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

CDA can be grouped by compound, therapeutic area, or program. If the CDA app is configured for URL-level grouping, the application name reflects the grouped app.

Use the filters at the top of each sheet to refine the displayed data.

Tip: Applied filters remain when navigating between sheets. Clear a selection from the Selections toolbar to remove the filter.

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

Important: The list of sheets does not include custom sheets specific to your organization.

CDA Home Page

The Home Page displays key performance indicators (KPIs) for subject status 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. Subjects must have a consent date before they are marked as Enrolled or Randomized.

Double-click a KPI to open the related sheet in a new browser tab. For example, double-click the Screen Failure KPI to open the Inclusion/Exclusion Criteria Not Met sheet.

Adverse Events (8 Sheets)

Adverse Events Bubble

Use the Adverse Events Bubble sheet to review the number of adverse events (AEs) and time to onset by system organ class or preferred term.

• The Special Interest AE filter supports both study-level and subject-level adverse events of special interest (AESIs). When subject-level AESIs are present, values with an asterisk (*) indicate subject-level AESIs. 
• Use the buttons on the left to select System Organ Class (default) or Preferred Term. 
• Click SAE to display serious adverse events only.
• Click the Study Day drop-down selector to select Study Day (default), Study Week, or Study Month.

Adverse Event Comparison

Use the Adverse Event Comparison sheet to compare adverse event (AE) data side by side using bar charts and a pivot table and evaluate differences in response to therapy.

• Use the filters above each chart to select the data to compare in the two bar charts. Filter by Study, Country, Site, Group Assignment, or Subject. 
• Use the drop-down selectors between the charts to configure the charts and pivot table:
  • Bars: Display bars by System Organ Class (default), Preferred Term, or Reported Term.
  • Segments: Display bar segments by Toxicity/Severity, Highest Toxicity/Severity, Seriousness, Action Taken, Outcome, Causality, Group Assignment, or Trt Emergent.
  • Measure: Display 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 affect the data or visualizations in the Adverse Event Comparison sheet.

Adverse Events Cross Tabulation

Use the Adverse Events Cross Tabulation sheet to review adverse events (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 supports both study-level and subject-level adverse events of special interest (AESIs). When subject-level AESIs are present, values with an asterisk (*) indicate subject-level AESIs. 
• Enter a value 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 that meet the threshold are highlighted in yellow. The highest and lowest proportions in each row display in red and green text. 
• Use the Row drop-down selector to select System Organ Class (default), High-Level Group Term, High-Level Term, Preferred Term, or Reported Term. When System Organ Class is selected, click the plus sign next to an SOC to drill down and view the corresponding Preferred Terms in the pivot table. 
• Use the 1st Column drop-down selector to select Study (default), Country, Site, or Group Assignment. 
• Use the 2nd Column drop-down selector to select Toxicity (default), Highest Toxicity, Seriousness, Action Taken, Outcome, Causality, or AE Duration. 
• In the pivot table header, click the plus sign to drill down and display the second column. 
• Click Adverse Event Summary to open the Adverse Event Summary sheet.

Adverse Events Duration

Use the Adverse Events Duration sheet to identify abnormal adverse event (AE) durations.

To populate 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 four-button group to select 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. Access requires the appropriate permission.

Adverse Event Summary

Use the Adverse Event Summary sheet to identify prevalent adverse events (AEs), review events that do not align with a drug's safety profile, examine AEs that led to treatment discontinuation, and evaluate reported events for potential safety signals and trends.

• The Special Interest AE filter supports both study-level and subject-level adverse events of special interest (AESIs). When subject-level AESIs are present, values with an asterisk (*) indicate subject-level AESIs. 
• Select Subject Counts (default) or Event Counts at the top right to update the two charts at the top. 
• Use the five-button group above the chart on the top left to update all three charts. Select System Organ Class (default), High-Level Group Term, High-Level Term, Preferred Term, or Reported Term. 
• Use the eight-button group above the chart on the top right to update the chart directly below. Select Toxicity (or Severity), Highest Toxicity (or Highest Severity), Seriousness, Action Taken, Outcome, Causality, AE Duration, or Group Assignment.

