Clinical Data Analytics (CDA) facilitates data exploration across domains and studies. This app is used to identify trends and outliers while providing traditional line listings, descriptive statistics, and visual patient profiles. It pulls data from the Reporting Data Mart, and always includes the most recent data integrated into elluminate.

CDA can be grouped by compound, therapeutic area, or program. If the CDA app is configured to be grouped at the URL level, the name reflects the grouped app.

Note: Studies with the Therapeutic Area designated as Oncology also includes additional oncology sheets.

CDA, like all Analytics apps, has several common features such as filtering, selection tools, bookmarks, etc. For details on all Analytics functionality, please refer to the Analytics section or the Analytics courses in the Learning Portal.

In this article, users can find information on all available out-of-the-box CDA sheets. Use the Table of Contents at the right to navigate to the sheets of interest.

Important: The list of sheets does not include custom sheets specific to the user's team.

CDA Home Page

The Home Page sheet displays key performance indicators (KPIs) on the status of the subjects across all studies (or selected studies), group assignment details, screened subjects by country, adverse event metrics, and coding metrics.

Note: The default method for assigning Enrolled and Randomized subject statuses in CDA uses the Consented date, meaning subjects must have a consent date prior to being marked as Enrolled or Randomized, which enhances accuracy in tracking subject progress across different study types.

Double-click a KPI to go to the sheet containing visualizations related to that KPI. For example, clicking the Screen Failure KPI, the Inclusion/Exclusion Criteria Not Met sheet opens in a new browser tab.

Tip: Any applied filters (shown in the Selections toolbar) remain when navigating to another sheet. Remove a filter by clicking the 'x' next to the filter in the Selections toolbar.

Adverse Events (12 Sheets)

Adverse Events Bubble

Use the Adverse Events Bubble sheet to track the number of AEs along with the time to onset by System Organ Class or Preferred Term. 

• The Special Interest AE filter on the top row supports both study-level and subject-level AESIs. When making a selection, if subject-level AESIs are present, values with an asterisk (*) indicate that they are subject-level.
• Use the buttons on the left to view by System Organ Class (default) or Preferred Term.
• Click SAE (red text) to view the results of SAEs only.
• To adjust the x-axis, click the Study Day drop-down selector and select Study Day (default), Study Week, or Study Month.

Adverse Event Comparison

Use the Adverse Event Comparison sheet to view a side-by-side graphical comparison and a pivot table of AE data using filters and drop-down selectors, and evaluate differences in response to a therapy.

• Use the filters located above each chart to select the data to compare in the 2 bar charts. Users can filter by Study, Country, Site, Group Assignment, and / or Subject.
• Use the drop-down selectors between the charts to view the charts and the pivot table by:
  • Bars: View the charts' bars by System Organ Class (default), Preferred Term, or Reported Term.
  • Segments: View the bar segments by Toxicity/Severity, Highest Toxicity/Severity, Seriousness, Action Taken, Outcome, Causality, Group Assignment, or Trt Emergent.
  • Measure: View the values by Subject % by Subcategory or Unique Subjects %.

Note: This sheet is not linked to global filters or selections made in other CDA sheets. Filters applied elsewhere do not impact the data or visualizations in the Adverse Event Comparison sheet.

Adverse Events Cross Tabulation

Use the Adverse Events Cross Tabulation sheet to examine AEs for all subjects by system organ class, high-level group term, high-level term, preferred term, or reported term, in a pivot table.

• The Special Interest AE filter on the top row supports both study-level and subject-level AESIs. When making a selection, if subject-level AESIs are present, values with an asterisk (*) indicate that they are subject-level.
• Enter a number in the 'Highlight proportions field where the highest and lowest values in a row differ by at least (n%)' input box; 1 is entered by default. Cells are highlighted in yellow that meet the criteria and the text color of the values are either red or green, indicating the highest and lowest proportion in each row.
• Use the Row drop-down selector to select from System Organ Class (default), High-Level Group Term, High-Level Term, Preferred Term, or Reported Term.
• When System Organ Class is selected as the row, users can click the plus sign next to any SOC to drill-down and view the corresponding Preferred Terms directly in the pivot table.
• Use the 1st Column drop-down selector to view by Study (default), Country, Site, or Group Assignment.
• Use the 2nd Column drop-down selector to view by Toxicity (default), Highest Toxicity, Seriousness, Action Taken, Outcome, Causality, or AE Duration.
• On the top row of the pivot table, click the plus sign to drill-down and see the 2nd column.
• Click the Adverse Event Summary button to navigate to that sheet.

