A A A Trial Summary TS.xpt Study Identifier Domain Abbreviation Sequence Number Trial Summary Parameter Short Name Trial Summary Parameter Parameter Value Parameter Null Flavor Parameter Value Code Name of the Reference Terminology Version of the Reference Terminology Unique sequence number dervied based on key variables per subject Demographics DM.xpt Supplemental Qualifiers for DM SUPPDM.xpt 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 Race Other Specify Random Number for Supp Related Domain Abbreviation Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Data Value Origin Qualifier Variable Name RACEOTH RANDNO Concatenation of Study number, Site ID and Subject indentifier Subject Element SE.xpt Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Element Code Description of Element Start Date/Time of Element End Date/Time of Element Planned Order of Element within Arm Epoch Unique sequence number dervied based on key variables per subject Set to earliest date for each element Set to proceeding elements start date Compare Date / Start Date of Collection / Event with Subject Element dates to assigned the correct EPOCH value. Subject Visits SV.xpt Study Identifier Domain Abbreviation Unique Subject Identifier Visit Number Visit Name Start Date/Time of Visit End Date/Time of Visit Study Day of Start of Visit Study Day of End of Visit Set to earliest visit date Set to proceeding visits earliest start date Number of days between First Date fo Exposure and Start Date of Collection / Event + 1. Number of days between First Date fo Exposure and End Date of Collection / Event + 1. Concomitant Meds CM.xpt Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Reported Name of Drug, Med, or Therapy Standardized Medication Name Category for Medication Indication Dose per Administration Dose Units Route of Administration Start Date/Time of Medication End Date/Time of Medication Study Day of Start of Medication Study Day of End of Medication Unique sequence number dervied based on key variables per subject Number of days between First Date fo Exposure and Start Date of Collection / Event + 1. Number of days between First Date fo Exposure and End Date of Collection / Event + 1. Exposure EX.xpt Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Name of Treatment Dose Dose Units Dose Form Dosing Frequency per Interval Intended Dose Regimen Route of Administration Epoch Start Date/Time of Treatment End Date/Time of Treatment Study Day of Start of Treatment Study Day of End of Treatment Unique sequence number dervied based on key variables per subject Number of days between First Date fo Exposure and Start Date of Collection / Event + 1. Number of days between First Date fo Exposure and End Date of Collection / Event + 1. Adverse Events AE.xpt Supplemental Qualifiers for AE SUPPAE.xpt Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Reported Term for the Adverse Event Lowest Level Term Lowest Level Term Code Dictionary-Derived Term Preferred Term Code High Level Term High Level Term Code High Level Group Term High Level Group Term Code Body System or Organ Class Body System or Organ Class Code Primary System Organ Class Primary System Organ Class Code Severity/Intensity Serious Event Action Taken with Study Treatment Causality Start Date/Time of Adverse Event End Date/Time of Adverse Event Study Day of Start of Adverse Event Study Day of End of Adverse Event AE Description Related Domain Abbreviation Identifying Variable Identifying Variable Value Evaluator Qualifier Variable Label Data Value Origin Qualifier Variable Name AEDESC Unique sequence number dervied based on key variables per subject Number of days between First Date fo Exposure and Start Date of Collection / Event + 1. Number of days between First Date fo Exposure and End Date of Collection / Event + 1. Disposition DS.xpt Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Reported Term for the Disposition Event Standardized Disposition Term Category for Disposition Event Epoch Start Date/Time of Disposition Event Study