Available Reports

Reports are grouped into functional categories, as listed below:

Demographics and Visits

Reports examining patient demographics and study visit attendance 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.
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.

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
Interventions Risk Report	Screening all interventions and calculates and generates forest plots of risk differences, relative risks or odds ratios

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
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 Risk Report	Screening all adverse eventsand calculates and generates forest plots of risk differences, relative risks or odds ratios
Clinical Events Distribution	Capturing clinical events specially tracked as being of interest to the particular study and reported in the CE domain.
Discontinuation Time to Event	Creating Kaplan-MeierSurvival Curves for time to study discontinuation and associated statistics, grouped by treatment arm
Events Distribution	Comparing Distributions of events from a domain and demographic variables across treatment arms 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.
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.
Mortality Time to Event	Grouping clinical mortality results by treatment arm and generating Kaplan-MeierSurvival Curves with associated statistics
Treatment Emergent Adverse Events Summary	Creating a tabular and graphical overview of treatment emergent adverse events for the safety population by actual treatment arm

Findings

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

Report	Choose this report for...
Constant Findings	Identifying tests from findings domains that have the same result for the entire study
Digit Preference	Assesses the use of terminal digits by study sites when reporting their clinical findings to identify those sites that might exhibit biases in rounding issues or other problems with how they report data.
Duplicate Records	Identifying sets of records that have identical values on more than one occasion within a subject or between subjects within a study site
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 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 Time Trends	Visualizing findings measurements across the timeline of a 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
Missing Findings	Determines whether individuals are missing data for all test codes across all Findings domains, based on data available at each visit number and time point number.
Outliers	Identifies outliers and identifies sites with excessive outliers.

Oncology1

Reports are described in the table below:

Report	Choose this report for...
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.

Reports