Created by Phil Ashworth (pashworth@ntlworld.com) Created with TopBraid Composer 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 MH 1 0 Medical_History 1 1 1 IE 0 1 1 Inclusion_Exclusion_Exceptions 1 0 1 1 1 0 0 1 1 1 Person 1 1 1 1 1 1 1 1 1 1 1 MB 1 0 1 1 1 1 0 1 1 1 1 1 1 1 1 1 Microbiology_Specimen 1 1 1 1 1 0 1 1 1 1 1 1 1 1 PP 1 1 1 1 1 1 1 1 PK_Parameters 1 1 1 1 1 0 1 1 0 0 1 1 1 1 1 1 1 1 1 1 1 0 1 1 1 1 0 1 1 1 0 1 1 1 0 1 1 1 1 1 Vital_Signs 1 1 1 VS 1 1 0 1 1 1 1 1 1 1 1 0 1 1 1 1 0 1 1 1 1 1 1 1 1 Findings_About 1 1 1 1 0 1 1 1 1 1 0 1 1 1 Related_Records 1 0 1 Subject 1 1 0 1 TA 1 0 0 0 1 1 1 0 Trial_Arm 0 0 1 1 Investigator 0 0 1 1 DM 1 0 1 1 1 1 1 1 1 1 1 1 1 1 Demographics 1 1 1 1 1 1 1 1 1 1 0 1 1 1 1 1 1 1 CE Clinical_Event 1 1 1 1 1 1 1 1 1 1 1 0 1 Physical_Exam 1 1 1 1 0 1 1 1 0 1 1 1 1 0 0 1 1 0 1 1 PE 1 1 1 DV 1 1 1 Protocol_Deviations 1 1 1 0 1 1 1 1 1 1 1 1 1 0 1 1 1 1 1 1 1 1 1 0 LB 1 1 1 1 1 1 0 1 1 1 1 1 1 0 1 1 1 1 1 1 1 1 1 1 1 1 Laboratory_Test 1 1 1 CO Comment 1 0 0 1 1 1 1 1 1 1 0 0 1 1 1 Disposition 1 1 1 1 DS 1 1 1 1 1 1 0 1 TE Trial Element 1 1 1 1 0 1 1 1 1 1 1 1 1 Microbiology_Susceptibility_Test 1 1 1 1 0 1 1 1 1 0 1 1 1 1 1 1 1 1 1 1 1 1 1 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 0 1 1 AE 1 1 1 Adverse_Event 1 1 1 0 1 1 1 1 1 1 1 1 1 1 1 1 0 1 1 1 Subject_Element 1 1 1 SE 0 Site 1 0 0 1 1 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Concomitant_Medication 1 1 1 1 1 1 1 1 1 1 1 1 1 1 CM 1 1 1 0 0 1 0 0 1 1 0 1 1 SV 0 0 0 0 1 0 0 1 0 1 1 0 0 1 0 0 0 Subject_Visit 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 Unique_Subject 0 1 0 0 1 1 1 0 0 1 0 1 1 1 1 1 1 1 1 1 1 1 0 1 1 0 1 1 EX 1 1 1 1 1 1 1 1 1 Exposure 1 1 1 1 1 1 1 1 1 1 1 1 0 1 1 1 1 1 1 1 1 0 DA 1 Drug_Accountability 0 1 1 Trial_Inclusion 1 1 TI 0 1 1 1 Substance_Use 1 0 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 SU 1 1 1 1 1 0 1 1 1 1 1 1 1 1 1 1 SC 1 1 1 Subject_Characteristics 1 1 1 1 1 1 1 0 1 1 1 1 ECG 1 1 1 1 0 1 1 1 1 1 ECG 1 1 1 1 0 1 1 1 0 1 0 1 1 1 1 1 0 1 1 0 1 1 1 1 1 1 1 1 1 1 1 1 Questionaire 1 1 1 1 1 1 1 QE 1 0 1 1 0 0 0 0 0 0 1 Trial_Visit 0 0 1 0 0 0 TV 0 1 0 0 1 1 0 0 0 1 0 1 0 TS 0 0 Trial_Summary Study 1 1 0 0 The study That ties all aspects togther 0 1 1 1 1 1 0 1 1 Supplemental 1 1 1 1 1 1 1 PC 0 0 1 1 1 1 PK_Concentration 1 1 1 1 1 1 1 1 1 1 1 1 0 1 1 1 1 1 1 1 1 1 1 1 1 has protocol deviation has comment has findings about has supplemental has related records has site has subject visit has disposition has element has questionaire has adverse event has micro biology sus test has laboratory test has substance use has subject characteristics has subject has exposure has vital signs has PKParameters has concomitant medicine has study has medical history has investigator has demographics has trial summary has subject Element has trial inclusion has clinical event has inclusion_Exclusion_Exception has visit has drug accountability has PKConcentration has micro biology specimen has ECG has unique subject has trial arm has physical exam EXENDTC