Note: Chart names update based on the selected buttons.

MedDRA Comparison Analysis

Use the MedDRA Comparison Analysis sheet to review adverse event (AE) data by MedDRA classification level for a study, group of studies, or program. Tabulations are presented by group assignment.

• The Special Interest AE filter supports both study-level and subject-level adverse events of special interest (AESIs). When subject-level AESIs are present, values with an asterisk (*) indicate subject-level AESIs. 
• Enter a value 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 that meet the threshold are highlighted in yellow. The highest and lowest proportions in each row display in red and green text. 
• To expand or collapse table rows, click the plus sign next to an item in the left column. To expand or collapse all rows, right-click the table, select Expand / collapse, and then select Expand all or Collapse all.

SMQ Comparison Analysis

Use the SMQ Comparison Analysis sheet to review adverse event (AE) data by Standardized MedDRA Queries (SMQs) for a study, group of studies, or program. Tabulations are presented by group assignment.

The MedDRA Version indicator identifies the MedDRA version used for the analysis. When the analysis uses a custom SMQ configuration, the indicator identifies the custom SMQ version. Click the MedDRA Version indicator to view the list of MedDRA versions.

• The Special Interest AE filter supports both study-level and subject-level adverse events of special interest (AESIs). When subject-level AESIs are present, values with an asterisk (*) indicate subject-level AESIs.
• Use the buttons on the left to select Broad SMQ (default), Narrow SMQ, or Both.
  • Uncategorized is included in both Broad and Narrow SMQs. Expand Uncategorized to view AEs that do not match a Broad or Narrow SMQ term.
• Enter a value 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 that meet the threshold are highlighted in yellow. The highest proportion in each row displays in red text, and the lowest proportion displays in green text.
• The SMQ Terms By Proportion distribution plot displays the proportion of subjects with adverse events for each SMQ term by group assignment. Use the plot to compare event proportions across group assignments and identify unusually high or low event rates.
• The SMQ Terms By Adverse Events & Subjects scatter plot compares the number of adverse events with the number of affected subjects by group assignment. Use the plot to identify concentrated event patterns, potential safety signals, or data requiring further review.
• The pivot table displays adverse event proportions by group assignment and provides information about how the proportions are calculated.
• To expand or collapse a pivot table row, click the plus sign next to an item. To expand or collapse all rows, right-click the table, select Expand / collapse, and then select Expand all or Collapse all.

Treatment Emergent AE Analysis

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

• Enter a value 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 that meet the threshold are highlighted in yellow. The highest and lowest proportions in each row display in red and green text. 
• Select up to two ages to define a specific age or age range.

Con. Meds (3 Sheets)

Con-Med Cross Tabulation

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

• Use the buttons on the left to select Subject Counts (default) or Medication Counts.
• In the tabulation chart, use the six-button group to select Occurrence (default), Route, CM Duration, Race, Sex, or Ethnicity.
  • To expand or collapse a table row, click the plus sign next to an item. To expand or collapse all rows, right-click the table, select Expand / collapse, and 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.

To display results, select one or more values from the Standardized Medication Name filter or column.

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, prohibited medications, and required non-study treatments. The sheet also supports evaluating whether medications are recorded on the appropriate CRF page based on treatment type, indication for use, or date.

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

Death Summary

Use the Death Summary sheet to review the primary cause of death and the relationship between deaths and adverse events to identify potential safety signals.

Demographics

Use the Demographics sheet to review subject counts, percentages, and age ranges.

• Use the six-button group at the top right to control the view of the three charts in the top half of the sheet. Select Country (default), Site, Group Assignment, Sex, Race, or Ethnicity. The selection updates the chart names.
• The sheet includes the following charts:
  • 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
• The Current Subject Population summary table displays subject counts by Subject Status. 
• The Subject Listing provides demographic and study details for each subject.

Disposition Summary

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

• Use the drop-down selector in the top right corner to select a Category for Disposition Event. Disposition Event is selected by default, and the selector supports a single selection. 
• To expand or collapse a table row, click the plus sign next to an item. To expand or collapse all rows, right-click the table, select Expand / collapse, and then select Expand all or Collapse all.
• The listing at the bottom of the sheet includes Category and Subcategory Disposition Event.

