---title: Indextoc: truetoc-depth: 4---------------------------------------------------------------------------### **Tables**#### ADA [ADAT01 -- Baseline Prevalence and Incidence of Treatment Emergent ADA](./tables/ADA/adat01.qmd) [ADAT02 -- Summary of Patients with Treatment-Induced ADA](./tables/ADA/adat02.qmd) [ADAT03 -- Summary of Serum Concentrations at Timepoints Where ADA Samples Were Collected and Analyzed](./tables/ADA/adat03.qmd) [ADAT04A -- Baseline Prevalence and Incidence of Treatment Emergent NAbs](./tables/ADA/adat04a.qmd) [ADAT04B -- Baseline Prevalence and Incidence of NAbs](./tables/ADA/adat04b.qmd)#### Adverse Events [AET01 -- Safety Summary](./tables/adverse-events/aet01.qmd) [AET01_AESI -- Safety Summary (Adverse Events of Special Interest)](./tables/adverse-events/aet01_aesi.qmd) [AET02 -- Adverse Events](./tables/adverse-events/aet02.qmd) [AET02_SMQ -- Adverse Events by Standardized MedDRA Query](./tables/adverse-events/aet02_smq.qmd) [AET03 -- Adverse Events by Greatest Intensity](./tables/adverse-events/aet03.qmd) [AET04 -- Adverse Events by Highest NCI CTCAE Grade](./tables/adverse-events/aet04.qmd) [AET04_PI -- Adverse Events Reported in $\geq$ 10% of Patients by Highest NCI CTCAE Grade](./tables/adverse-events/aet04_pi.qmd) [AET05 -- Adverse Event Rate Adjusted for Patient-Years at Risk -- First Occurrence](./tables/adverse-events/aet05.qmd) [AET05_ALL -- Adverse Event Rate Adjusted for Patient-Years at Risk -- All Occurrences](./tables/adverse-events/aet05_all.qmd) [AET06 -- Adverse Events by Baseline Characteristic](./tables/adverse-events/aet06.qmd) [AET06_SMQ -- Adverse Events by Baseline Characteristic, by SMQ and Preferred Term](./tables/adverse-events/aet06_smq.qmd) [AET07 -- Adverse Events Resulting in Death](./tables/adverse-events/aet07.qmd) [AET09 -- Adverse Events Related to Study Drug](./tables/adverse-events/aet09.qmd) [AET09_SMQ -- Adverse Events Related to Study Drug by Standardized MedDRA Query](./tables/adverse-events/aet09_smq.qmd) [AET10 -- Most Common ($\geq$ 5%) Adverse Events](./tables/adverse-events/aet10.qmd)#### Concomitant Medications [CMT01 -- Concomitant Medications (GNEDrug Legacy Coding)](./tables/concomitant-medications/cmt01.qmd) [CMT01A -- Concomitant Medications by Medication Class and Preferred Name](./tables/concomitant-medications/cmt01a.qmd) [CMT01B -- Concomitant Medications by Medication Class and Preferred Name](./tables/concomitant-medications/cmt01b.qmd) [CMT02_PT -- Concomitant Medications by Preferred Name (WHODrug Coding)](./tables/concomitant-medications/cmt02_pt.qmd)#### Deaths [DTHT01 -- Deaths](./tables/deaths/dtht01.qmd)#### Demography [DMT01 -- Demographics and Baseline Characteristics](./tables/demography/dmt01.qmd)#### Disclosures [DISCLOSUREST01 -- Disclosures Outputs](./tables/disclosures/disclosurest01.qmd) [EUDRAT01 -- Non-Serious Adverse Events Reported in $\geq$ 5% of Patients in Any Treatment Group -- Patients and Events](./tables/disclosures/eudrat01.qmd) [EUDRAT02 -- Serious Adverse Events, Fatal Serious Adverse Events, and Serious Adverse Events Related to Study Medication](./tables/disclosures/eudrat02.qmd)#### Disposition [DST01 -- Patient Disposition](./tables/disposition/dst01.qmd) [PDT01 -- Major Protocol Deviations](./tables/disposition/pdt01.qmd) [PDT02 -- Major Protocol Deviations Related to Epidemic/Pandemic](./tables/disposition/pdt02.qmd)#### ECG [EGT01 -- ECG Results and Change from Baseline by Visit](./tables/ECG/egt01.qmd) [EGT02 -- ECG Abnormalities (EGT02_1 & EGT02_2)](./tables/ECG/egt02.qmd) [EGT03 -- Shift Table of ECG Interval Data -- Baseline Versus Minimum/Maximum