End Date/Time of Treatment RANDNO Randomization Number PPDY Study Day of Specimen Collection Group ID LBGRPID Intended Dose Regimen CMDOSRGM MBNAM Vendor Name PCSTRESC Character Result/Finding in Std Format PPREFID Reference ID PCTEST pARAMETER Name EGSTRESN Numeric Result/Finding in Standard Units Reason ECG Not Performed EGREASND PCELTM Planned Elapsed Time from Time Point Ref SUCLASCD Substance Use Class Code CESTDTC Start Date/Time of Clinical Event MSSTRESC Character Result/Finding in Std Format Location of the Finding About FALOC Date/Time of Reference Time Point LBRFTDTC Reason Test Not Performed PCREASND CMMODIFY Modified Reported Name MHDECOD Dictionary-Derived Term Reference ID AEREFID Original Units SCORRESU Original Units FAORRESU LBNRIND H L N ABNORMAL Reference Range Upper Limit-Std Units VSSPID Sponsor-Defined Identifier Pattern of Adverse Event AEPATT PCTPTNUM Planned Time Point Number SCREASND Reason Not Performed MHENDTC End Date/Time of Medical History Event VSLOC Location of Vital Signs Measurement DASEQ Sequence Number Sequence Number EXSEQ CMDUR Duration of Medication Many One RELID Relationship Identifier Specimen Collection Location MSLOC CEENDTC End Date/Time of Clinical Event Date/Time of History Collection MHDTC Relationship Type One Many RELTYPE I/E Criterion Result in Std Format IESTRESC U Y N Standard Units QSSTRESU VSDY Study Day of Vital Signs Is Life Threatening N Y U AESLIFE CESTRF U DURING/ AFTER AFTER DURING BEFORE Start Relative to Reference Period Date/Time of Event Collection CEDTC VSGRPID Group ID Date/Time of Collection FADTC Name of the investigator for a site. INVNAM CESPID Sponsor-Defined Identifier QSREASND Reason Not Performed LBORNRHI Reference Range Upper Limit in Orig Unit N Y U Serious Event AESER DATESTCD Short Name of Accountability Assessment EXADJ Reason for Dose Adjustment Standard Units FASTRESU QSORRESU Original Units MBRESCAT Result Category Specimen Type LBSPEC Modified Reported Term AEMODIFY EXDOSU Dose Units SUDOSFRM Dose Form DVCAT Category for Protocol Deviation N Y U AESCAN Involves Cancer PPSTRESN Numeric Result/Finding in Standard Units Original Units MBORRESU Sequence Number PPSEQ Numeric Result/Finding in Standard Units FASTRESN Object of the Observation FAOBJ Rule for Start of Element TESTRL SCSTRESU MBSTRESN Numeric Result/Finding in Standard Units Sponsor-Defined Identifier MHSPID MSREFID Reference ID Study Day of Start of Substance Use SUSTDY Inclusion/Exclusion Subcategory IESCAT PEBLFL Baseline Flag N Y U QSTEST Question Name Subcategory for Disposition Event DSSCAT SCSPID Standardized Substance Name SUDECOD Reference ID DAREFID AEACNOTH Other Action Taken LBFAST Fasting Status N U Y SUSTAT Completion Status ND Reported Term for the Medical History MHTERM Date/Time of Collection IEDTC Subject Reference End Date/Time RFENDTC Body System or Organ Class Neurological Musculoskeletal Genitourinary Eyes-Ears-Nose-Throat Endocrine-Metabolic Allergies MHBODSYS LBDRVFL Derived Flag Total Daily Consumption SUDOSTOT SAFETY N Y U Safety