ECG (2 Sheets)

ECG - Descriptive Stats

Use the ECG - Descriptive Stats sheet to review the distribution of ECG results for each test by selected parameters. The box-and-whisker chart beneath the summary tabulations can help identify trends or outliers that require further investigation.

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

Use the buttons above the table to select 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 review changes in ECG results over time and identify potential proarrhythmic effects. Review reported results, change, and percent change from baseline or the previous visit.

Select one test to display the chart.

• Enter values in the Low Limit Value and High Limit Value fields to add reference lines to the chart.
• Click the y-axis drop-down arrow to select 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:
  • Visit Name (default), Study Month, Visit Number, Date of Collection, Study Day, Study Week, or Visit & Timepoint
  • Subject (default), Study Month, Visit Number, Date of Collection, Study Day, Study Week, or Visit & Timepoint

Exposure Data (2 Sheets)

Exposure Data

Use the Exposure Data sheet to review exposure data and dosing trends over time for each subject, including reasons for dose adjustments.

The Dosing Over Time/Subject (default) and Dose Change Over Time/Subject charts are available in a tabbed view and display data when one subject is selected.

• In both charts, use the x-axis drop-downs to select:
  • Start Date of Treatment (default) or Study Day of Start of Treatment
  • Name of Treatment (default) or Study Day of Start of Treatment
• In the Dose Change Over Time/Subject chart, use the y-axis drop-down to select % Change (default), which displays the percent difference from the previous dose, or Unit Change, which displays the dose change in units.

Exposure Summary

Use the Exposure Summary sheet to review dosing profiles, treatment duration, and the impact of dosing on study participation. The sheet also helps identify when subjects receiving combination treatments stop one medication before another.

Graphical Patient Profile

Use the Graphical Patient Profile (GPP) sheet to review selected subject data over time in graphical form. Review adverse events (AEs), exposure, laboratory data, and concomitant medications by date. Color-coded symbols identify outliers.

Select one subject to display data.

• Use the buttons above the chart to select Study Day (default), Study Week, Study Month, or Event Date.
• To scroll along the y-axis, click and drag up or down.
• To zoom in or out, place the pointer over the graph and scroll.

I/E Criteria Not Met

Use the Inclusion/Exclusion Criteria Not Met sheet to identify inclusion and exclusion criteria that may prevent enrollment.

In the treemap chart, box size represents the count.

Labs (9 Sheets)

Comparative Lab Results

Use the Comparative Lab Results sheet to compare two lab tests in 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 result for the selected tests. Click the drop-down arrow in the upper right to select Average, Minimum, Maximum, or Median.
• The table displays all results for the selected tests.

eDISH Plot

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

• For the eDISH Plot, use the buttons on the left to select ALT (default) or AST for the x-axis. 
• By default, all ALP results display. Use the drop-down to select ALP<2xULN or ALP>=2xULN. 
• No Window is selected by default, allowing maximum values to occur at any point during the study. Use the drop-down to select:
  • Window 30 days or Less when maximum values must occur within 30 days of each other.
  • Window Same Day when maximum values must occur on the same day.
• For the four charts on the right, use the buttons above the charts to select Study Week (default) or Study Day.

Lab - Descriptive Stats

Use the Lab - Descriptive Stats sheet to review the distribution of lab test results for each test by selected parameters. The box-and-whisker chart beneath the summary tabulations can help identify trends or outliers that require further investigation.

Select one test to populate the box-and-whisker chart.

• Use the buttons across the top to select Visit Name (default), Vendor Name, Study Day, Study Week, Study Month, Age Range, Sex, Ethnicity, Race, Site, or Group Assignment.
• To expand or collapse a table row, click the plus sign next to an item. To expand or collapse all rows, right-click the table, select Expand / collapse, and 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 for potential safety signals, inclusion or exclusion criteria violations, or situations that may require study therapy modification.

Select up to four tests.

