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|---|---|---|
| @@ -0,0 +1,343 @@ | ||
| Variable,Label,Dataset | ||
| STUDYID,Study Identifier,ADPC | ||
| USUBJID,Unique Subject Identifier,ADPC | ||
| SUBJID,Subject Identifier for the Study,ADPC | ||
| SITEID,Study Site Identifier,ADPC | ||
| ASEQ,Analysis Sequence Number,ADPC | ||
| REGION1,Geographic Region 1,ADPC | ||
| COUNTRY,Country,ADPC | ||
| ETHNIC,Ethnicity,ADPC | ||
| AGE,Age,ADPC | ||
| AGEU,Age Units,ADPC | ||
| AAGE,Analysis Age,ADPC | ||
| AAGEU,Analysis Age Unit,ADPC | ||
| AGEGR1,Pooled Age Group 1,ADPC | ||
| AGEGR2,Pooled Age Group 2,ADPC | ||
| AGEGR3,Pooled Age Group 3,ADPC | ||
| STRATwNM,Description of Stratum w,ADPC | ||
| STRATw,Randomized Value of Stratum w,ADPC | ||
| STRATwV,Verified Value of Stratum w,ADPC | ||
| SEX,Sex,ADPC | ||
| RACE,Race,ADPC | ||
| ITTFL,Intent-To-Treat Population Flag,ADPC | ||
| SAFFL,Safety Population Flag,ADPC | ||
| PPROTFL,Per-Protocol Population Flag,ADPC | ||
| TRT01P,Planned Treatment for Period 01,ADPC | ||
| TRT02P,Planned Treatment for Period 02,ADPC | ||
| TRT03P,Planned Treatment for Period 03,ADPC | ||
| TRT04P,Planned Treatment for Period 04,ADPC | ||
| TRT05P,Planned Treatment for Period 05,ADPC | ||
| TRT01A,Actual Treatment for Period 01,ADPC | ||
| TRT02A,Actual Treatment for Period 02,ADPC | ||
| TRT03A,Actual Treatment for Period 03,ADPC | ||
| TRT04A,Actual Treatment for Period 04,ADPC | ||
| TRT05A,Actual Treatment for Period 05,ADPC | ||
| TRTSEQP,Planned Sequence of Treatments,ADPC | ||
| TRTSEQA,Actual Sequence of Treatments,ADPC | ||
| TRTSDTM,Datetime of First Exposure to Treatment,ADPC | ||
| TRTSDT,Date of First Exposure to Treatment,ADPC | ||
| TRTEDTM,Datetime of Last Exposure to Treatment,ADPC | ||
| TRTEDT,Date of Last Exposure to Treatment,ADPC | ||
| DCUTDT,Date of Data Cut,ADPC | ||
| PCSEQ,Sequence Number,ADPC | ||
| PCGRPID,Group ID,ADPC | ||
| PCREFID,Reference ID,ADPC | ||
| PCSPID,Sponsor-Defined Identifier,ADPC | ||
| PCTESTCD,Pharmacokinetic Test Short Name,ADPC | ||
| PCTEST,Pharmacokinetic Test Name,ADPC | ||
| PCCAT,Test Category,ADPC | ||
| PCSCAT,Test Subcategory,ADPC | ||
| PCSTRESC,Character Result/Finding in Std Format,ADPC | ||
| PCSTRESN,Numeric Result/Finding in Standard Units,ADPC | ||
| PCSTRESU,Standard Units,ADPC | ||
| PCSTAT,Completion Status,ADPC | ||
| PCREASND,Reason Test Not Done,ADPC | ||
| PCSPEC,Specimen Material Type,ADPC | ||
| PCSPCCND,Specimen Condition,ADPC | ||