Population Flag LBDY Study Day of Specimen Collection LBORRESU Original Units PELOC Location of Physical Exam Finding PETEST Body System Examined EXGRPID Group ID PESTRESN Numeric Result/Finding in Standard Units AESCONG Congenital Anomaly or Birth Defect N Y U Planned Elapsed Time from Time Point Ref VSELTM CEDY Study Day of Event Collection Evaluator PEEVAL Finding in Original Units QSORRES CMCLAS Medication Class EGDTC Date/Time of ECG DMDTC Date/Time of Collection BEFORE COINCIDENT AFTER U SUSTTPT Start Reference Time Point Planned Elapsed Time from Time Point Ref MSELTM Dose per Administration CMDOSE Original Units EGORRESU PPCAT Test Category AGE UNITS AGEU YEARS WEEKS MONTHS HOURS DAYS' Start Date/Time of Adverse Event AESTDTC LBELTM Planned Elapsed Time from Time Point Ref IDVARVALN QORIG Origin Accountability Assessment Original Units DAORRESU LOINC Code MBLOINC Study Site Identifier SITEID PCTPT Planned Time Point Name MSORRESU Original Units DSREFID Reference ID PPREASND Reason Test Not Performed Comment COVAL MBSEQ Sequence Number U Y N Fasting Status PPFAST Date/Time of Examination PEDTC Group ID FAGRPID Dose Description EXDOSTXT Study Day of Collection IEDY Reference ID MBREFID Derived Flag Y U N QSDRVFL VSSTRESU Standard Units RAND Randomized Population Flag U Y N End Date/Time of Adverse Event AEENDTC MILD MODERATE SEVERE Severity/Intensity AESEV Planned Elapsed Time from Time Point Ref EGELTM MBTPTREF Time Point Reference MSSEQ Sequence Number TSSEQ Sequence Number PCSPEC Specimen Type Vendor Name EGNAM PESTRESC Character Result/Finding in Std. Format Reason Medical History Not Collected MHREASND Sequence Number QSSEQ CMSTDTC Start Date/Time of Medication Route of Administration PO SC IM IV Rectal Topical Nasal Inhaled SL Other CMROUTE MSLOINC LOINC Code AECONTRT Concomitant or Additional Trtmnt Given N Y U EXVAMTU Treatment Vehicle Amount Units PCSPID Sponsor-Defined Identifier CEBODSYS Body System or Organ Class EXELTM Planned Elapsed Time from Time Point Ref MBRFTDTC Date/Time of Reference Time Point VSRFTDTC Date/Time of Reference Time Point PPSTAT Completion Status ND Study Day of Start of Disposition Event DSSTDY Planned Time Point Name VSTPT MBTEST Microbiology Test or Finding Name U ONGOING COINCIDENT AFTER BEFORE MHENRTPT End Relative to Reference Time Point CMTRT Reported Name of Drug, Med, or Therapy Body System or Organ Class PEBODSYS TABRANCH Branch Baseline Flag N U Y QSBLFL Sequence Number DSSEQ Numeric Finding in Standard Units QSSTRESN Group ID PEGRPID EXDOSTOT Total Daily Dose Using EXDOSU Location of Dose Administration EXLOC SUDOSFRQ Use Frequency Per Interval WEIGHT TEMP SYSBP RESP PULSE MAP HR HEIGHT FRMSIZE DIABP BSA BODYFAT BMI VSTESTCD Vital Signs Test Short Name QVAL Data Value Study Day of ECG EGDY MSRFTDTC Date/Time of Reference Time Point LBSEQ Sequence Number MHENTPT End Reference Time Point Planned Time Point Number EGTPTNUM Start Date/Time of Element SESTDTC Sponsor-Defined Identifier IESPID MSTPTNUM Planned Time Point Number Ethnicity ETHNIC UNKNOWN