Day of Start of Disposition Event Unique sequence number dervied based on key variables per subject Number of days between First Date fo Exposure and Start Date of Collection / Event + 1. Medical History MH.xpt Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Reported Term for the Medical History Dictionary-Derived Term Category for Medical History Body System or Organ Class Start Date/Time of Medical History Event End Date/Time of Medical History Event Unique sequence number dervied based on key variables per subject Electrocardiogram EG.xpt Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number ECG Test or Examination Short Name ECG Test or Examination Name Category for ECG Result or Finding in Original Units Original Units Character Result/Finding in Std Format Numeric Result/Finding in Standard Units Standard Units Method of ECG Test Baseline Flag Visit Number Visit Name Date/Time of ECG Study Day of ECG Unique sequence number dervied based on key variables per subject Set to Y for latest record prior to dosing Number of days between First Date fo Exposure and Date of Collection / Event + 1. Laboratory Data LB.xpt Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Lab Test or Examination Short Name Lab Test or Examination Name Category for Lab Test Result or Finding in Original Units Original Units Reference Range Lower Limit in Orig Unit Reference Range Upper Limit in 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 Baseline Flag Visit Number Visit Name Date/Time of Specimen Collection Study Day of Specimen Collection Unique sequence number dervied based on key variables per subject Convert original results into standard results Convert original results into standard results Set to Y for latest record prior to dosing Number of days between First Date fo Exposure and Date of Collection / Event + 1. Convert original lower range into standard lower range Convert original upper range into standard upper range Physical Exam PE.xpt Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Body System Examined Short Name Body System Examined Category for Examination Body System or Organ Class Verbatim Examination Finding Character Result/Finding in Standard Format Visit Number Visit Name Date/Time of Examination Study Day of Examination Unique sequence number dervied based on key variables per subject Number of days between First Date fo Exposure and Date of Collection / Event + 1. Vital Signs VS.xpt Study Identifier Domain Abbreviation Unique Subject Identifier Sequence Number Vital Signs Test Short Name Vital Signs 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 Date/Time of Measurements Study Day of Vital Signs Unique sequence number dervied based on key variables per subject Set to Y for latest record prior to dosing Number of days between First Date fo Exposure and Date of Collection / Event + 1. Alkaline Phosphatase Alanine Aminotransferase Phosphate Blood Urea Nitrite Calcium Eosinophils Glucose Immunoglobulin A Immunoglobulin G Protein Sodium Triglycerides Erythrocytes Leukocytes Ketones Chloride Muscular System Abdomen Skin Head, Eyes, Ears, Neck and Throat Nervous System Actual Number of Subjects Adaptive Design Added on to Existing Treatments Planned Maximum Age of Subjects Planned Minimum Age of Subjects Biospecimen Retention Contains DNA Citation Used in Study Commercial Sponsor Status Comparative Treatment Name Confirmed Response Minimum Duration Current Therapy or Treatment Data Cutoff Description Data Cutoff Date Data Monitoring Committee Indicator Dose per Administration Dosing Frequency Dose Units Diagnostic Criteria ECG Reading Blinded ECG Continuous Monitoring ECG Planned Primary Lead ECG Used Same Lead ECG Read Method ECG Replicates at Baseline ECG Replicates On-Treatment ECG Twave Algorithm Email Address for XML File EMA Decision Number for PIP EudraCT Resubmission Indicator EudraVigilance Sender ID EudraVigilance Sender Organization Expanded Access Record NCT Number Expanded Access Status Planned Country of Investigational Sites