Adverse Events Duration

Use the Adverse Events Duration sheet to identify the abnormal durations with respect to adverse events.

To populate the AE Duration Distribution by PTs (Preferred Terms), select one Preferred Term from the Preferred Term filter in the top right.

• In the AE Duration by System Organ Class / High-Level Group Term / High-Level Term / Preferred Term chart, use the 4-button group to view by System Organ Class (default), High-Level Group Term, High-Level Term, or Preferred Term.
• In the listing, click a Unique Subject Identifier to open the Graphical Patient Profile in Data Central (if the user has permission).

Adverse Events Overlay Labs

Use the Adverse Events Overlay Labs sheet to review adverse events (AEs) against the relevant lab tests per subject. 

First select the adverse event and relevant lab tests from the Event filter, then select one subject from the Subject filter.

In the AE Listing or Lab Listing, click a Unique Subject Identifier to open the Graphical Patient Profile in Data Central (if the user has permission).

Adverse Event Summary

Use the Adverse Event Summary sheet to identify AEs that are prevalent in the subject population, identify event prevalence that is not in alignment with the safety profile of a drug, examine all AEs that led to treatment discontinuation, and evaluate all reported events for potential safety signals and trends.

• The Special Interest AE filter on the top row supports both study-level and subject-level AESIs. When making a selection, if subject-level AESIs are present, values with an asterisk (*) indicate that they are subject-level.
• Select the Subject Counts (default) or Event Counts button at the top right to adjust the view of the two charts at the top.
• Use the 5-button group above the chart on the top left to adjust the view of all three charts. Buttons include System Organ Class (default), High-Level Group Term, High-Level Term, Preferred Term, or Reported Term.
• Use the 8-button group above the chart, located on the top right, to adjust the view of the chart directly below. Buttons include Toxicity (or Severity), Highest Toxicity (or Highest Severity), Seriousness, Action Taken, Outcome, Causality, AE Duration, or Group Assignment.

Note: The names of the charts update based on the selected buttons.

AE/Prior and Concomitant Treatment Association

Use the AE/Prior and Concomitant Treatment Association sheet to review adverse events (AEs) that were treated in relation to the treatments used for those AEs. This process helps ensure that the treatment is clinically related to the AE and confirms that the date of treatment initiation matches the AE information.

• The Special Interest AE filter on the top row supports both study-level and subject-level AESIs. When making a selection, if subject-level AESIs are present, values with an asterisk (*) indicate that they are subject-level.

Exposure and Adverse Events

Click the name of sheet above to navigate to the sheet details.

Med Hist, AE and Prior and Concom Treatment

Use the Med Hist, AE and Prior and Concom Treatment sheet to ensure that the medical history, AE, and prior and concomitant treatments are consistent with logical data relationships. Users can review the information for a given treatment and verify that it corresponds to data entered on either the Medical History Listing (ongoing) or Adverse Events Listing.

MedDRA Comparison Analysis

Use the MedDRA Comparison Analysis sheet to review AE information by the levels of MedDRA classification. Review can be for a study, group of studies, or across a program. Tabulations are presented by group assignment.

• The Special Interest AE filter on the second row supports both study-level and subject-level AESIs. When making a selection, if subject-level AESIs are present, values with an asterisk (*) indicate that they are subject-level.
• Enter a number in the 'Highlight proportions where the highest and lowest values in a row differ by at least (n%)' input box; 1 is entered by default. Cells are highlighted in yellow that meet the criteria and the text color of the values are either red or green, indicating the highest and lowest proportion in each row.
• To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / Collapse in the context menu, then select Expand all or Collapse all.