NOT REPORTED NOT HISPANIC OR LATINO HISPANIC OR LATINO Evaluator EGEVAL AESHOSP Requires or Prolongs Hospitalization N Y U Study Day of Start of Adverse Event AESTDY Country COUNTRY Vendor Name LBNAM Planned Time Point Name EGTPT Trial Epoch EPOCH VSTPTNUM Planned Time Point Number End Date/Time of Specimen Collection PPENDTC Study Day of End of Substance Use SUENDY LBSTRESC Character Result/Finding in Std Format Result or Finding in Original Units FAORRES End Date/Time of Specimen Collection LBENDTC Group ID SUGRPID Sequence Number DVSEQ U N Y AEPRESP Pre-Specified Adverse Event PCSTRESN Numeric Result/Finding in Standard Units Reported Term for the Adverse Event AETERM EXCAT Category for Treatment SU Occurrence SUOCCUR U Y N CMDOSU Dose Units mg ug g mL ug/Kg mg/Kg mL/Kg mL/hr IU Tab(s) Cap(s) Other Sponsor-Defined Identifier CMSPID QLABEL Qualifier Variable Label VSPOS Vital Signs Position of Subject AECAT Category for Adverse Event Study Day of Collection DMDY Identifying Variable Value IDVARVAL Study Day of End of Adverse Event AEENDY Baseline Flag N U Y FABLFL Standard Units EGSTRESU Start Relative to Reference Period CMSTRF BEFORE DURING AFTER DURING/ AFTER U Evaluator QSEVAL SUSTRTPT Start Relative to Reference Time Point BEFORE COINCIDENT AFTER U Dose Form EXDOSFRM EXSTDY Study Day of Start of Treatment AESDISAB Persist or Signif Disability/Incapacity N Y U BRTHDTC Date/Time of Birth MHDY Study Day of History Collection Reason Not Examined PEREASND Sequence Number PCSEQ EGDRVFL Derived Flag N U Y Result Category MSRESCAT IESEQ Sequence Number DADY Study Day of Accountability Assessment PESPID Sponsor-Defined Identifier PCSCAT Subcategory for Organism Findings Sponsor-Defined Identifier EXSPID LAB Test or Examination Short Name LBTESTCD Start Relative to Reference Time Point BEFORE COINCIDENT AFTER U CMSTRTPT Start Relative to Reference Period SUSTRF AFTER BEFORE DURING DURING/AFTER UNKNOWN LBORNRLO Reference Range Lower Limit in Orig Unit Date/Time of Reference Time Point EGRFTDTC ELEMENT Description of Element Sponsor-Defined Identifier DSSPID Result or Finding in Original Units PPORRES CMCLASCD Medication Class Code Modified Reported Term PEMODIFY DAORRES Accountability Assessment in Original Units Element Code ETCD Category for Medical History PSYCHIATRIC HISTORY MEDICAL AND SURGICAL HISTORY MHCAT Completion Status ND FASTAT VSBLFL N U Y Baseline Flag MBLOC Specimen Collection Location Accountability Assessment in Std Format DASTRESC VSTPTREF Time Point Reference Category of Question QSCAT CMSEQ Sequence Number Time Point Reference QSTPTREF Subcategory for Findings About FASCAT EGSTRESC Character Result/Finding in Std Format Dosing Frequency Per Interval CMDOSFRQ MBSTRESC Character Result/Finding in Std Format MSTPT Planned Time Point Name MBELTM Planned Elapsed Time from Time Point Ref Findings About Test Name FATEST ARM Description of Arm Evaluator Evaluator Category for Findings About FACAT U DURING/ AFTER AFTER DURING BEFORE MHENRF End Relative to Reference Period SUBJID Subject