Index

---

Tables

ADA

        ADAT01 – Baseline Prevalence and Incidence of Treatment Emergent ADA

        ADAT02 – Summary of Patients with Treatment-Induced ADA

        ADAT03 – Summary of Serum Concentrations at Timepoints Where ADA Samples Were Collected and Analyzed

        ADAT04A – Baseline Prevalence and Incidence of Treatment Emergent NAbs

        ADAT04B – Baseline Prevalence and Incidence of NAbs

Adverse Events

        AET01 – Safety Summary

        AET01_AESI – Safety Summary (Adverse Events of Special Interest)

        AET02 – Adverse Events

        AET02_SMQ – Adverse Events by Standardized MedDRA Query

        AET03 – Adverse Events by Greatest Intensity

        AET04 – Adverse Events by Highest NCI CTCAE Grade

        AET04_PI – Adverse Events Reported in \(\geq\) 10% of Patients by Highest NCI CTCAE Grade

        AET05 – Adverse Event Rate Adjusted for Patient-Years at Risk – First Occurrence

        AET05_ALL – Adverse Event Rate Adjusted for Patient-Years at Risk – All Occurrences

        AET06 – Adverse Events by Baseline Characteristic

        AET06_SMQ – Adverse Events by Baseline Characteristic, by SMQ and Preferred Term

        AET07 – Adverse Events Resulting in Death

        AET09 – Adverse Events Related to Study Drug

        AET09_SMQ – Adverse Events Related to Study Drug by Standardized MedDRA Query

        AET10 – Most Common (\(\geq\) 5%) Adverse Events

Concomitant Medications

        CMT01 – Concomitant Medications (GNEDrug Legacy Coding)

        CMT01A – Concomitant Medications by Medication Class and Preferred Name

        CMT01B – Concomitant Medications by Medication Class and Preferred Name

        CMT02_PT – Concomitant Medications by Preferred Name (WHODrug Coding)

Deaths

        DTHT01 – Deaths

Demography

        DMT01 – Demographics and Baseline Characteristics

Disclosures

        DISCLOSUREST01 – Disclosures Outputs

        EUDRAT01 – Non-Serious Adverse Events Reported in \(\geq\) 5% of Patients in Any Treatment Group – Patients and Events

        EUDRAT02 – Serious Adverse Events, Fatal Serious Adverse Events, and Serious Adverse Events Related to Study Medication

Disposition

        DST01 – Patient Disposition

        PDT01 – Major Protocol Deviations

        PDT02 – Major Protocol Deviations Related to Epidemic/Pandemic

ECG

        EGT01 – ECG Results and Change from Baseline by Visit

        EGT02 – ECG Abnormalities (EGT02_1 & EGT02_2)

        EGT03 – Shift Table of ECG Interval Data – Baseline Versus Minimum/Maximum Post-Baseline

        EGT04 – Shift Table of Qualitative ECG Assessments

        EGT05_QTCAT – ECG Actual Values and Changes from Baseline by Visit

Efficacy

        AOVT01 – ANCOVA for Multiple End Points

        AOVT02 – ANCOVA with Single End Point and Customized Table

        AOVT03 – ANCOVA with Consideration of Interaction

        CFBT01 – Efficacy Data and Change from Baseline by Visit

        CMHT01 – Cochran-Mantel-Haenszel (CMH) Summary

        COXT01 – Cox Regression

        COXT02 – Multivariable Cox Regression

        DORT01 – Duration of Response

        LGRT02 – Multi-Variable Logistic Regression

        MMRMT01 – Tables for Mixed-Effect Model Repeated Measures Analysis

        ONCT05 – Objective Response Rate by Subgroup

        RATET01 – Event Rate Summary for Recurrent Events

        RBMIT01 – Tables for RBMI

        RSPT01 – Best Overall Response

        TTET01 – Time-To-Event Summary

Exposure

        EXT01 – Study Drug Exposure Table

Lab Results

        LBT01 – Laboratory Test Results and Change from Baseline by Visit

        LBT02 – Laboratory Test Results by Visit

        LBT03 – Laboratory Test Results Change from Baseline by Visit

        LBT04 – Laboratory Abnormalities Not Present at Baseline

        LBT05 – Laboratory Abnormalities with Single and Replicated Marked

        LBT06 – Laboratory Abnormalities by Visit and Baseline Status

        LBT07 – Laboratory Test Results with Highest NCI CTCAE Grade Post-Baseline

        LBT08 – Laboratory Test Results with Highest NCI CTCAE Grade at Any Time

        LBT09 – Liver Laboratory Tests – Patients with Elevated Post-Baseline AST or ALT Levels

        LBT10 – Liver Laboratory Tests – Patients with Elevated Post-Baseline AST or ALT Levels at Two Consecutive Visits (with Respect to ULN)

        LBT10_BL – Liver Laboratory Tests – Patients with Elevated Post-Baseline AST or ALT Levels at Two Consecutive Visits (with Respect to Baseline)

        LBT11 – Time to First Increase in Liver Laboratory Test Result Meeting Hy’s Law Laboratory Critieria (with Respect to ULN)

        LBT11_BL – Time to First Increase in Liver Laboratory Test Result Meeting Hy’s Law Laboratory Critieria (with Respect to Baseline)

        LBT12 – Liver Laboratory Tests by Time on Treatment – Patients with Elevated Post-Baseline AST or ALT Levels (with Respect to ULN)

        LBT12_BL – Liver Laboratory Tests by Time on Treatment – Patients with Elevated Post-Baseline AST or ALT Levels (with Respect to Baseline)

        LBT13 – NCI CTCAE Grade Laboratory Abnormalities by Visit and Baseline Grade

        LBT14 – Laboratory Test Results Shift Table – Highest NCI CTCAE Grade Post-Baseline by Baseline NCI CTCAE Grade