| PCMETHOD,Method of Test or Examination,ADPC | ||
| PCFAST,Fasting Status,ADPC | ||
| PCLLOQ,Lower Limit of Quantitation,ADPC | ||
| VISITNUM,Visit Number,ADPC | ||
| VISIT,Visit Name,ADPC | ||
| VISITDY,Planned Study Day of Visit,ADPC | ||
| EPOCH,Epoch,ADPC | ||
| PCDTC,Date/Time of Specimen Collection,ADPC | ||
| PCDY,Actual Study Day of Specimen Collection,ADPC | ||
| PCTPT,Planned Time Point Name,ADPC | ||
| PCTPTNUM,Planned Time Point Number,ADPC | ||
| PCSMPLID,Alternate Sample Identifier,ADPC | ||
| PCAINTP,Assay Interpretation,ADPC | ||
| PARAM,Parameter,ADPC | ||
| PARAMCD,Parameter Code,ADPC | ||
| PARCAT1,Parameter Category 1,ADPC | ||
| AVAL,Analysis Value,ADPC | ||
| AVALCAT1,Analysis Value Category 1,ADPC | ||
| AVALU,Analysis Value Unit,ADPC | ||
| AVALU,Analysis Value Unit,ADPC | ||
| BASE,Baseline Value,ADPC | ||
| BASETYPE,Baseline Type,ADPC | ||
| ABLFL,Baseline Record Flag,ADPC | ||
| ALLOQ,Analysis Lower Limit of Quantitation,ADPC | ||
| ADTM,Analysis Datetime,ADPC | ||
| ADT,Analysis Date,ADPC | ||
| ATM,Analysis Time,ADPC | ||
| ADY,Analysis Relative Day,ADPC | ||
| ADTF,Analysis Date Imputation Flag,ADPC | ||
| ATMF,Analysis Time Imputation Flag,ADPC | ||
| ASTDT,Analysis Start Date,ADPC | ||
| ASTTM,Analysis Start Time,ADPC | ||
| ASTDTM,Analysis Start Date/Time,ADPC | ||
| ASTDTF,Analysis Start Date Imputation Flag,ADPC | ||
| ASTTMF,Analysis Start Time Imputation Flag,ADPC | ||
| AENDT,Analysis End Date,ADPC | ||
| AENTM,Analysis End Time,ADPC | ||
| AENDTM,Analysis End Date/Time,ADPC | ||
| AENDTF,Analysis End Date Imputation Flag,ADPC | ||
| AENTMF,Analysis End Time Imputation Flag,ADPC | ||
| ATPT,Analysis Timepoint,ADPC | ||
| ATPT,Analysis Timepoint,ADPC | ||
| ATPTN,Analysis Timepoint (N),ADPC | ||
| ATPTN,Analysis Timepoint (N),ADPC | ||
| ATPTREF,Analysis Timepoint Reference,ADPC | ||
| AVISIT,Analysis Visit,ADPC | ||
| AVISIT,Analysis Visit,ADPC | ||
| AVISITN,Analysis Visit (N),ADPC | ||
| AVISITN,Analysis Visit (N),ADPC | ||
| APERIOD,Period,ADPC | ||
| APERIODC,Period (C),ADPC | ||
| FANLDT,First Date of Dose for Analyte,ADPC | ||
| FANLTM,First Time of Dose for Analyte,ADPC | ||
| FANLDTM,First Datetime of Dose for Analyte,ADPC | ||
| FANLDTMF,First Time of Dose Time Imputation Flag,ADPC | ||
| FANLEDT,First End Date of Dose for Analyte,ADPC | ||
| FANLETM,First End Time of Dose for Analyte,ADPC | ||
| FANLEDTM,First End Datetime of Dose for Analyte,ADPC | ||
| FANLEDTF,First End of Dose Time Imputation Flag,ADPC | ||
