HF-1002-CL-101 SDTM tabulation datasets for HF-1002-CL-101 HF-1002-CL-101 Trial Summary ts.xpt Trial Arms ta.xpt Trial Elements te.xpt Trial Visits tv.xpt Trial Inclusion/Exclusion Criteria ti.xpt Demographics dm.xpt Subject Elements se.xpt Subject Visits sv.xpt Exposure ex.xpt Supplemental Qualifiers for EX suppex.xpt Concomitant Medications cm.xpt Adverse Events ae.xpt Supplemental Qualifiers for AE suppae.xpt Medical History mh.xpt Disposition ds.xpt Supplemental Qualifiers for DS suppds.xpt Clinical Events ce.xpt Vital Signs vs.xpt Laboratory Test Results lb.xpt ECG Test Results eg.xpt Immunogenicity Specimen Assessments is.xpt Questionnaires qs.xpt Functional Tests ft.xpt Echocardiography (Custom) ze.xpt Physical Examination (Custom) pe.xpt Supplemental Qualifiers for PE supppe.xpt Related Records relrec.xpt Study Identifier Domain Abbreviation Sequence Number Trial Summary Parameter Short Name Trial Summary Parameter Parameter Value TSVAL1 Study Identifier Domain Abbreviation Planned Arm Code Description of Planned Arm Planned Order of Element within Arm Element Code Description of Element Branch Transition Rule Epoch Study Identifier Domain Abbreviation Element Code Description of Element Rule for Start of Element Rule for End of Element Study Identifier Domain Abbreviation Visit Number Visit Name Planned Study Day of Visit Planned Arm Code Description of Planned Arm Visit Start Rule Visit End Rule Study Identifier Domain Abbreviation IETESTCD Inclusion/Exclusion Criterion Inclusion/Exclusion Category Study Identifier Domain Abbreviation Unique Subject Identifier Subject Identifier for the Study Subject Reference Start Date/Time Subject Reference End Date/Time Date/Time of First Study Treatment Date/Time of Last Study Treatment Date/Time of Informed Consent Date/Time of End of Participation Date/Time of Death Subject Death Flag Study Site Identifier Date/Time of Birth Age Age Units Sex Race Ethnicity Planned Arm Code Description of Planned Arm Actual Arm Code Description of Actual Arm Country Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Element Code Description of Element Epoch Planned Order of Element within Arm Start Date/Time End Date/Time Study Identifier Domain Abbreviation Unique Subject Identifier Visit Number Visit Name Planned Study Day of Visit Epoch Start Date/Time End Date/Time Study Day of Start Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Name of Treatment Dose Dose Units Dose Form Route of Administration Visit Number Visit Name Epoch Start Date/Time End Date/Time Study Day of Start Study Day of End Study Identifier Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Evaluator Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Reported Name of Drug, Med, or Therapy Standardized Medication Medication Class Indication Dose Dose Units Dosing Frequency per Interval Route of Administration Start Date/Time End Date/Time Study Day of Start Study Day of End End Relative to Reference Time Point End Reference Time Point Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Reported Term for the Adverse Event Standardized Adverse Event Body System or Organ Class Serious Event Results in Death Requires or Prolongs Hospitalization Action Taken with Study Treatment Causality Outcome of Adverse Event Standard Toxicity Grade Concomitant or Additional Trtmnt Given Epoch Start Date/Time End Date/Time Study Day of Start Study Day of End End Relative to Reference Time Point End Reference Time Point Study Identifier Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Evaluator Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Reported Term for the Medical History Standardized Medical History Body System or Organ Class Category Start Date/Time End Relative to Reference Time Point End Reference Time Point Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Reported Term for the Disposition Event Standardized Disposition Term Category Subcategory Visit Number Visit Name Epoch Start Date/Time Study Day of Start Study Identifier Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Evaluator Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Reported Term for the Clinical Event Standardized Clinical Event Category Visit Number Visit Name Epoch Start Date/Time Study Day of Start Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Vital Signs Test Short Name Vital Signs Test Name Vital Signs Position of Subject Result or Finding in Original Units Original Units Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Baseline Flag Visit Number Visit Name Epoch Date/Time of Collection Study Day of Visit/Collection Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Category Lab Test Short Name Lab Test Name Result or Finding in Original Units Original Units Reference Range Lower Limit-Orig Unit Reference Range Upper Limit-Orig Unit Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Reference Range Lower Limit-Std Units Reference Range Upper Limit-Std Units Reference Range Indicator Specimen Type Baseline Flag Visit Number Visit Name Epoch Date/Time of Collection Study Day of Visit/Collection Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number ECG Test Short Name ECG Test Name Result or Finding in Original Units Original Units Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Baseline Flag Visit Number Visit Name Epoch Date/Time of Collection Study Day of Visit/Collection Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Category Immunogenicity Test Short Name Immunogenicity Test Name Result or Finding in Original Units Original Units Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Specimen Type Visit Number Visit Name Epoch Date/Time of Collection Study Day of Visit/Collection Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Category Question Test Short Name Question Test Name Result or Finding in Original Units Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Baseline Flag Visit Number Visit Name Epoch Date/Time of Collection Study Day of Visit/Collection Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Category Functional Test Test Short Name Functional Test Test Name Result or Finding in Original Units Original Units Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Baseline Flag Visit Number Visit Name Epoch Date/Time of Collection Study Day of Visit/Collection Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Category Echo Test Short Name Echo Test Name Result or Finding in Original Units Original Units Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Evaluator Baseline Flag Visit Number Visit Name Epoch Date/Time of Collection Study Day of Visit/Collection Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Exam Test Short Name Exam Test Name Result or Finding in Original Units Character Result/Finding in Std Format Visit Number Visit Name Epoch Date/Time of Collection Study Day of Visit/Collection Study Identifier Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Qualifier Variable Name Qualifier Variable Label Data Value Origin Evaluator Study Identifier Related Domain Abbreviation Unique Subject Identifier Identifying Variable Identifying Variable Value Relationship Type Relationship Identifier No Yes Unknown Not Applicable Male Female Unknown Recovered/Resolved Recovered/Resolved With Sequelae Recovering/Resolving Not Recovered/Not Resolved Fatal Unknown Not Applicable Dose Not Changed Drug Withdrawn Drug Interrupted Dose Reduced Dose Increased Unknown Oral Intracoronary Intravenous Subcutaneous Supine Standing Sitting Low Normal High Abnormal QD BID TID ONCE PRN