Using JMP Clinical | Reviews | Available Reports

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:.
DM Distribution
Compares distributions of demographic variables across treatment arms via a one-way ANOVA or contingency analysis.
Study Visits
Visit Order
Weekdays and Holidays
Perfect Scheduled Attendance
Compares the distributions of study visit days for each center compared to all other centers combined, and identifies unusual differences.
Birthdays and Initials
Enrollment Patterns
Patient Recruitment
Interventions
Reports describing interventions are described in the table below:.
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 Incidence Screen
Screening interventions by performing a Cochran-Mantel-Haenszel exact test on all 2x2 tables constructed from event incidence and treatment arm
Events
Reports examining patient study events are described in the table below:.
AE Distribution
Comparing Distributions of adverse events and demographic variables across treatment arms
AE Narrative
Treatment Emergent AE Summary
AE Incidence Screen
Screening adverse events by performing a Cochran-Mantel-Haenszel exact test on all 2x2 tables constructed from incidence and treatment arm
AE Resolution Screen
Screening adverse events by performing a Cochran-Mantel-Haenszel test on all 2x2 tables constructed from event resolution and treatment arm
AE Severity ANOVA
Screening adverse events by performing a mixed-model analysis of variance, with average ranked severity score as the dependent variable and customizable fixed and random effects
AE Time to Event
Screening adverse events by performing log-rank and Wilcoxon tests between treatment groups
Mortality Time to Event
Discontinuation Time to Event
Creating Kaplan-Meier Survival 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 Incidence Screen
Screening events from a domain by performing a Cochran-Mantel-Haenszel test on all 2x2 tables constructed from event incidence and treatment arm
Note: This report should be considered as two: DS Incidence Screen and MH Incidence Screen, depending on which domain is specified in the dialog.
Standardized MedDRA Queries Distribution
Compares distributions of SMQs across treatment arms.
Standardized MedDRA Queries Incidence Screen
AE Bayesian Hierarchical Model
Fitting Bayesian hierarchical models for adverse events, while taking into account a grouping variable
Findings
Reports examining patient findings are described in the table below:.
Comparing Distributions of findings and demographic variables across treatment arms
Findings Time Trends
Visualizing findings measurements across the timeline of a study
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 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 Waterfall Plots
Creating waterfall plots to show the distribution of changes in test measurements for a given Findings domain across subjects
Findings Bubble Plot
Tracking a pair of findings measurements over time with an animated Bubble Plot
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
Findings ANOVA
Screening findings measurements for a specified domain one at a time by performing a repeated-measures analysis of variance
Findings Time to Event
Defining events using one or more findings tests to be analyzed in a time-to-event analysis
Duplicate Records
Constant Findings
Digit Preference
Outliers
Missing Findings
Frequencies
Correlated Findings
Screening Bias
Summary Statistics
Oncology1
Reports are described in the table below:
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. Measurements plotted on the spider plot and summarized in the waterfall plot represent change or percent change of tumor burden from baseline in measurable/target lesions.
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.
Send2
Reports are described in the table below:
This process compares generates a static report (PDF or RTF) summarizing the general information and pathological observations for each animal in the study.
Reports
Reports are described in the table below:
Study Visit Report
Standard Safety Reports
Generating reports of adverse event counts and percentages by treatment arms, sex, and race
Comment Report
Cross Domain
Reports using data from across multiple domains are described in the table below:.
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
Multivariate Inliers and Outliers
Calculating Mahalanobis distance based on available data to detect subject inliers and outliers in multivariate space, and generating results by site to see which sites are extreme.
Cluster Subjects Across Study Sites
Constructs a cross domain data set and computes a distance matrix and performs hierarchical clustering of subjects across all of the study centers to identify pairs of subjects with a very small distance. This could be an indication that these subjects are in fact the same individual who has enrolled at multiple sites.
Cluster Subjects within Study Sites
Constructs a cross domain data set and computes a distance matrix and performs hierarchical clustering of subjects within each study center to identify pairs of subjects with a very small distance. This could be an indication that these subject are slightly modified copies of one another.
Risk Based Monitoring
Data Management
Click on a button corresponding to a subject utility. Refer to the table below for guidance..
Domain Viewer
Required Domain Report
Checks SAS data sets in the SDTM and ADaM folders that have been specified for the selected study, for all variables required for various JMP Clinical reports.
Review Status Distribution
Displaying the distribution of the review status of subjects in a study
Variable Report
Miscellaneous
Reports are described in the table below:.
Update Study Risk Data Set

1
Oncology reports are surfaced only when the current study contains oncology data sets.

2
SEND reports are surfaced only when the current study contains SEND data.