Post-Baseline](./tables/ECG/egt03.qmd) [EGT04 -- Shift Table of Qualitative ECG Assessments](./tables/ECG/egt04.qmd) [EGT05_QTCAT -- ECG Actual Values and Changes from Baseline by Visit](./tables/ECG/egt05_qtcat.qmd)#### Efficacy [AOVT01 -- ANCOVA for Multiple End Points](./tables/efficacy/aovt01.qmd) [AOVT02 -- ANCOVA with Single End Point and Customized Table](./tables/efficacy/aovt02.qmd) [AOVT03 -- ANCOVA with Consideration of Interaction](./tables/efficacy/aovt03.qmd) [CFBT01 -- Efficacy Data and Change from Baseline by Visit](./tables/efficacy/cfbt01.qmd) [CMHT01 -- Cochran-Mantel-Haenszel (CMH) Summary](./tables/efficacy/cmht01.qmd) [COXT01 -- Cox Regression](./tables/efficacy/coxt01.qmd) [COXT02 -- Multivariable Cox Regression](./tables/efficacy/coxt02.qmd) [DORT01 -- Duration of Response](./tables/efficacy/dort01.qmd) [LGRT02 -- Multi-Variable Logistic Regression](./tables/efficacy/lgrt02.qmd) [MMRMT01 -- Tables for Mixed-Effect Model Repeated Measures Analysis](./tables/efficacy/mmrmt01.qmd) [ONCT05 -- Objective Response Rate by Subgroup](./tables/efficacy/onct05.qmd) [RATET01 -- Event Rate Summary for Recurrent Events](./tables/efficacy/ratet01.qmd) [RBMIT01 -- Tables for RBMI](./tables/efficacy/rbmit01.qmd) [RSPT01 -- Best Overall Response](./tables/efficacy/rspt01.qmd) [TTET01 -- Time-To-Event Summary](./tables/efficacy/ttet01.qmd)#### Exposure [EXT01 -- Study Drug Exposure Table](./tables/exposure/ext01.qmd)#### Lab Results [LBT01 -- Laboratory Test Results and Change from Baseline by Visit](./tables/lab-results/lbt01.qmd) [LBT02 -- Laboratory Test Results by Visit](./tables/lab-results/lbt02.qmd) [LBT03 -- Laboratory Test Results Change from Baseline by Visit](./tables/lab-results/lbt03.qmd) [LBT04 -- Laboratory Abnormalities Not Present at Baseline](./tables/lab-results/lbt04.qmd) [LBT05 -- Laboratory Abnormalities with Single and Replicated Marked](./tables/lab-results/lbt05.qmd) [LBT06 -- Laboratory Abnormalities by Visit and Baseline Status](./tables/lab-results/lbt06.qmd) [LBT07 -- Laboratory Test Results with Highest NCI CTCAE Grade Post-Baseline](./tables/lab-results/lbt07.qmd) [LBT08 -- Laboratory Test Results with Highest NCI CTCAE Grade at Any Time](./tables/lab-results/lbt08.qmd) [LBT09 -- Liver Laboratory Tests -- Patients with Elevated Post-Baseline AST or ALT Levels](./tables/lab-results/lbt09.qmd) [LBT10 -- Liver Laboratory Tests -- Patients with Elevated Post-Baseline AST or ALT Levels at Two Consecutive Visits (with Respect to ULN)](./tables/lab-results/lbt10.qmd) [LBT10_BL -- Liver Laboratory Tests -- Patients with Elevated Post-Baseline AST or ALT Levels at Two Consecutive Visits (with Respect to Baseline)](./tables/lab-results/lbt10_bl.qmd) [LBT11 -- Time to First Increase in Liver Laboratory Test Result Meeting Hy's Law Laboratory Critieria (with Respect to ULN)](./tables/lab-results/lbt11.qmd) [LBT11_BL -- Time to First Increase in Liver Laboratory Test Result Meeting Hy's Law Laboratory Critieria (with Respect to Baseline)](./tables/lab-results/lbt11_bl.qmd) [LBT12 -- Liver Laboratory Tests by Time on Treatment -- Patients with Elevated Post-Baseline AST or ALT Levels (with Respect to ULN)](./tables/lab-results/lbt12.qmd) [LBT12_BL -- Liver Laboratory Tests by Time on Treatment -- Patients with Elevated Post-Baseline AST or ALT Levels (with Respect to Baseline)](./tables/lab-results/lbt12_bl.qmd) [LBT13 -- NCI CTCAE Grade Laboratory Abnormalities by Visit and Baseline Grade](./tables/lab-results/lbt13.qmd) [LBT14 -- Laboratory Test Results Shift Table -- Highest NCI CTCAE Grade Post-Baseline by Baseline NCI CTCAE