Available Reports

Reports are grouped into functional categories, as listed below:

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
	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

Findings

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

Report	Choose this report for...
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	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

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.

Reports

Reports are described in the table below:

Report	Choose this report for...
Comment Report	Generating a document of study comments obtained from source data pertaining to each subject.
DSUR/PSUR Report	Generating a report for updating regulatory agencies regarding the safety of a clinical trial design and execution for the purpose of securing permission for the continuance of the trial.

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
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
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.
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.
Treatment Emergent Adverse Events Summary	Creating a tabular and graphical overview of treatment emergent adverse events for the safety population by actual treatment arm

Data Quality