Clinical A 0 dose for placebo or vehicle indicates a dose interruption A_G A_G00 A_T A_T00 ADaM Folder Add treatment group difference threshold to select significant tests Additional Class Variables Additional Filter to Include Animals Additional Filter to Include Findings Tests Additional Filter to Include Subjects Additional Fixed Effects AE Narrative Template Age and Sex All study treatments are to be taken at least once per day Alpha Amount of Increment in the Remaining Enrollment (How Often to Simulate) Analyze: Analyze all tests from all findings domains Analyze findings using: Analyze Selected Site Categories Analyze Selected Sites Analyze sites with at least this many subjects: Analyze these digits: Animal Filter B_G B_G00 B_T B_T00 Baseline Time Window Begin Time Binary Variables in ADSL Body System Sorted Alphabetically Body System Sorted by p-Value By Age Group By Race By Sex By Variables Calculate baseline as: Calculate exact Mantel-Haenszel p-values Calculate Relative Risks to compare incidence in treatment groups versus a control Calculate Visit-matched baseline measurements Cardiovascular Character Findings Duration Time Window Method Class Variables Cluster subjects Color Theme Combine Supplemental Domain Combined New Study Name Compute Time Trends Concomitant medications are reported using: Conditions Summary Count multiple occurrences of an event per subject Count multiple occurrences of an intervention per subject Country Create Counts by Severity Create Hy’s Law 3D Plot Create summary statistic variables for numeric findings Current Date Death Age Analysis Death Age Group Death Days Death Gender Death Listing Death Race Derive visits from: Determine Resolved / Not Resolved Status using: Direction of the Treatment Group Difference Display cross-tabulation tables of Baseline versus Trial laboratory measurement elevations Display Subject Identifiers on Waterfall Plot x-Axis Display symmetrical axes for Shift Plots Display Visit summary statistic tables for each findings test Distribution Divisor for Lower Normal Limit Domain Dropout Group and Reason Dropout Listing Drug Body System Duration Time Scale Duration Time Windows Enable Future Snapshot Comparisons End Date End Time Ending Time Value Ethnicity Event Definition Event domains Event Name Event Type Events Exclude comparisons of treatment variables Exclude findings after the last day of study treatment Exclude subjects who experience the event at baseline Filter to Choose Adverse Events for RBM Filter to Choose Appropriate Disposition Event for Completion Status Filter to Choose Deviations for RBM Filter to Choose Disposition Event for Completion or Discontinuation Status Filter to Choose Healthcare Encounters for RBM Filter to Choose Inclusion or Exclusion Criteria for RBM Filter to Include Adverse Events Filter to Include Events Filter to Include Findings Tests Filter to Include Healthcare Encounters Filter to Include Interventions Filter to Include Specific Finding Filter to Include Visits Findings domains Findings Domain to Analyze Findings domain to include Findings Tests Fit model type Fixed Effects Gradient Convergence Criterion Generate summary statistics by visit Group 1 Group 2 Group 3 Group 4 Group 5 Group Level Healthcare encounters are reported using: Hepatotoxicity Patient Listing Hierarchical Clustering Method High and Low Labs Ignore duplicate records when covariates don’t match Ignore duplicate records within subject Import SAS Transport Files Import SAS Transport Files (If Available) Include a findings domain in the narrative Include adverse event reports Include closest on-study findings test dates: Include concomitant medication indication in narrative Include demographic reports Include disposition reports Include Exponentiated Estimates and Differences Include exposure (EX) in the narrative Include healthcare encounters (HO) in the narrative Include lab reports Include medical history reports Include on-study lab tests where reference range indicator is: Include p-values in addition to -log10(p-values) Include serious adverse events only Include subject-level table of contents Include summary for subjects with severe TEAE Include summary of baseline findings Include t-statistics Include the following adverse events: Include the following events: Include the following findings records: Include the following interventions: Incorporate Findings Time Points in plots Initial Number of Additional Centers Intervention domains Intervention Type Interventions JMP Script Output File Name L_A L_B Label Hy’s Law quadrants Lab Test Short Name for Alanine Aminotransferase Lab Test Short Name for Alkaline Phosphatase Lab Test Short Name for Aspartate Aminotransferase Lab Test Short Name for Bilirubin Linearly interpolate values List every model fit Listing Location of MedDRA ASCII Files -log10(p-Value) Cutoff log Transformation of Lab Measurements Lower or Higher Outcome Better LSMeans Difference Set for Volcano Plots LSMeans Treatment Control Level Match subjects based on: Maximum