Grade](./tables/lab-results/lbt14.qmd) [LBT15 -- Laboratory Test Shifts to NCI CTCAE Grade 3-4 Post-Baseline](./tables/lab-results/lbt15.qmd)#### Medical History [MHT01 -- Medical History](./tables/medical-history/mht01.qmd)#### Pharmacokinetic [PKCT01 -- Summary Concentration Table](./tables/pharmacokinetic/pkct01.qmd) [PKPT02 -- Pharmacokinetic Parameter Summary -- Plasma/Serum/Blood PK Parameters (Stats in Rows)](./tables/pharmacokinetic/pkpt02.qmd) [PKPT03 -- Pharmacokinetic Parameter Summary of Plasma by Treatment (Stats in Columns)](./tables/pharmacokinetic/pkpt03.qmd) [PKPT04 -- Pharmacokinetic Parameter Summary -- Urine PK Parameters (Stats in Rows)](./tables/pharmacokinetic/pkpt04.qmd) [PKPT05 -- Summary of Urinary PK Parameters by Treatment Arm (Stats in Columns)](./tables/pharmacokinetic/pkpt05.qmd) [PKPT06 -- Pharmacokinetic Parameter Summary -- Dose-Normalized PK Parameters (Stats in Rows)](./tables/pharmacokinetic/pkpt06.qmd) [PKPT07 -- Table of Mean Dose-Normalized Selected Pharmacokinetic Parameters (Stats in Columns)](./tables/pharmacokinetic/pkpt07.qmd) [PKPT08 -- Pharmacokinetic Parameter Summary of Cumulative Amount of Drug Eliminated and Cumulative Percentage of Drug Recovered (Stats in Columns)](./tables/pharmacokinetic/pkpt08.qmd) [PKPT11 -- Pharmacokinetic Parameter Estimated Ratios of Geometric Means and 90% Confidence Intervals for AUC and CMAX](./tables/pharmacokinetic/pkpt11.qmd)#### Risk Management Plan [RMPT01 -- Duration of Exposure for Risk Management Plan](./tables/risk-management-plan/rmpt01.qmd) [RMPT03 -- Extent of Exposure by Age Group and Gender for Risk Management Plan](./tables/risk-management-plan/rmpt03.qmd) [RMPT04 -- Extent of Exposure by Ethnic Origin for Risk Management Plan](./tables/risk-management-plan/rmpt04.qmd) [RMPT05 -- Extent of Exposure by Race for Risk Management Plan](./tables/risk-management-plan/rmpt05.qmd) [RMPT06 -- Seriousness, Outcomes, Severity, Frequency with 95% CI for Risk Management Plan](./tables/risk-management-plan/rmpt06.qmd)#### Safety [ENTXX -- Enrollment Variants](./tables/safety/enrollment01.qmd)#### Vital Signs [VST01 -- Vital Sign Results and Change from Baseline by Visit](./tables/vital-signs/vst01.qmd) [VST02 -- Vital Sign Abnormalities](./tables/vital-signs/vst02.qmd)------------------------------------------------------------------------### **Listings**#### ADA [ADAL02 -- Listing of Anti-Drug Antibody Data for Treatment Emergent ADA Positive Patients](./listings/ADA/adal02.qmd)#### Adverse Events [AEL01 -- Listing of Preferred Terms, Lowest Level Terms, and Investigator-Specified Adverse Event Terms](./listings/adverse-events/ael01.qmd) [AEL01_NOLLT -- Listing of Preferred Terms and Investigator-Specified Adverse Event Terms](./listings/adverse-events/ael01_nollt.qmd) [AEL02 -- Listing of Adverse Events](./listings/adverse-events/ael02.qmd) [AEL02_ED -- Listing of Adverse Events (for Early Development Studies)](./listings/adverse-events/ael02_ed.qmd) [AEL03 -- Listing of Serious Adverse Events](./listings/adverse-events/ael03.qmd) [AEL04 -- Listing of Patient Deaths](./listings/adverse-events/ael04.qmd)#### Concomitant Medications [CML01 -- Listing of Previous and Concomitant Medications](./listings/concomitant-medications/cml01.qmd) [CML02A_GL -- Listing of Concomitant Medication Class Level 2, Preferred Name, and Investigator-Specified Terms](./listings/concomitant-medications/cml02a_gl.qmd) [CML02B_GL -- Listing of Concomitant Medication Class, Preferred Name, and Investigator-Specified Terms](./listings/concomitant-medications/cml02b_gl.qmd)#### Disposition [DSL01 -- Listing of Patients with Study