FDA-Regulated Device Study Indicator FDA-Regulated Drug Study Indicator Healthy Subject Indicator Trial Disease/Condition Indication Intervention Model Intervention Type Protocol Keyword Trial Length Country of Manufacture Multiple Site EU State Trial Indicator Planned Number of Arms Number of Groups/Cohorts Number of Trial Sites EU State Trial Primary Objective Trial Secondary Objective Observational Model Observational Time Perspective Obs Study Population Description Observational Study Sampling Method Obs Study Sampling Method Description Exploratory Outcome Measure Primary Outcome Measure Secondary Outcome Measure Pharmacologic Class Pediatric Postmarket Study Indicator Pediatric Study Indicator Pediatric Investigation Plan Indicator Planned Number of Subjects Planned Trial Duration PubMed ID for Citation Used in Study Trial is Randomized Randomization Quotient Rare Disease Indicator Registry Identifier Resubmission Letter Relapse Criteria Route of Administration Retained Biospecimen Description Request for XML Copy of Study Indicator Stable Disease Minimum Duration Secure Delivery XML Required Indicator Study End Date Severity Criteria Sex of Participants Clinical Study Sponsor SUSAR Reporting to EVCTM Indicator SUSAR Reporting to NCA Indicator Single Site EU State Trial Indicator Study Start Date Substudy Details Substudy Planned Indicator Study Stop Rules Stratification Factor Study Type Trial Blinding Schema Control Type Diagnosis Group Therapeutic Area Trial Intent Type Trial Title Trial Phase Classification Target Follow-Up Duration Investigational Therapy or Treatment Trial Type URL Related to Study URL Related to Study Description Pulse Rate Diastolic Blood Pressure Systolic Blood Pressure Weight Height Alkaline Phosphatase Alanine Aminotransferase Phosphate Blood Urea Nitrite Calcium Eosinophils Glucose Immunoglobulin A Immunoglobulin G Protein Sodium Triglycerides Erythrocytes Leukocytes Ketones Chloride Muscular System Abdomen Skin Head, Eyes, Ears, Neck and Throat Nervous System Actual Number of Subjects Adaptive Design Added on to Existing Treatments Planned Maximum Age of Subjects Planned Minimum Age of Subjects Biospecimen Retention Contains DNA Citation Used in Study Commercial Sponsor Status Comparative Treatment Name Confirmed Response Minimum Duration Current Therapy or Treatment Data Cutoff Description Data Cutoff Date Data Monitoring Committee Indicator Dose per Administration Dosing Frequency Dose Units Diagnostic Criteria ECG Reading Blinded ECG Continuous Monitoring ECG Planned Primary Lead ECG Used Same Lead ECG Read Method ECG Replicates at Baseline ECG Replicates On-Treatment ECG Twave Algorithm Email Address for XML File EMA Decision Number for PIP EudraCT Resubmission Indicator EudraVigilance Sender ID EudraVigilance Sender Organization Expanded Access Record NCT Number Expanded Access Status Planned Country of Investigational Sites FDA-Regulated Device Study Indicator FDA-Regulated Drug Study Indicator Healthy Subject Indicator Trial Disease/Condition Indication Intervention Model Intervention Type Protocol Keyword Trial Length Country of Manufacture Multiple Site EU State Trial Indicator Planned Number of Arms Number of Groups/Cohorts Number of Trial Sites EU State Trial Primary Objective Trial Secondary Objective Observational Model Observational Time Perspective Obs Study Population Description Observational Study Sampling Method Obs Study Sampling Method Description Exploratory Outcome Measure Primary Outcome Measure Secondary Outcome Measure Pharmacologic Class Pediatric Postmarket Study Indicator Pediatric Study Indicator Pediatric Investigation Plan Indicator Planned Number of Subjects Planned Trial Duration PubMed ID for Citation Used in Study Trial is Randomized Randomization Quotient Rare Disease Indicator Registry Identifier Resubmission Letter Relapse Criteria Route of Administration Retained Biospecimen Description Request for XML Copy of Study Indicator Stable Disease Minimum Duration Secure Delivery XML Required Indicator Study