Probability of Meeting the Target Date to Initiate Adaptive Adjustment Mean Change from Baseline Mean Chemistry Values for Visit Mean Values Baseline Worst Medical history terms are reported using: Merge supplemental domain Minimum Probability of Meeting the Target Date to Stop Adding New Centers Model baseline as: Monitor Mortality Treatment Group mu_G00 mu_T00 Multiple Testing Method Multiplier for Upper Normal Limit Multiplier of Abnormal High Lab Test at Baseline Multiplier of Abnormal Low Lab Test at Baseline New Combined ADaM Folder New Combined SDTM or SEND Folder New SDTM Folder New Study Name Normalization of Lab Measurements Normalize laboratory values by: Number of Bins for Dose Group Number of Burn In Samples to Discard per Markov Chain Number of days around Adverse Event start date for reported related events Number of Days around Birthday Number of Days Delayed at New Centers Number of days prior to Adverse Event start date for reporting concomitant medications Number of decimals for numeric findings Number of decimals to display for event percentages in tables Number of decimals to display for summary statistics in tables Number of Duration Time Windows Number of Monte-Carlo Samples Number of Posterior Samples per Markov Chain Number of Simulations Number of Time Windows Offset for End of Dosing Output as PDF Output as RTF Output Data Set Output Folder Output report as Overall Summary Statistic to Display in Plots Overlay treatment groups in plots Overlay visits when treatment crossover is detected Patient Population by Age Patient Population by Race Patient Population by Sex Patient Population by Treatment Patient Visit Count PDF Percent Body System Percent Drug Body System Percent Occurrence Threshold Perform Double FDR Adjustment Perform incidence analysis using the following SMQs: Perform Matched-Pairs analysis of Baseline versus Trial measurements for each treatment group Perform treatment comparison analysis for demographic variables Plot average time trends across treatment groups Plot findings measurements as: Plot standardized residuals Pool subjects in average time trend plots when treatment crossover is detected Race Random Effects Random seed for simulation Refer to findings tests using: Reference Treatment Level Reference Value or Day Relationship to Drug Remove all variables with missing values Remove tests when percentage of subjects expected for a test is equal to or below: Remove unscheduled visits Remove variables from analysis with a missing data percentage of at least: Report healthcare encounters this many days around Adverse Event start date: Report the following healthcare encounters: Response Type Restrict plots to measurements within a starting time and ending time Risk Threshold Data Set Round numeric findings results RTF SAE Listing SDTM or SEND Folder Seed Number Select a task Select the population to include in the analysis Selected ADaM Domains Selected SDTM Domains Selected Studies Set Age Groups Set custom reference lines for bubble plot Set custom reference lines for Hy’s Law plots Set reference line for transaminase tests Set reference line for bilirubin Set reference line for x-Axis Set Reference Line for y-Axis Severity Sex Show ULN and LLN reference lines for lab tests Show standard error bars for treatment group time trends Significant Changes Size of Time Window in Days SMQ Folder Special visit numbers Specify Target Enrollment Specify the Number of Independent Markov Chains Specify the Rate of Thinning Specify the Seed Value Start Date Starting Time Value Stratification Variables Study Study Name Subject Filter Subsequent visits Summarize multiple records per day using: Summarize sites with at least this many subjects: Summary Report Summary Statistic for Findings Data Summary Statistic for Trial Data Summary Statistic to Compute Within Time Windows or Visits Summary Statistics to Display in Tables Supplemental SAS data set for RBM Target Date Target Enrollment Target Enrollment of Subjects per Week per Site tau2_G00 tau2_T00 Term Level Test Treatment Level Define events as: Time Lag (in Days) for Classifying Hy’s Law Cases Time Scale Time Unit Time Windows for Start of AE Time Window Method Totals Treatment Control Level Treatment end date is equivalent to the start date Treatment Group Difference Cutoff Treatment Variable Treatment or Comparison Variable Treatment or Comparison Variable to Use Trial Time Windows Truncate Early Recruitment Data Truncation Date Use log scaling to display findings test measurements Use result or finding in: Use site active date from the Risk Data Set, if available Use site active date from the Study Risk Data Set, if available Use subject identifier for study in lieu of unique subject identifier, if available Use the following time scale for exposure time Use the Last Randomization Date as Current Date Vendor Visit Number 1 Visit Number 2 Visit Number to Compare to Visit 1 x-Axis Findings Test Short Name Value x-Axis for Volcano Plot y-Axis Findings Test Short Name Value