Report Option Descriptions 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 Adverse Events Additional Filter to Include Animals Additional Filter to Include Disease Response Records Additional Filter to include Events Additional Filter to Include Findings Records Additional Filter to Include Findings Tests Additional Filter to Include Subjects Additional Filter to include tumor results records Additional Fixed Effects AE Narrative Template Age and Sex Age Group 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 for: Analyze Selected Site Categories Analyze Selected Sites Analyze sites with at least this many subjects: Analyze these digits: Animal Filter Annotate Plots with Selected Disposition Events Annotate disposition events and new lesions that occur between tumor results visits: Attempt study combinations when study variables don’t match 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 variables for table transpose By Race By Sex By Variables Calculate baseline as: Calculate exact Mantel-Haenszel p-values Calculate Overall Response Rate as Calculate Relative Risks to compare incidence in treatment groups versus a control Calculate Visit-matched baseline measurements Cardiovascular Character Findings Class Variables Cluster subjects Color Theme Combine Supplemental Domain Combined New Study Name Compute Time Trends Consider BY variables in the analysis Consider Group Level to identify unique event terms Concomitant Medications 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 additional distributions for selected variables Create Age Group Table Create Counts by Severity Create Hy’s Law 3D Plot Create summary statistic variables for numeric findings Category for Response Assessment Criteria Identification Current Date Death Age Analysis Death Age Group Death Days Death Gender Death Listing Death Race Default value for lesions marked TOO SMALL TO MEASURE Derive visits from: Determine Resolved / Not Resolved Status using: Direction of the Treatment Group Difference Disease Response Test for Analysis Display cross-tabulation tables of Baseline versus Trial laboratory measurement elevations Display shift tables of Baseline versus Trial laboratory measurement elevations Display shift tables by Treatment Variable values Display subject count bar charts on average time trend plots Display Subject Identifiers on swimmer plot y-axis 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 Scale to Plot on X-Axis Duration Time Window Method Duration Time Windows Enable Future Snapshot Comparisons End Date End Date Variable to Use for Censoring End Date Variable to Use for Subject Duration 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 Appropriate Supplemental AE Records for Multiple Causalities or Actions 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 Exposure Records Filter to Include Findings Tests Filter to Include Healthcare Encounters Filter to Include Interventions Filter to Include Specific Finding Filter to Include Visits Filter to only include Target Lesions in numeric result summaries Findings domains Findings Domain to Analyze Findings Domain Tests for Analysis Findings domain tests to include Findings domain to include Findings Tests Fit model type Fixed Effects Gender Gradient Convergence Criterion Generate summary statistics by visit Group 1 Group 2 Group 3 Group 4 Group 5 Group Level Groups Subjects by Treatment Variable Healthcare encounters are reported using: Hepatotoxicity Patient Listing Hierarchical Clustering Method High and Low Labs High Baseline Lab Tests Ignore available treatment emergent flags Ignore duplicate records when covariates don’t match Ignore duplicate records within subject Import SAS Transport Files Use SAS Transport Files Include a findings domain in the narrative Include adverse event reports Include Age Include aggregate subject count and percentages for shift table categories Include closest on-study findings test dates: Include concomitant medication indication in narrative textInclude a summary table of concomitant medications Include concomitant medication indication in narrative textInclude a summary table of concomitant medications Include demographic reports Include disposition reports Include event domains Include events with overall percent occurrence greater than Include events or interventions experienced by at least this percent of patients: Include Exponentiated Estimates and Differences Include exposure (EX) in the narrative Include findings domains Include healthcare encounters (HO) in the narrative Include intervention domains Include interventions with overall percent occurrence greater than 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 Progressive Disease responses on swimmer plot Include serious adverse events only Include Sex Include Stable Disease responses on swimmer plot 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 exposure Include the following findings records: Include the following interventions: Include the reported event term in the header only when different than the coded term 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 Limit reported related events to those that are serious Linearly interpolate values List every model fit Listing Location of MedDRA ASCII Files -log10(p-Value) Cutoff log Transformation of Lab Measurements Low Baseline Lab Tests Lower or Higher Outcome Better LSMeans Difference Set for Volcano Plots LSMeans Treatment Control Level Mark subjects with selected disposition events in the waterfall plot 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 Medical history terms are reported using: Medical history terms are summarized as a 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 Censor End Date (in Study Days) Offset for End of Dosing Only include BY variables if they are domain keys Only include on-trial measurements Only mark the first occurrence of a new lesion for each subject 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 Oneway or Contingency Analysis Perform treatment comparison analysis for demographic variables Plot average time trends across treatment groups Plot findings measurements as: Plot standardized residuals Plot tumor results measurements as: Pool subjects in average time trend plots when treatment crossover is detected Preserve trailing zero in decimals for result in original units Prompt when exiting unsaved Review Template 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 Follow-up Records 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 color to represent Complete Response Select the color to represent Partial Response Select the color to represent Progressive Disease Select the color to represent Stable Disease Select the analysis population 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 lines connecting the responses Show markers only when response changes Show Shaded Confidence Intervals on Survival Plot 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 visits to exclude Specify Target Enrollment Specify the Number of Independent Markov Chains Specify the Rate of Thinning Specify the Seed Value Start Date Starting Number for Tables Starting Time Value Stratification Variables Study Study Name Study Site Select saved subject Filter Subsequent visits Subset of Visits to Analyze Subset of Domains to Analyze for Events Subset of Domains to Analyze for Interventions Subset of Visits to Analyze for Findings Summarize multiple records per day using: Summarize subgroups with at least this many subjects Summarize sites with this many levels or fewer: Summarize sites with at least this many subjects: Summarize tumor lesion measurement results by: 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 AE Narrative Supplemental SAS data set for RBM Table Prefix 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 Scale for trend plot x-Axis Time Unit Time Windows for Start of AE Time Window Method Totals Transpose so that columns are 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 Tumor Result Summary to Display in Waterfall Plot Tumor Results Test for Analysis Type of Study Use Grey Scale for Bar Color Use log scaling to display findings test measurements Use Related Records (RELREC) data set to identify concomitant medications that were given due to the event Use result or finding in: Use Review Subject Filter for subject-level reports 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 Variables to include in Report Filter Vendor Visit Number 1 Visit Number 2 Visit Number to Compare to Visit 1 x-Axis Findings Test X-Axis for Volcano Plot Y-Axis Findings Test Combine this Study with Study from Update Tab Combine with: Combined Study Name Delete Study Dependent Variable Input SAS Data Set Label Variable List-Style Specification of Lock-In Class Predictor Variables List-Style Specification of Lock-In Continuous Predictor Variables List-Style Specification of Predictor Class Variables List-Style Specification of Predictor Continuous Variables Lock-In Class Predictor Variables Lock-In Continuous Predictor Variables New Study Name Output Folder Predictor Class Variables Predictor Continuous Variables Study Study Name Weight Variable