Identifier FASEQ Sequence Number Lower Limit of Quantitation PCLLOQ Category for Medication CMCAT Visit Number VISITNUM Treatment Vehicle EXTRTV CEREASND ND Reason Clinical Event Not Collected Start Date/Time of Visit SVSTDTC PCORRESU Original Units SESEQ Sequence Number AESOD Occurred with Overdose N Y U Organism Test or Finding Name MSTEST Substance Use Consumption SUDOSE Result or Finding in Original Units MBORRES SUENRTPT U AFTER COINCIDENT BEFORE End Relative to Reference Time Point Lead Location Used for Measurement EGLOC Dosing Frequency per Interval EXDOSFRQ AEDUR Duration of Adverse Event TSVAL TSVAL MHOCCUR Medical History Occurrence U N Y CEENRF End Relative to Reference Period U DURING/ AFTER AFTER DURING BEFORE Transition Rule TATRANS Identifying Variable IDVAR COEVAL Evaluator SCSTRESN Numeric Result/Finding in Standard Units EGXFN ECG External File Name QNAM Qualifier Variable Name DSCAT Category for Disposition Event DISPOSITION EVENT OTHER EVENT PROTOCOL MILESTONE Inclusion/Exclusion Criterion IETEST Standard Units PCSTRESU Domain Abbreviation DOMAIN VSSTRESC Character Result/Finding in Std Format FASTRESC Character Result/Finding in Std Format TSPARMCD Trial Summary Parameter Short Name Sequence Number COSEQ Date/Time of Measurements VSDTC LBSPID Sponsor-Defined Identifier Test Category PCCAT Protocol Deviation Coded Term DVDECOD QSEVLINT Evaluation Interval ECG Test or Examination Name EGTEST Sequence Number SUSEQ Sequence Number SCSEQ Category for Examination PECAT Sponsor-Defined Identifier MBSPID QSRFTDTC Date/Time of Reference Time Point AEGRPID Group ID QSSPID Sponsor-Defined Identifier MSNAM Vendor Name MSTPTREF Time Point Reference Sequence Number MHSEQ Toxicity LBTOX LBTPTNUM Planned Time Point Number EGSPID Sponsor-Defined Identifier FADY Study Day of Collection EGSCAT Subcategory for ECG MBDTC Date/Time of Specimen Collection Standard Toxicity Grade AETOXGR Start Date/Time of Medical History Event MHSTDTC CESEV Severity/Intensity Subcategory for Examination PESCAT Reason Test Not Done LBREASND PPSPID Sponsor-Defined Identifier EGSTAT ND Completion Status Planned Time Point Number QSTPTNUM EXTPTREF Time Point Reference Name of Actual Treatment EXTRT Date/Time of Specimen Collection PCDTC INVID An identifier to describe the Investigator for the study. Subcategory of Assessment DASCAT CMDOSFRM Dose Form Planned Time Point Name LBTPT AEENRTPT End Relative to Reference Time Point BEFORE COINCIDENT AFTER ONGOING U AESDTH Results in Death N Y U N U Y Baseline Flag LBBLFL Reason Medication Not Collected CMREASND PPEVLINT Evaluation Interval UN U M F SEX Sex SUPRESP N Y U SU Pre-Specified ND MSSTAT Completion Status SEUPDES End Date/Time of Substance Use SUENDTC SCSTAT Completion Status ND PCFAST N Y U Fasting Status EGTPTREF Time Point Reference Study Day of End of Medication CMENDY Category for ECG EGCAT MSMETHOD Method of Test or Examination Microbiology Organism Finding Short Name MSTESTCD Modified Substance Name SUMODIFY TIVERS Protocol Criteria Versions ND MHSTAT Completion