End Date Severity Criteria Sex of Participants Clinical Study Sponsor SUSAR Reporting to EVCTM Indicator SUSAR Reporting to NCA Indicator Single Site EU State Trial Indicator Study Start Date Substudy Details Substudy Planned Indicator Study Stop Rules Stratification Factor Study Type Trial Blinding Schema Control Type Diagnosis Group Therapeutic Area Trial Intent Type Trial Title Trial Phase Classification Target Follow-Up Duration Investigational Therapy or Treatment Trial Type URL Related to Study URL Related to Study Description Pulse Rate Diastolic Blood Pressure Systolic Blood Pressure Weight Height QTAG " QTCUNS " INTP " PRAG " ALP " ALT " PHOS " BUN " CA " EOS " GLUC " IGA " IGG " PROT " SODIUM " TRIG " RBC " WBC " KETONES " CL " MUSCULO " ABDOMEN " SKIN " HEENT " NERVOUS " ACTSUB " ADAPT " ADDON " AGEMAX " AGEMIN " BIOSPRET " CITNSTDY " CMSPSTAT " COMPTRT " CRMDUR " CURTRT " DCUTDESC " DCUTDTC " DMCIND " DOSE " DOSFRQ " DOSU " DXCRIT " EGBLIND " EGCTMON " EGLEADPR " EGLEADSM " EGRDMETH " EGREPLBL " EGREPLTR " EGTWVALG " EMAILXML " EMPIPDCN " EURSBIND " EVSNDID " EVSNDORG " EXPARECN " EXPASTAT " FCNTRY " FDADEIND " FDADRIND " HLTSUBJI " INDIC " INTMODEL " INTTYPE " KEYWORD " LENGTH " MNFCNTRY " MSEUTIND " NARMS " NCOHORT " NUMSEUST " OBJPRIM " OBJSEC " OBSMODEL " OBSTIMP " OBSTPOPD " OBSTSMM " OBSTSMMD " OUTMSEXP " OUTMSPRI " OUTMSSEC " PCLAS " PDPSTIND " PDSTIND " PIPIND " PLANSUB " PLNTRDUR " PUBMEDID " RANDOM " RANDQT " RDIND " REGID " RESUBLTR " RLPSCRIT " ROUTE " RTSPCDES " RXMLCIND " SDMDUR " SDXMLIND " SENDTC " SEVCRIT " SEXPOP " SPONSOR " SREVIND " SRNCAIND " SSEUTIND " SSTDTC " SSTDYDTL " SSTDYIND " STOPRULE " STRATFCT " STYPE " TBLIND " TCNTRL " TDIGRP " THERAREA " TINDTP " TITLE " TPHASE " TRGFUDUR " TRT " TTYPE " URLSTDY " URLSTDYD " PULSE " DIABP " SYSBP " WEIGHT " HEIGHT " QTAG QTCUNS INTP PRAG ALP ALT PHOS BUN CA EOS GLUC IGA IGG PROT SODIUM TRIG RBC WBC KETONES CL MUSCULO ABDOMEN SKIN HEENT NERVOUS ACTSUB ADAPT ADDON AGEMAX AGEMIN BIOSPRET CITNSTDY CMSPSTAT COMPTRT CRMDUR CURTRT DCUTDESC DCUTDTC DMCIND DOSE DOSFRQ DOSU DXCRIT EGBLIND EGCTMON EGLEADPR EGLEADSM EGRDMETH EGREPLBL EGREPLTR EGTWVALG EMAILXML EMPIPDCN EURSBIND EVSNDID EVSNDORG EXPARECN EXPASTAT FCNTRY FDADEIND FDADRIND HLTSUBJI INDIC INTMODEL INTTYPE KEYWORD LENGTH MNFCNTRY MSEUTIND NARMS NCOHORT NUMSEUST OBJPRIM OBJSEC OBSMODEL OBSTIMP OBSTPOPD OBSTSMM OBSTSMMD OUTMSEXP OUTMSPRI OUTMSSEC PCLAS PDPSTIND PDSTIND PIPIND PLANSUB PLNTRDUR PUBMEDID RANDOM RANDQT RDIND REGID RESUBLTR RLPSCRIT ROUTE RTSPCDES RXMLCIND SDMDUR SDXMLIND SENDTC SEVCRIT SEXPOP SPONSOR SREVIND SRNCAIND SSEUTIND SSTDTC SSTDYDTL SSTDYIND STOPRULE STRATFCT STYPE TBLIND TCNTRL TDIGRP THERAREA TINDTP TITLE TPHASE TRGFUDUR TRT TTYPE URLSTDY URLSTDYD PULSE DIABP SYSBP WEIGHT HEIGHT PRIOR MEDICATION CONCOMITANT MEDICATION Wales Adverse Events Concomitant Meds Demographics Disposition Electrocardiogram Exposure Laboratory Data Medical History Physical Exam Subject Element Subject Visits Trial Summary Vital Signs Disposition Event Other Event Protocol Milestone 12 Lead ECG 12 Lead Unspecified NORMAL ABNORMAL SCREENING TREATMENT FOLLOW-UP NOT HISPANIC OR LATINO Once cap Chemistry Hematology Urinalysis NEGATIVE POSITIVE Medical History Surgical History ADVERSE EVENT COMPLETED Died Recurrent Disease FAILURE TO MEET RANDOMIZATION CRITERIA LACK OF EFFICACY LOST TO FOLLOW-UP NON-COMPLIANCE WITH STUDY DRUG Other PHYSICIAN DECISION PREGNANCY Progressive Disease PROTOCOL DEVIATION RECOVERY SCREEN FAILURE SITE TERMINATED BY SPONSOR STUDY TERMINATED BY SPONSOR TECHNICAL PROBLEMS WITHDRAWAL BY PARENT/GUARDIAN WITHDRAWAL BY SUBJECT LOW HIGH No Information No Not Applicable Unknown Yes Physical Exam AMERICAN INDIAN OR ALASKA NATIVE ASIAN BLACK OR AFRICAN AMERICAN NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER WHITE Intraoral Route of Administration Female Male Unknown UNDIFFERENTIATED Milligram Milliliter Micromole per Milliliter Microliter SCREENING DAY 1 END OF STUDY Millimeter of Mercury Beats per Minute Annotated Case Report Form