| PCRFTDT,Reference Date of Dose for Analyte,ADPC | ||
| PCRFTTM,Reference Time of Dose for Analyte,ADPC | ||
| PCRFTDTM,Reference Datetime of Dose for Analyte,ADPC | ||
| PCRFEDT,Reference End Date of Dose for Analyte,ADPC | ||
| PCRFETM,Reference End Time of Dose for Analyte,ADPC | ||
| PCRFEDTM,Ref. End Datetime of Dose for Analyte,ADPC | ||
| NFRLT,Nom. Rel. Time from Analyte First Dose,ADPC | ||
| AFRLT,Act. Rel. Time from Analyte First Dose,ADPC | ||
| TMPCTDF,Percent Diff. Nominal vs. Actual Time,ADPC | ||
| FRLTU,Rel. Time from First Dose Unit,ADPC | ||
| NEFRLT,Nom. Rel. End Time from First Dose,ADPC | ||
| AEFRLT,Act. Rel. End Time from First Dose,ADPC | ||
| NRRLT,Nominal Rel. Time from Ref. Dose,ADPC | ||
| ARRLT,Actual Rel. Time from Ref. Dose,ADPC | ||
| MRRLT,Modified Rel. Time from Ref. Dose,ADPC | ||
| RRLTU,Rel. Time from Ref. Dose Unit,ADPC | ||
| NERRLT,Nominal Rel. End Time from Ref. Dose,ADPC | ||
| NERRLT,Nominal Rel. End Time from Ref. Dose,ADPC | ||
| AERRLT,Actual Rel. End Time from Ref. Dose,ADPC | ||
| AERRLT,Actual Rel. End Time from Ref. Dose,ADPC | ||
| MERRLT,Modified Rel. End Time from Ref. Dose,ADPC | ||
| MERRLT,Modified Rel. End Time from Ref. Dose,ADPC | ||
| CHG,Change from Baseline,ADPC | ||
| CRIT1,Analysis Criterion 1,ADPC | ||
| CRIT1FL,Criterion 1 Evaluation Result Flag,ADPC | ||
| CRIT1FL,Criterion 1 Evaluation Result Flag,ADPC | ||
| DTYPE,Derivation Type,ADPC | ||
| SPARSFL,Sparse Flag,ADPC | ||
| NCAXFL,PK NCA Exclusion Flag,ADPC | ||
| NCAXFN,PK NCA Exclusion Flag (N),ADPC | ||
| NCAwXRS,Reason w for PK NCA Exclusion,ADPC | ||
| NCAwXRSN,Reason for PK NCA Exclusion of w (N),ADPC | ||
| PKSUMXF,PK Summary Exclusion Flag,ADPC | ||
| PKSUMXFN,PK Summary Exclusion Flag (N),ADPC | ||
| METABFL,Metabolite Flag,ADPC | ||
| COHORT,Subject Cohort,ADPC | ||
| COHORTN,Subject Cohort (N),ADPC | ||
| ROUTE,Route,ADPC | ||
| TRTRINT,Planned Treatment Interval,ADPC | ||
| TRTRINTU,Planned Treatment Interval Units,ADPC | ||
| DOSPCTDF,Percent Diff. Nominal vs. Actual Dose,ADPC | ||
| DOSEFRQ,Dose Frequency,ADPC | ||
| DOSEP,Planned Treatment Dose,ADPC | ||
| DOSEA,Actual Treatment Dose,ADPC | ||
| DOSEPU,Planned Treatment Dose Units,ADPC | ||
| DOSEAU,Actual Treatment Dose Units,ADPC | ||
| ACYCLE,Analysis Cycle,ADPC | ||
| ACYCLEC,Analysis Cycle (C),ADPC | ||
| ADOSEDUR,Actual Duration of Treatment Dose,ADPC | ||
| NDOSEDUR,Nominal duration of Treatment Dose,ADPC | ||
| DOSEDURU,Duration of Treatment Dose Units,ADPC | ||
| VOLUME,Volume Value,ADPC | ||