Status Derived Flag PCDRVFL N U Y DAGRPID Group ID MBTESTCD Microbiology Test or Finding Short Name Group ID CMGRPID LBCAT Chemistry Hematology Urinalysis Category for Lab Test pARAMETER Name PPTEST EGGRPID Group ID PCDY Study Day of Specimen Collection PPSTRESC Character Result/Finding in Std Format Age in AGEU at RFSTDTC AGE PCREFID Reference ID EGORRES Result or Finding in Original Units Evaluator FAEVAL CH CL VSCSIND Reference Range Indicator - PCS Flag AEENTPT End Reference Time Point Vendor Name PCNAM CEDECOD Dictionary-Derived Term Time Point Reference LBTPTREF DVSTDTC Start Date/Time of Deviation SCSTRESC Character Result/Finding in Std Format Result or Finding in Original Units SCORRES DOSE INCREASED DOSE NOT CHANGED DOSE REDUCED DRUG INTERRUPTED DRUG WITHDRAWN NOT APPLICABLE UNKNOWN Action Taken with Study Treatment AEACN Dose per Administration EXDOSE EGPOS SITTING PRONE STANDING SUPINE TRENDELENBURG REVERSE TRENDELENBURG RIGHT LATERAL DECUBITUS LEFT LATERAL DECUBITUS FOWLERS SEMI-FOWLERS ECG Position of Subject TSPARM Trial Summary Parameter PCSPCCND Specimen Condition Parameter Short Name PCTESTCD LBTEST LAB Test or Examination Name PCEVLINT Evaluation Interval Reason Not Performed FAREASND Question Short Name QSTESTCD Standard Toxicity Grade LBTOXGR ND Completion Status MBSTAT Character Result/Finding in Std Format QSSTRESC Study Day of Start of Medication CMSTDY CODTC Date/Time of Comment Completion Status LBSTAT ND ND Completion Status VSSTAT Body System or Organ Class AEBODSYS EXDUR Duration of Treatment LBSTNRHI Reference Range Upper Limit-Std Units End Date/Time of Specimen Collection PCENDTC Planned Elapsed Time from Time Point Ref PPELTM DASPID Sponsor-Defined Identifier CECAT Category for Clinical Event Group ID QSGRPID SVUPDES Description of Unplanned Visit Sponsor-Defined Identifier SUSPID Inclusion/Exclusion Criterion Short Name IETESTCD Reason Substance Use Not Collected SUREASND Sponsor-Defined Identifier DVSPID MSREASND Reason Microbiology Not Performed Study Day of Finding QSDY EXTPT Planned Time Point Name QSTPT Planned Time Point Name SCCAT Category for Subject Characteristic Derived Flag N U Y MBDRVFL CEOCCUR Y N U Clinical Event Occurrence MBREASND Reason Microbiology Not Performed CESEQ Sequence Number MBSPCCND Specimen Condition MBSPEC Specimen Type Subject Characteristic SCTEST Subcategory for Question QSSCAT MSSTRESU Standard Units TEENRL Rule for End of Element CMSCAT Subcategory for Medication CESCAT Subcategory for Clinical Event CESTAT ND Completion Status Parameter Short Name PPTESTCD Subject Reference Start Date/Time RFSTDTC AELOC Location of Event End Reference Time Point CEENTPT TIRL Inclusion/Exclusion Criterion Rule DSDECOD Standardized Disposition Term WITHDRAWAL BY SUBJECT TECHNICAL PROBLEMS STUDY TERMINATED BY SPONSOR SCREEN FAILURE RECOVERY PROTOCOL VIOLATION PROGRESSIVE DISEASE PREGNANCY PHYSICIAN DECISION OTHER NON-COMPLIANCE WITH STUDY DRUG LOST TO FOLLOW-UP LACK OF EFFICACY DEATH COMPLETED ADVERSE EVENT N U Y CM Pre-Specified CMPRESP CMENRF