SMQ Comparison Analysis

Use the SMQ Comparison Analysis sheet to review AE information by Standard MedDRA Queries (SMQ). Review can be for a study, group of studies, or across a program. Tabulations are presented by group assignment. The blue button indicates the MedDRA version being used, clicking the button opens the MedDRA list of versions.

• The Special Interest AE filter on the top row supports both study-level and subject-level AESIs. When making a selection, if subject-level AESIs are present, values with an asterisk (*) indicate that they are subject-level.
• Use the buttons on the left to view by Broad SMQ (default) or Narrow SMQ button.
  • Uncategorized is listed in both Broad and Narrow SMQs, when expanded it includes all AEs that do not fit into any of the Broad or Narrow SMQ terms.
• Enter a number in the 'Highlight proportions where the highest and lowest values in a row differ by at least (n%)' input box; 1 is entered by default. Cells are highlighted in yellow that meet the criteria and the text color of the values are either red or green, indicating the highest and lowest proportion in each row.
• To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.

Treatment Emergent AE Analysis

Use the Treatment Emergent AE Analysis sheet to review the instances of AEs that started on or after the first dose of study medication. Tabulations present the number of events and subjects by various demographic parameters.

• Enter a number in the 'Highlight proportions where the highest and lowest values in a row differ by at least (n%)' input box; 1 is entered by default. Cells are highlighted in yellow that meet the criteria and the text color of the values are either red or green, indicating the highest and lowest proportion in each row.
• Select up to two ages to define a specific age or age range.

Con. Meds (5 Sheets)

AE/Prior and Concomitant Treatment Association

Click the name of sheet above to navigate to the sheet details.

Con-Med Cross Tabulation

Use the Con-Med Cross Tabulation sheet to examine prior and concomitant treatments for all subjects by medication class and the standardized medication name. 

• Use the buttons on the left to view by Subject Counts (default) or Medication Counts.
• In the tabulation chart, use the 6-button group to view by Occurrence (default), Route, CM Duration, Race, Sex, or Ethnicity.
  • To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.

Con-Med Group

Use the Con-Med Group sheet to identify and review subjects who received specific combinations of non-study treatments.

For the sheet to work properly, make selections from the Standardized Medication Name filter or column.

Med Hist, AE and Prior and Concom Treatment

Click the name of sheet above to navigate to the sheet details.

Prior and Concomitant Treatment Summary

Use the Prior and Concomitant Treatment Summary sheet to review non-study treatments in relation to inclusion and exclusion criteria, as well as use of prohibited medications and per-protocol use of required non-study treatments. Additionally, it can be used to evaluate whether certain medications are recorded on the proper CRF page per instructions based on treatment type, indication for use, or date.

• Use the buttons on the left to view by Subject Counts (default) or Medication Counts.
• For the chart on the right, use the top two buttons to view by Standardized Medication (default) or ATC 2 Text.
  • Use the 6-button group to view by Occurrence, Route, CM Duration, Race, Sex, or Ethnicity. 

Death Summary

Use the Death Summary sheet to view the primary cause of death and examine the relationship between death and adverse events for the identification of potential safety signals.

Demographics

Use the Demographics sheet to view and explore counts, percentages, and age ranges for all subjects. 

• Use the 6-button group at the top right to control the view of all three charts on the top half of the sheet. Buttons include Country (default), Site, Group Assignment, Sex, Race, or Ethnicity. The selection updates the chart names.
• Charts include:
  • Subject Counts by Country / etc. - vertical bar chart
  • Subject Counts by Country / etc.  - pie chart
  • Subject Counts by Age and Country / etc. - stacked bar chart
• Current Subject Population is a summary table (lower left) that displays the count of subjects by Subject Status.
• Use the Subject Listing (lower right) to access the subject's demographic and study details.

Disposition Summary

Use the Disposition Summary sheet to review disposition / status events for all subjects and the period in which they occurred. Examine all events or only the latest.

• Use the drop-down selector in the top right corner to select the Category for Disposition Event from all available categories. It defaults to Disposition Event, allows for single selection, and returns the associated data.
• To expand or collapse the rows in the table on the right, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / Collapse in the context menu, then select Expand all or Collapse all.
• Both the Category and the Subcategory Disposition Event are in the listing at the bottom of the sheet.

