Index

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Tables

Adverse Events

        TSFAE01A – Overall Summary of Subjects With Treatment-emergent Adverse Events

        TSFAE01B – Overall Summary of Subjects With Treatment-emergent Adverse Events

        TSFAE02 – Subjects With Treatment-emergent Adverse Events by System Organ Class and Preferred Term

        TSFAE02A – Subjects With Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and Subgroup

        TSFAE03 – Subjects With Treatment-emergent Serious Adverse Events by System Organ Class and Preferred Term

        TSFAE03A – Subjects With Treatment-emergent Serious Adverse Events by System Organ Class, Preferred Term, and Subgroup

        TSFAE04 – Subjects With Treatment-emergent Adverse Events Leading to Permanent Discontinuation of Study Treatment by System Organ Class and Preferred Term

        TSFAE04A – Subjects With Treatment-emergent Adverse Events Leading to Permanent Discontinuation of Study Treatment by System Organ Class, Preferred Term, and Subgroup

        TSFAE05 – Subjects With Treatment-emergent Related Adverse Events by System Organ Class and Preferred Term

        TSFAE05A – Subjects With Treatment-emergent Related Adverse Events by System Organ Class, Preferred Term, and Subgroup

        TSFAE06A – Subjects With Treatment-emergent Adverse Events With Frequency >=5% in Any Treatment Group by Preferred Term

        TSFAE06B – Subjects With Treatment-emergent Adverse Events With Frequency >=5% in Drug-treated Group and >=2% More Often in Drug-treated Group Than Placebo-treated Group by Preferred Term

        TSFAE07A – Subjects With Treatment-emergent Adverse Events of Special Interest - AESI Grouping

        TSFAE07B – Subjects With Treatment-emergent Adverse Events of Special Interest - AESI Grouping

        TSFAE08 – Subjects With Treatment-emergent Adverse Events (Excluding Serious Adverse Events) With Frequency >=5% in Any Treatment Group by System Organ Class and Preferred Term

        TSFAE09 – Subjects With Treatment-emergent Adverse Events by System Organ Class

        TSFAE10 – Subjects With Treatment-emergent Related Adverse Events With Frequency >=X% in Any Treatment Group by Preferred Term

        TSFAE11 – Subjects With Treatment-emergent Adverse Events With Frequency >=x% in Any Treatment Group by System Organ Class and Preferred Term

        TSFAE12 – Subjects With Treatment-emergent Adverse Events Leading to Dose Modification of Study Treatment by System Organ Class and Preferred Term

        TSFAE13 – Exposure-adjusted Incidence Rate Analysis by Preferred Term

        TSFAE14 – Subjects With Treatment-emergent Serious Adverse Events by Organ System and OCMQ (Narrow)

        TSFAE15 – Subjects With Treatment-emergent Adverse Events Leading to Discontinuation of Study Treatment by Organ System and OCMQ (Narrow)

        TSFAE16 – Subjects With Treatment-emergent Adverse Events by Organ System and OCMQ (Broad and Narrow)

        TSFAE17A – Subjects With Treatment-emergent Serious Adverse Events by Organ System, OCMQ (Narrow) / (Broad) and Preferred Term

        TSFAE17B – Subjects With Treatment-emergent Adverse Events Leading to Discontinuation of Study Treatment by Organ System, OCMQ (Narrow) / (Broad) and Preferred Term

        TSFAE17C – Subjects With Treatment-emergent Adverse Events by Organ System, OCMQ (Narrow) / (Broad) and Preferred Term

        TSFAE17D – Subjects With Treatment-emergent Adverse Events by Organ System, OCMQ (Narrow) / (Broad) and Preferred Term

        TSFAE20A – Demographic Characteristics for Subjects With Treatment-emergent Adverse Events

        TSFAE20B – Demographic Characteristics for Subjects With Serious Treatment-emergent Adverse Events

        TSFAE20C – Demographic Characteristics for Subjects With Treatment-emergent Adverse Events - OCMQ of Interest / Preferred Term of Interest

        TSFAE19A – Subjects With Treatment-emergent Adverse Events by Male-specific OCMQ (Narrow) / (Broad) and Preferred Term

        TSFAE19B – Subjects With Treatment-emergent Adverse Events by Male-specific OCMQ (Narrow) / (Broad) and Preferred Term

        TSFAE19C – Subjects With Treatment-emergent Adverse Events by Female-specific OCMQ (Narrow) / (Broad) and Preferred Term