• Use the Reference Lines drop-down selector in the upper right to display or hide reference lines.
• By default, the charts display Visit Name on the x-axis. Click the drop-down arrow next to Visit Name in the upper right corner to select Visit Number, Study Day, Study Week, Study Month, Date of Collection, or Visit & Timepoint.
• In all charts, click the y-axis drop-down arrow to select Results (multiple) (default), Change from Baseline, % Change from Baseline, Change from Previous Visit, % Change from Previous Visit, or Absolute Change from Baseline.
  • For Change from Baseline, % Change from Baseline, and Absolute Change from Baseline, Visit 0 (the baseline visit) displays a value of 0.
  • For Change from Previous Visit and % Change from Previous Visit, the earliest recorded visit is blank because no prior value is available for comparison.
  • Results (multiple) displays the original lab result values in the units in which they were collected, such as ng/mL.

Lab Result Trends

Use the Lab Result Trends sheet to review lab test results using different comparisons to identify potential safety signals and inclusion or exclusion criteria violations based on baseline values.

Select one test.

• In the middle chart, click the y-axis drop-down to select Average Post Baseline (multiple) (default), Min Post Baseline (multiple), or Max Post Baseline (multiple).
  • Click the x-axis drop-down arrow to select 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 and identify subjects with missing lab test results that may require follow-up.

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

Labs Summary

Use the Labs Summary sheet to review summary results for each collected lab test.

• By default, the table displays the Average result across all test results. Click the drop-down arrow next to Average to select Minimum, Maximum, or Median. 
• Use the six-button group to select Visit Name (default), Vendor Name, Group Assignment, Site, Sex, or Toxicity. 
• To expand or collapse a table row, click the plus sign next to an item. To expand or collapse all rows, right-click the table, select Expand / collapse, and then select Expand all or Collapse all.

Labs Summary - Distribution Plot

Use the Labs Summary - Distribution Plot sheet to compare lab test results by group assignment and identify potential safety signals. The distance between the dots represents the magnitude of differences between group assignments based on the selected measure.

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

Liver Lab Test Analysis

Use the Liver Lab Test Analysis sheet to review liver function test abnormalities and identify subjects who may meet Hy's Law criteria.

Medical History (2 Sheets)

Medical History Cross Tabulation

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

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

Medical History Summary

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

• Use the buttons on the left to select 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 select System Organ Class (default) or Preferred Term.

Oncology (11 Sheets)

ECOG Performance Status

Use the ECOG Performance Status sheet to review Eastern Cooperative Oncology Group (ECOG) performance status data and assess how disease affects a subject's ability to perform daily activities and tolerate treatment.

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

Objective Response Rate

Use the Objective Response Rate sheet to review drug efficacy based on objective response rate over the study duration.

Response Duration

Use the Response Duration sheet to review the duration and timing of response relative to study participation for each subject.

Survival Summary

Use the Survival Summary sheet to review the duration of each subject's participation in the treatment and follow-up phases and overall study duration.

• In the Subject Duration chart, use the tabs to select 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:
  • Group Assignment (default), Overall Survival, or Progression Free Survival
  • Study Free Survival (default), Overall Survival, or Progression Free Survival

Note: Subjects with a status of 'Screen Failed' or 'In Screening' are excluded from this sheet because they have not received treatment and are not included in the analysis.

Swimmers Plot with Subjects' Overall Response

Use the Swimmers Plot with Subjects' Overall Response sheet to review each subject's overall response over time.

Select one study from the Study filter and one response type from the Response Type filter.

• Use the buttons on the left to select Group Assignment (default) or Disease Type.
• Use the buttons at the top center to display All Subjects (default), subjects who are on treatment, or subjects who are off treatment.

Tumor Identification

Use the Tumor Identification sheet to review the prevalence of tumors among subjects across one or more studies.

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

Tumor Measurement Spider Plot

Use the Tumor Measurement Spider Plot sheet to review tumor measurement percentage change from baseline by subject and selected dimensions.

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

Tumor Response

Use the Tumor Response sheet to review a summary of tumor response and individual subject response over time.

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

Tumor Results

Use the Tumor Results sheet to review tumor measurement results over time, including the sum of lesions and change from baseline in the sum of lesions.