Drug Withdrawn Due to Adverse Events](./listings/disposition/dsl01.qmd) [DSL02 -- Listing of Patients Who Discontinued Early from Study](./listings/disposition/dsl02.qmd)#### Development Safety Update Report [DSUR4 -- Listing of Patients Who Died During Reporting Period](./listings/development-safety-update-report/dsur4.qmd)#### ECG [EGL01 -- Listing of ECG Data: Safety-Evaluable Patients](./listings/ECG/egl01.qmd)#### Exposure [EXL01 -- Listing of Exposure to Study Drug](./listings/exposure/exl01.qmd)#### Lab Results [LBL01 -- Listing of Laboratory Test Results](./listings/lab-results/lbl01.qmd) [LBL01_RLS -- Listing of Laboratory Test Results Using Roche Safety Lab Standardization](./listings/lab-results/lbl01_rls.qmd) [LBL02A -- Listing of Laboratory Abnormalities (constant units)](./listings/lab-results/lbl02a.qmd) [LBL02A_RLS -- Listing of Laboratory Abnormalities Defined by Roche Safety Lab Standardization](./listings/lab-results/lbl02a_rls.qmd) [LBL02B -- Listing of Laboratory Abnormalities (variable units)](./listings/lab-results/lbl02b.qmd)#### Medical History [MHL01 -- Listing of Medical History and Concurrent Diseases](./listings/medical-history/mhl01.qmd)#### Pharmacokinetic [PKCL01 -- Listing of Drug A Concentration by Treatment Group, Patient and Nominal Time](./listings/pharmacokinetic/pkcl01.qmd) [PKCL02 -- Listing of Drug A Urine Concentration and Volumes](./listings/pharmacokinetic/pkcl02.qmd) [PKPL01 -- Listing of Drug A Plasma PK Parameters](./listings/pharmacokinetic/pkpl01.qmd) [PKPL02 -- Listing of Drug A Urine PK Parameters](./listings/pharmacokinetic/pkpl02.qmd) [PKPL04 -- Listing of Individual Drug A AUCIFO and CMAX Ratios Following Drug A or Drug B](./listings/pharmacokinetic/pkpl04.qmd)#### Vital Signs [VSL01 -- Listing of Vital Signs: Safety-Evaluable Patients](./listings/vital-signs/vsl01.qmd)------------------------------------------------------------------------### **Graphs**#### Efficacy [FSTG01 -- Subgroup Analysis of Best Overall Response](./graphs/efficacy/fstg01.qmd) [FSTG02 -- Subgroup Analysis of Survival Duration](./graphs/efficacy/fstg02.qmd) [KMG01 -- Kaplan-Meier Plot](./graphs/efficacy/kmg01.qmd) [MMRMG01 -- Plots for Mixed-Effect Model Repeated Measures Analysis](./graphs/efficacy/mmrmg01.qmd) [MMRMG02 -- Forest Plot for Mixed-Effect Model Repeated Measures](./graphs/efficacy/mmrmg02.qmd)#### Pharmacokinetic [PKCG01 -- Plot of PK Concentration Over Time by Subject](./graphs/pharmacokinetic/pkcg01.qmd) [PKCG02 -- Plot of PK Concentration Over Time by Cohort/Treatment Group/Dose](./graphs/pharmacokinetic/pkcg02.qmd) [PKCG03 -- Plot of Mean PK Concentration Over Time by Cohort](./graphs/pharmacokinetic/pkcg03.qmd) [PKPG01 -- Plot of Mean Cumulative Percentage (%) of Recovered Drug in Urine](./graphs/pharmacokinetic/pkpg01.qmd) [PKPG02 -- Pharmacokinetic Parameter Summary of Serum PK Parameters by Treatment](./graphs/pharmacokinetic/pkpg02.qmd) [PKPG03 -- Box Plot of Pharmacokinetic Parameters by Visit -- Plasma](./graphs/pharmacokinetic/pkpg03.qmd) [PKPG04 -- Box Plot of Pharmacokinetic Parameters by Visit -- Plasma](./graphs/pharmacokinetic/pkpg04.qmd) [PKPG06 -- Boxplot of Metabolite to Parent Ratios by Treatment](./graphs/pharmacokinetic/pkpg06.qmd)#### Other [BRG01 -- Bar Chart](./graphs/other/brg01.qmd) [BWG01 -- Box Plot](./graphs/other/bwg01.qmd) [CIG01 -- Confidence Interval Plot](./graphs/other/cig01.qmd) [IPPG01 -- Individual Patient Plot Over Time](./graphs/other/ippg01.qmd) [LTG01 -- Lattice Plot of Laboratory Tests by Treatment Group Over Time](./graphs/other/ltg01.qmd) [MNG01 -- Mean Plot](./graphs/other/mng01.qmd)