Chevron Catalog2 years ago
GENERAL | General Concepts | 1. Input dataset and dataset names | 2. Expected variables in input analysis dataset | 3. Character vs Factor | 4. Testing the codes for plot generation | General Control Arguments | 1. lbl_overall: Column of Total | 2. Column counts: N=xxx | TABLES | Safety Summary (AET01) | 1. Safety Summary | 2. Safety Summary with Modified Rows | Safety Summary (Adverse Events of Special Interest) (AET01_AESI) | 1. Safety Summary (Adverse Events of Special Interest) | 2. Safety Summary (Adverse Events of Special Interest) (optional lines) | 3. Safety Summary (Adverse Events of Special Interest) (for studies with multiple drugs) | Adverse Events (AET02) | 1. Adverse Events | 2. Adverse Events (with High-level Term) | 3. Adverse Events (Preferred Terms only) | Adverse Events by Greatest Intensity(AET03) | 1. Adverse Events by Greatest Intensity | Adverse Events by Highest NCI CTCAE Grade (AET04) | 1. Adverse Events by Highest NCI CTCAE Grade | 2. Adverse Events by Highest NCI CTCAE Grade (Fill in of Grades) | 3. Adverse Events by Highest NCI CTCAE Grade with modified grouping of grade | Adverse Event Rate Adjusted for Patient-Years at Risk - First Occurrence (AET05) | 1. Adverse Event Rate Adjusted for Patient-Years at Risk - First Occurrence | 2. Adverse Event Rate Adjusted for Patient-Years at Risk - First Occurrence (setting type of confidence interval) | Adverse Event Rate Adjusted for Patient-Years at Risk - All Occurrences (AET05_ALL) | 1. Adverse Event Rate Adjusted for Patient-Years at Risk - All Occurrences | 2. Adverse Event Rate Adjusted for Patient-Years at Risk - All Occurrences (setting type of confidence interval) | Most Common (>=5%) Adverse Events (AET10) | 1. Most Common (>=5%) Adverse Events | 2. Most Common (>=8%) Adverse Events (setting threshold) | Absolute Value and Change from Baseline by Visit (CFBT01) | 1. Absolute Value and Change from Baseline by Visit | 2. Absolute Value and Change from Baseline by Visit without Screening | 3. Absolute Value by Visit | Concomitant Medications by Medication Class and Preferred Name (CMT01A) | 1. Concomitant Medications by Medication Class and Preferred Name | 2. Concomitant Medications by Medication Class and Preferred Name (changing ATC class level) | 3. Concomitant Medications by Medication Class and Preferred Name (classes sorted by frequency) | 4. Concomitant Medications by Medication Class and Preferred Name (total number of treatments per medication class suppressed) | Concomitant Medications by Preferred Name (CMT02_PT) | 1. Concomitant Medications by Preferred Name | Cox Regression (COXT01) | 1. Cox Regression | 2. Cox Regression (with interaction term) | 3. Cox Regression (specifying covariates) | 4. Cox Regression (setting strata, ties, and alpha level) | Multi-variable Cox Regression (COXT02) | 1. Multi-variable Cox Regression | 2. Multi-variable Cox Regression (specifying covariates) | 3. Multi-variable Cox Regression (setting strata, ties, and alpha level) | Demographics and Baseline Characteristics (DMT01) | 1. Demographics and Baseline Characteristics with All Patients | 2. Demographics and Baseline Characteristics without All Patients | 3. Demographics and Baseline Characteristics with an additional study specific continuous variable | 4. Demographics and Baseline Characteristics with an additional study specific categorical variable | 5. Demographics and Baseline Characteristics with additional vital signs baseline values from ADVS or ADSUB | Patient Disposition (DST01) | 1. Patient Disposition | 2. Patient Disposition (with grouping of reasons) | 3. Patient Disposition (adding end of treatment status) | 4. Patient Disposition (adding details of study ongoing status) | Deaths (DTHT01) | 1. Deaths | 2. Deaths (adding "Primary Cause of Death" details for 'Other' category) | 3. Deaths (adding summary by days from last study drug administration) | ECG Results and Change from Baseline by Visit (EGT01) | 1. ECG Results and Change from Baseline by Visit | ECG Abnormalities (Regardless of Abnormality at Baseline) (EGT02_1) | 1. ECG Abnormalities (Regardless of Abnormality at Baseline) | ECG Abnormalities (Among Subject Without Abnormality at Baseline) (EGT02_2) | 1. ECG Abnormalities (Among Subject Without Abnormality at Baseline) | Shift Table of ECG Interval Data - Baseline versus Minimum/Maximum Post-Baseline (EGT03) | 1. Shift Table of ECG Interval Data - Baseline versus Minimum Post-Baseline | 2. Shift Table of ECG Interval Data - Baseline versus Maximum Post-Baseline | ECG Actual Values and Changes from Baseline by Visit (EGT05_QTCAT) | 1. ECG Actual Values and Changes from Baseline by Visit | 2. ECG Actual Values and Changes from Baseline by Visit (removing default analyses) | Study Drug Exposure (EXT01) | 1. Study Drug Exposure | Laboratory Test Results and Change from Baseline by Visit (LBT01) | 1. Laboratory Test Results and Change from Baseline by Visit | 2. Laboratory Test Results and Change from Baseline by Visit (customized precision) | Laboratory Abnormalities (LBT04) | 1. Laboratory Abnormalities | Laboratory Abnormalities with Single and Replicated Marked (LBT05) | 1. Laboratory Abnormalities with Single and Replicated Marked | 2. Laboratory