        LBT15 – Laboratory Test Shifts to NCI CTCAE Grade 3-4 Post-Baseline

Medical History

        MHT01 – Medical History

Pharmacokinetic

        PKCT01 – Summary Concentration Table

        PKPT02 – Pharmacokinetic Parameter Summary – Plasma/Serum/Blood PK Parameters (Stats in Rows)

        PKPT03 – Pharmacokinetic Parameter Summary of Plasma by Treatment (Stats in Columns)

        PKPT04 – Pharmacokinetic Parameter Summary – Urine PK Parameters (Stats in Rows)

        PKPT05 – Summary of Urinary PK Parameters by Treatment Arm (Stats in Columns)

        PKPT06 – Pharmacokinetic Parameter Summary – Dose-Normalized PK Parameters (Stats in Rows)

        PKPT07 – Table of Mean Dose-Normalized Selected Pharmacokinetic Parameters (Stats in Columns)

        PKPT08 – Pharmacokinetic Parameter Summary of Cumulative Amount of Drug Eliminated and Cumulative Percentage of Drug Recovered (Stats in Columns)

        PKPT11 – Pharmacokinetic Parameter Estimated Ratios of Geometric Means and 90% Confidence Intervals for AUC and CMAX

Risk Management Plan

        RMPT01 – Duration of Exposure for Risk Management Plan

        RMPT03 – Extent of Exposure by Age Group and Gender for Risk Management Plan

        RMPT04 – Extent of Exposure by Ethnic Origin for Risk Management Plan

        RMPT05 – Extent of Exposure by Race for Risk Management Plan

        RMPT06 – Seriousness, Outcomes, Severity, Frequency with 95% CI for Risk Management Plan

Safety

        ENTXX – Enrollment Variants

Vital Signs

        VST01 – Vital Sign Results and Change from Baseline by Visit

        VST02 – Vital Sign Abnormalities

---

Listings

ADA

        ADAL02 – Listing of Anti-Drug Antibody Data for Treatment Emergent ADA Positive Patients

Adverse Events

        AEL01 – Listing of Preferred Terms, Lowest Level Terms, and Investigator-Specified Adverse Event Terms

        AEL01_NOLLT – Listing of Preferred Terms and Investigator-Specified Adverse Event Terms

        AEL02 – Listing of Adverse Events

        AEL02_ED – Listing of Adverse Events (for Early Development Studies)

        AEL03 – Listing of Serious Adverse Events

        AEL04 – Listing of Patient Deaths

Concomitant Medications

        CML01 – Listing of Previous and Concomitant Medications

        CML02A_GL – Listing of Concomitant Medication Class Level 2, Preferred Name, and Investigator-Specified Terms

        CML02B_GL – Listing of Concomitant Medication Class, Preferred Name, and Investigator-Specified Terms

Disposition

        DSL01 – Listing of Patients with Study Drug Withdrawn Due to Adverse Events

        DSL02 – Listing of Patients Who Discontinued Early from Study

Development Safety Update Report

        DSUR4 – Listing of Patients Who Died During Reporting Period

ECG

        EGL01 – Listing of ECG Data: Safety-Evaluable Patients

Exposure

        EXL01 – Listing of Exposure to Study Drug

Lab Results

        LBL01 – Listing of Laboratory Test Results

        LBL01_RLS – Listing of Laboratory Test Results Using Roche Safety Lab Standardization

        LBL02A – Listing of Laboratory Abnormalities (constant units)

        LBL02A_RLS – Listing of Laboratory Abnormalities Defined by Roche Safety Lab Standardization

        LBL02B – Listing of Laboratory Abnormalities (variable units)

Medical History

        MHL01 – Listing of Medical History and Concurrent Diseases

Pharmacokinetic

        PKCL01 – Listing of Drug A Concentration by Treatment Group, Patient and Nominal Time

        PKCL02 – Listing of Drug A Urine Concentration and Volumes

        PKPL01 – Listing of Drug A Plasma PK Parameters

        PKPL02 – Listing of Drug A Urine PK Parameters

        PKPL04 – Listing of Individual Drug A AUCIFO and CMAX Ratios Following Drug A or Drug B

Vital Signs

        VSL01 – Listing of Vital Signs: Safety-Evaluable Patients

---

Graphs

Efficacy

        FSTG01 – Subgroup Analysis of Best Overall Response

        FSTG02 – Subgroup Analysis of Survival Duration

        KMG01 – Kaplan-Meier Plot

        MMRMG01 – Plots for Mixed-Effect Model Repeated Measures Analysis

        MMRMG02 – Forest Plot for Mixed-Effect Model Repeated Measures

Pharmacokinetic

        PKCG01 – Plot of PK Concentration Over Time by Subject

        PKCG02 – Plot of PK Concentration Over Time by Cohort/Treatment Group/Dose

        PKCG03 – Plot of Mean PK Concentration Over Time by Cohort

        PKPG01 – Plot of Mean Cumulative Percentage (%) of Recovered Drug in Urine

        PKPG02 – Pharmacokinetic Parameter Summary of Serum PK Parameters by Treatment

        PKPG03 – Box Plot of Pharmacokinetic Parameters by Visit – Plasma

        PKPG04 – Box Plot of Pharmacokinetic Parameters by Visit – Plasma

        PKPG06 – Boxplot of Metabolite to Parent Ratios by Treatment

Other

        BRG01 – Bar Chart

        BWG01 – Box Plot

        CIG01 – Confidence Interval Plot

        IPPG01 – Individual Patient Plot Over Time

        LTG01 – Lattice Plot of Laboratory Tests by Treatment Group Over Time

        MNG01 – Mean Plot