• 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
  • 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:
    • Visit Name (default), Days from Baseline, or Study Day of Tumor Measurement
    • 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 select All Study Days or Study Days >=0. 
• The listing at the bottom of the sheet provides tumor measurement data and additional details in tabular format.

Waterfall Plot

Use the Waterfall Plot sheet to review the best percentage change in tumor size from baseline based on the selected evaluation criteria.

• Enter values in the Low Limit Value and High Limit Value fields to add reference lines. 
• RECIST is selected by default. Click the drop-down arrow next to RECIST to select RANO or LUGANO.

Physical Exam Results

Use the Physical Exam Results sheet to review physical exam results, identify patterns in abnormal findings across the subject population, and compare findings with medical history and adverse events.

Subject Status

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

For studies configured in Data Central, click the link in the Graphical Profile Link column to open the subject's Graphical Patient Profile in Data Central.

Vital Signs (3 Sheets)

Vital Signs - Descriptive Stats

Use the Vital Signs - Descriptive Stats sheet to review the distribution of vital signs results for each test by selected parameters. The box-and-whisker chart beneath the summary tabulations can help identify trends or outliers that require further investigation.

Select one test to populate the box-and-whisker chart.

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

Vital Signs Result Trends

Use the Vital Signs Result Trends sheet to review vital signs results by test, identify outliers and potential safety signals, and identify inclusion or exclusion criteria violations based on average, minimum, and maximum baseline values. The sheet also displays the distribution of vital signs test results by frequency.

Select one test.

• For the chart on the left, enter lower and upper limits to add or adjust 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 and identify potential safety signals or inclusion or exclusion criteria violations.

Select one test.

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

Multi-Domain Sheets (5 Sheets)

Adverse Events Overlay Labs & Vitals

Use the Adverse Events Overlay Labs & Vitals sheet to review adverse events (AEs) in relation to relevant laboratory or vital signs test results for each subject.

Select the adverse event and relevant laboratory or vital signs tests from the Event filter, then select one subject from the Subject filter. Based on the selected Event values, the chart and listings display either AE and laboratory data or AE and vital signs data.

Use the chart to review measurement results and reference limits in relation to the timing of AEs.

• In the AE Listing, Lab Listing, or VS Listing, click a Unique Subject Identifier to open the Graphical Patient Profile in Data Central. Access requires the appropriate permission.

AE/Prior and Concomitant Treatment Association

Use the AE/Prior and Concomitant Treatment Association sheet to review adverse events (AEs) in relation to the prior and concomitant treatments used for those events. The sheet helps evaluate whether a treatment is clinically related to an AE and whether the treatment start date aligns with the AE information.

• The Special Interest AE filter supports both study-level and subject-level adverse events of special interest (AESIs). When subject-level AESIs are present, values with an asterisk (*) indicate subject-level AESIs.

Exposure and Adverse Events

Use the Exposure and Adverse Events sheet to identify potential safety signals in adverse event (AE) and dosing data and evaluate changes in dosing associated with AEs.

Select one subject from the Subject filter or one reason from the Reason for Dose Adjustment filter.

Med Hist, AE and Prior and Concom Treatment

Use the Med Hist, AE and Prior and Concom Treatment sheet to review medical history, adverse event (AE), and prior and concomitant treatment data for consistent and logical relationships. Review a treatment to determine whether it corresponds to data in the Medical History Listing (ongoing) or Adverse Events Listing.

LB and VS Listings

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

• In the Lab Listing, cells in the Numeric Result in Standard Units column are highlighted based on the reference limits:

  • Values below the lower limit are highlighted in yellow.
  • Values above the upper limit are highlighted in red.

Application Information

Use the Application Information sheet to view What's New information for the current CDA version, data refresh information by domain, special interest adverse events and prohibited medications, a glossary of CDA terms, links to the Standards module and MedDRA website, the Data Model Profile chart, and eClinical Solutions Support contact information.

The Data Model Profile chart compares the number of actual data cells with the target number of standard application cells.

The MedDRA Version indicator identifies the MedDRA version used by CDA. When CDA uses a custom SMQ configuration, the indicator identifies the custom SMQ version. Click the MedDRA Version link to view the list of MedDRA versions.