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CSR

Clinical study report: the ADaM data sets and the standard outputs

By Kenneth Yan, 2026-10-17.

Made from SDTM snapshot DBR-1.

ADaM data sets

Data setLabelRecords
ADSLSubject-Level Analysis300
ADLBCAnalysis Dataset Lab Blood Chemistry65,875
ADVSVital Signs Analysis Dataset24,054
ADAEAdverse Events Analysis Dataset1,268
ADEGECG Analysis Dataset6,915
ADCMConcomitant Medications Analysis Dataset891
ADMHMedical History Analysis Dataset775
ADEXExposure Analysis Dataset2,400
ADRSTumor Response Analysis Dataset4,950
ADTRTumor Results Analysis Dataset11,858
ADLBHAnalysis Dataset Lab Hematology58,125
ADTTETime to Event Analysis Dataset690

Tables, listings and figures

OutputTitleKindMade
14.1.1Subject Dispositiontable2026-10-17
14.1.2Demographic and Baseline Characteristicstable2026-10-17
14.3.4.3Summary of Vital Signs by Visittable2026-10-17
14.1.4Concomitant Medications by Standardized Medication Nametable2026-10-17
14.1.5Medical History by System Organ Class and Preferred Termtable2026-10-17
14.1.3Summary of Exposure to Study Treatmenttable2026-10-17
14.3.4.1Summary of Laboratory Values: Chemistry by Visittable2026-10-17
14.3.5.1Shifts from Baseline to End of Treatment in Laboratory Values: Chemistrytable2026-10-17
14.2.1.1Kaplan-Meier Plot of Overall Survivalgraph2026-10-17
14.2.1.2Kaplan-Meier Plot of Progression Free Survivalgraph2026-10-17
14.2.1.3Kaplan-Meier Plot of Duration of Responsegraph2026-10-17
14.2.6.1Summary of Overall Survivaltable2026-10-17
14.2.6.2Summary of Progression Free Survivaltable2026-10-17
14.2.6.3Summary of Duration of Responsetable2026-10-17
14.3.4.4Summary of ECG Parameters by Visittable2026-10-17
14.3.6.1Subjects with Notable QTcF Valuestable2026-10-17
14.2.5.1Best Overall Response (Confirmed) by Investigatortable2026-10-17
14.2.5.2Best Overall Response (Confirmation Not Required) by Investigatortable2026-10-17
14.2.7.1Best Percent Change from Baseline in the Sum of Diameters of Target Lesionsgraph2026-10-17
14.3.1.1Overview of Treatment-Emergent Adverse Eventstable2026-10-17
14.3.1.2Treatment-Emergent Adverse Events by System Organ Class and Preferred Termtable2026-10-17
14.3.1.3Serious Treatment-Emergent Adverse Events by System Organ Class and Preferred Termtable2026-10-17
14.3.1.4Subjects with Treatment-Emergent Adverse Events by System Organ Classgraph2026-10-17
14.3.1.5Treatment-Related Treatment-Emergent Adverse Events by System Organ Class and Preferred Termtable2026-10-17
14.3.1.6Treatment-Emergent Adverse Events Leading to Discontinuation of Study Treatment by System Organ Class and Preferred Termtable2026-10-17
14.3.1.7Treatment-Emergent Adverse Events by System Organ Class, Preferred Term and Maximum Severitytable2026-10-17
14.3.2.1Listing of Adverse Events Leading to Deathlisting2026-10-17
14.3.2.2Listing of Serious Adverse Eventslisting2026-10-17
14.3.2.3Listing of Adverse Events Leading to Discontinuation of Study Treatmentlisting2026-10-17
16.2.7Listing of Treatment-Emergent Adverse Eventslisting2026-10-17
14.3.4.2Summary of Laboratory Values: Hematology by Visittable2026-10-17
14.3.5.2Shifts from Baseline to End of Treatment in Laboratory Values: Hematologytable2026-10-17

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