| VOLUMEU,Volume Value Unit,ADPC | ||
| SPWEIGHT,Specimen Weight Value,ADPC | ||
| SPWEIGHU,Specimen Weight Value Unit,ADPC | ||
| WTBL,Weight at Baseline,ADPC | ||
| HTBL,Height at Baseline,ADPC | ||
| IBWBL,Ideal Body Weight (IBW) at Baseline,ADPC | ||
| LBMBL,Lean Body Mass (LBM) at Baseline,ADPC | ||
| BMIBL,BMI at Baseline,ADPC | ||
| BSABL,BSA at Baseline,ADPC | ||
| SBPBL,Systolic BP at Baseline,ADPC | ||
| DBPBL,Diastolic BP at Baseline,] | ||
| TOBBL,Smoking Status at Baseline,ADPC | ||
| ALCOBL,Alcohol at Baseline,ADPC | ||
| TEMPBL,Temperature at Baseline,ADPC | ||
| PULSBL,Pulse rate at Baseline,ADPC | ||
| ADA,Treatment Emergent ADA status,ADPC | ||
| AAGBL,Alpha-1 Acid Glycoprotein at Baseline,ADPC | ||
| CREATBL,Creatinine at Baseline (BLOOD),ADPC | ||
| CRCLBL,CrCL at Baseline,ADPC | ||
| ALBUBL,Albumin at Baseline,ADPC | ||
| EOSBL,Eosinophils at Baseline,ADPC | ||
| BUNBL,Blood Urea Nitrogen at Baseline,ADPC | ||
| CALCBL,Calcium at Baseline,ADPC | ||
| CLBL,Chloride at Baseline,ADPC | ||
| PHBL,Phosphate at Baseline,ADPC | ||
| PLATEBL,Platelet Count at Baseline,ADPC | ||
| WBCBL,WBC Count at Baseline,ADPC | ||
| GGTBL,GGT at Baseline,ADPC | ||
| GLUCBL,Glucose at Baseline,ADPC | ||
| HCTBL,Hematocrit at Baseline,ADPC | ||
| HGBBL,Hemoglobin at Baseline,ADPC | ||
| ALKPHBL,Alkaline Phosphatase at Baseline,ADPC | ||
| KBL,Potassium at Baseline,ADPC | ||
| LYMBL,Lymphocytes at Baseline,ADPC | ||
| MONOBL,Monocytes at Baseline,ADPC | ||
| NABL,Sodium at Baseline,ADPC | ||
| NEUBL,Neutrophils at Baseline,ADPC | ||
| RBCBL,RBC Count at Baseline,ADPC | ||
| TBILIBL,Bilirubin at Baseline (BLOOD),ADPC | ||
| TPROTBL,Total Protein at Baseline (BLOOD),ADPC | ||
| SGOTBL,SGOT-AST at Baseline,ADPC | ||
| SGPTBL,SGPT-ALT at Baseline,ADPC | ||
| RRBL,RR Duration at Baseline,ADPC | ||
| PRBL,PR Duration at Baseline,ADPC | ||
| QRSBL,QRS Duration at Baseline,ADPC | ||
| QTBL,QT duration at Baseline,ADPC | ||
| QTCBBL,QTcB at Baseline,ADPC | ||
| QTCFBL,QTcF at Baseline,ADPC | ||
| HRBL,Heart Rate at Baseline,ADPC | ||
| WTBLU,Weight at Baseline (Unit),ADPC | ||
| HTBLU,Height at Baseline (Unit),ADPC | ||
| IBWBLU,IBW at Baseline (Unit),ADPC | ||
| LBWBLU,LBM at Baseline (Unit),ADPC | ||
| BMIBLU,BMI at Baseline (Unit),ADPC | ||
| BSABLU,BSA at Baseline (Unit),ADPC | ||
| SBPBLU,Systolic BP at Baseline (Unit),ADPC | ||
| DBPBLU,Diastolic BP at Baseline (Unit),ADPC | ||
| TOBBLU,Smoking Status at Baseline (Unit),ADPC | ||
| PULSBLU,Pulse rate at Baseline (Unit),ADPC | ||