Abnormalities with Single and Replicated Marked showing all categories | 3. Laboratory Abnormalities with Single and Replicated Marked with study specific MLAs | Laboratory Abnormalities by Visit and Baseline Status (LBT06) | 1. Laboratory Abnormalities by Visit and Baseline Status | Laboratory Test Results with Highest NCI CTCAE Grade Post-Baseline (LBT07) | 1. Laboratory Test Results with Highest NCI CTCAE Grade Post-Baseline | Laboratory Test Results Shift Table - Highest NCI-CTCAE Grade Post-Baseline by Baseline NCI-CTCAE Grade (LBT14) | 1. Laboratory Test Results Shift Table - Highest NCI-CTCAE Grade Post-Baseline by Baseline NCI-CTCAE Grade (High) | 2. Laboratory Test Results Shift Table - Highest NCI-CTCAE Grade Post-Baseline by Baseline NCI-CTCAE Grade (Low) | 3. Laboratory Test Results Shift Table - Highest NCI-CTCAE Grade Post-Baseline by Baseline NCI-CTCAE Grade (High) Without Patients with Missing Baseline | 4. Laboratory Test Results Shift Table - Highest NCI-CTCAE Grade Post-Baseline by Baseline NCI-CTCAE Grade (Low) with Missing Baseline Considered as Grade 0 | 4. Laboratory Test Results Shift Table - Highest NCI-CTCAE Grade Post-Baseline by Baseline NCI-CTCAE Grade (with fill in of grades) | Medical History (MHT01) | 1. Medical History | 2. Medical History showing additional column 'All Patients' | Major Protocol Deviations (PDT01) | 1. Major Protocol Deviations | Reasons for Major Protocol Deviations Related to Epidemic/Pandemic (PDT02) | 1. Reasons for Major Protocol Deviations Related to Epidemic/Pandemic | Duration of Exposure for Risk Management Plan (RMPT01) | 1. Duration of Exposure for Risk Management Plan | Extent of Exposure by Age Group and Gender for Risk Management Plan (RMPT03) | 1. Extent of Exposure by Age Group and Gender for Risk Management Plan | Extent of Exposure by Ethnic Origin for Risk Management Plan (RMPT04) | 1. Extent of Exposure by Ethnic Origin for Risk Management Plan | Extent of Exposure by Race for Risk Management Plan (RMPT05) | 1. Extent of Exposure by Race for Risk Management Plan | Best Overall Response (RSPT01) | 1. Best Overall Response | 2. Best Overall Response (Ordering of treatment groups) | 3. Best Overall Response (selecting sections to display) | 4. Best Overall Response (with stratified analysis) | 5. Best Overall Response (modifying analysis details like type of confidence interval, alpha level, test for p-value) | 6. Best Overall Response (modifying the definition of overall response) | Time-to-event Summary (TTET01) | 1. Time-to-event Summary | 2. Time-to-event Summary (selecting sections to display) | 3. Time-to-event Summary (modifying analysis details like confidence interval type, ties, and alpha level) | 4. Time-to-event Summary (with stratified analysis) | 5. Time-to-event Summary (modifying time point for the "survival at xx months" analysis) | 6. Time-to-event Summary (modifying the p-value method for testing hazard ratio) | Vital Signs (VST01) | 1. Vital Sign Results and Change from Baseline by Visit | Vital Signs Abnormalities (Regardless of Abnormality at Baseline) (VST02_1) | 1. Vital Sign Abnormalities (Regardless of Abnormality at Baseline) | Vital Signs Abnormalities (Among Subject Without Abnormality at Baseline) (VST02_2) | 1. Vital Sign Abnormalities (Among Subject Without Abnormality at Baseline) | LISTINGS | Glossary of Adverse Event Preferred Terms and Investigator-Specified Terms (AEL01_NOLLT) | 1. Glossary of Adverse Event Preferred Terms and Investigator-Specified Terms | Graphics | Forest Plot for Odds Ratio (FSTG01) | 1. Forest Plot for Odds Ratio (with subgroup analysis) | 2. Forest Plot for Odds Ratio (with a user-defined confidence level) | 3. Forest Plot for Odds Ratio (with p-values and/or different statistics) | 4. Forest Plot for Odds Ratio (with user-defined subgroup analysis) | 5. Forest Plot for Odds Ratio (with stratified analysis) | 6. Forest Plot for Odds Ratio (without proportional sizing of the odds ratio symbol) | Forest Plot for Hazard Ratio (FSTG02) | 1. Forest Plot for Hazard Ratio (with subgroup analysis) | 2. Forest Plot for Hazard Ratio (with p-values and/or different statistics) | 3. Forest Plot for Hazard Ratio (with user-defined subgroup analysis) | 4. Forest Plot for Hazard Ratio (with stratified analysis) | 5. Forest Plot for Hazard Ratio (without proportional sizing of the hazard ratio symbol) | Kaplan-Meier Plot (KMG01) | 1. Kaplan-Meier Plot (without comparative statistics) | 2. Kaplan-Meier Plot (with comparative statistics) | 3. Kaplan-Meier Plot (without censoring marks) | 4. Kaplan-Meier Plot (without estimation of median survival time) | 5. Kaplan-Meier Plot (with statistical annotation of either median or min of survival time) | 6. Kaplan-Meier Plot (without the table of patients at risk) | Mean Plot (MNG01) | 1. Plot of Mean and Confidence Interval (with Table Section) | 2. Plot of Mean and Confidence Interval of Change from Baseline of Vital Signs | 3. Plot of Mean (+/-SD) (Changing the Statistics) | 4. Plot of Mean and Confidence Interval (Modify Alpha Level) | 5. Plot of Mean and Confidence Interval (With Number of Patients Only) | 6. Plot of Mean and Confidence Interval (without Table Section)
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