ECG (2 Sheets)

ECG - Descriptive Stats

Use the ECG - Descriptive Stats sheet to view the distribution of ECG results for each test by various parameters. The box-and-whisker chart beneath the summary tabulations can be used to identify potential trends or outliers in a test requiring further investigation.

To populate the ECG Results box-and-whisker chart, select one test.

Use the buttons above the table to view results by Visit Name (default), Visit Number, Study Day, Study Week, Study Month, Age Range, Sex, Ethnicity, Race, Site, or Group Assignment.

ECG Results Over Time

Use the ECG Results Over Time sheet to examine changes in ECG over time to detect proarrhythmic effects. Review reported results, change, and percent change from either baseline or the previous visit. 

One test must be selected.

• Enter values in the Low Limit Value and High Limit Value fields to apply reference lines to the chart.
• Click the y-axis drop-down arrow to select from Results (beats/min) (default), % Change from Previous Visit, % Change from Baseline, Change from Previous Visit, or Change from Baseline.
• Click the x-axis drop-down arrows to select from Visit Name (default), Study Month, Visit Number, Date of Collection, Study Day, Study Week, or Visit & Timepoint, and Subject (default) Study Month, Visit Number, Date of Collection, Study Day, Study Week, or Visit & Timepoint.

Exposure Data (3 Sheets)

Exposure and Adverse Events

Use the Exposure and Adverse Events sheet to identify safety signals in AEs and dosing data, as well as correlate changes to dosing based on AEs.

Select one Subject or one Reason for Dose Adjustment.

Exposure Data

Use the Exposure Data sheet to review exposure data and explore dosing trends over time for each subject, including reasons for dose adjustments. Apply the filters Study, Subject, Treatment, and / or EX Start Date to narrow the focus of the analysis.

The two subject-level charts, Dosing Over Time/Subject (default) and Dose Change Over Time/Subject, are displayed in a tabbed container and are populated when a single subject is selected.

Both charts feature two x-axis drop-downs allowing users to view data by Start Date of Treatment (default) or Study Day of Start of Treatment, and by Name of Treatment (default) or Study Day of Start of Treatment. The Dose Change Over Time/Subject chart also includes a y-axis drop-down to switch between % Change (default; the percent difference from the previous dose) or Unit Change (the dose change in units).

Exposure Summary

Use the Exposure Summary sheet to view dosing profiles and monitor the duration of subjects' treatment, identify instances where subjects on combination treatments stop one medication before the other, and understand the impact of dosing on subject participation in the study.

Graphical Patient Profile

Use the Graphical Patient Profile (GPP) sheet to review selected subject data over time in graphical form. Users can review AEs, Exposure, Laboratory Data, and Concomitant Medications by date, with symbols color-coded to identify outliers.

One subject must be selected.

• Use the buttons above the chart to view by Study Day (default), Study Week, Study Month, or Event Date.
• To scroll along the y-axis, hold and drag up or down.
• To zoom in or out, place the mouse pointer anywhere on the graph and scroll.

I/E Criteria Not Met

Use the Inclusion/Exclusion Criteria Not Met sheet to identify specific inclusion / exclusion criteria that may be preventing enrollment.

In the treemap chart, the size of the box is proportional to the count.

Labs (11 Sheets)

Adverse Events Overlay Labs

Click the sheet name above to navigate to that sheet's details.

Comparative Lab Results

Use the Comparative Lab Results sheet to compare two lab tests against each other, displayed as a scatter plot.

Select two lab tests from the Test filter.

• Select a Vendor Name to display reference lines.
• By default, the scatter plot displays the average test result score for the selected tests. Click the drop-down arrow in the upper right to select from Average, Minimum, Maximum, or Median.
• The table displays all the test results for the selected tests.

eDISH Plot

Use the eDISH Plot sheet to identify subjects of interest who show evidence of potential drug-induced liver injury based on liver function tests using established criteria such as Hy's Law.