| AAGBLU,AAG at baseline (Unit),ADPC | ||
| CREATBLU,Creat at baseline (BLOOD),ADPC | ||
| CRCLBLU,CrCL at baseline (BLOOD),ADPC | ||
| ALBUBLU,Albumin at baseline (Unit),ADPC | ||
| EOSBLU,Eosinophils at baseline (Unit),ADPC | ||
| BUNBLU,Blood Urea Nitrogen at baseline (Unit),ADPC | ||
| CALCBLU,Calcium at baseline (Unit),ADPC | ||
| CLBLU,Chloride at baseline (Unit),ADPC | ||
| PHBLU,Phosphate at baseline (Unit),ADPC | ||
| PLATEBLU,Platelet Count at baseline (Unit),ADPC | ||
| WBCBLU,WBC Count at baseline (Unit),ADPC | ||
| GGTBLU,GGT at Baseline (Unit),ADPC | ||
| GLUBLU,Glucose at Baseline (Unit),ADPC | ||
| HCTBLU,HCT at Baseline (Unit),ADPC | ||
| HGBBLU,HGB at Baseline (Unit),ADPC | ||
| ALKPHBLU,Alkaline Phosphatase at Baseline (Unit),ADPC | ||
| KBLU,Potassium at Baseline (Unit),ADPC | ||
| LYMBLU,Lymphocytes at Baseline (Unit),ADPC | ||
| MONOBLU,Monocytes at Baseline (Unit),ADPC | ||
| NABLU,Sodium at Baseline (Unit),ADPC | ||
| NEUBLU,Neutrophils at Baseline (Unit),ADPC | ||
| RBCBLU,RBC Count at Baseline (Unit),ADPC | ||
| TBILIBLU,Bilirubin at Baseline (Unit),ADPC | ||
| TPROTBLU,Total Protein at Baseline (Unit),ADPC | ||
| SGOTBLU,SGOT-AST at Baseline (Unit),ADPC | ||
| SGPTBLU,SGPT-ALT at Baseline (Unit),ADPC | ||
| RRBLU,RR Duration at Baseline (Unit),ADPC | ||
| PRBLU,PR Duration at Baseline (Unit),ADPC | ||
| QRSBLU,QRS Duration at Baseline (Unit),ADPC | ||
| QTBLU,QT Duration at Baseline (Unit),ADPC | ||
| QTCBBLU,QTcB at Baseline (Unit),ADPC | ||
| QTCFBLU,QTcF at Baseline (Unit),ADPC | ||
| HRBLU,Heart Rate at Baseline (Unit),ADPC | ||
| DRUG,Medication Name,ADPC | ||
| REGIME,Regimen of Medication,ADPC | ||
| FRMUL,Treatment Formulation,ADPC | ||
| DOSNO,Dose Number,ADPC | ||
| FEDSTATE,Fasted / Fed Status,ADPC | ||
| ANL01FL,Analysis Flag 01,ADPC | ||
| ANL02FL,Analysis Flag 02,ADPC | ||
| ANL03FL,Analysis Flag 03,ADPC | ||
| ANL04FL,Analysis Flag 04,ADPC | ||
| ANL05FL,Analysis Flag 05,ADPC | ||
| STUDYID,Study Identifier,ADPP | ||
| USUBJID,Unique Subject Identifier,ADPP | ||
| SUBJID,Subject Identifier for the Study,ADPP | ||
| SITEID,Study Site Identifier,ADPP | ||
| ASEQ,Analysis Sequence Number,ADPP | ||
| REGION1,Geographic Region 1,ADPP | ||
| COUNTRY,Country,ADPP | ||
| ETHNIC,Ethnicity,ADPP | ||
| AGE,Age,ADPP | ||
| AGEU,Age Units,ADPP | ||
| AAGE,Analysis Age,ADPP | ||
| AAGEU,Analysis Age Unit,ADPP | ||
| AGEGR1,Pooled Age Group 1,ADPP | ||
| AGEGR2,Pooled Age Group 2,ADPP | ||
| AGEGR3,Pooled Age Group 3,ADPP | ||
