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Summary of Observed and Change from Baseline by Scheduled Visits - Hematology Laboratory Test

Summary of Observed and Change from Baseline by Scheduled Visits - Vital Signs

Overview of Adverse Events

Subjects With Adverse Events Leading to Treatment Discontinuation by System Organ Class and Preferred Term

Subjects With Serious Adverse Events by System Organ Class and Preferred Term

Subjects With Common Adverse Events Occurring at ≥X% Frequency

Subjects With Adverse Events by System Organ Class and Preferred Term

Baseline Demographic and Clinical Characteristics

Subject Disposition

Duration of Treatment Exposure

QORIG Values Not Matching Define-XML v2.1 Origin Type Values

Standard(s)SDTMIG