• For the eDISH Plot, use the buttons on the left to adjust the x-axis from ALT (default) to AST.
• By default, all ALP results display; click the drop-down to select from ALP<2xULN, or ALP>=2xULN.
• By default, No Window is selected (the max values can fall at any point within the study); click the drop-down to select from Window 30 days or Less (the max values must fall within 30 days of each other), or Window Same Day (the max values must fall on the same day).
• For the four charts on the right, use the buttons above the charts view by Study Week (default) or Study Day.

Lab - Descriptive Stats

Use the Lab - Descriptive Stats sheet to view the distribution of lab test results for each test by various parameters. The box-and-whisker chart beneath the summary tabulations can be used to identify potential trends or outliers in a test requiring further investigation.

To populate the box-and-whisker chart, select only one test.

• Use the buttons across the top to view by Visit Name (default), Vendor Name, Study Day, Study Week, Study Month, Age Range, Sex, Ethnicity, Race, Site, or Group Assignment.
• To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.

Lab Result Review Over Time

Use the Lab Result Review Over Time sheet to review up to four lab tests over time at once. Review for potential safety signals, inclusion/exclusion violation criteria, or situations where study therapy should be modified. 

Select up to four tests.

• Use the Reference Lines drop-down selector in the upper right to toggle between viewing with the reference lines on or off, reducing visual clutter.
• By default, the charts display the Visit Name on the x-axis. Click the drop-down arrow next to Visit Name in the upper right corner to select from Visit Number, Study Day, Study Week, Study Month, Date of Collection, or Visit & Timepoint.

• In all the charts, click the y-axis drop-down arrow to select from Results (multiple) (default), Change from Baseline, % Change from Baseline, Change from Previous Visit, % Change from Previous Visit, or Absolute Change from Baseline.

  For the Change from Baseline, % Change from Baseline, or Absolute Change from Baseline options, Visit 0 (the baseline visit) shows a value of 0. For the Change from Previous Visit or % Change from Previous Visit options, the earliest recorded visit is blank, because there is no prior value to compare. The Results option displays the original lab result values in the units in which they were collecte as d (e.g., ng/mL).

Lab Result Trends

Use the Lab Result Trends sheet to review lab data by test through various combinations of comparison to identify potential safety signals. Additionally, this sheet allows for the identification of inclusion/exclusion criteria violations through the evaluation of baseline values. 

Select only one test.

• In the middle chart, click the y-axis drop-down to select from Average Post Baseline (multiple) (default), Min Post Baseline (multiple), or Max Post Baseline (multiple).
  • Click the x-axis drop-down arrow to select from Baseline (multiple) (default), Min Post Baseline (multiple), or Max Post Baseline (multiple).

Lab Vendor Details

Use the Lab Vendor Details sheet to track lab results by vendor to aid in follow-up when there are subjects with missing lab test results. 

• Use the buttons on the left to view Lab Test or Examination Name (default) or Lab Test or Examination Short Name.
• By default, the pivot table displays by Visit Name. Click the Visit Name drop-down in the top right corner to select from Visit Number, Study Day, Study Week, or Study Month.
• To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.

Labs Summary

Use the Labs Summary sheet to examine summary lab test results for each test collected, based on any applied filters. 

• By default, the table displays the average test result score across all the test results. Click the drop-down arrow next to Average to select from Minimum, Maximum, or Median.
• Use the 6-button group to view by Visit Name (default), Vendor Name, Group Assignment, Site, Sex, or Toxicity.
• To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.

Labs Summary - Distribution Plot

Use the Labs Summary - Distribution Plot sheet to explore differences in test results by group assignment, which may identify safety issues. The distance between the dots indicates the magnitude of differences in the test results between the group assignments based on the selected parameter (average, minimum, maximum, and median).

• By default, the plot displays the average test result score across all the test results. Click the drop-down arrow next to Average to select from Minimum, Maximum, or Median.
• Use the buttons on the left to view Lab Test or Examination Name (default) or Lab Test or Examination Short Name.

LB and VS Listings

Use the LB and VS Listings sheet to review lab data and vital signs together. 

• Within the Lab Listing, when the Numeric Result in Standard Units is less than the lower limit, the background color of the cell is yellow.
  • If the Numeric Result in Standard Units is greater than the upper limit, the background color of the cell is red.