        TSFAE19D – Subjects With Treatment-emergent Adverse Events by Female-specific OCMQ (Narrow) / (Broad) and Preferred Term

        TSFAE21A – Subjects With Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and Severity

        TSFAE21B – Subjects With Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and Toxicity Grade

        TSFAE21C – Subjects With Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and Severity

        TSFAE21D – Subjects With Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and Toxicity Grade

        TSFAE22A – Subjects With Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and Race

        TSFAE22B – Subjects With Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and Sex

        TSFAE22C – Subjects With Treatment-emergent Adverse Events by System Organ Class, Preferred Term, and Age

        TSFAE23A – Subjects With Related Treatment-emergent Serious Adverse Events by Preferred Term

        TSFAE23B – Subjects With Related Fatal Treatment-emergent Adverse Events by Preferred Term

        TSFAE23C – Subjects With Related Treatment-emergent Adverse Events Leading to Discontinuation of Study Treatment by Preferred Term

        TSFAE23D – Subjects With Related Non-serious Treatment-emergent Adverse Events by Preferred Term

        TSFDTH01 – Deaths

        TSFAE24A – Overall Summary of Treatment-emergent Adverse Events by Severity

        TSFAE24B – Overall Summary of Treatment-emergent Adverse Events by Toxicity Grade

        TSFAE24C – Subjects With Treatment-emergent Adverse Events and Related Treatment-emergent Adverse Events by System Organ Class and Preferred Term

        TSFAE24D – Subjects With Treatment-emergent Adverse Events Toxicity Grade >=3 With Frequency >=x% in Any Treatment Group by System Organ Class and Preferred Term

        TSFAE24F – Subjects With Treatment-emergent Adverse Events With Frequency >=x% in Any Treatment Group by System Organ Class and Preferred Term and Onset Time

Clinical Laboratory Evaluation

        TSFLAB01 – Mean Change From Baseline for Laboratory Category Laboratory Data Over Time

        TSFLAB01A – Mean Change From Baseline for Laboratory Category Laboratory Data Over Time by Subgroup

        TSFLAB02 – Subjects With >=1 Laboratory Category Laboratory Values With Elevated or Low Values Meeting Specified Levels Based on Worst On-treatment Value

        TSFLAB02A – Subjects With >=1 Laboratory Category Laboratory Values With Elevated or Low Values Meeting Specified Levels Based on Worst On-treatment Value by Subgroup

        TSFLAB02B – Subjects With Laboratory Category Laboratory Values With Elevated or Low Values Meeting Specified Levels Over Time

        TSFLAB03 – Subjects With >=1 Laboratory Values With Elevated or Low Values Based on Worst On-treatment Value Using NCI-CTCAE Criteria

        TSFLAB03A – Subjects With >=1 Laboratory Values With Elevated or Low Values Based on Worst On-treatment Value Using NCI-CTCAE Criteria by Subgroup

        TSFLAB04A – Subjects With Last/Any On-treatment Chemistry Values >= Level 2 Criteria

        TSFLAB04B – Subjects With Last/Any On-treatment Hematology Values >= Level 2 Criteria

        TSFLAB05 – Subjects With Last/Any On-treatment Laboratory Values >= Grade 2 Based on NCI-CTCAE Criteria

        TSFLAB06 – Shift in Laboratory Category Laboratory Values From Baseline to Time Point

        TSFLAB07 – Shift in Laboratory Values From Baseline to Worst Grade During Time Period Based on NCI-CTCAE Criteria

Demographic

        TSIDEM01 – Demographics and Baseline Characteristics

        TSIDEM02 – Subjects by Region, Country/Territory, and Site

        TSIMH01 – Medical History/Medical History of Interest by System Organ Class and Preferred Term

Disposition of Subjects

        TSIDS01 – Subject Screening and Enrollment

        TSIDS02 – Subject Disposition

        TSIDS02A – Subject Disposition by Subgroup

Electrocardiograms

        TSFECG01 – Mean Change From Baseline for ECG Data Over Time

        TSFECG01A – Mean Change From Baseline for ECG Data Over Time by Subgroup

        TSFECG02 – Categorized Corrected QT Interval Values Over Time

        TSFECG03 – Categorized Change From Baseline to Maximum On-treatment Corrected QT Interval