End Relative to Reference Period BEFORE DURING AFTER DURING/ AFTER U MSSPEC Specimen Type MSORRES Result or Finding in Original Units SCTESTCD Subject Characteristic Short Name LBSTRESN Numeric Result/Finding in Standard Units Specimen Condition LBSPCCND PCTPTREF Time Point Reference RACE WHITE BLACK OR AFRICAN AMERICAN ASIAN HISPANIC AMERICAN INDIAN OR ALASKA NATIVE OTHER NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER Race Method of Test or Examination LBMETHOD I/E Criterion Original Result N Y U IEORRES DSGRPID Group ID Planned Time Point Number PPTPTNUM LBSTNRC Reference Range for Char Rslt-Std Units MBDY Study Day of MB Specimen Collection Substance Use Class SUCLAS DSSTDTC Start Date/Time of Disposition Event Derived Flag Y U N PPDRVFL Subcategory for Organism Findings PPSCAT PPRFTDTC Date/Time of Reference Time Point Group ID PPGRPID VSDRVFL Y U N Derived Flag MBCAT Category for Microbiology Finding Subcategory for Lab Test LBSCAT Group ID MSGRPID Category for Organism Findings MSCAT Substance Use Consumption Text SUDOSTXT AESPID Sponsor-Defined Identifier LBORRES Result or Finding in Original Units CMDOSTOT Total Daily Dose SCGRPID Group ID BEFORE DURING AFTER DURING/ AFTER U End Relative to Reference Period AEENRF SCSCAT Subcategory for Subject Characteristic SUENRF UNKNOWN DURING/AFTER DURING BEFORE AFTER End Relative to Reference Period NOT RELATED POSSIBLY RELATED RELATED Causality AEREL ARMCD Arm Code ND QSSTAT Completion Status SUROUTE Route of Administration MSSPID Sponsor-Defined Identifier MBSCAT Subcategory for Microbiology Finding LBCSIND Reference Range Indicator - PCS Flag CL CH CEREFID Reference ID QSDTC Date/Time of Finding Lot Number EXLOT Intended Dose Regimen EXDOSRGM Vendor Name PPNAM PEDY Study Day of Examination DAREASND Reason ECG Not Performed DSDTC Date/Time of Collection Category for Vital Signs VSCAT End Reference Time Point U AFTER COINCIDENT BEFORE SUENTPT Related Domian RDOMAIN EXSTDTC Start Date/Time of Treatment CETERM Reported Term for the Clinical Event MSDTC Date/Time of Specimen Collection Group ID TSGRPID Standard Units MBSTRESU LBREFID Specimen ID N U Y Baseline Flag EGBLFL Dictionary-Derived Term AEDECOD Specimen Condition MSSPCCND CEENRTPT BEFORE COINCIDENT AFTER U End Relative to Reference Time Point SVENDTC End Date/Time of Visit PESTRESU Standard Units DVSCAT Subcategory for Protocol Deviation PEORRES Verbatim Examination Finding MBTPT Planned Time Point Name PPDTC Date/Time of Specimen Collection Method of ECG Test EGMETHOD CMDECOD Standardized Medication Name LBDTC Date/Time of Specimen Collection Findings About Test Short Name FATESTCD Study Day of Examination SCDY DADTC Date/Time of Drug Accountability Assessment Time Point Reference PPTPTREF PETESTCD Body System Examined Short Name End Date/Time of Medication CMENDTC CMINDC Indication DATEST Name of Accountability Assessment AESCAT Subcategory for Adverse Event Planned Study Day of Visit VISITDY TVENRL Visit End Rule TAETORD Order of Element within Arm Visit Start Rule TVSTRL PPMETHOD