Liver Lab Test Analysis

Use the Liver Lab Test Analysis sheet to review liver function test abnormalities and to detect possible Hy's Law subjects. 

Medical History (3 Sheets)

Med Hist, AE and Prior and Concom Treatment

Click the sheet name above to navigate to the sheet details.

Medical History Cross Tabulation

Use the Medical History Cross Tabulation sheet to examine the medical history for all subjects by system organ class and preferred terms. 

• Use the buttons on the left to view by Subject Counts (default) or Event Counts.
• In the cross tabulation, use the 8-button group to view by Category (default), MH Duration, Race, Sex, Ethnicity, SubCategory, Occurrence, or Completion Status.
• To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.

Medical History Summary

Use the Medical History Summary sheet to review the medical history for all subjects and examine medical history events in relation to study protocol's inclusion and exclusion criteria.

• Use the buttons on the left to view by Subject Counts (default) or Event Counts.
• In the MH Subject / Event Counts by System Organ Class / Preferred Term and Category chart, use the buttons above the chart to view by System Organ Class (default) or Preferred Term.

Oncology (11 Sheets)

ECOG Performance Status

Use the ECOG Performance Status sheet to view data that indicates the ability of subjects to tolerate serious illness(es), specifically for chemotherapy. The Eastern Cooperative Oncology Group (ECOG) performance assesses how a disease affects the daily living abilities of the subject.

• In the ECOG Performance Score chart, click the x-axis drop-down arrows to select Visit Name (default) or Study Day of Assessment, and Score (default) or Study Day of Assessment.
• In the ECOG Performance Score Over Time chart, click the x-axis drop-down arrows to select Visit Name (default) or Study Day of Assessment, and Subject (default) or Study Day of Assessment.

Objective Response Rate

Use the Objective Response Rate sheet to view the drug efficacy (reviewing the objective response rate) over the study duration.

Response Duration

Use the Response Duration sheet to examine the timeline of response relative to participation in the study for each subject.

Survival Summary

Use the Survival Summary sheet to examine the duration of subject's participation in the treatment and follow-up phases, as well as their overall duration in the study. 

• In the Subject Duration chart, use the tabs to view the Subject Duration - Months (default), or Subject Duration - Days.
• In the Survival Days by Group Assignment chart, click the y-axis drop-down arrows to select from Group Assignment (default), Overall Survival, or Progression Free Survival, and Study Free Survival (default), Overall Survival, or Progression Free Survival.

Note: Subjects with a status of 'Screen Failed' or 'In Screening' have been removed from this sheet as they have not received treatment and therefore should not be part of the analysis.

Swimmers Plot with Subjects' Overall Response

Use the Swimmers Plot with Subjects' Overall Response sheet to view subjects' overall response over time for each subject in a clinical trial. 

Select one Study and one Response Type.

Use the buttons on the left to view by Group Assignment (default) or Disease Type.

Use the buttons at the top center to view results by all subjects (default) or only those who are on treatment or off treatment.

Tumor Identification

Use the Tumor Identification sheet to examine the prevalence of tumors present among subjects in a study or studies. 

In the chart on the right, use the tabs to view the New Lesion Counts (default), or the Subjects Counts.

Tumor Measurement Spider Plot

Use the Tumor Measurement Spider Plot sheet to view tumor measurement percentage change from baseline by Subject and Group Assignment, Disease Type, Best Overall Response, Sex, or Race.

• By default, RECIST evaluation is selected, click the down arrow next to RECIST to select from RANO or LUGANO.
• Use the buttons to view by Group Assignment (default), Disease Type, Best Overall Response, Sex, or Race.
• Select between All Study Days (default) or Study Days >=0.
• Enter the Low Limit Value and High Limit Value to add reference lines.
• Click the x-axis drop-down arrows to select from Study Day of Tumor Measurement (default), Study Month of Tumor Measurement, or Study Week of Tumor Measurement, and Subject (default), Study Month of Tumor Measurement, or Study Week of Tumor Measurement.
• Use the listing at the bottom of the sheet to view the information in tabular format, along with additional details.

Tumor Response

Use the Tumor Response sheet to review of a summary of the response, and drill-down to view individual subject response over time for subjects of interest.

