Available Reports

Reports are grouped into functional categories, as listed below:

Subject Level

Reports using data from across multiple domains are described in the table below:.

Report	Choose this report for...
Study Flow Diagram	Generates a flow diagram to summarize the overall clinical trial data flow.
Patient Profiles	Profiling subjects is a powerful way to view all of the data for one or more subjects, enabling you to view their entire history and determine potential causes for unexpected events or findings.
Demographics Distribution	Compares distributions of demographic variables across treatment arms via a one-way ANOVA or contingency analysis.
Study Visits	Generating a graphical display and tabulation of study visit attendance.
Create Cross Domain Data	Adding data for various domains to the ADSL table corresponding to incidence of variables in the AE, CM, LB, and MH domains and a summary statistic for LB, EG, and VS domain values

Adverse Events

Reports examining patient study events are described in the table below:

Report	Choose this report for...
Adverse Events Distribution	Comparing Distributions of adverse events and demographic variables across treatment arms for single occurrences of the events.
Adverse Events Multiple Occurrences Distribution	Comparing Distributions of adverse events and demographic variables across treatment armsfor multiple occurrences of the events.
Adverse Events Incidence Rates	Tabulating the number of occurrences of each event and calculating their incidence rates.
Adverse Events Narrative	Generating adverse event narratives for clinical study reports
Adverse Events Time to Event	Screens all adverse eventsby performing log-rank and Wilcoxon tests between treatment groups. The time to first occurrence of the adverse event is used as the response.
Adverse Events Risk Report	Screening all adverse eventsand calculates and generates forest plots of risk differences, relative risks or odds ratios
Medical Query Risk Report	Screens medical query terms by performing Cochran-Mantel-Haenszel (CMH) tests on all 2 x 2 tables constructed from event incidence and treatment arm. Output is a two-sided plot with a dot plot showing percent occurrence and forest plot showing risk measurement.
Algorithmic FDA Medical Query Risk Report	This process uses FMQs with associated algorithms together with data from DMSEX to query AE, LB, and CM for subjects meeting the specified qualifications and the performs Cochran-Mantel-Haenszel (CMH) tests on all 2 x 2 tables constructed from event incidence and treatment arm. Output is a two-sided plot with a dot plot showing percent occurrence and forest plot showing risk measurement along with a table listing number (and percentage) of subjects exhibiting each FMQ by specific qualification.
Custom Medical Query Risk Report	Calculates risk measurements for custom medical queries defined in the adverse events dataset.
Treatment Emergent Adverse Events Summary	Creating a tabular and graphical overview of treatment emergent adverse events for the safety population by actual treatment arm

Other Events

Reports examining patient study events are described in the table below:

Report	Choose this report for...
Clinical Events Distribution	Capturing clinical events specially tracked as being of interest to the particular study and reported in the CE domain.
Events Distribution	Comparing Distributions of events from a domain and demographic variables across treatment arms for single occurrences of the events. Note: This report should be considered as two: DS Distribution and MH Distribution, depending on which domain is specified in the dialog.
Events Multiple Occurrences Distribution	Comparing Distributions of events from a domain and demographic variables across treatment arms for multiple occurrences of the events. Note: This report should be considered as two: DS Distribution and MH Distribution, depending on which domain is specified in the dialog.
Events Risk Report	Screening all events from the specified domain and calculates and generates forest plots of risk differences, relative risks or odds ratios Note: This report should be considered as two: DS Risk Report and MH Risk Report, depending on which domain is specified in the dialog.
Mortality Time to Event	Grouping clinical mortality results by treatment arm and generating Kaplan-MeierSurvival Curves with associated statistics
Discontinuation Time to Event	Creating Kaplan-MeierSurvival Curves for time to study discontinuation and associated statistics, grouped by treatment arm
Disposition Distribution	Comparing Distributions of dispositions across treatment arms with associated risk differences.

Interventions

Reports describing interventions are described in the table below:

Report	Choose this report for...
Exposure Summary	Generating an exposure summary and plot for all subjects in a study of an investigational product, by dose and exposure time for the safety population, by treatment
Interventions Distribution	Comparing Distributions of interventions and demographic variables across treatment arms for single occurrences.
Interventions Multiple Occurrences Distribution	Comparing Distributions of interventions and demographic variables across treatment arms for multiple occurrences.
Interventions Risk Report	Screening all interventions and calculates and generates forest plots of risk differences, relative risks or odds ratios

Findings

Reports examining patient findings are described in the table below:.

Report	Choose this report for...
Acute Kidney Injury	This report assesses the results of multiple lab tests enabling you to determine whether trial subjects have sustained acute kidney injury as a result of receiving the trial drug. Analysis results are presented and summarized in multiple graphs and tables.
Drug-induced Liver Injury	This report assesses the results of multiple lab tests enabling you to determine whether trial subjects have sustained drug-induced liver damage. Analysis results are presented and summarized in multiple graphs and tables.
Findings Box Plots	Displaying Box Plots by treatment group representing the change from baseline in measurements for each test for a specified findings domain across various time windows or points in a study
Findings Distribution	Comparing Distributions of findings and demographic variables across treatment arms
Findings Mean Change from Baseline Tables	Listing the number (and percentage) of patients in each treatment arm at each visit for each specified test and then calculating the mean change from baseline for all patients in each group.
Findings Shift Plots	Displaying Shift Plots to compare test measurements for a specified findings domain at baseline versus on-therapy values, and performing a matched pairs analysis on average score during baseline and a summary score during the trial
Findings Shift Tables	Collecting all of the specified findings test results and constructing a table listing the number (and percentage) of subjects in each treatment arm that are considered high, normal, or low for each test, grouped by visit.
Findings Time Trends	Enables you to visualize findings measurements across the time line of the study.
Findings Waterfall Plots	Creating waterfall plots to show the distribution of changes in test measurements for a given Findings domain across subjects
Hy’s Law Screening	Visualizing peak values for lab measurements pertaining to Hy’s Law for detecting potential liver toxicity for all subjects across treatment arms

Oncology1

Reports are described in the table below:

Report	Choose this report for...
Disease Response Swimmer Plot	This process creates a disease response swimmer plot and tables around either the best or last recorded response rates and calculated objective response rate for solid tumor oncology clinical trials. The results of these assessments are summarized based on selecting either the Best response per subject, based on preferred order: CR, PR, SD, PD for controlled terms, respectively, or Last recorded response. The objective response rate (the sum and percentage of subjects who had CR + PR assessment result) is also calculated and listed in the summary table.
Progression Free Survival	Progression free survival is used to describe how long patients can go without the disease without getting worse. This process uses a modified survival plot and hazard ratio plot to compare the number and percentage of patients who have tumor progression or death, with patients who show no tumor progression or death at the cut-off date.
Tumor Response	This process uses the TR, TU (optional), and RS (optional) oncology domains to create spider plots showing tumor results and waterfall plots showing Best or Last recorded responses.

Reports