Method of Test or Examination PESTAT ND Completion Status DASTRESN Accountability Assessment in Std Units SUSTDTC Start Date/Time of Substance Use Treatment Emergent U Y N AETRTEM MHREFID Reference ID DASTRESU Accountability Assessment Standard Units MHMODIFY Modified Reported Term CEGRPID Group ID N U Y MSBLFL Baseline Flag Method of Test or Examination PEMETHOD Subcategory for Organism Findings MSSCAT CMENRTPT U AFTER COINCIDENT BEFORE End Relative to Reference Time Point ECG Reference ID EGREFID MSSTRESN Numeric Result/Finding in Standard Units PCMETHOD Method of Test or Examination Standard Units PPSTRESU Y U N CM Occurrence CMOCCUR VSORRESU Original Units CEPRESP Clinical Event Pre-Specified U N Y VSREASND Reason Not Performed EXENDY Study Day of End of Treatment MBTPTNUM Planned Time Point Number SVSTDY Actual Study Day of Visit MSDY Study Day of MB Specimen Collection Planned Duration of Element TEDUR Group ID MBGRPID SEENDTC End Date/Time of Element Completion Status DASTAT ND PCSTAT Completion Status ND PCRFTDTC Date/Time of Reference Time Point Route of Administration EXROUTE VSORRES Result or Finding in Original Units MHGRPID Group ID PCORRES Result or Finding in Original Units PPLLOQ Lower Limit of Quantitation CESTRTPT Start Relative to Reference Time Point U AFTER COINCIDENT BEFORE DVREFID Reference ID PCGRPID Group ID CESTTPT Start Reference Time Point VISIT Visit Name VSSTRESN Standard Units U N Y Medical History Event Pre-Specified MHPRESP VSSEQ Sequence Number Original Units PPORRESU EXTPTNUM Planned Time Point Number MHSCAT Subcategory for Medical History EXTRTV Treatment Vehicle Amount LBSTRESU Standard Units PESEQ Sequence Number Study Day of End of Visit SVENDY AESMIE N Y U Other Medically Important Serious Event Dose Description CMDOSTXT Derived Flag Y U N MSDRVFL DACAT Category of Accountability Assessment Subcategory for Treatment EXSCAT Method of Test or Examination MBMETHOD PPSPCCND Specimen Condition AERELNST Relationship to Non-Study Treatment LOINC Code LBLOINC Protocol Deviation Term DVTERM Y U N MBBLFL Baseline Flag Reported Term for the Disposition Event DSTERM Planned Elapsed Time from Time Point Ref QSELTM VSTEST Vital Signs Test Name WEIGHT TEMP SYSBP RESP PULSE MAP HR HEIGHT FRMSIZE DIABP BSA BODYFAT BMI ND Completion Status CMSTAT Subcategory for Vital Signs VSSCAT Sequence Number AESEQ EXCLUSION INCLUSION Inclusion/Exclusion Category IECAT SCDTC SCDTC SUSCAT Subcategory for Substance Use AEOUT Outcome of Adverse Event FATAL NOT RECOVERED/NOT RESOLVED RECOVERED/RESOLVED RECOVERED/RESOLVED WITH SEQUELAE RECOVERING/RESOLVING UNKNOWN Consumption Units SUDOSU Comment Reference COREF ECG Test or Examination Short Name EGTESTCD LBSTNRLO Reference Range Lower Limit-Std Units Reported Name of Substance SUTRT CMSTTPT Start Reference Time Point Sequence Number EGSEQ PPTPT Planned Time Point Name Sponsor-Defined Identifier FASPID SUCAT Category for Substance Use End Date/Time of Deviation DVENDTC Specimen Type PPSPEC Study Identifier STUDYID Unique Subject Identifier USUBJID