        TSFECG04 – Shift From Baseline to Maximum On-treatment Corrected QT Interval

        TSFECG05 – Subjects With ECG Values Outside Specified Limits Based on On-treatment Value and Over Time

Pharmacokinetics

        TPK01A – Matrix Active Study Agent/Analyte Concentrations (units) Over Time

        TPK01B – Matrix Active Study Agent/Analyte Concentrations (units) Over Time

        TPK02 – Matrix Active Study Agent/Analyte Concentrations (units) Over Time by Body Weight - Quartiles

        TPK03 – Subjects With Matrix Active Study Agent/Analyte Concentrations Below the Lowest Quantification Level (LLOQ/LLOQxMRD and units) Over Time

Exposure

        TSIEX01 – Duration of Treatment

        TSIEX02 – Study Treatment Administration

        TSIEX03 – Study Treatment Administration

        TSIEX04 – Number of Cycles Received

        TSIEX06 – Subjects Who Received Study Treatment Over Time

        TSIEX07 – Dose Levels Over Time

        TSIEX08 – Incidence and Reason for Dose Modification

        TSIEX09 – Distribution of Subjects by Study Treatment Lot

        TSIEX10 – Study Treatment Compliance

        TSIEX11 – Incidence and Reason for Treatment Modification for Infusions

Prior and Concomitant Therapies

        TSICM01 – Concomitant Medications

        TSICM02 – Concomitant Medications

        TSICM03 – Concomitant Medications Received by >=xx% of Subjects

        TSICM04 – Concomitant Medications Received by >=xx% of Subjects

        TSICM05 – Prior Medications

        TSICM06 – Prior Medications

        TSICM07 – Concomitant Medications of Interest

        TSICM08 – Concomitant Medications of Interest

Vital Signs and Physical Findings

        TSFVIT01 – Mean Change From Baseline in Blood Pressure Over Time

        TSFVIT01A – Mean Change From Baseline in Blood Pressure Over Time by Subgroup

        TSFVIT02 – Subjects With Maximum On-treatment Systolic Blood Pressure by Category of Blood Pressure

        TSFVIT03 – Subjects With Maximum On-treatment Diastolic Blood Pressure by Category of Blood Pressure

        TSFVIT04 – Subjects Meeting Specific On-treatment Hypotension Levels

        TSFVIT05 – Subjects With On-treatment Clinically Important Vital Signs Over Time

        TSFVIT06 – Subjects With Treatment-emergent Orthostatic Hypotension During Treatment Period

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Listings

Adverse Events

        LSFAE01 – Listing of Treatment-emergent Adverse Events

        LSFAE02 – Listing of Treatment-emergent Serious Adverse Events

        LSFAE03 – Listing of Treatment-emergent Adverse Events Leading to Permanent Discontinuation of Study Treatment

        LSFAE04 – Listing of Adverse Events Leading to Death

        LSFAE05 – Listing of Treatment-emergent Adverse Events of Special Interest - Specify AESI Grouping

        LSFAE06A – Selected Narrow / Broad OCMQs

        LSFAE06B – Selected Narrow / Broad OCMQs

        LSFDTH01 – Listing of Deaths

Clinical Laboratory Evaluation

        LSFLAB01 – Listing of Subjects With Criteria Laboratory Values

Demographic

        LSIDEM01 – Listing of Demographics and Baseline Characteristics

        LSIDEM02 – Randomization Listing

        LSIMH01 – Listing of Medical History/Medical History of Interest

Disposition of Subjects

        LSIDS01 – Listing of Subjects Who Permanently Discontinued Treatment

        LSIDS02 – Listing of Subjects Who Discontinued Study Participation Prematurely

        LSIDS03 – Listing of Subjects Who Were Unblinded During the Study

        LSIDS04 – Listing of Subjects Who Were Randomized but Never Treated

        LSIDS05 – Listing of Overall Study Start and End Dates

Electrocardiograms

        LSFECG01 – Listing of Subjects With Criteria ECG Values

        LSFECG02 – Listing of ECG Values

Exposure

        LSIEX01 – Listing of Study Treatment Administration

        LSIEX02 – Listing of Study Treatment Batch Lot Number

        LSIEX03 – Listing of Study Treatment Administration for Infusions

Prior and Concomitant Therapies

        LSICM01 – Listing of Medications

Vital Signs and Physical Findings

        LSFVIT01 – Listing of Subjects With Clinically Important Vital Signs

        LSFVIT02 – Listing of Vital Signs