| STRATwNM,Description of Stratum w,ADPP | ||
| STRATw,Randomized Value of Stratum w,ADPP | ||
| STRATwV,Verified Value of Stratum w,ADPP | ||
| SEX,Sex,ADPP | ||
| RACE,Race,ADPP | ||
| ITTFL,Intent-To-Treat Population Flag,ADPP | ||
| SAFFL,Safety Population Flag,ADPP | ||
| PPROTFL,Per-Protocol Population Flag,ADPP | ||
| TRT01P,Planned Treatment for Period 01,ADPP | ||
| TRTxxP,Planned Treatment for Period xx,ADPP | ||
| TRT01A,Actual Treatment for Period 01,ADPP | ||
| TRTxxA,Actual Treatment for Period xx,ADPP | ||
| TRTSEQP,Planned Sequence of Treatments,ADPP | ||
| TRTSEQA,Actual Sequence of Treatments,ADPP | ||
| TRTSDTM,Datetime of First Exposure to Treatment,ADPP | ||
| TRTSDT,Date of First Exposure to Treatment,ADPP | ||
| TRTEDTM,Datetime of Last Exposure to Treatment,ADPP | ||
| TRTEDT,Date of Last Exposure to Treatment,ADPP | ||
| DCUTDT,Date of Data Cut,ADPP | ||
| PPSEQ,Sequence Number,ADPP | ||
| PPGRPID,Group ID,ADPP | ||
| PPSPID,Sponsor-Defined Identifier,ADPP | ||
| PPTESTCD,Parameter Short Name,ADPP | ||
| PPTEST,Parameter Name,ADPP | ||
| PPCAT,Parameter Category,ADPP | ||
| PPSCAT,Parameter Subcategory,ADPP | ||
| PPSTRESC,Character Result/Finding in Std Format,ADPP | ||
| PPSTRESN,Numeric Result/Finding in Standard Units,ADPP | ||
| PPSTRESU,Standard Units,ADPP | ||
| PPSTAT,Completion Status,ADPP | ||
| PPREASND,Reason Parameter Not Calculated,ADPP | ||
| PPSPEC,Specimen Material Type,ADPP | ||
| PPDTC,Date/Time of Parameter Calculations,ADPP | ||
| PPRFTDTC,Date/Time of Reference Point,ADPP | ||
| PPSTINT,Planned Start of Assessment Interval,ADPP | ||
| PPENINT,Planned End of Assessment Interval,ADPP | ||
| PARAM,Parameter,ADPP | ||
| PARAMCD,Parameter Code,ADPP | ||
| PARCAT1,Parameter Category 1,ADPP | ||
| PARCAT1,Parameter Category 1,ADPP | ||
| AVAL,Analysis Value,ADPP | ||
| AVALC,Analysis Value (C),ADPP | ||
| ADTM,Analysis Datetime,ADPP | ||
| ADT,Analysis Date,ADPP | ||
| ATM,Analysis Time,ADPP | ||
| ADY,Analysis Relative Day,ADPP | ||
| ADTF,Analysis Date Imputation Flag,ADPP | ||
| ATMF,Analysis Time Imputation Flag,ADPP | ||
| ATPT,Analysis Timepoint,ADPP | ||
| ATPT,Analysis Timepoint,ADPP | ||
| ATPTN,Analysis Timepoint (N),ADPP | ||
| ATPTN,Analysis Timepoint (N),ADPP | ||
| AVISIT,Analysis Visit,ADPP | ||
| AVISIT,Analysis Visit,ADPP | ||
| AVISITN,Analysis Visit (N),ADPP | ||
| AVISITN,Analysis Visit (N),ADPP | ||
| ANALYTE,Analyte,ADPC | ||
| EVID,Event ID,ADPC | ||
| DOSEU,Treatment Dose Units,ADPC |