structured so that parameter and classification are variables. In most cases, SHIFT1 essentially replaces TABLE2 (see above). View TABLE2 Examples
TABLE3 is used to produce row summary statistics for a parameter or parameter/timepoint with dosing displayed as columns. Examples of this type of table are vital signs, ECGs and efficacy. The dataset is structured so that parameter and classification are variables (e.g. test and value respectively), in contrast to demographics where each parameter is an individual variable (e.g. sex, race, etc.). View TABLE3 Examples
TABLE4 is used to produce a table of column summary statistics on result and change from baseline for a parameter, dose and timepoint (displayed as rows). There is an option for counting the number of subjects below and above the reference range, which is commonly used for laboratory data. Examples of this type of table are labs, vital signs and ECGs. The dataset is structured so that parameter and classification are variables (e.g. test and value respectively), in contrast to demographics where each parameter is an individual variable (e.g. sex, race, etc.). View TABLE4 Examples
TABLE5 is used to produce a table of range shift displays with baseline as the row variable and post baseline as the column variables. Ranges can be flagged as Low, Normal, High (L, N, H) or Abnormal, Normal (A, N). View TABLE5 Examples
GRAPH1 creates a PROC GCHART Vertical Bar Chart that can display frequency and group percent of discrete parameters or can display frequency and mean values for continuous parameters. The parameter to be summarized is specified by the user, as are an optional grouping variable and an optional paging parameter. This macro is specific to data that is structured as one record per subject or one record per subject within a BY group, if a BY group is used. Examples of this type of data are demographics data, end of study data, and vital signs data BY visit. View GRAPH1 Examples
GRAPH2 creates a PROC GCHART Horizontal Bar Chart that can display frequency and group percent of discrete parameters such as adverse event term or medication term. The parameter to be summarized is specified by the user, as are an optional grouping variable and an optional paging parameter. This macro is specific to data that is structured as multiple records per subject. Examples of this type of data are adverse event or medications. View GRAPH2 Examples
GRAPH3 creates a PROC GPLOT that can display a Scatter Plot of data at contrasting time points for continuous parameters such as electrocardiogram data, laboratory data and vital signs data results. The parameters to be plotted are specified by the user, as are an optional paging parameter. Additionally, there are options to display reference lines for mean values, display reference lines for reference ranges and allow the selection of an INTERPOL value. This macro is specific to data that is structured as parameters and/or time points per subject. View GRAPH3 Examples
GRAPH4 creates a PROC GPLOT that can display a Plot of mean values with standard error in the mean or a box plot of mean values with the 25% and 75% for data at contrasting time points for continuous parameters such as electrocardiogram data, laboratory data and vital signs data results. The parameters to be plotted are specified by the user, as are an optional paging parameter. Additionally, there are options to display vertical reference and to allow the selection of an INTERPOL value. This macro is specific to data that is structured as parameters and/or time points per subject. View GRAPH4 Examples