To populate the RECIST Response Trend Over Study Day chart, select one subject.

Tumor Results

Use the Tumor Results sheet to explore tumor measurement results over time. The sum of lesions and the change from baseline in the sum of lesions presented.

• In the Sum of Lesions Over Time (mm) chart, click the x-axis drop-down arrows to select Visit Name (default) or Study Day of Tumor Measurement and Subject (default) or Study Day of Tumor Measurement.
• In the Change from Baseline-Sum of Lesions chart, click the y-axis drop-down arrow to select Change from Baseline-Sum of Lesions (default) or % Change from Baseline-Sum of Lesions.
  • Click the x-axis drop-down arrows to select from Visit Name (default), Days from Baseline, or Study Day of Tumor Measurement, and Subject (default), Days from Baseline, or Study Day of Tumor Measurement.
• When viewing the charts by Study Day of Tumor Measurement, use the buttons on the top right to toggle the view between All Study Days and Study Days >= 0.
• Use the listing at the bottom of the sheet to view the data in tabular format with additional details.

Waterfall Plot

Use the Waterfall Plot sheet to view the best percentage change in tumor size from baseline by the choice of evaluation criteria.

• Enter the Low Limit Value and High Limit Value to add reference lines.
• By default, RECIST evaluation is selected, click the down arrow next to RECIST to select from RANO or LUGANO.

Physical Exam Results

Use the Physical Exam Results sheet to review the results of physical exams. Identify subjects with abnormal findings for patterns in the subject population and compare findings against medical history and adverse events.

Subject Status

Use the Subject Status sheet to review a subject's current progress in a study. 

If the study is configured in Data Central, click the link in the Graphical Profile Link column for a subject to access the  subject's Graphical Patient Profile in Data Central.

Vital Signs (4 Sheets)

LB and VS Listings

Click the name of sheet above to navigate to the sheet details.

Vital Signs - Descriptive Stats

Use the Vital Signs - Descriptive Stats sheet to view the distribution of vital signs data for each test by various parameters. The box-and-whisker chart beneath the summary tabulations can be used to identify potential trends or outliers in a test requiring further investigation.

To populate the box-and-whisker chart, select only one test.

• Use the buttons to view by Visit Name (default), Visit Number, Study Day, Study Week, Study Month, Age Range, Sex, Ethnicity, Race, Site, or Group Assignment.
• To expand or collapse the rows in the table, click the plus sign next to an item in the column on the left, or right-click anywhere in the table and select Expand / collapse in the context menu, then select Expand all or Collapse all.

Vital Signs Result Trends

Use the Vital Signs Result Trends sheet to review vital signs data by test to identify outliers for potential safety signals. Identify inclusion/exclusion criteria violations based on average, minimum, and maximum baseline values. Review vital signs test results distribution by frequency.

Select one test.

• For the chart on the left, enter lower and upper limits to add or adjust the reference lines.
  • Click the y-axis drop-down arrow to select Average Post Baseline (default), Min Post Baseline , or Max Post Baseline.
  • Click the x-axis drop-down arrow to select Baseline (default), Min Post Baseline, or Max Post Baseline.

Vital Signs Results Over Time

Use the Vital Signs Results Over Time sheet to review vital signs results over time, identify potential safety signals, and inclusion/exclusion criteria violations. 

Select one test.

• For the chart on the left, enter the Low Limit Value and High Limit Value to add reference lines.
  • Click the y-axis drop-down arrow to select Results (default), % Change from Previous Visit, or % Change from Baseline.

Application Information

Use the Application Information sheet to view application information, such as what's new in CDA for the current version, the last data refresh date (by domain), a list of special interest adverse events and prohibited medications, a glossary of terms used in CDA, and links to the Standards module, a link to the MedDRA website, the Data Model Profile chart which displays the Actual Cells (number of base data cells) vs the Target Cells (number of standard application cells), and eCS support contact information.

Download Sheet Descriptions

Click the links below to Download the PDF with full sheet descriptions.

• CDA 25.2 Sheet Descriptions Table.pdf300 KB
• CDA 25.2 Home Page Description Table.pdf400 KB